Influenza, Human
Conditions
Keywords
Grippe, Flu, Influenza, Vaccine, RNA vaccine
Brief summary
This study will be divided into two substudies - Substudy A (SSA) and Substudy B (SSB) Substudy A This is a Phase 1 randomized substudy to evaluate the safety and immunogenicity of monovalent influenza modRNA vaccine (mIRV) and bivalent influenza modRNA vaccine (bIRV) at various dose levels, and quadrivalent influenza modRNA vaccine (qIRV), in participants 65 to 85 years of age. Participants will receive at Vaccination 1 either: * 1 of 4 dose levels of mIRV (either A or B Strain), * 1 of 4 dose levels of bIRV (containing both A and B strains), * qIRV (at 1 dose level), or * A licensed quadrivalent influenza vaccine (QIV). At approximately 8 weeks following Vaccination 1, participants will be unblinded and QIV (Vaccination 2) administered to participants not having previously received this at Vaccination 1. Additionally, participants who previously received QIV at Vaccination 1 will receive one of the following for Vaccination 2: * mIRV encoding A strain at dose level 4, or * mIRV encoding B strain at dose level 4. Substudy B This is a randomized substudy to evaluate the safety and immunogenicity of the following vaccination schedules in participants 65 to 85 years of age: 2-Visit Schedules * 2 doses of qIRV (at a dose level 1), administered 21 days apart. * 2 doses of licensed QIV, administered 21 days apart (as a control group) * A dose of licensed QIV following by a dose of bIRV encoding 2 A strains at dose level combination 1 or 2, administered 21 days apart. 1-Visit Schedules * A dose of licensed QIV administered concurrently in the opposite arm with bIRV encoding 2 A strains at dose level combination 1 or 2. * A dose of bIRV encoding 2 A strains administered concurrently in the opposite arm with a dose of bIRV encoding 2 B strains.at dose level 1. * A dose of qIRV encoding 2 A strains and 2 B strains at dose level 2 (at one of two possible dose level combinations). * A dose of qIRV encoding 2 A strains and 2 B strains at dose level 3. * 1 dose of licensed QIV (as a control group). Substudy B In participants 18 to 64 years of age: -A dose of qIRV encoding 2 A strains and 2 B strains at a dose level combination 1 or 2.
Interventions
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
SSA: observer-blinded, sponsor unblind SSB: single-blind, sponsor unblind
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
Substudy A Inclusion Criteria: * Male or female participants 65 to 85 years of age. * Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. * Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study. * Male participant who is able to father children and willing to use an acceptable method of contraception; or female participant not of childbearing potential; or male participant not able to father children. * Capable of giving signed informed consent.
Exclusion criteria
* Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. * History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention. * Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. * Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. * Women who are pregnant or breastfeeding. * Allergy to egg proteins (egg or egg products) or chicken proteins. * Participant who has had significant exposure to laboratory-confirmed SARS-CoV-2 infection, COVID-19, or influenza in the past 14 days known prior to Visit 1 * Any participant who has a SARS-CoV-2 RT-PCR or antigen test in the past 10 days prior to Visit 1 that has not been confirmed as negative. * Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study. * Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or planned receipt throughout the study. * Vaccination with any influenza vaccine within 6 months (175 days) before study intervention administration. * Any participant who has received or plans to receive a modRNA-platform SARS-CoV-2 vaccine within 60 days of Visit 1 * Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation. * Screening hematology/blood chemistry lab \>=Grade 1 abnormality. Except Bilirubin, other stable Grade1 abnormalities may be considered eligible by Investigator. * Screening ECG that is consistent with probable or possible myocarditis or pericarditis, or demonstrates clinically relevant abnormalities that may affect participant safety or study results. * Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members. * Participation in strenuous or endurance exercise through Visit 3. * Prior history of heart disease. Substudy B Inclusion Criteria: * Male or female participants 65 to 85 years of age or .Male or female participants 18 to 64 years of age * Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. * Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study. * For participants 65 to 85 years of age at the time of enrollment, receipt of licensed influenza vaccination for the 2021-2022 northern hemisphere season \>4 months (120 days) before study intervention administration. * Capable of giving signed informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | From Day 1 to Day 7 after Vaccination 1 | Local reactions included pain at the injection site, redness and swelling and were recorded by participants in an electronic diary. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 centimeter (cm). Redness and swelling were graded as mild (Grade 1): greater than (\>) 2.0 cm to 5.0 cm; moderate (Grade 2): \>5.0 cm to 10.0 cm; severe (Grade 3): \>10 cm; potentially life-threatening (Grade 4): necrosis or exfoliative dermatitis (redness) and necrosis (swelling). Pain at injection site was graded as mild (Grade 1): did not interfere with activity; moderate (Grade 2): interfered with activity; severe (Grade 3): prevented daily activity and potentially life-threatening (Grade 4): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Exact 2-sided confidence interval was based on the Clopper and Pearson method. |
| Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | From Day 1 to Day 7 after Vaccination 2 | Local reactions included pain at the injection site, redness and swelling and were recorded by participants in an electronic diary. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 cm. Redness and swelling were graded as mild (Grade 1): \>2.0 cm to 5.0 cm; moderate (Grade 2): \>5.0 cm to 10.0 cm; severe (Grade 3): \>10 cm; potentially life-threatening (Grade 4): necrosis or exfoliative dermatitis. Pain at injection site was graded as mild (Grade 1): did not interfere with activity; moderate (Grade 2): interfered with activity; severe (Grade 3): prevented daily activity and potentially life-threatening (Grade 4): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Exact 2-sided confidence interval was based on the Clopper and Pearson method. |
| Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | From Day 1 to Day 7 After Vaccination 1 | Systemic events included fever, vomiting, diarrhea, headache,fatigue,chills,new/worsened muscle pain & new/worsened joint pain & recorded by participants in an electronic diary.Fever defined as oral temperature greater than equal to(\>=)38.0 degrees Celsius(deg C) & categorized as\>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C,\>38.9 to 40.0 deg C & \>40.0 deg C. Vomiting graded as:Grade(G)1:1-2 times in 24 hours(h);G2:\>2 times in 24h;G3:required Intravenous (IV) hydration.Diarrhea graded as: G1:2-3 loose stools in 24h;G2: 4-5 loose stools in 24h;G3: 6 or more loose stools in 24h.Headache,fatigue,chills, new/worsened muscle pain & new/worsened joint pain:G1:didn't interfere with activity;G2: some interference with activity;G3:prevented daily routine activity.For all systemic events except fever, Grade 4=emergency room visit or hospitalization. Grade 4 events were classified by the investigator or medically qualified person.Exact 2-sided confidence interval based on Clopper and Pearson method. |
| Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | From Day 1 to Day 7 after Vaccination 2 | Systemic events included fever, vomiting, diarrhea, headache, fatigue, chills, new/worsened muscle pain & new /worsened joint pain & recorded by participants in electronic diary. Fever defined as oral temperature \>=38.0 deg C & categorized as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C & \>40.0 deg C. Vomiting graded as: Grade(G) 1: 1-2 times in 24 h; G2: \>2 times in 24 h; G3: required IV hydration. Diarrhea graded as: G1: 2-3 loose stools in 24 h; G2: 4-5 loose stools in 24 h; G3: 6 or more loose stools in 24 h. Headache, fatigue, chills, new/worsened muscle pain & new/worsened joint pain: G1: didn't interfere with activity; G2: some interference with activity; G3: prevented daily routine activity. For all systemic events except fever, Grade 4= emergency room visit or hospitalization. Grade 4 events were classified by the investigator or medically qualified person. Exact 2-sided confidence interval based on Clopper and Pearson method. |
| Percentage of Participants Reporting Adverse Events After Vaccination 1: Substudy A | From Day 1 up to 4 weeks After Vaccination 1 | An adverse event (AE) was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e, excluding local reactions and systematic events) were reported in this outcome measure. |
| Percentage of Participants Reporting Adverse Events After Vaccination 2: Substudy A | From Day 1 up to 4 weeks After vaccination 2 | An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure. |
| Percentage of Participants Reporting Serious Adverse Events (SAE) From First Vaccination to 6 Months After Last Vaccination: Substudy A | From vaccination 1 on day 1 up to 6 months after vaccination 2 | An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event. |
| Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | 2 days after vaccination 1 | Hematology parameters included erythrocytes, lymphocytes, neutrophils, eosinophils/leukocytes, erythrocyte (ery) mean corpuscular volume, ery. mean corpuscular hemoglobin and ery. mean corpuscular hemoglobin concentration. The primary criteria were as follows erythrocytes, lymphocytes, neutrophils: \<0.8\*lower limit of normal (LLN); Lymphocytes/Leukocytes, Eosinophils/Leukocytes, Monocytes/Leukocytes: \>1.2\*upper limit of normal (ULN); Ery. Mean Corpuscular Volume:\>1.1\*ULN; Ery. Mean Corpuscular Hemoglobin and Ery.Mean Corpuscular hemoglobin Concentration: \< 0.9\*LLN. Also add 95% CI was based on Clopper and Pearson method. |
| Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | 1 week after vaccination 1 | Hematology parameters included erythrocytes, neutrophils, eosinophils/leukocytes, monocytes/leukocytes, ery mean corpuscular hemoglobin. The primary criteria were as follows erythrocytes and neutrophils: \<0.8\* LLN; Eosinophils/Leukocytes and Monocytes/Leukocytes: \>1.2\* ULN; Ery. Mean Corpuscular Hemoglobin:\>1.1\*ULN. 95% CI was based on Clopper and Pearson method. |
| Percentage of Participants With Abnormal Chemistry Values at 2 Days After Vaccination 1: Substudy A | 2 days after vaccination 1 | Chemistry parameters included blood urea nitrogen and C-reactive protein. The primary criteria were as follows Blood Urea Nitrogen: \> 1.3\*ULN; C Reactive Protein: \> 1.1\*ULN. 95% CI was based on Clopper and Pearson method. |
| Percentage of Participants With Abnormal Chemistry Values at 1 Week After Vaccination 1: Substudy A | 1 week after vaccination 1 | Chemistry parameters included blood urea nitrogen and C-reactive protein. The primary criteria were as follows Blood Urea Nitrogen: \> 1.3\*ULN; C Reactive Protein: \> 1.1\*ULN. Also add 95% CI was based on Clopper and Pearson method. |
| Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | From Baseline (prior to vaccination 1) to 2 days after vaccination 1 | Hematology parameters included hemoglobin, lymphocytes, neutrophils decrease, platelets decrease, white blood cells (WBC) decrease and WBC increase. Laboratory abnormalities were graded by Food and Drug Administration (FDA) toxicity grading scale for healthy adult volunteers enrolled in preventive vaccine clinical trials as grade 1=mild; grade 2=moderate; grade 3=severe and grade 4=potentially life-threatening. Percentage of participants with shift in hematology values were reported in this outcome measure. Categories with at least 1 non-zero data values showing any shift in Grade from baseline to 2 days after vaccination 1 were reported. Participants whose grade category was unchanged (e.g. normal to normal) were not reported. |
| Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | From Baseline (prior to vaccination 1) to 1 week after vaccination 1 | Hematology parameters included hemoglobin, lymphocytes, neutrophils decrease, WBC decrease and WBC increase. Laboratory abnormalities were graded by FDA toxicity grading scale for healthy adult volunteers enrolled in preventive vaccine clinical trials as grade 1=mild; grade 2=moderate; grade 3=severe and grade 4=potentially life-threatening. Percentage of participants with shift in hematology values were reported in this outcome measure. Categories with at least 1 non-zero data values showing any shift in Grade from baseline to 1 week after vaccination 1 were reported. Participants whose grade category was unchanged (e.g. normal to normal) were not reported. |
| Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | From Baseline (prior to vaccination 1) to 2 days after vaccination 1 | Chemistry abnormalities were graded by toxicity grading scale for healthy adult volunteers enrolled in preventive vaccine clinical trials as grade 1=mild; grade 2=moderate; grade 3=severe and grade 4=potentially life-threatening. Percentage of participants with shift in chemistry values were reported in this outcome measure. Categories with at least 1 non-zero data values showing any shift in Grade from baseline to 2 days after vaccination 1 (post-baseline) were reported. Participants whose grade category was unchanged (e.g. normal to normal) were not reported. The parameters reported were - Alanine Aminotransferase Increased (ALP), Alkaline Phosphatase Increased (ALP), Aspartate Aminotransferase Increased (AST), Creatinine Increased and Urea Nitrogen. |
| Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | From Baseline (prior to vaccination 1) to 1 week after vaccination 1 | Chemistry abnormalities were graded by toxicity grading scale for healthy adult volunteers enrolled in preventive vaccine clinical trials as grade 1=mild; grade 2=moderate; grade 3=severe and grade 4=potentially life-threatening. Percentage of participants with shift in chemistry values were reported in this outcome measure. Categories with at least 1 non-zero data values showing any shift in Grade from baseline to 1 week after vaccination 1 (post-baseline) were reported. Participants whose grade category was unchanged (e.g. normal to normal) were not reported. The parameters reported were - Alanine Aminotransferase Increased, Alkaline Phosphatase Increased, Aspartate Aminotransferase Increased, Creatinine Increased and Urea Nitrogen. |
| Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 2 Days After Vaccination 1: Substudy A | 2 days after vaccination 1 | An ECG abnormality was defined as any new abnormality that, as judged by a cardiologist, was consistent with probable or possible myocarditis or pericarditis, including: Sustained atrial or ventricular arrhythmias, Second-degree Mobitz Type II or worse atrioventricular block, new bundle branch block and Diffuse ST-segment elevation or PR-segment inversion, compatible with pericarditis. |
| Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 1 Week After Vaccination 1: Substudy A | 1 week after vaccination 1 | An ECG abnormality was defined as any new abnormality that, as judged by a cardiologist, was consistent with probable or possible myocarditis or pericarditis, including: Sustained atrial or ventricular arrhythmias, Second-degree Mobitz Type II or worse atrioventricular block, new bundle branch block and Diffuse ST-segment elevation or PR-segment inversion, compatible with pericarditis. |
| Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | From Day 1 to Day 7 after vaccination | Local reactions included pain at the injection site, redness and swelling and were recorded by participants in an electronic diary. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 cm. Redness and swelling were graded as mild (Grade 1): \>2.0 cm to 5.0 cm; moderate (Grade 2): \>5.0 cm to 10.0 cm; severe (Grade 3): \>10 cm; potentially life-threatening (Grade 4): necrosis or exfoliative dermatitis. Pain at injection site was graded as mild (Grade 1): did not interfere with activity; moderate (Grade 2): interfered with activity; severe (Grade 3): prevented daily activity and potentially life-threatening (Grade 4): emergency room visit or hospitalization for severe pain. Exact 2-sided confidence interval was based on the Clopper and Pearson method. |
| Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | From Day 1 to Day 7 after vaccination 1 | Local reactions included pain at the injection site, redness and swelling and were recorded by participants in an electronic diary. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 cm. Redness and swelling were graded as mild (Grade 1): \>2.0 cm to 5.0 cm; moderate (Grade 2): \>5.0 cm to 10.0 cm; severe (Grade 3): \>10 cm; potentially life-threatening (Grade 4): necrosis or exfoliative dermatitis. Pain at injection site was graded as mild (Grade 1): did not interfere with activity; moderate (Grade 2): interfered with activity; severe (Grade 3): prevented daily activity and potentially life-threatening (Grade 4): emergency room visit or hospitalization for severe pain. Exact 2-sided confidence interval was based on the Clopper and Pearson method. |
| Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | From Day 1 to Day 7 after vaccination 2 | Local reactions included pain at the injection site, redness and swelling and were recorded by participants in an electronic diary. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 cm. Redness and swelling were graded as mild (Grade 1): \>2.0 cm to 5.0 cm; moderate (Grade 2): \>5.0 cm to 10.0 cm; severe (Grade 3): \>10 cm; potentially life-threatening (Grade 4): necrosis or exfoliative dermatitis. Pain at injection site was graded as mild (Grade 1): did not interfere with activity; moderate (Grade 2): interfered with activity; severe (Grade 3): prevented daily activity and potentially life-threatening (Grade 4): emergency room visit or hospitalization for severe pain. Exact 2-sided confidence interval was based on the Clopper and Pearson method. |
| Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | From Day 1 to Day 7 after vaccination 1 for all arms; From Day 1 to Day 7 after vaccination 2 for 2 doses of qIRV (dose level 1), 2-visit schedule arm | Local reactions included pain at the injection site, redness and swelling and were recorded by participants in an electronic diary. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 cm. Redness and swelling were graded as mild (Grade 1): \>2.0 cm to 5.0 cm; moderate (Grade 2): \>5.0 cm to 10.0 cm; severe (Grade 3): \>10 cm; potentially life-threatening (Grade 4): necrosis or exfoliative dermatitis. Pain at injection site was graded as mild (Grade 1): did not interfere with activity; moderate (Grade 2): interfered with activity; severe (Grade 3): prevented daily activity and potentially life-threatening (Grade 4): emergency room visit or hospitalization for severe pain. Exact 2-sided confidence interval was based on the Clopper and Pearson method. |
| Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | From Day 1 to Day 7 after vaccination | Systemic events included fever, vomiting, diarrhea, headache, fatigue, chills, new/worsened muscle pain & new /worsened joint pain & recorded by participants in electronic diary. Fever defined as oral temperature \>=38.0 deg C & categorized as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C & \>40.0 deg C. Vomiting graded as: G 1: 1-2 times in 24 hrs; G 2: \>2 times in 24 hrs; G 3: required IV hydration; G 4: emergency room visit/ hospitalization for hypotensive shock. Diarrhea graded as: G 1: 2-3 loose stools in 24 hrs; G 2: 4-5 loose stools in 24 hrs; G 3: 6 or more loose stools in 24 hrs & G 4: emergency room visit/ hospitalization. Headache, fatigue, chills, new/worsened muscle pain & new/worsened joint pain: G 1: didn't interfere with activity; G 2: some interference with activity; G 3: prevented daily routine activity & G 4: emergency room visit/ hospitalization. Exact 2-sided confidence interval based on Clopper and Pearson method. |
| Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | From Day 1 to Day 7 after vaccination 1 | Systemic events included fever, vomiting, diarrhea, headache, fatigue, chills, new/worsened muscle pain & new /worsened joint pain & recorded by participants in electronic diary. Fever defined as oral temperature \>=38.0 deg C & categorized as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C & \>40.0 deg C. Vomiting graded as: G 1: 1-2 times in 24 hrs; G 2: \>2 times in 24 hrs; G 3: required IV hydration; G 4: emergency room visit/ hospitalization for hypotensive shock. Diarrhea graded as: G 1: 2-3 loose stools in 24 hrs; G 2: 4-5 loose stools in 24 hrs; G 3: 6 or more loose stools in 24 hrs & G 4: emergency room visit/ hospitalization. Headache, fatigue, chills, new/worsened muscle pain & new/worsened joint pain: G 1: didn't interfere with activity; G 2: some interference with activity; G 3: prevented daily routine activity & G 4: emergency room visit/ hospitalization. Exact 2-sided confidence interval based on Clopper and Pearson method. |
| Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | From day 1 to day 7 of vaccination 2 | Systemic events included fever, vomiting, diarrhea, headache, fatigue, chills, new/worsened muscle pain & new /worsened joint pain & recorded by participants in electronic diary. Fever defined as oral temperature \>=38.0 deg C & categorized as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C & \>40.0 deg C. Vomiting graded as: G 1: 1-2 times in 24 hrs; G 2: \>2 times in 24 hrs; G 3: required IV hydration; G 4: emergency room visit/ hospitalization for hypotensive shock. Diarrhea graded as: G: 1: 2-3 loose stools in 24 hrs; G 2: 4-5 loose stools in 24 hrs; G 3: 6 or more loose stools in 24 hrs & G 4: emergency room visit/ hospitalization. Headache, fatigue, chills, new/worsened muscle pain & new/worsened joint pain: G 1: didn't interfere with activity; G 2: some interference with activity; G 3: prevented daily routine activity & G 4: emergency room visit/ hospitalization. Exact 2-sided confidence interval based on Clopper and Pearson method. |
| Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | From Day 1 to Day 7 after vaccination 1 for all arms; From Day 1 to Day 7 after vaccination 2 for 2 doses of qIRV (dose level 1), 2-visit schedule arm | Systemic events included fever, vomiting, diarrhea, headache, fatigue, chills, new/worsened muscle pain & new /worsened joint pain & recorded by participants in electronic diary. Fever defined as oral temperature \>=38.0 deg C & categorized as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C & \>40.0 deg C. Vomiting graded as: G 1: 1-2 times in 24 hrs; G 2: \>2 times in 24 hrs; G 3: required IV hydration; G 4: emergency room visit/ hospitalization for hypotensive shock. Diarrhea graded as: G 1: 2-3 loose stools in 24 hrs; G 2: 4-5 loose stools in 24 hrs; G 3: 6 or more loose stools in 24 hrs & G 4: emergency room visit/ hospitalization. Headache, fatigue, chills, new/worsened muscle pain & new/worsened joint pain: G 1: didn't interfere with activity; G 2: some interference with activity; G 3: prevented daily routine activity & G 4: emergency room visit/ hospitalization. Exact 2-sided confidence interval based on Clopper and Pearson method. |
| Percentage of Participants Reporting Adverse Events From First Vaccination Until 4 Weeks After Last Vaccination: Substudy B | From first vaccination to 4 weeks after last vaccination (i.e., Vaccination 1 for 1-visit schedule arms and Vaccination 2 for 2-visit schedule arms) | An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (i.e, excluding local reactions and systematic events) were reported in this outcome measure. |
| Percentage of Participants Reporting Serious Adverse Events From First Vaccination Until 6 Months After Last Vaccination: Substudy B | From first vaccination to 6 month after last vaccination (i.e., Vaccination 1 for 1-visit schedule arms and Vaccination 2 for 2-visit schedule arms) | An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event. |
| Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination 1 for 2-Visit Schedule (Initial Enrollment): Substudy B | 2 days after vaccination 1 | Percentage of participants reporting abnormal troponin I laboratory values 2 days after vaccination 1 were reported in this outcome measure. |
| Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination 2 for 2-Visit Schedule (Initial Enrollment): Substudy B | 2 days after vaccination 2 | Percentage of participants reporting abnormal troponin I laboratory values 2 days after vaccination 2 were reported in this outcome measure. |
| Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | 2 days after vaccination | Percentage of participants reporting abnormal troponin I laboratory values 2 days after vaccination were reported in this outcome measure. |
| Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination for Expanded Enrollment: Substudy B | 2 days after last vaccination (i.e., Vaccination 1 for 1-visit schedule arms and Vaccination 2 for 2-visit schedule arms) | Percentage of participants reporting abnormal troponin I laboratory values 2 days after vaccination were reported in this outcome measure. |
| Percentage of Participants Reporting New ECG Abnormalities 2 Days After Vaccination 1 for 2-Visit Schedule (Initial Enrollment): Substudy B | 2 days after vaccination 1 | Twelve lead ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. An ECG abnormality was defined as any new abnormality that, as judged by a cardiologist, was consistent with probable or possible myocarditis or pericarditis, including: Sustained atrial or ventricular arrhythmias, Second-degree Mobitz Type II or worse atrioventricular block, new bundle branch block and Diffuse ST-segment elevation or PR-segment inversion, compatible with pericarditis. |
| Percentage of Participants Reporting New ECG Abnormalities 2 Days After Vaccination 2 for 2-Visit Schedule (Initial Enrollment): Substudy B | 2 days after vaccination 2 | Twelve lead ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. An ECG abnormality was defined as any new abnormality that, as judged by a cardiologist, was consistent with probable or possible myocarditis or pericarditis, including: Sustained atrial or ventricular arrhythmias, Second-degree Mobitz Type II or worse atrioventricular block, new bundle branch block and Diffuse ST-segment elevation or PR-segment inversion, compatible with pericarditis. |
| Percentage of Participants Reporting New ECG Abnormalities 2 Days After Vaccination 1 for 1-Visit Schedule (Initial Enrollment): Substudy B | 2 days after vaccination 1 | Twelve lead ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. An ECG abnormality was defined as any new abnormality that, as judged by a cardiologist, was consistent with probable or possible myocarditis or pericarditis, including: Sustained atrial or ventricular arrhythmias, Second-degree Mobitz Type II or worse atrioventricular block, new bundle branch block and Diffuse ST-segment elevation or PR-segment inversion, compatible with pericarditis. |
| Percentage of Participants Reporting New ECG Abnormalities 2 Days After Vaccination for Expanded Enrollment: Substudy B | 2 days after last vaccination (i.e., Vaccination 1 for 1-visit schedule arms and Vaccination 2 for 2-visit schedule arms) | Twelve lead ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. An ECG abnormality was defined as any new abnormality that, as judged by a cardiologist, was consistent with probable or possible myocarditis or pericarditis, including: Sustained atrial or ventricular arrhythmias, Second-degree Mobitz Type II or worse atrioventricular block, new bundle branch block and Diffuse ST-segment elevation or PR-segment inversion, compatible with pericarditis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | Weeks 1, 4 and 8 after vaccination 1 | GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the lower limit of quantitation (LLOQ) were set to 0.5\*LLQ. |
| Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | Before vaccination to 1, 4 and 8 weeks after vaccination 1 | Geometric mean fold rise (GMFR) was defined as ratios of the results after vaccination to the results before vaccination. GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ. When prevaccination assay results were lower than the LLOQ and the postvaccination results were greater than or equal to the LLOQ, the prevaccination assay results were set to LLOQ for the GMFR calculation. |
| Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | At 1, 4 and 8 Weeks after vaccination 1 | Seroconversion was defined as an HAI titer \<1:10 prior to vaccination and \>=1:40 at the time point of interest, or an HAI titer of \>=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Exact 2-sided 95% CI was based on the Clopper and Pearson method. |
| Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | Before vaccination 1 on day 1 and 1, 4 and 8 weeks after vaccination 1 | Percentage of participants with HAI titer \>=1:40 for each strain before vaccination 1 and at 1, 4 and 8 weeks after vaccination 1 is presented in this outcome measure. Exact 2-sided 95% CI was based on the Clopper and Pearson method. |
| Percentage of Participants Who Achieved HAI Seroconversion for All Strains at 1, 4, and 8 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A | At 1, 4, and 8 weeks After vaccination 1 | Seroconversion was defined as an HAI titer \<1:10 prior to vaccination and \>=1:40 at the time point of interest, or an HAI titer of \>=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Exact 2-sided 95% CI was based on the Clopper and Pearson method. |
| Percentage of Participants With HAI Titers>=1:40 for All Strains Before Vaccination and at 1, 4, and 8 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A | Before vaccination 1 on day 1 and 1, 4, and 8 weeks after vaccination 1 | Percentage of participants with HAI titer \>=1:40 for all strains before vaccination 1 and 1, 4 and 8 weeks after vaccination 1 is presented in this outcome measure. Exact 2-sided 95% CI was based on the Clopper and Pearson method. |
| Geometric Mean Ratio (GMR) of HAI Titers for Each Strain at 4 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A | 4 weeks After vaccination 1 | GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution) and were reported in the descriptive section. GMRs were estimated by the ratio of the GMTs between vaccine groups, using licensed QIV group as reference and were reported in the statistical analysis section. |
| Difference in Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A | 4 weeks after vaccination 1 | Seroconversion was defined as an HAI titer \<1:10 prior to vaccination and \>=1:40 at the time point of interest, or an HAI titer of \>=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Percentage of participants achieving seroconversion for each strain at 4 weeks after vaccination 1 and exact 2-sided 95% CI based on the Clopper and Pearson method is presented in the descriptive section. Difference in percentage of participants achieving HAI seroconversion for each strain at 4 weeks after vaccination 1 is presented in the statistical analysis section. |
| HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | Before vaccination 1, 2 and, 1, 4, and 8 weeks after the last vaccination (i.e. after vaccination 1 for 1-vist schedule arms and after vaccination 2 for 2-visit schedule arms) | GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ. |
| HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to vaccination 1 and 2, and at 1, 4, and 8 weeks after the last vaccination (i.e. after vaccination 1 for 1-vist schedule arms and after vaccination 2 for 2-visit schedule arms) | GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 × LLOQ. |
| HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | From before vaccination 2 to 1, 4, and 8 weeks after the last vaccination | GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\* LLOQ. When prevaccination assay results were lower than the LLOQ and the postvaccination results were greater than or equal to the LLOQ, the prevaccination assay results were set to LLOQ for the GMFR calculation. |
| HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | From before vaccination 1 to prior to vaccination 2, 1, 4, and 8 weeks after the last vaccination (i.e., vaccination 1 and 2 for 1-visit schedule and 2 visit schedule, respectively) | GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ. When prevaccination assay results were lower than the LLOQ and the postvaccination results were greater than or equal to the LLOQ, the prevaccination assay results were set to LLOQ for the GMFR calculation. |
| Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | Prior to vaccination 2 and at 1, 4, and 8 Weeks After last Vaccination | Seroconversion was defined as an HAI titer \<1:10 prior to vaccination and \>=1:40 at the time point of interest, or an HAI titer \>=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Exact 2-sided CI was based on the Clopper and Pearson method. |
| Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to vaccination 2 (2-visit arms only), 1, 4 and 8 weeks after last vaccination (i.e., vaccination 1 for 1 visit and vaccination 2 for 2 visit) | Seroconversion was defined as an HAI titer\<1:10 prior to vaccination and\>=1:40 at the time point of interest,or an HAI titer\>=1:10 prior to vaccination with a 4-fold rise at the time point of interest.Exact 2-sided CI was based on the Clopper and Pearson method. |
| Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | Before vaccination 1 and 2 and at 1, 4 and 8 weeks after last vaccination (i.e. after vaccination 1 for 1-vist schedule arms and after vaccination 2 for 2-visit schedule arms) | Proportion of participants achieving HAI titers \>= 1:40 for each strain before vaccination and at 1, 4 and 8 weeks after vaccination is reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method. |
| Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Before vaccination 1 and 2 (for 2-visit only), and 1, 4 and 8 weeks after last vaccination (i.e., vaccination 1 for 1-visit arms and vaccination 2 for 2-visit arms) | Percentage of participants achieving HAI titers \>= 1:40 for each strain before vaccinations 1 and 2 and at 1, 4 and 8 weeks after last vaccination is reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method. |
| Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | Prior to vaccination 2 (for 2-visit schedule only) and at 1, 4, and 8 weeks after last vaccination (after vaccination 1 for 1-visit schedule and after vaccination 2 for 2-visit schedule) | Seroconversion was defined as an HAI titer\<1:10 prior to vaccination and\>=1:40 at the time point of interest,or an HAI titer\>=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Exact 2-sided CI was based on the Clopper and Pearson method. |
| Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to vaccination 2 (for 2-visit schedule only) and at 1, 4, and 8 weeks after last vaccination (after vaccination 1 for 1-visit schedule and after vaccination 2 for 2-visit schedule) | Seroconversion was defined as an HAI titer\<1:10 prior to vaccination and\>=1:40 at the time point of interest,or an HAI titer\>=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Exact 2-sided CI was based on the Clopper and Pearson method. |
| Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | Prior to vaccination 1 and 2, and at 1, 4, and 8 weeks after last vaccination (after vaccination 1 for 1-visit schedule and after vaccination 2 for 2-visit schedule) | Percentage of participants with HAI titers \>=1:40 for all strains before vaccinations 1 and 2 and 1, 4, and 8 weeks after the last vaccination is reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method. |
| Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (after vaccination 1 for 1-visit schedule and after vaccination 2 for 2-visit schedule) | Percentage of participants with HAI titers \>=1:40 for all strains before vaccinations 1 and 2 and 1, 4, and 8 weeks after the last vaccination is reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method. |
| HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | Before vaccination and 1, 4, and 8 Weeks After the Vaccination | HAI GMT before vaccination and at 1, 4, and 8 weeks after vaccination was described in this outcome measure. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). |
| HAI GMFR From Before Vaccination to 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | Before vaccination to 1, 4, and 8 Weeks After Vaccination | GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ. When prevaccination assay results were lower than the LLOQ and the postvaccination results were greater than or equal to the LLOQ, the pre vaccination assay results were set to LLOQ for the GMFR calculation. |
| Percentage of Participants Achieving HAI Seroconversion for Each Strain at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 1, 4, and 8 Weeks After Vaccination | Seroconversion was defined as an HAI titer\<1:10 prior to vaccination and\>=1:40 at the time point of interest,or an HAI titer\>=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Exact 2-sided CI was based on the Clopper and Pearson method. |
| Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | Before vaccination and 1, 4, and 8 Weeks After Vaccination | Percentage of participants with HAI titers \>=1:40 for each strain before vaccination and 1, 4, and 8 weeks after vaccination is reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method. |
| Percentage of Participants Achieving HAI Seroconversion for All Strains at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 1, 4, and 8 Weeks After Vaccination | Seroconversion was defined as an HAI titer\<1:10 prior to vaccination and\>=1:40 at the time point of interest,or an HAI titer\>=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Exact 2-sided CI was based on the Clopper and Pearson method. |
| Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccination and 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | Before vaccination and 1, 4, and 8 Weeks After Vaccination | Percentage of participants with HAI titers \>=1:40 for all strains before vaccination and 1, 4, and 8 weeks after vaccination is reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method. |
Countries
United States
Participant flow
Recruitment details
This study was conducted across 2 substudies-Substudy A and Substudy B.
Pre-assignment details
A total of 1158 participants (substudy A: 256+ substudy B: 902) were enrolled and randomized to receive study treatment.
Participants by arm
| Arm | Count |
|---|---|
| SSA: mIRV A (Dose Level 1) + QIV Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2). | 16 |
| SSA: mIRV A (Dose Level 2) + QIV Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2). | 15 |
| SSA: mIRV A (Dose Level 3) + QIV Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2). | 14 |
| SSA: mIRV A (Dose Level 4) + QIV Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2). | 14 |
| SSA: mIRV A - Licensed QIV Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2). | 15 |
| SSA: mIRV B (Dose Level 1) + QIV Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2). | 17 |
| SSA: mIRV B (Dose Level 2) + QIV Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2). | 14 |
| SSA: mIRV B (Dose Level 3) + QIV Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2). | 15 |
| SSA: mIRV B (Dose Level 4) + QIV Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2). | 14 |
| SSA: mIRV B - Licensed QIV Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2). | 15 |
| SSA: bIRV AB (Dose Level Combination 1) + QIV Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2). | 14 |
| SSA: bIRV AB (Dose Level Combination 2) + QIV Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2). | 16 |
| SSA: bIRV AB (Dose Level Combination 3) + QIV Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2). | 15 |
| SSA: bIRV AB (Dose Level Combination 4) + QIV Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2). | 15 |
| SSA: bIRV AB-Licensed QIV Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2). | 15 |
| SSA: qIRV (Dose Level 1) + QIV Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2). | 15 |
| SSA: qIRV - Licensed QIV Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2). | 15 |
| SSB: 2 Doses qIRV (Dose Level 1), 2 Visit Schedule: Initial Enrollment Participants aged 65 to 85 years received intramuscular injections with 2 doses qIRV at dose level 1 administered 21 days apart as a part of initial enrollment. | 14 |
| SSB: Licensed QIV + bIRV AA (Dose Level Combination 1), 2- Visit Schedule: Initial Enrollment Participants aged 65 to 85 years received a single intramuscular injection of licensed QIV followed by a single intramuscular injection of bIRV encoding AA strains at dose level combination 1 administered 21 days apart as a part of initial enrollment. | 15 |
| SSB: Licensed QIV + bIRV AA (Dose Level Combination 2), 2- Visit Schedule: Initial Enrollment Participants aged 65 to 85 years received a single intramuscular injection of licensed QIV followed by a single intramuscular injection of bIRV encoding AA strains at dose level combination 2 administered 21 days apart as a part of initial enrollment. | 16 |
| SSB: 2 Doses of Licensed QIV, 2-visit Schedule: Initial Enrollment Participants aged 65 to 85 years received two doses of licensed QIV administered 21 days apart as a part of initial enrollment. | 16 |
| SSB: Licensed QIV +bIRV AA (Dose Level Combination 1), 1-visit Schedule: Initial Enrollment Participants aged 65 to 85 years received a single intramuscular injection of licensed QIV administered concurrently in the opposite arm with a single intramuscular injection of bIRV AA (dose level combination 1) as part of initial enrollment. | 16 |
| SSB: Licensed QIV +bIRV AA (Dose Level Combination 2), 1-visit Schedule: Initial Enrollment Participants aged 65 to 85 years received a single intramuscular injection of licensed QIV administered concurrently in the opposite arm with a single intramuscular injection of bIRV AA (dose level combination 2) as a part of initial enrollment. | 15 |
| SSB: qIRV (Dose Level 2, Dose Combination 1), 1-visit Schedule: Initial Enrollment Participants aged 65 to 85 years received a single intramuscular injection of qIRV dose level 2, encoding 2A strains and 2B strains (dose combination 1) as a part of initial enrollment. | 16 |
| SSB: qIRV (Dose Level 2, Dose Combination 2), 1-Visit Schedule: Initial Enrollment Participants aged 65 to 85 years received a single intramuscular injection of qIRV dose level 2, dose combination 2 administered at day 1 as a part of initial enrollment. | 16 |
| SSB: bIRV AA + bIRV BB ( Both Dose Level Combination 1), 1-visit Schedule: Initial Enrollment Participants aged 65 to 85 years received a single intramuscular injection of bIRV AA + bIRV BB both dose level combination 1 administered at day 1 as a part of initial enrollment. | 14 |
| SSB: 1 Dose of Licensed QIV, 1 Visit Schedule: Initial Enrollment Participants aged 65 to 85 years received a single intramuscular injection of licensed QIV as part of initial enrollment. | 15 |
| SSB: qIRV (Dose Level 3), 1-Visit Schedule: Initial Enrollment Participants aged 65 to 85 years received a single intramuscular injection of qIRV dose level 3 administered at day 1 as a part of initial enrollment. | 15 |
| SSB: qIRV (Dose Level 1), 1-visit Schedule, 18-64 Years: Expanded Enrollment Participants aged 18 to 64 years received a single intramuscular injection of qIRV dose level 1 as a part of expanded enrollment. | 131 |
| SSB: qIRV (Dose Level 2), 1-visit Schedule, 18-64 Years : Expanded Enrollment Participants aged 18 to 64 years received a single intramuscular injection of qIRV dose level 2 as a part of expanded enrollment. | 131 |
| SSB: qIRV (Dose Level 1), 1-visit Schedule, 65 to 85 Years: Expanded Enrollment Participants aged 65 to 85 years received a single intramuscular injection of qIRV dose level 1 as a part of expanded enrollment | 116 |
| SSB: qIRV (Dose Level 2, Dose Combination 1), 1-visit Schedule, 65 to 85 Years: Expanded Enrollment Participants aged 65 to 85 years received a single intramuscular injection of qIRV dose level 2, encoding 2A strains and 2B strains (dose combination 1) at Day 1 as part of expanded enrollment. | 117 |
| SSB: 1 Dose of Licensed QIV, 1-visit Schedule: Expanded Enrollment Participants aged 65 to 85 years received a single intramuscular injection of licensed QIV as a part of expanded enrollment. | 115 |
| SSB: 2 Doses qIRV (Dose Level 1), 2 Visit Schedule: Expanded Enrollment Participants aged 65 to 85 years received intramuscular injections with 2 doses qIRV at dose Level 1 administered 21 days apart as a part of expanded enrollment. | 117 |
| Total | 1,149 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 | FG018 | FG019 | FG020 | FG021 | FG022 | FG023 | FG024 | FG025 | FG026 | FG027 | FG028 | FG029 | FG030 | FG031 | FG032 | FG033 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Substudy A | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Substudy A | No longer met eligibility criteria | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Substudy A | Not vaccinated | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Substudy B: Expanded Enrollment | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 3 | 3 | 2 | 0 |
| Substudy B: Expanded Enrollment | Not vaccinated | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 1 | 0 | 0 | 0 |
| Substudy B: Expanded Enrollment | Refused study procedure | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Substudy B: Expanded Enrollment | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 3 | 3 | 3 | 0 |
| SubStudy B: Initial Enrollment | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| SubStudy B: Initial Enrollment | Not vaccinated | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| SubStudy B: Initial Enrollment | Physician Decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| SubStudy B: Initial Enrollment | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | SSA: mIRV A (Dose Level 1) + QIV | SSA: mIRV A (Dose Level 2) + QIV | SSA: mIRV A (Dose Level 3) + QIV | SSA: mIRV A (Dose Level 4) + QIV | SSA: mIRV A - Licensed QIV | SSA: mIRV B (Dose Level 1) + QIV | SSA: mIRV B (Dose Level 2) + QIV | SSA: mIRV B (Dose Level 3) + QIV | SSA: mIRV B (Dose Level 4) + QIV | SSA: mIRV B - Licensed QIV | SSA: bIRV AB (Dose Level Combination 1) + QIV | SSA: bIRV AB (Dose Level Combination 2) + QIV | SSA: bIRV AB (Dose Level Combination 3) + QIV | SSA: bIRV AB (Dose Level Combination 4) + QIV | SSA: bIRV AB-Licensed QIV | SSA: qIRV (Dose Level 1) + QIV | SSA: qIRV - Licensed QIV | SSB: 2 Doses qIRV (Dose Level 1), 2 Visit Schedule: Initial Enrollment | SSB: Licensed QIV + bIRV AA (Dose Level Combination 1), 2- Visit Schedule: Initial Enrollment | SSB: Licensed QIV + bIRV AA (Dose Level Combination 2), 2- Visit Schedule: Initial Enrollment | SSB: 2 Doses of Licensed QIV, 2-visit Schedule: Initial Enrollment | SSB: Licensed QIV +bIRV AA (Dose Level Combination 1), 1-visit Schedule: Initial Enrollment | SSB: Licensed QIV +bIRV AA (Dose Level Combination 2), 1-visit Schedule: Initial Enrollment | SSB: qIRV (Dose Level 2, Dose Combination 1), 1-visit Schedule: Initial Enrollment | SSB: qIRV (Dose Level 2, Dose Combination 2), 1-Visit Schedule: Initial Enrollment | SSB: bIRV AA + bIRV BB ( Both Dose Level Combination 1), 1-visit Schedule: Initial Enrollment | SSB: 1 Dose of Licensed QIV, 1 Visit Schedule: Initial Enrollment | SSB: qIRV (Dose Level 3), 1-Visit Schedule: Initial Enrollment | SSB: qIRV (Dose Level 1), 1-visit Schedule, 18-64 Years: Expanded Enrollment | SSB: qIRV (Dose Level 2), 1-visit Schedule, 18-64 Years : Expanded Enrollment | SSB: qIRV (Dose Level 1), 1-visit Schedule, 65 to 85 Years: Expanded Enrollment | SSB: qIRV (Dose Level 2, Dose Combination 1), 1-visit Schedule, 65 to 85 Years: Expanded Enrollment | SSB: 1 Dose of Licensed QIV, 1-visit Schedule: Expanded Enrollment | SSB: 2 Doses qIRV (Dose Level 1), 2 Visit Schedule: Expanded Enrollment | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized <18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized >=18 years | 16 Participants | 15 Participants | 14 Participants | 14 Participants | 15 Participants | 17 Participants | 14 Participants | 15 Participants | 14 Participants | 15 Participants | 14 Participants | 16 Participants | 15 Participants | 15 Participants | 15 Participants | 15 Participants | 15 Participants | 14 Participants | 15 Participants | 16 Participants | 16 Participants | 16 Participants | 15 Participants | 16 Participants | 16 Participants | 14 Participants | 15 Participants | 15 Participants | 131 Participants | 131 Participants | 116 Participants | 117 Participants | 115 Participants | 117 Participants | 1149 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 7 Participants | 3 Participants | 5 Participants | 5 Participants | 3 Participants | 8 Participants | 5 Participants | 4 Participants | 4 Participants | 4 Participants | 4 Participants | 4 Participants | 12 Participants | 9 Participants | 9 Participants | 10 Participants | 8 Participants | 8 Participants | 12 Participants | 10 Participants | 11 Participants | 9 Participants | 14 Participants | 74 Participants | 77 Participants | 50 Participants | 60 Participants | 55 Participants | 55 Participants | 546 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 14 Participants | 13 Participants | 13 Participants | 13 Participants | 10 Participants | 11 Participants | 10 Participants | 9 Participants | 11 Participants | 6 Participants | 11 Participants | 11 Participants | 11 Participants | 11 Participants | 11 Participants | 10 Participants | 2 Participants | 6 Participants | 7 Participants | 6 Participants | 8 Participants | 7 Participants | 4 Participants | 6 Participants | 3 Participants | 6 Participants | 1 Participants | 57 Participants | 54 Participants | 65 Participants | 56 Participants | 60 Participants | 62 Participants | 598 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 6 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 20 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants | 3 Participants | 1 Participants | 3 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants | 2 Participants | 1 Participants | 4 Participants | 2 Participants | 4 Participants | 3 Participants | 1 Participants | 2 Participants | 4 Participants | 1 Participants | 2 Participants | 1 Participants | 20 Participants | 20 Participants | 21 Participants | 12 Participants | 14 Participants | 11 Participants | 143 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants | 0 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 8 Participants |
| Race (NIH/OMB) White | 14 Participants | 14 Participants | 14 Participants | 13 Participants | 13 Participants | 13 Participants | 13 Participants | 12 Participants | 14 Participants | 14 Participants | 13 Participants | 15 Participants | 14 Participants | 15 Participants | 12 Participants | 13 Participants | 13 Participants | 13 Participants | 10 Participants | 14 Participants | 11 Participants | 12 Participants | 13 Participants | 14 Participants | 12 Participants | 13 Participants | 11 Participants | 14 Participants | 98 Participants | 107 Participants | 92 Participants | 101 Participants | 96 Participants | 104 Participants | 964 Participants |
| Sex: Female, Male Female | 8 Participants | 7 Participants | 7 Participants | 4 Participants | 6 Participants | 7 Participants | 11 Participants | 10 Participants | 9 Participants | 11 Participants | 7 Participants | 7 Participants | 12 Participants | 6 Participants | 7 Participants | 10 Participants | 8 Participants | 10 Participants | 8 Participants | 8 Participants | 6 Participants | 9 Participants | 8 Participants | 8 Participants | 7 Participants | 8 Participants | 7 Participants | 9 Participants | 77 Participants | 74 Participants | 61 Participants | 60 Participants | 67 Participants | 65 Participants | 629 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants | 7 Participants | 10 Participants | 9 Participants | 10 Participants | 3 Participants | 5 Participants | 5 Participants | 4 Participants | 7 Participants | 9 Participants | 3 Participants | 9 Participants | 8 Participants | 5 Participants | 7 Participants | 4 Participants | 7 Participants | 8 Participants | 10 Participants | 7 Participants | 7 Participants | 8 Participants | 9 Participants | 6 Participants | 8 Participants | 6 Participants | 54 Participants | 57 Participants | 55 Participants | 57 Participants | 48 Participants | 52 Participants | 520 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk | EG020 affected / at risk | EG021 affected / at risk | EG022 affected / at risk | EG023 affected / at risk | EG024 affected / at risk | EG025 affected / at risk | EG026 affected / at risk | EG027 affected / at risk | EG028 affected / at risk | EG029 affected / at risk | EG030 affected / at risk | EG031 affected / at risk | EG032 affected / at risk | EG033 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 15 | 0 / 14 | 0 / 14 | 0 / 15 | 0 / 17 | 0 / 14 | 0 / 15 | 0 / 14 | 0 / 15 | 0 / 14 | 0 / 16 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 14 | 0 / 15 | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 15 | 0 / 16 | 0 / 15 | 0 / 131 | 0 / 131 | 0 / 116 | 0 / 117 | 0 / 115 | 0 / 14 | 0 / 16 | 0 / 15 | 0 / 117 |
| other Total, other adverse events | 9 / 16 | 9 / 15 | 7 / 14 | 9 / 14 | 11 / 15 | 9 / 17 | 8 / 14 | 9 / 15 | 8 / 14 | 12 / 15 | 9 / 14 | 9 / 16 | 11 / 15 | 11 / 15 | 11 / 15 | 13 / 15 | 12 / 15 | 12 / 14 | 11 / 15 | 9 / 16 | 9 / 16 | 10 / 16 | 10 / 15 | 8 / 16 | 7 / 15 | 87 / 131 | 92 / 131 | 71 / 116 | 76 / 117 | 52 / 115 | 6 / 14 | 7 / 16 | 8 / 15 | 82 / 117 |
| serious Total, serious adverse events | 0 / 16 | 0 / 15 | 0 / 14 | 0 / 14 | 0 / 15 | 1 / 17 | 0 / 14 | 0 / 15 | 0 / 14 | 1 / 15 | 1 / 14 | 0 / 16 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 14 | 0 / 15 | 0 / 16 | 0 / 16 | 1 / 16 | 0 / 15 | 0 / 16 | 0 / 15 | 0 / 131 | 2 / 131 | 1 / 116 | 0 / 117 | 0 / 115 | 0 / 14 | 0 / 16 | 0 / 15 | 0 / 117 |
Outcome results
Primary
Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination 1 for 2-Visit Schedule (Initial Enrollment): Substudy B
Percentage of participants reporting abnormal troponin I laboratory values 2 days after vaccination 1 were reported in this outcome measure.
Time frame: 2 days after vaccination 1
Population: Safety population included all the participants who received the study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination 1 for 2-Visit Schedule (Initial Enrollment): Substudy B | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination 1 for 2-Visit Schedule (Initial Enrollment): Substudy B | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination 1 for 2-Visit Schedule (Initial Enrollment): Substudy B | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination 1 for 2-Visit Schedule (Initial Enrollment): Substudy B | 0 Percentage of participants |
Primary
Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination 2 for 2-Visit Schedule (Initial Enrollment): Substudy B
Percentage of participants reporting abnormal troponin I laboratory values 2 days after vaccination 2 were reported in this outcome measure.
Time frame: 2 days after vaccination 2
Population: Safety population included all the participants who received the study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination 2 for 2-Visit Schedule (Initial Enrollment): Substudy B | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination 2 for 2-Visit Schedule (Initial Enrollment): Substudy B | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination 2 for 2-Visit Schedule (Initial Enrollment): Substudy B | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination 2 for 2-Visit Schedule (Initial Enrollment): Substudy B | 0 Percentage of participants |
Primary
Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
Percentage of participants reporting abnormal troponin I laboratory values 2 days after vaccination were reported in this outcome measure.
Time frame: 2 days after vaccination
Population: Safety population included all the participants who received the study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | 0 Percentage of participants |
Primary
Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination for Expanded Enrollment: Substudy B
Percentage of participants reporting abnormal troponin I laboratory values 2 days after vaccination were reported in this outcome measure.
Time frame: 2 days after last vaccination (i.e., Vaccination 1 for 1-visit schedule arms and Vaccination 2 for 2-visit schedule arms)
Population: Safety population included all the participants who received the study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination for Expanded Enrollment: Substudy B | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination for Expanded Enrollment: Substudy B | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination for Expanded Enrollment: Substudy B | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination for Expanded Enrollment: Substudy B | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination for Expanded Enrollment: Substudy B | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination for Expanded Enrollment: Substudy B | 0 Percentage of participants |
Primary
Percentage of Participants Reporting Adverse Events After Vaccination 1: Substudy A
An adverse event (AE) was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e, excluding local reactions and systematic events) were reported in this outcome measure.
Time frame: From Day 1 up to 4 weeks After Vaccination 1
Population: Vaccination 1 safety population included all participants who received Vaccination 1.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Adverse Events After Vaccination 1: Substudy A | 12.5 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Adverse Events After Vaccination 1: Substudy A | 20.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Adverse Events After Vaccination 1: Substudy A | 7.1 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Adverse Events After Vaccination 1: Substudy A | 14.3 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Adverse Events After Vaccination 1: Substudy A | 20.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Adverse Events After Vaccination 1: Substudy A | 17.6 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Adverse Events After Vaccination 1: Substudy A | 28.6 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Adverse Events After Vaccination 1: Substudy A | 13.3 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Adverse Events After Vaccination 1: Substudy A | 21.4 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Adverse Events After Vaccination 1: Substudy A | 6.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Adverse Events After Vaccination 1: Substudy A | 50.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Adverse Events After Vaccination 1: Substudy A | 18.8 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Adverse Events After Vaccination 1: Substudy A | 40.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Adverse Events After Vaccination 1: Substudy A | 13.3 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Adverse Events After Vaccination 1: Substudy A | 26.7 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Adverse Events After Vaccination 1: Substudy A | 20.0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Adverse Events After Vaccination 1: Substudy A | 6.7 Percentage of participants |
Primary
Percentage of Participants Reporting Adverse Events After Vaccination 2: Substudy A
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Time frame: From Day 1 up to 4 weeks After vaccination 2
Population: Vaccination 2 safety population included all participants who received Vaccination 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Adverse Events After Vaccination 2: Substudy A | 9.1 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Adverse Events After Vaccination 2: Substudy A | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Adverse Events After Vaccination 2: Substudy A | 8.1 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Adverse Events After Vaccination 2: Substudy A | 14.3 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Adverse Events After Vaccination 2: Substudy A | 25.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Adverse Events After Vaccination 2: Substudy A | 28.6 Percentage of participants |
Primary
Percentage of Participants Reporting Adverse Events From First Vaccination Until 4 Weeks After Last Vaccination: Substudy B
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (i.e, excluding local reactions and systematic events) were reported in this outcome measure.
Time frame: From first vaccination to 4 weeks after last vaccination (i.e., Vaccination 1 for 1-visit schedule arms and Vaccination 2 for 2-visit schedule arms)
Population: Safety population included all the participants who received the study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Adverse Events From First Vaccination Until 4 Weeks After Last Vaccination: Substudy B | 7.1 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Adverse Events From First Vaccination Until 4 Weeks After Last Vaccination: Substudy B | 13.3 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Adverse Events From First Vaccination Until 4 Weeks After Last Vaccination: Substudy B | 6.3 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Adverse Events From First Vaccination Until 4 Weeks After Last Vaccination: Substudy B | 6.3 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Adverse Events From First Vaccination Until 4 Weeks After Last Vaccination: Substudy B | 12.5 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Adverse Events From First Vaccination Until 4 Weeks After Last Vaccination: Substudy B | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Adverse Events From First Vaccination Until 4 Weeks After Last Vaccination: Substudy B | 6.3 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Adverse Events From First Vaccination Until 4 Weeks After Last Vaccination: Substudy B | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Adverse Events From First Vaccination Until 4 Weeks After Last Vaccination: Substudy B | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Adverse Events From First Vaccination Until 4 Weeks After Last Vaccination: Substudy B | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Adverse Events From First Vaccination Until 4 Weeks After Last Vaccination: Substudy B | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Adverse Events From First Vaccination Until 4 Weeks After Last Vaccination: Substudy B | 1.5 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Adverse Events From First Vaccination Until 4 Weeks After Last Vaccination: Substudy B | 3.1 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Adverse Events From First Vaccination Until 4 Weeks After Last Vaccination: Substudy B | 6.9 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Adverse Events From First Vaccination Until 4 Weeks After Last Vaccination: Substudy B | 8.5 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Adverse Events From First Vaccination Until 4 Weeks After Last Vaccination: Substudy B | 7.0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Adverse Events From First Vaccination Until 4 Weeks After Last Vaccination: Substudy B | 12.0 Percentage of participants |
Primary
Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in an electronic diary. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 cm. Redness and swelling were graded as mild (Grade 1): \>2.0 cm to 5.0 cm; moderate (Grade 2): \>5.0 cm to 10.0 cm; severe (Grade 3): \>10 cm; potentially life-threatening (Grade 4): necrosis or exfoliative dermatitis. Pain at injection site was graded as mild (Grade 1): did not interfere with activity; moderate (Grade 2): interfered with activity; severe (Grade 3): prevented daily activity and potentially life-threatening (Grade 4): emergency room visit or hospitalization for severe pain. Exact 2-sided confidence interval was based on the Clopper and Pearson method.
Time frame: From Day 1 to Day 7 after vaccination 1
Population: Safety population included all the participants who received the study intervention.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Moderate | 28.6 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Swelling: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Redness: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Mild | 21.4 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Redness: Severe | 7.1 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Redness: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Redness: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Swelling: Mild | 14.3 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Swelling: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Swelling: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Redness: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Swelling: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Redness: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Mild | 40.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Moderate | 6.7 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Swelling: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Redness: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Swelling: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Swelling: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Redness: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Swelling: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Redness: Mild | 6.3 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Redness: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Redness: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Redness: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Swelling: Mild | 6.3 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Swelling: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Swelling: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Mild | 31.3 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Swelling: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Swelling: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Redness: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Redness: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Redness: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Swelling: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Swelling: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Redness: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Mild | 25.0 Percentage of participants |
Primary
Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in an electronic diary. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 centimeter (cm). Redness and swelling were graded as mild (Grade 1): greater than (\>) 2.0 cm to 5.0 cm; moderate (Grade 2): \>5.0 cm to 10.0 cm; severe (Grade 3): \>10 cm; potentially life-threatening (Grade 4): necrosis or exfoliative dermatitis (redness) and necrosis (swelling). Pain at injection site was graded as mild (Grade 1): did not interfere with activity; moderate (Grade 2): interfered with activity; severe (Grade 3): prevented daily activity and potentially life-threatening (Grade 4): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Exact 2-sided confidence interval was based on the Clopper and Pearson method.
Time frame: From Day 1 to Day 7 after Vaccination 1
Population: Vaccination 1 safety population included all the participants who received vaccination 1. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Mild | 25.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Mild | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Mild | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Mild | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Mild | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Mild | 33.3 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Mild | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Mild | 42.9 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Moderate | 7.1 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Mild | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Moderate | 14.3 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Mild | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Mild | 50.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Mild | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Moderate | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Moderate | 6.7 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Mild | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Severe | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Moderate | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Mild | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Severe | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Mild | 53.3 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Moderate | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Severe | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Moderate | 5.9 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Mild | 5.9 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Moderate | 5.9 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Mild | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Mild | 29.4 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Moderate | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Moderate | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Mild | 28.6 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Moderate | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Mild | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Mild | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Moderate | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Mild | 42.9 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Mild | 14.3 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Moderate | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Moderate | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Moderate | 7.1 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Mild | 7.1 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Mild | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Moderate | 7.1 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Mild | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Moderate | 7.1 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Mild | 28.6 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Moderate | 7.1 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Mild | 6.7 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Mild | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Severe | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Moderate | 6.7 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Mild | 40.0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Moderate | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Severe | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Severe | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Moderate | 6.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Mild | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Severe | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Moderate | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Moderate | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Mild | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Severe | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Severe | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Mild | 42.9 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Moderate | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Severe | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Mild | 6.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Mild | 25.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Severe | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Severe | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Moderate | 6.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Mild | 6.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Moderate | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Moderate | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Mild | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Severe | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Moderate | 6.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Severe | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Moderate | 6.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Severe | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Mild | 53.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Mild | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Moderate | 6.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Severe | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Mild | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Mild | 46.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Severe | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Moderate | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Moderate | 13.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Severe | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Mild | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Moderate | 13.3 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Moderate | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Severe | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Mild | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Moderate | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Severe | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Moderate | 6.7 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Severe | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Mild | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Mild | 40.0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Grade 4 | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Moderate | 6.7 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Moderate | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Moderate | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Mild | 80.0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Grade 4 | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Severe | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Mild | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Grade 4 | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Mild | 6.7 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Severe | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Grade 4 | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Severe | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Mild | 53.3 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Moderate | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Severe | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Grade 4 | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Mild | 6.7 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Severe | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Severe | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Mild | 6.7 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Pain at injection site: Moderate | 13.3 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Grade 4 | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Redness: Grade 4 | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A | Swelling: Moderate | 0 Percentage of participants |
Primary
Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in an electronic diary. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 cm. Redness and swelling were graded as mild (Grade 1): \>2.0 cm to 5.0 cm; moderate (Grade 2): \>5.0 cm to 10.0 cm; severe (Grade 3): \>10 cm; potentially life-threatening (Grade 4): necrosis or exfoliative dermatitis. Pain at injection site was graded as mild (Grade 1): did not interfere with activity; moderate (Grade 2): interfered with activity; severe (Grade 3): prevented daily activity and potentially life-threatening (Grade 4): emergency room visit or hospitalization for severe pain. Exact 2-sided confidence interval was based on the Clopper and Pearson method.
Time frame: From Day 1 to Day 7 after vaccination 2
Population: Safety population included all the participants who received the study intervention. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Moderate | 7.7 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Swelling: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Redness: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Mild | 30.8 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Redness: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Redness: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Redness: Moderate | 7.7 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Swelling: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Swelling: Moderate | 7.7 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Swelling: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Redness: Moderate | 7.1 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Swelling: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Redness: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Mild | 42.9 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Swelling: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Redness: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Swelling: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Swelling: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Redness: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Swelling: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Redness: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Redness: Moderate | 6.7 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Redness: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Redness: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Swelling: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Swelling: Moderate | 6.7 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Swelling: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Mild | 13.3 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Moderate | 6.7 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Swelling: Moderate | 6.3 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Swelling: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Redness: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Redness: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Redness: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Swelling: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Swelling: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Redness: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Mild | 18.8 Percentage of participants |
Primary
Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in an electronic diary. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 cm. Redness and swelling were graded as mild (Grade 1): \>2.0 cm to 5.0 cm; moderate (Grade 2): \>5.0 cm to 10.0 cm; severe (Grade 3): \>10 cm; potentially life-threatening (Grade 4): necrosis or exfoliative dermatitis. Pain at injection site was graded as mild (Grade 1): did not interfere with activity; moderate (Grade 2): interfered with activity; severe (Grade 3): prevented daily activity and potentially life-threatening (Grade 4): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Exact 2-sided confidence interval was based on the Clopper and Pearson method.
Time frame: From Day 1 to Day 7 after Vaccination 2
Population: Vaccination 2 safety population included all the participants who received vaccination 2. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. Data for mIRV A + Licensed QIV is missing as there was no e-diary data transmitted.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Pain at injection site: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Pain at injection site: Moderate | 12.5 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Swelling: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Pain at injection site: Mild | 50.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Redness: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Redness: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Pain at injection site: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Swelling: Mild | 12.5 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Redness: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Swelling: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Redness: Mild | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Swelling: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Pain at injection site: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Swelling: Mild | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Pain at injection site: Mild | 33.3 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Redness: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Swelling: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Pain at injection site: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Swelling: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Redness: Mild | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Redness: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Pain at injection site: Moderate | 66.7 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Swelling: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Redness: Moderate | 33.3 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Pain at injection site: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Redness: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Redness: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Swelling: Mild | 14.3 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Swelling: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Swelling: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Swelling: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Pain at injection site: Mild | 57.1 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Pain at injection site: Moderate | 14.3 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Redness: Mild | 14.3 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Redness: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Pain at injection site: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Pain at injection site: Mild | 30.4 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Swelling: Severe | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Swelling: Moderate | 4.3 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Redness: Mild | 4.3 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Swelling: Mild | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Pain at injection site: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Pain at injection site: Moderate | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Redness: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Redness: Moderate | 8.7 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Pain at injection site: Severe | 4.3 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Swelling: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Redness: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Pain at injection site: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Pain at injection site: Moderate | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Swelling: Moderate | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Redness: Moderate | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Swelling: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Swelling: Mild | 16.7 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Pain at injection site: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Redness: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Redness: Mild | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Pain at injection site: Mild | 50.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Redness: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A | Swelling: Severe | 0 Percentage of participants |
Primary
Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in an electronic diary. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 cm. Redness and swelling were graded as mild (Grade 1): \>2.0 cm to 5.0 cm; moderate (Grade 2): \>5.0 cm to 10.0 cm; severe (Grade 3): \>10 cm; potentially life-threatening (Grade 4): necrosis or exfoliative dermatitis. Pain at injection site was graded as mild (Grade 1): did not interfere with activity; moderate (Grade 2): interfered with activity; severe (Grade 3): prevented daily activity and potentially life-threatening (Grade 4): emergency room visit or hospitalization for severe pain. Exact 2-sided confidence interval was based on the Clopper and Pearson method.
Time frame: From Day 1 to Day 7 after vaccination
Population: Safety population included all the participants who received the study intervention.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Swelling: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Swelling: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Swelling: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Redness: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Redness: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Redness: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Redness: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Moderate | 6.3 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Swelling: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Mild | 31.3 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Redness: Mild | 6.7 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Redness: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Moderate | 20.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Swelling: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Swelling: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Mild | 40.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Swelling: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Redness: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Redness: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Swelling: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Swelling: Mild | 6.3 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Redness: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Moderate | 18.8 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Redness: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Swelling: Moderate | 6.3 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Swelling: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Mild | 31.3 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Swelling: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Redness: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Redness: Mild | 6.3 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Redness: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Redness: Moderate | 6.7 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Redness: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Redness: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Swelling: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Swelling: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Swelling: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Swelling: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Mild | 13.3 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Mild | 14.3 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Redness: Mild | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Redness: Severe | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Redness: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Moderate | 14.3 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Swelling: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Swelling: Severe | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Severe | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Swelling: Mild | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Redness: Moderate | 14.3 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Swelling: Moderate | 14.3 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Swelling: Severe | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Swelling: Mild | 6.3 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Swelling: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Redness: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Mild | 25.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Redness: Severe | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Moderate | 12.5 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Redness: Moderate | 6.3 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Severe | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Redness: Mild | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Swelling: Moderate | 12.5 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Swelling: Severe | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Redness: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Swelling: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Severe | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Redness: Mild | 20.0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Swelling: Mild | 6.7 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Redness: Severe | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Swelling: Moderate | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Moderate | 6.7 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Pain at injection site: Mild | 33.3 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Redness: Moderate | 6.7 Percentage of participants |
Primary
Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in an electronic diary. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 cm. Redness and swelling were graded as mild (Grade 1): \>2.0 cm to 5.0 cm; moderate (Grade 2): \>5.0 cm to 10.0 cm; severe (Grade 3): \>10 cm; potentially life-threatening (Grade 4): necrosis or exfoliative dermatitis. Pain at injection site was graded as mild (Grade 1): did not interfere with activity; moderate (Grade 2): interfered with activity; severe (Grade 3): prevented daily activity and potentially life-threatening (Grade 4): emergency room visit or hospitalization for severe pain. Exact 2-sided confidence interval was based on the Clopper and Pearson method.
Time frame: From Day 1 to Day 7 after vaccination 1 for all arms; From Day 1 to Day 7 after vaccination 2 for 2 doses of qIRV (dose level 1), 2-visit schedule arm
Population: Safety population included all the participants who received the study intervention. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed'(n) = number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Swelling: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Pain at injection site: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Swelling: Moderate | 5.3 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Redness: Moderate | 3.8 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Pain at injection site: Severe | 0.8 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Pain at injection site: Moderate | 21.4 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Redness: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Pain at injection site: Mild | 38.2 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Redness: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Redness: Mild | 6.1 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Swelling: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Swelling: Mild | 4.6 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Swelling: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Swelling: Mild | 9.9 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Redness: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Swelling: Moderate | 6.9 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Pain at injection site: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Pain at injection site: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Pain at injection site: Mild | 33.6 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Redness: Moderate | 1.5 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Redness: Mild | 10.7 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Redness: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Pain at injection site: Moderate | 29.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Swelling: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Redness: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Redness: Mild | 0.9 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Redness: Moderate | 2.6 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Redness: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Swelling: Mild | 5.2 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Swelling: Moderate | 4.3 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Swelling: Severe | 0.9 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Swelling: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Pain at injection site: Mild | 38.3 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Pain at injection site: Moderate | 6.1 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Pain at injection site: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Pain at injection site: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Redness: Moderate | 3.4 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Redness: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Pain at injection site: Moderate | 13.7 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Pain at injection site: Mild | 40.2 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Swelling: Moderate | 6.8 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Swelling: Mild | 3.4 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Redness: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Pain at injection site: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Redness: Mild | 4.3 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Swelling: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Swelling: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Pain at injection site: Severe | 0.9 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Redness: Severe | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Redness: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Swelling: Severe | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Swelling: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Pain at injection site: Mild | 26.3 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Redness: Moderate | 1.8 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Pain at injection site: Moderate | 1.8 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Pain at injection site: Severe | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Redness: Mild | 2.6 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Pain at injection site: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Swelling: Mild | 0.9 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Swelling: Moderate | 4.4 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Redness: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Redness: Mild | 2.6 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: Pain at injection site: Severe | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Swelling: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Swelling: Severe | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Pain at injection site: Severe | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: Swelling: Moderate | 3.1 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: Swelling: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: Pain at injection site: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Redness: Severe | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: Swelling: Severe | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Pain at injection site: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: Redness: Mild | 4.1 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: Redness: Moderate | 5.1 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: Redness: Severe | 1.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: Redness: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: Swelling: Mild | 5.1 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Pain at injection site: Mild | 41.7 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Redness: Moderate | 1.7 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Swelling: Mild | 8.7 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: Pain at injection site: Moderate | 8.2 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: Pain at injection site: Mild | 33.7 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Swelling: Moderate | 1.7 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B | Pain at injection site: Moderate | 8.7 Percentage of participants |
Primary
Percentage of Participants Reporting New ECG Abnormalities 2 Days After Vaccination 1 for 1-Visit Schedule (Initial Enrollment): Substudy B
Twelve lead ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. An ECG abnormality was defined as any new abnormality that, as judged by a cardiologist, was consistent with probable or possible myocarditis or pericarditis, including: Sustained atrial or ventricular arrhythmias, Second-degree Mobitz Type II or worse atrioventricular block, new bundle branch block and Diffuse ST-segment elevation or PR-segment inversion, compatible with pericarditis.
Time frame: 2 days after vaccination 1
Population: Safety population included all the participants who received the study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting New ECG Abnormalities 2 Days After Vaccination 1 for 1-Visit Schedule (Initial Enrollment): Substudy B | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting New ECG Abnormalities 2 Days After Vaccination 1 for 1-Visit Schedule (Initial Enrollment): Substudy B | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting New ECG Abnormalities 2 Days After Vaccination 1 for 1-Visit Schedule (Initial Enrollment): Substudy B | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting New ECG Abnormalities 2 Days After Vaccination 1 for 1-Visit Schedule (Initial Enrollment): Substudy B | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting New ECG Abnormalities 2 Days After Vaccination 1 for 1-Visit Schedule (Initial Enrollment): Substudy B | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting New ECG Abnormalities 2 Days After Vaccination 1 for 1-Visit Schedule (Initial Enrollment): Substudy B | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting New ECG Abnormalities 2 Days After Vaccination 1 for 1-Visit Schedule (Initial Enrollment): Substudy B | 0 Percentage of participants |
Primary
Percentage of Participants Reporting New ECG Abnormalities 2 Days After Vaccination 1 for 2-Visit Schedule (Initial Enrollment): Substudy B
Twelve lead ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. An ECG abnormality was defined as any new abnormality that, as judged by a cardiologist, was consistent with probable or possible myocarditis or pericarditis, including: Sustained atrial or ventricular arrhythmias, Second-degree Mobitz Type II or worse atrioventricular block, new bundle branch block and Diffuse ST-segment elevation or PR-segment inversion, compatible with pericarditis.
Time frame: 2 days after vaccination 1
Population: Safety population included all the participants who received the study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting New ECG Abnormalities 2 Days After Vaccination 1 for 2-Visit Schedule (Initial Enrollment): Substudy B | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting New ECG Abnormalities 2 Days After Vaccination 1 for 2-Visit Schedule (Initial Enrollment): Substudy B | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting New ECG Abnormalities 2 Days After Vaccination 1 for 2-Visit Schedule (Initial Enrollment): Substudy B | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting New ECG Abnormalities 2 Days After Vaccination 1 for 2-Visit Schedule (Initial Enrollment): Substudy B | 0 Percentage of participants |
Primary
Percentage of Participants Reporting New ECG Abnormalities 2 Days After Vaccination 2 for 2-Visit Schedule (Initial Enrollment): Substudy B
Twelve lead ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. An ECG abnormality was defined as any new abnormality that, as judged by a cardiologist, was consistent with probable or possible myocarditis or pericarditis, including: Sustained atrial or ventricular arrhythmias, Second-degree Mobitz Type II or worse atrioventricular block, new bundle branch block and Diffuse ST-segment elevation or PR-segment inversion, compatible with pericarditis.
Time frame: 2 days after vaccination 2
Population: Safety population included all the participants who received the study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting New ECG Abnormalities 2 Days After Vaccination 2 for 2-Visit Schedule (Initial Enrollment): Substudy B | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting New ECG Abnormalities 2 Days After Vaccination 2 for 2-Visit Schedule (Initial Enrollment): Substudy B | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting New ECG Abnormalities 2 Days After Vaccination 2 for 2-Visit Schedule (Initial Enrollment): Substudy B | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting New ECG Abnormalities 2 Days After Vaccination 2 for 2-Visit Schedule (Initial Enrollment): Substudy B | 0 Percentage of participants |
Primary
Percentage of Participants Reporting New ECG Abnormalities 2 Days After Vaccination for Expanded Enrollment: Substudy B
Twelve lead ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. An ECG abnormality was defined as any new abnormality that, as judged by a cardiologist, was consistent with probable or possible myocarditis or pericarditis, including: Sustained atrial or ventricular arrhythmias, Second-degree Mobitz Type II or worse atrioventricular block, new bundle branch block and Diffuse ST-segment elevation or PR-segment inversion, compatible with pericarditis.
Time frame: 2 days after last vaccination (i.e., Vaccination 1 for 1-visit schedule arms and Vaccination 2 for 2-visit schedule arms)
Population: Safety population included all the participants who received the study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting New ECG Abnormalities 2 Days After Vaccination for Expanded Enrollment: Substudy B | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting New ECG Abnormalities 2 Days After Vaccination for Expanded Enrollment: Substudy B | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting New ECG Abnormalities 2 Days After Vaccination for Expanded Enrollment: Substudy B | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting New ECG Abnormalities 2 Days After Vaccination for Expanded Enrollment: Substudy B | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting New ECG Abnormalities 2 Days After Vaccination for Expanded Enrollment: Substudy B | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting New ECG Abnormalities 2 Days After Vaccination for Expanded Enrollment: Substudy B | 0 Percentage of participants |
Primary
Percentage of Participants Reporting Serious Adverse Events From First Vaccination Until 6 Months After Last Vaccination: Substudy B
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event.
Time frame: From first vaccination to 6 month after last vaccination (i.e., Vaccination 1 for 1-visit schedule arms and Vaccination 2 for 2-visit schedule arms)
Population: Safety population included all the participants who received the study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Serious Adverse Events From First Vaccination Until 6 Months After Last Vaccination: Substudy B | 0.00 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Serious Adverse Events From First Vaccination Until 6 Months After Last Vaccination: Substudy B | 0.00 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Serious Adverse Events From First Vaccination Until 6 Months After Last Vaccination: Substudy B | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Serious Adverse Events From First Vaccination Until 6 Months After Last Vaccination: Substudy B | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Serious Adverse Events From First Vaccination Until 6 Months After Last Vaccination: Substudy B | 6.3 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Serious Adverse Events From First Vaccination Until 6 Months After Last Vaccination: Substudy B | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Serious Adverse Events From First Vaccination Until 6 Months After Last Vaccination: Substudy B | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Serious Adverse Events From First Vaccination Until 6 Months After Last Vaccination: Substudy B | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Serious Adverse Events From First Vaccination Until 6 Months After Last Vaccination: Substudy B | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Serious Adverse Events From First Vaccination Until 6 Months After Last Vaccination: Substudy B | 0.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Serious Adverse Events From First Vaccination Until 6 Months After Last Vaccination: Substudy B | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Serious Adverse Events From First Vaccination Until 6 Months After Last Vaccination: Substudy B | 0.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Serious Adverse Events From First Vaccination Until 6 Months After Last Vaccination: Substudy B | 1.5 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Serious Adverse Events From First Vaccination Until 6 Months After Last Vaccination: Substudy B | 0.9 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Serious Adverse Events From First Vaccination Until 6 Months After Last Vaccination: Substudy B | 0.0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Serious Adverse Events From First Vaccination Until 6 Months After Last Vaccination: Substudy B | 0.0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Serious Adverse Events From First Vaccination Until 6 Months After Last Vaccination: Substudy B | 0 Percentage of participants |
Primary
Percentage of Participants Reporting Serious Adverse Events (SAE) From First Vaccination to 6 Months After Last Vaccination: Substudy A
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event.
Time frame: From vaccination 1 on day 1 up to 6 months after vaccination 2
Population: Safety population included all the participants who received the study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Serious Adverse Events (SAE) From First Vaccination to 6 Months After Last Vaccination: Substudy A | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Serious Adverse Events (SAE) From First Vaccination to 6 Months After Last Vaccination: Substudy A | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Serious Adverse Events (SAE) From First Vaccination to 6 Months After Last Vaccination: Substudy A | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Serious Adverse Events (SAE) From First Vaccination to 6 Months After Last Vaccination: Substudy A | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Serious Adverse Events (SAE) From First Vaccination to 6 Months After Last Vaccination: Substudy A | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Serious Adverse Events (SAE) From First Vaccination to 6 Months After Last Vaccination: Substudy A | 5.9 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Serious Adverse Events (SAE) From First Vaccination to 6 Months After Last Vaccination: Substudy A | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Serious Adverse Events (SAE) From First Vaccination to 6 Months After Last Vaccination: Substudy A | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Serious Adverse Events (SAE) From First Vaccination to 6 Months After Last Vaccination: Substudy A | 0.0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Serious Adverse Events (SAE) From First Vaccination to 6 Months After Last Vaccination: Substudy A | 6.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Serious Adverse Events (SAE) From First Vaccination to 6 Months After Last Vaccination: Substudy A | 7.1 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Serious Adverse Events (SAE) From First Vaccination to 6 Months After Last Vaccination: Substudy A | 0.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Serious Adverse Events (SAE) From First Vaccination to 6 Months After Last Vaccination: Substudy A | 0.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Serious Adverse Events (SAE) From First Vaccination to 6 Months After Last Vaccination: Substudy A | 0.0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Serious Adverse Events (SAE) From First Vaccination to 6 Months After Last Vaccination: Substudy A | 0.0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Serious Adverse Events (SAE) From First Vaccination to 6 Months After Last Vaccination: Substudy A | 0.0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Serious Adverse Events (SAE) From First Vaccination to 6 Months After Last Vaccination: Substudy A | 0.0 Percentage of participants |
Primary
Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
Systemic events included fever, vomiting, diarrhea, headache, fatigue, chills, new/worsened muscle pain & new /worsened joint pain & recorded by participants in electronic diary. Fever defined as oral temperature \>=38.0 deg C & categorized as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C & \>40.0 deg C. Vomiting graded as: G 1: 1-2 times in 24 hrs; G 2: \>2 times in 24 hrs; G 3: required IV hydration; G 4: emergency room visit/ hospitalization for hypotensive shock. Diarrhea graded as: G 1: 2-3 loose stools in 24 hrs; G 2: 4-5 loose stools in 24 hrs; G 3: 6 or more loose stools in 24 hrs & G 4: emergency room visit/ hospitalization. Headache, fatigue, chills, new/worsened muscle pain & new/worsened joint pain: G 1: didn't interfere with activity; G 2: some interference with activity; G 3: prevented daily routine activity & G 4: emergency room visit/ hospitalization. Exact 2-sided confidence interval based on Clopper and Pearson method.
Time frame: From Day 1 to Day 7 after vaccination 1
Population: Safety population included all the participants who received the study intervention.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Headache: Mild | 7.1 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Fever: >38.4 degree C to 38.9 degree C | 7.1 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Fever: >38.9 degree C to 40.0 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Fever: >40.0 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Fatigue: Mild | 14.3 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Fatigue: Moderate | 21.4 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Fatigue: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Fatigue: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Fever: >=38.0 degree C to 38.4°C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Headache: Moderate | 28.6 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Headache: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Headache: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Chills: Mild | 14.3 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Chills: Moderate | 7.1 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Chills: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Chills: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Mild | 21.4 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Moderate | 14.3 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Mild | 7.1 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Moderate | 14.3 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Fatigue: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Mild | 6.7 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Moderate | 6.7 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Headache: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Headache: Moderate | 13.3 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Mild | 6.7 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Fatigue: Mild | 40.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Chills: Mild | 20.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Headache: Mild | 13.3 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Fever: >40.0 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Chills: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Fatigue: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Fever: >38.9 degree C to 40.0 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Fatigue: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Chills: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Headache: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Fever: >38.4 degree C to 38.9 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Chills: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Fever: >=38.0 degree C to 38.4°C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Headache: Mild | 6.3 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Headache: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Headache: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Headache: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Chills: Mild | 6.3 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Chills: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Chills: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Chills: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Mild | 6.3 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Fever: >=38.0 degree C to 38.4°C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Fever: >38.4 degree C to 38.9 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Fever: >38.9 degree C to 40.0 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Fever: >40.0 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Fatigue: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Fatigue: Moderate | 6.3 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Fatigue: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Fatigue: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Headache: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Chills: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Fever: >=38.0 degree C to 38.4°C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Chills: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Fatigue: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Fever: >38.4 degree C to 38.9 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Headache: Mild | 12.5 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Chills: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Headache: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Fever: >38.9 degree C to 40.0 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Chills: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Fatigue: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Fever: >40.0 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Headache: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Fatigue: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Fatigue: Mild | 31.3 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Moderate | 6.3 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Grade 4 | 0.0 Percentage of participants |
Primary
Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A
Systemic events included fever, vomiting, diarrhea, headache,fatigue,chills,new/worsened muscle pain & new/worsened joint pain & recorded by participants in an electronic diary.Fever defined as oral temperature greater than equal to(\>=)38.0 degrees Celsius(deg C) & categorized as\>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C,\>38.9 to 40.0 deg C & \>40.0 deg C. Vomiting graded as:Grade(G)1:1-2 times in 24 hours(h);G2:\>2 times in 24h;G3:required Intravenous (IV) hydration.Diarrhea graded as: G1:2-3 loose stools in 24h;G2: 4-5 loose stools in 24h;G3: 6 or more loose stools in 24h.Headache,fatigue,chills, new/worsened muscle pain & new/worsened joint pain:G1:didn't interfere with activity;G2: some interference with activity;G3:prevented daily routine activity.For all systemic events except fever, Grade 4=emergency room visit or hospitalization. Grade 4 events were classified by the investigator or medically qualified person.Exact 2-sided confidence interval based on Clopper and Pearson method.
Time frame: From Day 1 to Day 7 After Vaccination 1
Population: Vaccination 1 safety population included all participants who received the study vaccination 1. 'Number Analyzed' signifies number of participants evaluable for the specified rows. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Mild | 12.5 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Mild | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Mild | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Moderate | 12.5 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >40.0 deg C | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Mild | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Mild | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >38.9 deg C to 40.0 deg C | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Mild | 18.8 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >38.4 deg C to 38.9 deg C | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Mild | 18.8 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >=38.0 deg C to 38.4 deg C | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Mild | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Mild | 13.3 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >40.0 deg C | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >38.9 deg C to 40.0 deg C | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >38.4 deg C to 38.9 deg C | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >=38.0 deg C to 38.4 deg C | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Mild | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Mild | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Mild | 6.7 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Mild | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Moderate | 13.3 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Mild | 6.7 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >=38.0 deg C to 38.4 deg C | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >38.4 deg C to 38.9 deg C | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Mild | 14.3 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >38.9 deg C to 40.0 deg C | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Mild | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Mild | 7.1 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Severe | 7.1 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Mild | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Mild | 7.1 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >40.0 deg C | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Mild | 7.1 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Mild | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Mild | 14.3 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Mild | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Mild | 7.1 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Mild | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >=38.0 deg C to 38.4 deg C | 7.1 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >38.4 deg C to 38.9 deg C | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >38.9 deg C to 40.0 deg C | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >40.0 deg C | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Mild | 35.7 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Mild | 21.4 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Severe | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Moderate | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Severe | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Severe | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Moderate | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Mild | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Mild | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >40.0 deg C | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Severe | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Mild | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Severe | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Mild | 6.7 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Moderate | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Moderate | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Moderate | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >38.9 deg C to 40.0 deg C | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Moderate | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Mild | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Mild | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >38.4 deg C to 38.9 deg C | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Severe | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >=38.0 deg C to 38.4 deg C | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Moderate | 6.7 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Mild | 6.7 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Moderate | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Mild | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Mild | 11.8 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Moderate | 5.9 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Moderate | 11.8 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Moderate | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >38.9 deg C to 40.0 deg C | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >=38.0 deg C to 38.4 deg C | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Moderate | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >40.0 deg C | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Mild | 5.9 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Mild | 5.9 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Moderate | 5.9 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Mild | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Mild | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Mild | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >38.4 deg C to 38.9 deg C | 5.9 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Moderate | 5.9 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >=38.0 deg C to 38.4 deg C | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Moderate | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Mild | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Moderate | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Mild | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Mild | 7.1 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >40.0 deg C | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Mild | 7.1 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Moderate | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >38.9 deg C to 40.0 deg C | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Moderate | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >38.4 deg C to 38.9 deg C | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Mild | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Moderate | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Moderate | 21.4 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Mild | 7.1 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Mild | 7.1 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Moderate | 14.3 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >38.4 deg C to 38.9 deg C | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Mild | 14.3 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Moderate | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Mild | 14.3 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Mild | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Mild | 14.3 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Moderate | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Moderate | 14.3 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Mild | 14.3 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Moderate | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Moderate | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >=38.0 deg C to 38.4 deg C | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >38.9 deg C to 40.0 deg C | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Moderate | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >40.0 deg C | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Mild | 14.3 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Mild | 7.1 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Moderate | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >=38.0 deg C to 38.4 deg C | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Moderate | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >38.9 deg C to 40.0 deg C | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Moderate | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Mild | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >38.4 deg C to 38.9 deg C | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Moderate | 14.3 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Mild | 7.1 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Mild | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Mild | 21.4 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Moderate | 14.3 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Moderate | 7.1 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Mild | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Mild | 7.1 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >40.0 deg C | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Moderate | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Mild | 7.1 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Moderate | 7.1 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Severe | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Severe | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Mild | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Mild | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Moderate | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Severe | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Moderate | 26.7 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Severe | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Moderate | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Severe | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Mild | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Moderate | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >38.4 deg C to 38.9 deg C | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >40.0 deg C | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Moderate | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Severe | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Moderate | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >=38.0 deg C to 38.4 deg C | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Mild | 33.3 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Mild | 6.7 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Moderate | 13.3 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Severe | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Mild | 13.3 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >38.9 deg C to 40.0 deg C | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Severe | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Mild | 13.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Mild | 28.6 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Severe | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Moderate | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >38.9 deg C to 40.0 deg C | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Severe | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Severe | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Moderate | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Severe | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Mild | 7.1 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Moderate | 7.1 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Severe | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >=38.0 deg C to 38.4 deg C | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Severe | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >40.0 deg C | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Moderate | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Severe | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Mild | 14.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Mild | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >38.4 deg C to 38.9 deg C | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Moderate | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Moderate | 7.1 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Mild | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Moderate | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Mild | 7.1 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Mild | 14.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Moderate | 6.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Severe | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Mild | 12.5 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Severe | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Mild | 6.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Moderate | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Severe | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Severe | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Moderate | 6.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Severe | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Moderate | 6.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >=38.0 deg C to 38.4 deg C | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >38.4 deg C to 38.9 deg C | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Mild | 6.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Moderate | 6.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >38.9 deg C to 40.0 deg C | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Mild | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >40.0 deg C | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Mild | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Severe | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Mild | 18.8 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Moderate | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Moderate | 6.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Mild | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Severe | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Moderate | 6.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Severe | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >=38.0 deg C to 38.4 deg C | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Moderate | 26.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Moderate | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Mild | 20.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Mild | 13.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Moderate | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Mild | 26.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Severe | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Moderate | 13.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Mild | 6.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >40.0 deg C | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Moderate | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >38.9 deg C to 40.0 deg C | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Severe | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >38.4 deg C to 38.9 deg C | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Mild | 20.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Severe | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Mild | 20.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Mild | 20.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Severe | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Moderate | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Severe | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Severe | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >=38.0 deg C to 38.4 deg C | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Severe | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >38.9 deg C to 40.0 deg C | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Mild | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Mild | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Severe | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Moderate | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Severe | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Mild | 46.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >40.0 deg C | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Severe | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Mild | 6.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Moderate | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Mild | 6.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Moderate | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Moderate | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Severe | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Moderate | 13.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Moderate | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >38.4 deg C to 38.9 deg C | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Moderate | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Severe | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Mild | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Mild | 6.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Severe | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Mild | 6.7 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Moderate | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Severe | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Mild | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Moderate | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Severe | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Mild | 6.7 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Moderate | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Severe | 6.7 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Mild | 6.7 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Moderate | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Severe | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Mild | 6.7 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Moderate | 6.7 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Severe | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >=38.0 deg C to 38.4 deg C | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >38.4 deg C to 38.9 deg C | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >38.9 deg C to 40.0 deg C | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >40.0 deg C | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Mild | 13.3 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Moderate | 13.3 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Severe | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Grade 4 | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Mild | 20.0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Moderate | 6.7 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Severe | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Severe | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Moderate | 13.3 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Mild | 26.7 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >40.0 deg C | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >38.9 deg C to 40.0 deg C | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >38.4 deg C to 38.9 deg C | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >=38.0 deg C to 38.4 deg C | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Mild | 13.3 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Mild | 26.7 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Grade 4 | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Severe | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Moderate | 6.7 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Mild | 0.0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Grade 4 | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Severe | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Moderate | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Moderate | 6.7 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Mild | 6.7 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Grade 4 | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Severe | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Moderate | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Mild | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Grade 4 | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Severe | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Grade 4 | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Severe | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Moderate | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Mild | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Grade 4 | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Severe | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Moderate | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Grade 4 | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Moderate | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Moderate | 20.0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Mild | 0.0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Mild | 33.3 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Severe | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >40.0 deg C | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Grade 4 | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >38.9 deg C to 40.0 deg C | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Moderate | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >38.4 deg C to 38.9 deg C | 6.7 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Severe | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fever: >=38.0 deg C to 38.4 deg C | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Moderate | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Grade 4 | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Moderate | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Mild | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Mild | 13.3 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Diarrhea: Mild | 13.3 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Severe | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Grade 4 | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Moderate | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Grade 4 | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened joint pain: Mild | 6.7 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Grade 4 | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Grade 4 | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Vomiting: Severe | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Severe | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Mild | 6.7 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | New or worsened muscle pain: Moderate | 13.3 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Chills: Severe | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Headache: Grade 4 | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A | Fatigue: Severe | 0 Percentage of participants |
Primary
Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B
Systemic events included fever, vomiting, diarrhea, headache, fatigue, chills, new/worsened muscle pain & new /worsened joint pain & recorded by participants in electronic diary. Fever defined as oral temperature \>=38.0 deg C & categorized as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C & \>40.0 deg C. Vomiting graded as: G 1: 1-2 times in 24 hrs; G 2: \>2 times in 24 hrs; G 3: required IV hydration; G 4: emergency room visit/ hospitalization for hypotensive shock. Diarrhea graded as: G: 1: 2-3 loose stools in 24 hrs; G 2: 4-5 loose stools in 24 hrs; G 3: 6 or more loose stools in 24 hrs & G 4: emergency room visit/ hospitalization. Headache, fatigue, chills, new/worsened muscle pain & new/worsened joint pain: G 1: didn't interfere with activity; G 2: some interference with activity; G 3: prevented daily routine activity & G 4: emergency room visit/ hospitalization. Exact 2-sided confidence interval based on Clopper and Pearson method.
Time frame: From day 1 to day 7 of vaccination 2
Population: Safety population included all the participants who received the study intervention. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | New or worsened muscle pain: Mild | 23.1 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Vomiting: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Diarrhea: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Vomiting: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Fatigue: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Vomiting: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Diarrhea: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Diarrhea: Mild | 7.7 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | New or worsened joint pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Diarrhea: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | New or worsened joint pain: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Headache: Mild | 7.7 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Fatigue: Mild | 23.1 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Headache: Moderate | 7.7 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | New or worsened joint pain: Mild | 7.7 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Headache: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Fever: >40.0 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Headache: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Fever: >=38.0 degree C to 38.4 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Fatigue: Moderate | 7.7 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | New or worsened muscle pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Fever: >38.4 degree C to 38.9 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Fever: >38.9 degree C to 40.0 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | New or worsened muscle pain: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Chills: Mild | 15.4 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Chills: Moderate | 7.7 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | New or worsened joint pain: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | New or worsened muscle pain: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Chills: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Fatigue: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Chills: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Vomiting: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Fatigue: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Vomiting: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | New or worsened joint pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Diarrhea: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | New or worsened muscle pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Vomiting: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | New or worsened joint pain: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Chills: Mild | 14.3 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Headache: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Vomiting: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | New or worsened joint pain: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Diarrhea: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Fever: >40.0 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Vomiting: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Fatigue: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Fever: >=38.0 degree C to 38.4 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | New or worsened muscle pain: Moderate | 7.1 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Diarrhea: Mild | 7.1 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Chills: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Diarrhea: Moderate | 7.1 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Chills: Moderate | 7.1 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Fever: >38.4 degree C to 38.9 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Fatigue: Moderate | 7.1 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Headache: Mild | 14.3 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | New or worsened muscle pain: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | New or worsened joint pain: Mild | 14.3 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Chills: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Headache: Moderate | 7.1 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Fatigue: Mild | 21.4 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Fever: >38.9 degree C to 40.0 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | New or worsened muscle pain: Mild | 7.1 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Headache: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Headache: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Fever: >40.0 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Fatigue: Mild | 13.3 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Fatigue: Moderate | 13.3 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Fatigue: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Fatigue: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Headache: Mild | 26.7 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Headache: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Fever: >38.9 degree C to 40.0 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Headache: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Fever: >=38.0 degree C to 38.4 degree C | 6.7 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Fever: >38.4 degree C to 38.9 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Chills: Mild | 6.7 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Chills: Moderate | 6.7 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Chills: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Chills: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Vomiting: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Vomiting: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Vomiting: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Vomiting: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Diarrhea: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Diarrhea: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Diarrhea: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Diarrhea: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | New or worsened muscle pain: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | New or worsened muscle pain: Moderate | 6.7 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | New or worsened muscle pain: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | New or worsened muscle pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | New or worsened joint pain: Mild | 6.7 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | New or worsened joint pain: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | New or worsened joint pain: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | New or worsened joint pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Chills: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Chills: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Fatigue: Moderate | 6.3 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | New or worsened muscle pain: Mild | 12.5 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Chills: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Chills: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Fatigue: Mild | 12.5 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | New or worsened muscle pain: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Headache: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Fever: >38.4 degree C to 38.9 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | New or worsened joint pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | New or worsened muscle pain: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Fever: >=38.0 degree C to 38.4 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Headache: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | New or worsened joint pain: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | New or worsened muscle pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Headache: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Headache: Mild | 12.5 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Fever: >40.0 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | New or worsened joint pain: Mild | 12.5 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Fatigue: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Diarrhea: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Fatigue: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Diarrhea: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Vomiting: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Vomiting: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Fever: >38.9 degree C to 40.0 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Diarrhea: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Vomiting: Moderate | 6.3 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Vomiting: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | New or worsened joint pain: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B | Diarrhea: Grade 4 | 0.0 Percentage of participants |
Primary
Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A
Systemic events included fever, vomiting, diarrhea, headache, fatigue, chills, new/worsened muscle pain & new /worsened joint pain & recorded by participants in electronic diary. Fever defined as oral temperature \>=38.0 deg C & categorized as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C & \>40.0 deg C. Vomiting graded as: Grade(G) 1: 1-2 times in 24 h; G2: \>2 times in 24 h; G3: required IV hydration. Diarrhea graded as: G1: 2-3 loose stools in 24 h; G2: 4-5 loose stools in 24 h; G3: 6 or more loose stools in 24 h. Headache, fatigue, chills, new/worsened muscle pain & new/worsened joint pain: G1: didn't interfere with activity; G2: some interference with activity; G3: prevented daily routine activity. For all systemic events except fever, Grade 4= emergency room visit or hospitalization. Grade 4 events were classified by the investigator or medically qualified person. Exact 2-sided confidence interval based on Clopper and Pearson method.
Time frame: From Day 1 to Day 7 after Vaccination 2
Population: Vaccination 2 safety population included all participants who received vaccination 2. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows. Data for mIRV A + Licensed QIV is missing as there was no e-diary data transmitted.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Headache: Mild | 12.5 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Fever: >38.4 deg C to 38.9 deg C | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Fever: >38.9 deg C to 40.0 deg C | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Fever: >40.0 deg C | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Fatigue: Mild | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Fatigue: Moderate | 25.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Fatigue: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Fatigue: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Fever: >=38.0 deg C to 38.4 deg C | 12.5 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Headache: Moderate | 12.5 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Headache: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Headache: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Chills: Mild | 12.5 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Chills: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Chills: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Chills: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Vomiting: Mild | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Vomiting: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Vomiting: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Vomiting: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Diarrhea: Mild | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Diarrhea: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | New or worsened muscle pain: Mild | 12.5 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | New or worsened muscle pain: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | New or worsened muscle pain: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | New or worsened muscle pain: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | New or worsened joint pain: Mild | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | New or worsened joint pain: Moderate | 12.5 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | New or worsened joint pain: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | New or worsened joint pain: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Diarrhea: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Diarrhea: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Vomiting: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | New or worsened joint pain: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Chills: Moderate | 66.7 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | New or worsened joint pain: Moderate | 66.7 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | New or worsened joint pain: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Vomiting: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Headache: Mild | 33.3 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Chills: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Fatigue: Moderate | 100.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Vomiting: Mild | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Chills: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Fever: >38.9 deg C to 40.0 deg C | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Fever: >38.4 deg C to 38.9 deg C | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Fatigue: Mild | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Headache: Moderate | 33.3 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Fatigue: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Fever: >=38.0 deg C to 38.4 deg C | 66.7 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | New or worsened muscle pain: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Diarrhea: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Headache: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Fatigue: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | New or worsened muscle pain: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Diarrhea: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | New or worsened muscle pain: Moderate | 33.3 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Headache: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Fever: >40.0 deg C | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | New or worsened muscle pain: Mild | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Diarrhea: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Diarrhea: Mild | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Chills: Mild | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | New or worsened joint pain: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Vomiting: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | New or worsened muscle pain: Mild | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Fatigue: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Headache: Mild | 28.6 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | New or worsened joint pain: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Headache: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Headache: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Headache: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Chills: Mild | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Chills: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | New or worsened joint pain: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Chills: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Chills: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Vomiting: Mild | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Diarrhea: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Vomiting: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Vomiting: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | New or worsened joint pain: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Vomiting: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Diarrhea: Mild | 14.3 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Diarrhea: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Fatigue: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | New or worsened muscle pain: Moderate | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | New or worsened muscle pain: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | New or worsened muscle pain: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Fever: >=38.0 deg C to 38.4 deg C | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Fever: >38.4 deg C to 38.9 deg C | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Diarrhea: Severe | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Fever: >38.9 deg C to 40.0 deg C | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Fever: >40.0 deg C | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | New or worsened joint pain: Mild | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Fatigue: Mild | 42.9 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Fatigue: Moderate | 14.3 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | New or worsened muscle pain: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Headache: Moderate | 13.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | New or worsened muscle pain: Mild | 4.3 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Fever: >=38.0 deg C to 38.4 deg C | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | New or worsened joint pain: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Vomiting: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Fever: >40.0 deg C | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | New or worsened joint pain: Mild | 4.3 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Fever: >38.4 deg C to 38.9 deg C | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Diarrhea: Severe | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | New or worsened muscle pain: Moderate | 4.3 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | New or worsened joint pain: Severe | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Diarrhea: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Headache: Mild | 4.3 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Chills: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Diarrhea: Mild | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Headache: Severe | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Chills: Severe | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Fatigue: Severe | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Vomiting: Mild | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Diarrhea: Moderate | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Fever: >38.9 deg C to 40.0 deg C | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | New or worsened muscle pain: Severe | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Chills: Mild | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Vomiting: Moderate | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Headache: Grade 4 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Chills: Moderate | 4.3 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | New or worsened joint pain: Moderate | 4.3 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Fatigue: Moderate | 8.7 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Vomiting: Severe | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Fatigue: Mild | 13.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Fatigue: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Fever: >38.9 deg C to 40.0 deg C | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Vomiting: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Diarrhea: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Diarrhea: Mild | 16.7 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | New or worsened joint pain: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Headache: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Fever: >40.0 deg C | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Diarrhea: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Fatigue: Moderate | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | New or worsened muscle pain: Mild | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Diarrhea: Moderate | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | New or worsened joint pain: Moderate | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | New or worsened muscle pain: Moderate | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Headache: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | New or worsened joint pain: Mild | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | New or worsened muscle pain: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Headache: Moderate | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Fatigue: Mild | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Fever: >=38.0 deg C to 38.4 deg C | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | New or worsened muscle pain: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Headache: Mild | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Fever: >38.4 deg C to 38.9 deg C | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Fatigue: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Chills: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Chills: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | New or worsened joint pain: Severe | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Vomiting: Mild | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Chills: Moderate | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Vomiting: Moderate | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Chills: Mild | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Fatigue: Grade 4 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A | Vomiting: Severe | 0 Percentage of participants |
Primary
Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
Systemic events included fever, vomiting, diarrhea, headache, fatigue, chills, new/worsened muscle pain & new /worsened joint pain & recorded by participants in electronic diary. Fever defined as oral temperature \>=38.0 deg C & categorized as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C & \>40.0 deg C. Vomiting graded as: G 1: 1-2 times in 24 hrs; G 2: \>2 times in 24 hrs; G 3: required IV hydration; G 4: emergency room visit/ hospitalization for hypotensive shock. Diarrhea graded as: G 1: 2-3 loose stools in 24 hrs; G 2: 4-5 loose stools in 24 hrs; G 3: 6 or more loose stools in 24 hrs & G 4: emergency room visit/ hospitalization. Headache, fatigue, chills, new/worsened muscle pain & new/worsened joint pain: G 1: didn't interfere with activity; G 2: some interference with activity; G 3: prevented daily routine activity & G 4: emergency room visit/ hospitalization. Exact 2-sided confidence interval based on Clopper and Pearson method.
Time frame: From Day 1 to Day 7 after vaccination
Population: Safety population included all the participants who received the study intervention.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Headache: Mild | 12.5 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fever: >38.4 degree C to 38.9 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fever: >38.9 degree C to 40.0 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fever: >40.0 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fatigue: Mild | 12.5 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fatigue: Moderate | 18.8 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fatigue: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fatigue: grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fever: >=38.0 degree C to 38.4 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Headache: Moderate | 18.8 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Headache: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Headache: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Chills: Mild | 12.5 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Chills: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Chills: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Chills: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Mild | 12.5 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Moderate | 12.5 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Mild | 6.3 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Headache: Moderate | 13.3 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Chills: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fever: >38.4 degree C to 38.9 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Chills: Mild | 13.3 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Headache: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Headache: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fever: >=38.0 degree C to 38.4 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fatigue: Mild | 13.3 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Moderate | 6.7 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Chills: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Mild | 13.3 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fever: >40.0 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fatigue: Moderate | 20.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Headache: Mild | 6.7 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Chills: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Mild | 13.3 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fatigue: grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fever: >38.9 degree C to 40.0 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fatigue: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fever: >38.4 degree C to 38.9 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fatigue: grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Headache: Mild | 18.8 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fatigue: Moderate | 12.5 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fever: >38.9 degree C to 40.0 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Headache: Moderate | 6.3 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Headache: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fever: >=38.0 degree C to 38.4 degree C | 6.3 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Headache: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Chills: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Mild | 6.3 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Chills: Moderate | 12.5 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Chills: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fatigue: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Chills: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fatigue: Mild | 12.5 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Moderate | 12.5 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Mild | 18.8 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fever: >40.0 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Mild | 6.7 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Headache: Mild | 13.3 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Chills: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fever: >38.9 degree C to 40.0 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fatigue: grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fatigue: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Chills: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fatigue: Mild | 26.7 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Headache: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Moderate | 6.7 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Headache: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fever: >=38.0 degree C to 38.4 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Chills: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fatigue: Moderate | 6.7 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Mild | 6.7 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Headache: Moderate | 6.7 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fever: >40.0 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Chills: Moderate | 6.7 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fever: >38.4 degree C to 38.9 degree C | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Mild | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fatigue: Moderate | 21.4 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fatigue: Severe | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fatigue: grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fatigue: Mild | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Headache: Mild | 14.3 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Headache: Moderate | 7.1 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Headache: Severe | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Headache: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Chills: Mild | 7.1 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Chills: Moderate | 7.1 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Chills: Severe | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Moderate | 21.4 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Chills: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Mild | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Severe | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Mild | 14.3 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Severe | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Severe | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Mild | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Moderate | 21.4 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Severe | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fever: >=38.0 degree C to 38.4 degree C | 7.1 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fever: >38.4 degree C to 38.9 degree C | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fever: >38.9 degree C to 40.0 degree C | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fever: >40.0 degree C | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Headache: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Moderate | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Headache: Severe | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Chills: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fever: >=38.0 degree C to 38.4 degree C | 6.3 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fatigue: Mild | 18.8 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Moderate | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Headache: Moderate | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Mild | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fatigue: Moderate | 6.3 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fever: >38.4 degree C to 38.9 degree C | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Mild | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Chills: Severe | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Headache: Mild | 6.3 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fatigue: Severe | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Chills: Moderate | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fever: >38.9 degree C to 40.0 degree C | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fever: >40.0 degree C | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Mild | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Severe | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Mild | 6.3 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Moderate | 6.3 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Severe | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Chills: Mild | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Moderate | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Severe | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fatigue: grade 4 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Severe | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fever: >38.9 degree C to 40.0 degree C | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Moderate | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fatigue: Severe | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Severe | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Moderate | 6.7 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Mild | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Mild | 20.0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Chills: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Moderate | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Chills: Severe | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Chills: Moderate | 6.7 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Severe | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Chills: Mild | 6.7 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Headache: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Headache: Severe | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened joint pain: Mild | 13.3 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fever: >40.0 degree C | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fever: >=38.0 degree C to 38.4 degree C | 13.3 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fatigue: Moderate | 13.3 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Headache: Moderate | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fever: >38.4 degree C to 38.9 degree C | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Headache: Mild | 20.0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fatigue: grade 4 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Fatigue: Mild | 13.3 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Mild | 6.7 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Severe | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Diarrhea: Moderate | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | New or worsened muscle pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B | Vomiting: Severe | 0.0 Percentage of participants |
Primary
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Systemic events included fever, vomiting, diarrhea, headache, fatigue, chills, new/worsened muscle pain & new /worsened joint pain & recorded by participants in electronic diary. Fever defined as oral temperature \>=38.0 deg C & categorized as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C & \>40.0 deg C. Vomiting graded as: G 1: 1-2 times in 24 hrs; G 2: \>2 times in 24 hrs; G 3: required IV hydration; G 4: emergency room visit/ hospitalization for hypotensive shock. Diarrhea graded as: G 1: 2-3 loose stools in 24 hrs; G 2: 4-5 loose stools in 24 hrs; G 3: 6 or more loose stools in 24 hrs & G 4: emergency room visit/ hospitalization. Headache, fatigue, chills, new/worsened muscle pain & new/worsened joint pain: G 1: didn't interfere with activity; G 2: some interference with activity; G 3: prevented daily routine activity & G 4: emergency room visit/ hospitalization. Exact 2-sided confidence interval based on Clopper and Pearson method.
Time frame: From Day 1 to Day 7 after vaccination 1 for all arms; From Day 1 to Day 7 after vaccination 2 for 2 doses of qIRV (dose level 1), 2-visit schedule arm
Population: Safety population included all the participants who received the study intervention. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed'(n) = number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fatigue: Mild | 15.3 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Diarrhea: Moderate | 1.5 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Vomiting: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Diarrhea: Mild | 10.7 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Vomiting: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fatigue: Severe | 1.5 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fatigue: Moderate | 26.7 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened joint pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Vomiting: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fever: >40.0 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fever: >38.9 degree C to 40.0 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fever: >38.4 degree C to 38.9 degree C | 0.8 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fever: >=38.0 degree C to 38.4 degree C | 3.1 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Headache: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Headache: Moderate | 25.2 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened joint pain: Severe | 0.8 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened joint pain: Moderate | 9.2 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Headache: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Vomiting: Mild | 2.3 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened joint pain: Mild | 8.4 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Chills: Mild | 9.9 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened muscle pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened muscle pain: Severe | 0.8 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Chills: Moderate | 9.2 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened muscle pain: Moderate | 13.7 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Chills: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Headache: Mild | 13.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened muscle pain: Mild | 13.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Diarrhea: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Chills: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fatigue: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Diarrhea: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened muscle pain: Moderate | 18.3 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Vomiting: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fatigue: Severe | 2.3 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Diarrhea: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Headache: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Vomiting: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Headache: Moderate | 18.3 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Diarrhea: Mild | 5.3 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened muscle pain: Mild | 13.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Vomiting: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened joint pain: Mild | 9.2 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Diarrhea: Moderate | 1.5 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fatigue: Moderate | 22.1 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened muscle pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Chills: Severe | 0.8 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fatigue: Mild | 16.8 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Chills: Mild | 9.9 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fever: >40.0 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Vomiting: Mild | 1.5 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fever: >38.9 degree C to 40.0 degree C | 1.5 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Chills: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fever: >38.4 degree C to 38.9 degree C | 1.5 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened muscle pain: Severe | 0.8 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fever: >=38.0 degree C to 38.4 degree C | 5.3 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fatigue: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Headache: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened joint pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened joint pain: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Diarrhea: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Chills: Moderate | 9.9 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Headache: Mild | 17.6 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened joint pain: Moderate | 8.4 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Headache: Moderate | 4.3 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened muscle pain: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Headache: Severe | 0.9 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Headache: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Chills: Mild | 3.5 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Chills: Moderate | 3.5 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Chills: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Chills: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Vomiting: Mild | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Vomiting: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Vomiting: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Vomiting: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Diarrhea: Mild | 3.5 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Diarrhea: Moderate | 0.9 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Diarrhea: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Diarrhea: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened muscle pain: Mild | 8.7 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened muscle pain: Moderate | 7.8 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened muscle pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened joint pain: Mild | 6.1 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened joint pain: Moderate | 7.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened joint pain: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened joint pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fever: >=38.0 degree C to 38.4 degree C | 0.9 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fever: >38.4 degree C to 38.9 degree C | 1.7 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fever: >38.9 degree C to 40.0 degree C | 0.9 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fever: >40.0 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fatigue: Mild | 13.9 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fatigue: Moderate | 19.1 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fatigue: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fatigue: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Headache: Mild | 15.7 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Headache: Moderate | 13.7 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Vomiting: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Headache: Mild | 13.7 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fatigue: Mild | 21.4 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Vomiting: Moderate | 0.9 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened muscle pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fever: >38.4 degree C to 38.9 degree C | 1.7 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fatigue: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened joint pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fatigue: Moderate | 19.7 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened joint pain: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened muscle pain: Mild | 10.3 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Chills: Moderate | 7.7 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Vomiting: Mild | 1.7 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Headache: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fever: >38.9 degree C to 40.0 degree C | 0.9 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Vomiting: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened muscle pain: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Diarrhea: Mild | 3.4 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fever: >=38.0 degree C to 38.4 degree C | 3.4 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Chills: Severe | 0.9 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened joint pain: Mild | 6.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened joint pain: Moderate | 11.1 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fatigue: Severe | 0.9 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Diarrhea: Moderate | 0.9 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Headache: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Diarrhea: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fever: >40.0 degree C | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Chills: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened muscle pain: Moderate | 11.1 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Diarrhea: Severe | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Chills: Mild | 9.4 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Diarrhea: Severe | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened joint pain: Moderate | 0.9 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Diarrhea: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened joint pain: Severe | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fever: >=38.0 degree C to 38.4 degree C | 2.6 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened muscle pain: Moderate | 2.6 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Headache: Moderate | 1.8 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fatigue: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fever: >38.4 degree C to 38.9 degree C | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened joint pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Chills: Severe | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fever: >38.9 degree C to 40.0 degree C | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Chills: Mild | 4.4 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Chills: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fever: >40.0 degree C | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fatigue: Severe | 0.9 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fatigue: Mild | 12.3 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened muscle pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened muscle pain: Severe | 0.9 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Headache: Mild | 8.8 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fatigue: Moderate | 7.9 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Headache: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Vomiting: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Vomiting: Severe | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Diarrhea: Mild | 5.3 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Vomiting: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened joint pain: Mild | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened muscle pain: Mild | 4.4 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Diarrhea: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Vomiting: Mild | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Chills: Moderate | 0.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Headache: Severe | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: Vomiting: Moderate | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Chills: Severe | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Diarrhea: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Chills: Moderate | 4.3 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened muscle pain: Mild | 9.6 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fatigue: Severe | 2.6 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened muscle pain: Moderate | 1.7 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Chills: Mild | 7.8 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened muscle pain: Severe | 0.9 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Headache: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened muscle pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened joint pain: Mild | 2.6 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Headache: Severe | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Chills: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened joint pain: Moderate | 2.6 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Headache: Moderate | 4.3 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened joint pain: Severe | 0.9 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | New or worsened joint pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: Fever: >=38.0 degree C to 38.4 degree C | 2.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: Fever: >38.9 degree C to 40.0 degree C | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: Fever: >40.0 degree C | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: Fatigue: Mild | 11.2 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: Fatigue: Moderate | 17.3 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: Fatigue: Severe | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: Fatigue: grade 4 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: Headache: Mild | 12.2 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: Headache: Moderate | 12.2 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: Headache: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: Chills: Mild | 8.2 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: Chills: Moderate | 6.1 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: Chills: Severe | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: Chills: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: Vomiting: Mild | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Diarrhea: Severe | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: Vomiting: Severe | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: Vomiting: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: Diarrhea: Mild | 2.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: Diarrhea: Severe | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: New or worsened muscle pain: Severe | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: New or worsened joint pain: Severe | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: New or worsened joint pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: New or worsened joint pain: Moderate | 4.1 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fatigue: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fever: >=38.0 degree C to 38.4 degree C | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: New or worsened joint pain: Mild | 4.1 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: New or worsened muscle pain: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fever: >38.4 degree C to 38.9 degree C | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: New or worsened muscle pain: Moderate | 6.1 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: New or worsened muscle pain: Mild | 6.1 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fever: >38.9 degree C to 40.0 degree C | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: Diarrhea: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: Diarrhea: Moderate | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fever: >40.0 degree C | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: Headache: Severe | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Post vaccination 2: Fever: >38.4 degree C to 38.9 degree C | 3.1 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fatigue: Mild | 9.6 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Vomiting: Severe | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Fatigue: Moderate | 8.7 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Vomiting: Grade 4 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Diarrhea: Mild | 3.5 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Vomiting: Moderate | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Vomiting: Mild | 0.9 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Diarrhea: Moderate | 1.7 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B | Headache: Mild | 8.7 Percentage of participants |
Primary
Percentage of Participants With Abnormal Chemistry Values at 1 Week After Vaccination 1: Substudy A
Chemistry parameters included blood urea nitrogen and C-reactive protein. The primary criteria were as follows Blood Urea Nitrogen: \> 1.3\*ULN; C Reactive Protein: \> 1.1\*ULN. Also add 95% CI was based on Clopper and Pearson method.
Time frame: 1 week after vaccination 1
Population: Vaccination 1 safety population included all participants who received vaccination 1. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Abnormal Chemistry Values at 1 Week After Vaccination 1: Substudy A | C-reactive protein | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Abnormal Chemistry Values at 1 Week After Vaccination 1: Substudy A | Blood Urea Nitrogen | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Abnormal Chemistry Values at 1 Week After Vaccination 1: Substudy A | C-reactive protein | 6.7 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Abnormal Chemistry Values at 1 Week After Vaccination 1: Substudy A | Blood Urea Nitrogen | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Abnormal Chemistry Values at 1 Week After Vaccination 1: Substudy A | C-reactive protein | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Abnormal Chemistry Values at 1 Week After Vaccination 1: Substudy A | Blood Urea Nitrogen | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Abnormal Chemistry Values at 1 Week After Vaccination 1: Substudy A | C-reactive protein | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Abnormal Chemistry Values at 1 Week After Vaccination 1: Substudy A | Blood Urea Nitrogen | 7.1 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Abnormal Chemistry Values at 1 Week After Vaccination 1: Substudy A | Blood Urea Nitrogen | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Abnormal Chemistry Values at 1 Week After Vaccination 1: Substudy A | C-reactive protein | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Abnormal Chemistry Values at 1 Week After Vaccination 1: Substudy A | C-reactive protein | 6.3 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Abnormal Chemistry Values at 1 Week After Vaccination 1: Substudy A | Blood Urea Nitrogen | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Abnormal Chemistry Values at 1 Week After Vaccination 1: Substudy A | C-reactive protein | 7.1 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Abnormal Chemistry Values at 1 Week After Vaccination 1: Substudy A | Blood Urea Nitrogen | 7.1 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Abnormal Chemistry Values at 1 Week After Vaccination 1: Substudy A | Blood Urea Nitrogen | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Abnormal Chemistry Values at 1 Week After Vaccination 1: Substudy A | C-reactive protein | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Abnormal Chemistry Values at 1 Week After Vaccination 1: Substudy A | C-reactive protein | 7.1 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Abnormal Chemistry Values at 1 Week After Vaccination 1: Substudy A | Blood Urea Nitrogen | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Abnormal Chemistry Values at 1 Week After Vaccination 1: Substudy A | C-reactive protein | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Abnormal Chemistry Values at 1 Week After Vaccination 1: Substudy A | Blood Urea Nitrogen | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Abnormal Chemistry Values at 1 Week After Vaccination 1: Substudy A | Blood Urea Nitrogen | 7.1 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Abnormal Chemistry Values at 1 Week After Vaccination 1: Substudy A | C-reactive protein | 7.1 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Abnormal Chemistry Values at 1 Week After Vaccination 1: Substudy A | Blood Urea Nitrogen | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Abnormal Chemistry Values at 1 Week After Vaccination 1: Substudy A | C-reactive protein | 6.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Abnormal Chemistry Values at 1 Week After Vaccination 1: Substudy A | Blood Urea Nitrogen | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Abnormal Chemistry Values at 1 Week After Vaccination 1: Substudy A | C-reactive protein | 6.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Abnormal Chemistry Values at 1 Week After Vaccination 1: Substudy A | C-reactive protein | 6.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Abnormal Chemistry Values at 1 Week After Vaccination 1: Substudy A | Blood Urea Nitrogen | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Abnormal Chemistry Values at 1 Week After Vaccination 1: Substudy A | Blood Urea Nitrogen | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Abnormal Chemistry Values at 1 Week After Vaccination 1: Substudy A | C-reactive protein | 6.7 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Abnormal Chemistry Values at 1 Week After Vaccination 1: Substudy A | Blood Urea Nitrogen | 6.7 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Abnormal Chemistry Values at 1 Week After Vaccination 1: Substudy A | C-reactive protein | 13.3 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Abnormal Chemistry Values at 1 Week After Vaccination 1: Substudy A | Blood Urea Nitrogen | 6.7 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Abnormal Chemistry Values at 1 Week After Vaccination 1: Substudy A | C-reactive protein | 0 Percentage of participants |
Primary
Percentage of Participants With Abnormal Chemistry Values at 2 Days After Vaccination 1: Substudy A
Chemistry parameters included blood urea nitrogen and C-reactive protein. The primary criteria were as follows Blood Urea Nitrogen: \> 1.3\*ULN; C Reactive Protein: \> 1.1\*ULN. 95% CI was based on Clopper and Pearson method.
Time frame: 2 days after vaccination 1
Population: Vaccination 1 safety population included all participants who received vaccination 1. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Abnormal Chemistry Values at 2 Days After Vaccination 1: Substudy A | C Reactive Protein | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Abnormal Chemistry Values at 2 Days After Vaccination 1: Substudy A | Blood Urea Nitrogen | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Abnormal Chemistry Values at 2 Days After Vaccination 1: Substudy A | C Reactive Protein | 6.7 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Abnormal Chemistry Values at 2 Days After Vaccination 1: Substudy A | Blood Urea Nitrogen | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Abnormal Chemistry Values at 2 Days After Vaccination 1: Substudy A | C Reactive Protein | 14.3 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Abnormal Chemistry Values at 2 Days After Vaccination 1: Substudy A | Blood Urea Nitrogen | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Abnormal Chemistry Values at 2 Days After Vaccination 1: Substudy A | Blood Urea Nitrogen | 14.3 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Abnormal Chemistry Values at 2 Days After Vaccination 1: Substudy A | C Reactive Protein | 21.4 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Abnormal Chemistry Values at 2 Days After Vaccination 1: Substudy A | C Reactive Protein | 26.7 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Abnormal Chemistry Values at 2 Days After Vaccination 1: Substudy A | Blood Urea Nitrogen | 6.7 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Abnormal Chemistry Values at 2 Days After Vaccination 1: Substudy A | Blood Urea Nitrogen | 6.3 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Abnormal Chemistry Values at 2 Days After Vaccination 1: Substudy A | C Reactive Protein | 18.8 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Abnormal Chemistry Values at 2 Days After Vaccination 1: Substudy A | C Reactive Protein | 7.1 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Abnormal Chemistry Values at 2 Days After Vaccination 1: Substudy A | Blood Urea Nitrogen | 7.1 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Abnormal Chemistry Values at 2 Days After Vaccination 1: Substudy A | Blood Urea Nitrogen | 13.3 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Abnormal Chemistry Values at 2 Days After Vaccination 1: Substudy A | C Reactive Protein | 26.7 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Abnormal Chemistry Values at 2 Days After Vaccination 1: Substudy A | C Reactive Protein | 30.8 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Abnormal Chemistry Values at 2 Days After Vaccination 1: Substudy A | Blood Urea Nitrogen | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Abnormal Chemistry Values at 2 Days After Vaccination 1: Substudy A | Blood Urea Nitrogen | 6.7 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Abnormal Chemistry Values at 2 Days After Vaccination 1: Substudy A | C Reactive Protein | 20.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Abnormal Chemistry Values at 2 Days After Vaccination 1: Substudy A | Blood Urea Nitrogen | 7.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Abnormal Chemistry Values at 2 Days After Vaccination 1: Substudy A | C Reactive Protein | 15.4 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Abnormal Chemistry Values at 2 Days After Vaccination 1: Substudy A | Blood Urea Nitrogen | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Abnormal Chemistry Values at 2 Days After Vaccination 1: Substudy A | C Reactive Protein | 25.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Abnormal Chemistry Values at 2 Days After Vaccination 1: Substudy A | C Reactive Protein | 40.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Abnormal Chemistry Values at 2 Days After Vaccination 1: Substudy A | Blood Urea Nitrogen | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Abnormal Chemistry Values at 2 Days After Vaccination 1: Substudy A | Blood Urea Nitrogen | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Abnormal Chemistry Values at 2 Days After Vaccination 1: Substudy A | C Reactive Protein | 28.6 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Abnormal Chemistry Values at 2 Days After Vaccination 1: Substudy A | Blood Urea Nitrogen | 6.7 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Abnormal Chemistry Values at 2 Days After Vaccination 1: Substudy A | C Reactive Protein | 20.0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Abnormal Chemistry Values at 2 Days After Vaccination 1: Substudy A | Blood Urea Nitrogen | 13.3 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Abnormal Chemistry Values at 2 Days After Vaccination 1: Substudy A | C Reactive Protein | 26.7 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Abnormal Chemistry Values at 2 Days After Vaccination 1: Substudy A | Blood Urea Nitrogen | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Abnormal Chemistry Values at 2 Days After Vaccination 1: Substudy A | C Reactive Protein | 20.0 Percentage of participants |
Primary
Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A
Hematology parameters included erythrocytes, neutrophils, eosinophils/leukocytes, monocytes/leukocytes, ery mean corpuscular hemoglobin. The primary criteria were as follows erythrocytes and neutrophils: \<0.8\* LLN; Eosinophils/Leukocytes and Monocytes/Leukocytes: \>1.2\* ULN; Ery. Mean Corpuscular Hemoglobin:\>1.1\*ULN. 95% CI was based on Clopper and Pearson method.
Time frame: 1 week after vaccination 1
Population: Vaccination 1 safety population included all participants who received the study vaccination 1. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Eosinophils/Leukocytes | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Erythrocytes | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Ery. Mean Corpuscular Hemoglobin | 6.3 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Monocytes/Leukocytes | 12.5 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Erythrocytes | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Monocytes/Leukocytes | 6.7 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Eosinophils/Leukocytes | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Ery. Mean Corpuscular Hemoglobin | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Monocytes/Leukocytes | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Ery. Mean Corpuscular Hemoglobin | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Erythrocytes | 7.7 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Eosinophils/Leukocytes | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Ery. Mean Corpuscular Hemoglobin | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Monocytes/Leukocytes | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Erythrocytes | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Eosinophils/Leukocytes | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Erythrocytes | 6.7 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Eosinophils/Leukocytes | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Ery. Mean Corpuscular Hemoglobin | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Monocytes/Leukocytes | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Eosinophils/Leukocytes | 6.3 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Ery. Mean Corpuscular Hemoglobin | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Erythrocytes | 6.3 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Monocytes/Leukocytes | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Monocytes/Leukocytes | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Erythrocytes | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Eosinophils/Leukocytes | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Ery. Mean Corpuscular Hemoglobin | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Eosinophils/Leukocytes | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Ery. Mean Corpuscular Hemoglobin | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Erythrocytes | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Monocytes/Leukocytes | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Eosinophils/Leukocytes | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Erythrocytes | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Ery. Mean Corpuscular Hemoglobin | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Monocytes/Leukocytes | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Eosinophils/Leukocytes | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Ery. Mean Corpuscular Hemoglobin | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Monocytes/Leukocytes | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Erythrocytes | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Monocytes/Leukocytes | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Eosinophils/Leukocytes | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Erythrocytes | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophils | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Erythrocytes | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Monocytes/Leukocytes | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophils | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Eosinophils/Leukocytes | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophils | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Eosinophils/Leukocytes | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Erythrocytes | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Monocytes/Leukocytes | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Monocytes/Leukocytes | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Eosinophils/Leukocytes | 6.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophils | 6.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Erythrocytes | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Eosinophils/Leukocytes | 7.1 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophils | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Erythrocytes | 7.1 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Monocytes/Leukocytes | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Monocytes/Leukocytes | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Ery. Mean Corpuscular Hemoglobin | 6.7 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Eosinophils/Leukocytes | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Erythrocytes | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Ery. Mean Corpuscular Hemoglobin | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Monocytes/Leukocytes | 7.1 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Erythrocytes | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A | Eosinophils/Leukocytes | 0 Percentage of participants |
Primary
Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A
Hematology parameters included erythrocytes, lymphocytes, neutrophils, eosinophils/leukocytes, erythrocyte (ery) mean corpuscular volume, ery. mean corpuscular hemoglobin and ery. mean corpuscular hemoglobin concentration. The primary criteria were as follows erythrocytes, lymphocytes, neutrophils: \<0.8\*lower limit of normal (LLN); Lymphocytes/Leukocytes, Eosinophils/Leukocytes, Monocytes/Leukocytes: \>1.2\*upper limit of normal (ULN); Ery. Mean Corpuscular Volume:\>1.1\*ULN; Ery. Mean Corpuscular Hemoglobin and Ery.Mean Corpuscular hemoglobin Concentration: \< 0.9\*LLN. Also add 95% CI was based on Clopper and Pearson method.
Time frame: 2 days after vaccination 1
Population: Vaccination 1 safety population included all participants who received vaccination 1. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Erythrocytes | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Ery. Mean Corpuscular HGB Concentration | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Ery. Mean Corpuscular Hemoglobin | 6.7 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Neutrophils | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Ery. Mean Corpuscular Volume | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Monocytes/Leukocytes | 6.7 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Eosinophils/Leukocytes | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Neutrophils | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Ery. Mean Corpuscular Volume | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Monocytes/Leukocytes | 13.3 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Erythrocytes | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Eosinophils/Leukocytes | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Ery. Mean Corpuscular HGB Concentration | 6.7 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Ery. Mean Corpuscular Hemoglobin | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Neutrophils | 7.7 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Ery. Mean Corpuscular Volume | 7.7 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Ery. Mean Corpuscular Hemoglobin | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Eosinophils/Leukocytes | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Monocytes/Leukocytes | 7.7 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Ery. Mean Corpuscular HGB Concentration | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Erythrocytes | 7.7 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Erythrocytes | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Eosinophils/Leukocytes | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Monocytes/Leukocytes | 28.6 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Ery. Mean Corpuscular Volume | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Ery. Mean Corpuscular Hemoglobin | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Ery. Mean Corpuscular HGB Concentration | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Neutrophils | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Eosinophils/Leukocytes | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Ery. Mean Corpuscular HGB Concentration | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes | 6.7 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Neutrophils | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Ery. Mean Corpuscular Volume | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Erythrocytes | 6.7 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Ery. Mean Corpuscular Hemoglobin | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Monocytes/Leukocytes | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Ery. Mean Corpuscular Volume | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Erythrocytes | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Ery. Mean Corpuscular HGB Concentration | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Eosinophils/Leukocytes | 6.7 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Monocytes/Leukocytes | 13.3 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Ery. Mean Corpuscular Hemoglobin | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Neutrophils | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Eosinophils/Leukocytes | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Ery. Mean Corpuscular Volume | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Monocytes/Leukocytes | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Erythrocytes | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Ery. Mean Corpuscular Hemoglobin | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Ery. Mean Corpuscular HGB Concentration | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Neutrophils | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Ery. Mean Corpuscular HGB Concentration | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Erythrocytes | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Monocytes/Leukocytes | 7.1 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Eosinophils/Leukocytes | 7.1 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Neutrophils | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Ery. Mean Corpuscular Volume | 7.1 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Ery. Mean Corpuscular Hemoglobin | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Monocytes/Leukocytes | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Ery. Mean Corpuscular HGB Concentration | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Ery. Mean Corpuscular Hemoglobin | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Eosinophils/Leukocytes | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Erythrocytes | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Neutrophils | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Ery. Mean Corpuscular Volume | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Eosinophils/Leukocytes | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Erythrocytes | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Neutrophils | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Monocytes/Leukocytes | 6.7 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Ery. Mean Corpuscular Volume | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Ery. Mean Corpuscular Hemoglobin | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Ery. Mean Corpuscular HGB Concentration | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Monocytes/Leukocytes | 7.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Neutrophils | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Erythrocytes | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Erythrocytes | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Neutrophils | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Monocytes/Leukocytes | 13.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Monocytes/Leukocytes | 13.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Erythrocytes | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Neutrophils | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Neutrophils | 7.1 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Erythrocytes | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Monocytes/Leukocytes | 14.3 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Neutrophils | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Erythrocytes | 6.7 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Monocytes/Leukocytes | 20.0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Erythrocytes | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Monocytes/Leukocytes | 14.3 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Ery. Mean Corpuscular Hemoglobin | 7.1 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Ery. Mean Corpuscular Hemoglobin | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes | 6.7 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Monocytes/Leukocytes | 6.7 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A | Erythrocytes | 0 Percentage of participants |
Primary
Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A
Chemistry abnormalities were graded by toxicity grading scale for healthy adult volunteers enrolled in preventive vaccine clinical trials as grade 1=mild; grade 2=moderate; grade 3=severe and grade 4=potentially life-threatening. Percentage of participants with shift in chemistry values were reported in this outcome measure. Categories with at least 1 non-zero data values showing any shift in Grade from baseline to 1 week after vaccination 1 (post-baseline) were reported. Participants whose grade category was unchanged (e.g. normal to normal) were not reported. The parameters reported were - Alanine Aminotransferase Increased, Alkaline Phosphatase Increased, Aspartate Aminotransferase Increased, Creatinine Increased and Urea Nitrogen.
Time frame: From Baseline (prior to vaccination 1) to 1 week after vaccination 1
Population: Vaccination 1 safety population included all participants who received vaccination 1. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Creatinine Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | AST Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | ALP Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | ALT Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | AST Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | ALP Increased: Baseline Normal to Grade 1 | 6.7 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | ALT Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Creatinine Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Creatinine Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | ALT Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | AST Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | ALP Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Creatinine Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | AST Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Grade 1 to Grade 2 | 7.1 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | ALP Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | ALT Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | AST Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Creatinine Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | ALP Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | ALT Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 1 | 6.3 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | ALT Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | AST Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | ALP Increased: Baseline Normal to Grade 1 | 6.3 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Creatinine Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Creatinine Increased: Baseline Normal to Grade 1 | 7.1 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | ALT Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | AST Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 1 | 14.3 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | ALP Increased: Baseline Normal to Grade 1 | 7.1 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | AST Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Creatinine Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | ALT Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | ALP Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | ALT Increased: Baseline Normal to Grade 1 | 7.1 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Creatinine Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | AST Increased: Baseline Normal to Grade 1 | 14.3 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | ALP Increased: Baseline Normal to Grade 1 | 7.1 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | ALP Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | AST Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Creatinine Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | ALT Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | AST Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Creatinine Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | ALT Increased: Baseline Normal to Grade 1 | 7.1 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | ALP Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | ALT Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | AST Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | ALP Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Creatinine Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | AST Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Creatinine Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | ALP Increased: Baseline Normal to Grade 1 | 6.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | ALT Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | ALT Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | ALP Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 1 | 6.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | AST Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Creatinine Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | ALT Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | AST Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | ALP Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Creatinine Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | ALT Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | AST Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | ALP Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Creatinine Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | Creatinine Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | AST Increased: Baseline Normal to Grade 1 | 13.3 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | ALT Increased: Baseline Normal to Grade 1 | 6.7 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A | ALP Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
Primary
Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A
Chemistry abnormalities were graded by toxicity grading scale for healthy adult volunteers enrolled in preventive vaccine clinical trials as grade 1=mild; grade 2=moderate; grade 3=severe and grade 4=potentially life-threatening. Percentage of participants with shift in chemistry values were reported in this outcome measure. Categories with at least 1 non-zero data values showing any shift in Grade from baseline to 2 days after vaccination 1 (post-baseline) were reported. Participants whose grade category was unchanged (e.g. normal to normal) were not reported. The parameters reported were - Alanine Aminotransferase Increased (ALP), Alkaline Phosphatase Increased (ALP), Aspartate Aminotransferase Increased (AST), Creatinine Increased and Urea Nitrogen.
Time frame: From Baseline (prior to vaccination 1) to 2 days after vaccination 1
Population: Vaccination 1 safety population included all participants who received vaccination 1. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Creatinine Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | ALP Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | ALT Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 1 | 6.3 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | AST Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Creatinine Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | AST Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | ALT Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | ALP Increased: Baseline Normal to Grade 1 | 1.67 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | ALT Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Creatinine Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | ALP Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | AST Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 1 | 7.1 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 1 | 7.1 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | AST Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | ALT Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Creatinine Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | ALP Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 2 | 7.1 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Grade 1 to Grade 2 | 7.1 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | ALT Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | AST Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Creatinine Increased: Baseline Normal to Grade 1 | 6.7 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | ALP Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 1 | 6.7 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Grade 1 to Grade 2 | 6.3 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | ALP Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | AST Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Creatinine Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | ALT Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | ALP Increased: Baseline Normal to Grade 1 | 14.3 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Creatinine Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | AST Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | ALT Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | ALT Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | AST Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Grade 1 to Grade 2 | 6.7 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Creatinine Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | ALP Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Creatinine Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | ALT Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | AST Increased: Baseline Normal to Grade 1 | 14.3 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | ALP Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 1 | 13.3 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | ALP Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | AST Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Creatinine Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | ALT Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | AST Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Creatinine Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | ALT Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | ALP Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | AST Increased: Baseline Normal to Grade 1 | 6.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Creatinine Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | ALP Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | ALT Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | AST Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | ALT Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | ALP Increased: Baseline Normal to Grade 1 | 6.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Creatinine Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Creatinine Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | ALT Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | AST Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | ALP Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 1 | 6.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | ALT Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | AST Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 2 | 6.7 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | ALP Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Creatinine Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | ALT Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | ALP Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | AST Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Creatinine Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 1 | 6.7 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Creatinine Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | ALP Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | ALT Increased: Baseline Normal to Grade 1 | 6.7 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | AST Increased: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A | Urea Nitrogen: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
Primary
Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A
Hematology parameters included hemoglobin, lymphocytes, neutrophils decrease, WBC decrease and WBC increase. Laboratory abnormalities were graded by FDA toxicity grading scale for healthy adult volunteers enrolled in preventive vaccine clinical trials as grade 1=mild; grade 2=moderate; grade 3=severe and grade 4=potentially life-threatening. Percentage of participants with shift in hematology values were reported in this outcome measure. Categories with at least 1 non-zero data values showing any shift in Grade from baseline to 1 week after vaccination 1 were reported. Participants whose grade category was unchanged (e.g. normal to normal) were not reported.
Time frame: From Baseline (prior to vaccination 1) to 1 week after vaccination 1
Population: Vaccination 1 safety population included all participants who received vaccination 1. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Lymphocytes: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Grade 2 to Grade 3 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Lymphocytes: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Grade 2 to Grade 3 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 1 | 7.7 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Normal to Grade 1 | 7.7 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Lymphocytes: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Grade 2 to Grade 3 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 1 | 7.7 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Lymphocytes: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 1 | 7.1 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Grade 2 to Grade 3 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Grade 2 to Grade 3 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Lymphocytes: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 2 | 6.7 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 1 | 6.3 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Grade 2 to Grade 3 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Lymphocytes: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 1 | 14.3 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 1 | 7.1 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Lymphocytes: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Grade 2 to Grade 3 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Lymphocytes: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 1 | 7.7 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Grade 2 to Grade 3 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Grade 2 to Grade 3 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Lymphocytes: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Lymphocytes: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Grade 2 to Grade 3 | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 1 | 7.1 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Lymphocytes: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Grade 2 to Grade 3 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Grade 2 to Grade 3 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 1 | 6.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Lymphocytes: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Lymphocytes: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Grade 2 to Grade 3 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Grade 2 to Grade 3 | 6.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Lymphocytes: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 1 | 6.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 1 | 7.1 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Lymphocytes: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Grade 2 to Grade 3 | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Lymphocytes: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Grade 2 to Grade 3 | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 1 | 6.7 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 1 | 14.3 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 1 | 7.1 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Lymphocytes: Baseline Grade 1 to Grade 2 | 7.1 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Normal to Grade 2 | 7.1 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A | Neutrophil decrease: Baseline Grade 2 to Grade 3 | 0 Percentage of participants |
Primary
Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A
Hematology parameters included hemoglobin, lymphocytes, neutrophils decrease, platelets decrease, white blood cells (WBC) decrease and WBC increase. Laboratory abnormalities were graded by Food and Drug Administration (FDA) toxicity grading scale for healthy adult volunteers enrolled in preventive vaccine clinical trials as grade 1=mild; grade 2=moderate; grade 3=severe and grade 4=potentially life-threatening. Percentage of participants with shift in hematology values were reported in this outcome measure. Categories with at least 1 non-zero data values showing any shift in Grade from baseline to 2 days after vaccination 1 were reported. Participants whose grade category was unchanged (e.g. normal to normal) were not reported.
Time frame: From Baseline (prior to vaccination 1) to 2 days after vaccination 1
Population: Vaccination 1 safety population included all participants who received vaccination 1. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Neutrophil Decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Platelets Decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Platelets Decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 1 | 6.7 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Neutrophil Decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 1 | 6.7 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 1 | 6.7 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 1 | 7.7 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Platelets Decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Neutrophil Decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 1 | 7.7 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 1 | 15.4 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Platelets Decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 1 | 14.3 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Neutrophil Decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 1 | 6.7 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Neutrophil Decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Platelets Decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 2 | 6.7 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Neutrophil Decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Platelets Decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 1 | 7.1 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Neutrophil Decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 1 | 14.3 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Platelets Decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 2 | 7.1 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Neutrophil Decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Grade 1 to Grade 2 | 7.1 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Platelets Decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Platelets Decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Neutrophil Decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 1 | 6.7 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Neutrophil Decrease: Baseline Normal to Grade 1 | 6.7 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Platelets Decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Platelets Decrease: Baseline Normal to Grade 1 | 7.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Neutrophil Decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 2 | 1.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Neutrophil Decrease: Baseline Normal to Grade 1 | 6.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Platelets Decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Platelets Decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Neutrophil Decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Neutrophil Decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 1 | 7.1 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Platelets Decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Platelets Decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Neutrophil Decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 1 | 6.7 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Grade 1 to Grade 2 | 6.7 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Platelets Decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Neutrophil Decrease: Baseline Normal to Grade 1 | 7.1 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 1 | 7.1 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | WBC increase: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Platelets Decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Neutrophil Decrease: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 2 | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Grade 1 to Grade 2 | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | WBC decrease: Baseline Normal to Grade 1 | 6.7 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Hemoglobin: Baseline Normal to Grade 1 | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 2 | 6.7 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A | Lymphocytes: Baseline Normal to Grade 1 | 0 Percentage of participants |
Primary
Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 1 Week After Vaccination 1: Substudy A
An ECG abnormality was defined as any new abnormality that, as judged by a cardiologist, was consistent with probable or possible myocarditis or pericarditis, including: Sustained atrial or ventricular arrhythmias, Second-degree Mobitz Type II or worse atrioventricular block, new bundle branch block and Diffuse ST-segment elevation or PR-segment inversion, compatible with pericarditis.
Time frame: 1 week after vaccination 1
Population: Vaccination 1 safety population included all participants who received vaccination 1.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 1 Week After Vaccination 1: Substudy A | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 1 Week After Vaccination 1: Substudy A | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 1 Week After Vaccination 1: Substudy A | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 1 Week After Vaccination 1: Substudy A | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 1 Week After Vaccination 1: Substudy A | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 1 Week After Vaccination 1: Substudy A | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 1 Week After Vaccination 1: Substudy A | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 1 Week After Vaccination 1: Substudy A | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 1 Week After Vaccination 1: Substudy A | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 1 Week After Vaccination 1: Substudy A | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 1 Week After Vaccination 1: Substudy A | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 1 Week After Vaccination 1: Substudy A | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 1 Week After Vaccination 1: Substudy A | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 1 Week After Vaccination 1: Substudy A | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 1 Week After Vaccination 1: Substudy A | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 1 Week After Vaccination 1: Substudy A | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 1 Week After Vaccination 1: Substudy A | 0 Percentage of participants |
Primary
Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 2 Days After Vaccination 1: Substudy A
An ECG abnormality was defined as any new abnormality that, as judged by a cardiologist, was consistent with probable or possible myocarditis or pericarditis, including: Sustained atrial or ventricular arrhythmias, Second-degree Mobitz Type II or worse atrioventricular block, new bundle branch block and Diffuse ST-segment elevation or PR-segment inversion, compatible with pericarditis.
Time frame: 2 days after vaccination 1
Population: Vaccination 1 safety population included all participants who received vaccination 1. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 2 Days After Vaccination 1: Substudy A | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 2 Days After Vaccination 1: Substudy A | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 2 Days After Vaccination 1: Substudy A | 0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 2 Days After Vaccination 1: Substudy A | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 2 Days After Vaccination 1: Substudy A | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 2 Days After Vaccination 1: Substudy A | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 2 Days After Vaccination 1: Substudy A | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 2 Days After Vaccination 1: Substudy A | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 2 Days After Vaccination 1: Substudy A | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 2 Days After Vaccination 1: Substudy A | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 2 Days After Vaccination 1: Substudy A | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 2 Days After Vaccination 1: Substudy A | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 2 Days After Vaccination 1: Substudy A | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 2 Days After Vaccination 1: Substudy A | 0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 2 Days After Vaccination 1: Substudy A | 0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 2 Days After Vaccination 1: Substudy A | 0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 2 Days After Vaccination 1: Substudy A | 0 Percentage of participants |
Secondary
Difference in Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A
Seroconversion was defined as an HAI titer \<1:10 prior to vaccination and \>=1:40 at the time point of interest, or an HAI titer of \>=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Percentage of participants achieving seroconversion for each strain at 4 weeks after vaccination 1 and exact 2-sided 95% CI based on the Clopper and Pearson method is presented in the descriptive section. Difference in percentage of participants achieving HAI seroconversion for each strain at 4 weeks after vaccination 1 is presented in the statistical analysis section.
Time frame: 4 weeks after vaccination 1
Population: Vaccination 1 EIP included all eligible participants who received vaccination 1; had blood drawn for assay testing within the specified time frame (26-35 days) after Vaccination 1; had at least 1 valid and determinate assay result at the 4-week post-vaccination 1 visit and had no major protocol deviations before Vaccination 2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Difference in Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A | A1 | 92.9 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Difference in Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A | A2 | 57.1 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Difference in Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A | B1 | 14.3 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Difference in Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A | B2 | 21.4 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Difference in Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A | B2 | 20.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Difference in Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A | A1 | 66.7 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Difference in Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A | B1 | 26.7 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Difference in Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A | A2 | 40.0 Percentage of participants |
Comparison: Strain: A195% CI: [-4.5, 53.5]
Comparison: Strain: A295% CI: [-19.2, 49.4]
Comparison: Strain: B195% CI: [-41.7, 19.1]
Comparison: Strain: B295% CI: [-29.2, 32.5]
Secondary
Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A
Geometric mean fold rise (GMFR) was defined as ratios of the results after vaccination to the results before vaccination. GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ. When prevaccination assay results were lower than the LLOQ and the postvaccination results were greater than or equal to the LLOQ, the prevaccination assay results were set to LLOQ for the GMFR calculation.
Time frame: Before vaccination to 1, 4 and 8 weeks after vaccination 1
Population: Vaccination 1 evaluable immunogenicity population included all eligible participants who received vaccination 1; had blood drawn for assay testing within the specified time frame (26-35 days) after vaccination 1; had at least 1 valid and determinate assay result at the 4-week post-vaccination 1 visit and had no major protocol deviations before vaccination 2. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 2.3 Fold Rise |
| SSA: mIRV A (Dose Level 1) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 2.7 Fold Rise |
| SSA: mIRV A (Dose Level 1) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 4.0 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 2.7 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 3.8 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 5.4 Fold Rise |
| SSA: mIRV A (Dose Level 3) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 4.0 Fold Rise |
| SSA: mIRV A (Dose Level 3) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 2.2 Fold Rise |
| SSA: mIRV A (Dose Level 3) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 4.0 Fold Rise |
| SSA: mIRV A (Dose Level 4) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 4.7 Fold Rise |
| SSA: mIRV A (Dose Level 4) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 12.7 Fold Rise |
| SSA: mIRV A (Dose Level 4) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 7.7 Fold Rise |
| SSA: mIRV A - Licensed QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 2.4 Fold Rise |
| SSA: mIRV A - Licensed QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 3.1 Fold Rise |
| SSA: mIRV A - Licensed QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 3.8 Fold Rise |
| SSA: mIRV B (Dose Level 1) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 3.6 Fold Rise |
| SSA: mIRV B (Dose Level 1) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 2.6 Fold Rise |
| SSA: mIRV B (Dose Level 1) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 1.8 Fold Rise |
| SSA: mIRV B (Dose Level 2) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 1.4 Fold Rise |
| SSA: mIRV B (Dose Level 2) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 2.2 Fold Rise |
| SSA: mIRV B (Dose Level 2) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 2.1 Fold Rise |
| SSA: mIRV B (Dose Level 3) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 2.9 Fold Rise |
| SSA: mIRV B (Dose Level 3) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 4.5 Fold Rise |
| SSA: mIRV B (Dose Level 3) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 1.8 Fold Rise |
| SSA: mIRV B (Dose Level 4) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 3.0 Fold Rise |
| SSA: mIRV B (Dose Level 4) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 3.8 Fold Rise |
| SSA: mIRV B (Dose Level 4) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 2.4 Fold Rise |
| SSA: mIRV B - Licensed QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 2.1 Fold Rise |
| SSA: mIRV B - Licensed QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 1.6 Fold Rise |
| SSA: mIRV B - Licensed QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 2.1 Fold Rise |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 3.5 Fold Rise |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 2.0 Fold Rise |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 17.4 Fold Rise |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 13.0 Fold Rise |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 2.8 Fold Rise |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 5.5 Fold Rise |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 4.0 Fold Rise |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 2.2 Fold Rise |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 6.3 Fold Rise |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 4.0 Fold Rise |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 1.9 Fold Rise |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 1.7 Fold Rise |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 6.5 Fold Rise |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 1.8 Fold Rise |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 4.8 Fold Rise |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 1.7 Fold Rise |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 3.4 Fold Rise |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 2.4 Fold Rise |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 5.2 Fold Rise |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 6.5 Fold Rise |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 3.8 Fold Rise |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 1.7 Fold Rise |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 1.9 Fold Rise |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 1.7 Fold Rise |
| SSA: bIRV AB-Licensed QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 4.0 Fold Rise |
| SSA: bIRV AB-Licensed QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 1.4 Fold Rise |
| SSA: bIRV AB-Licensed QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 4.5 Fold Rise |
| SSA: bIRV AB-Licensed QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 2.2 Fold Rise |
| SSA: bIRV AB-Licensed QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 3.0 Fold Rise |
| SSA: bIRV AB-Licensed QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 1.9 Fold Rise |
| SSA: qIRV (Dose Level 1) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B2 | 1.2 Fold Rise |
| SSA: qIRV (Dose Level 1) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 1.6 Fold Rise |
| SSA: qIRV (Dose Level 1) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 1.4 Fold Rise |
| SSA: qIRV (Dose Level 1) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 1.7 Fold Rise |
| SSA: qIRV (Dose Level 1) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B2 | 1.6 Fold Rise |
| SSA: qIRV (Dose Level 1) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A2 | 2.6 Fold Rise |
| SSA: qIRV (Dose Level 1) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 5.2 Fold Rise |
| SSA: qIRV (Dose Level 1) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 8.8 Fold Rise |
| SSA: qIRV (Dose Level 1) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 4.4 Fold Rise |
| SSA: qIRV (Dose Level 1) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A2 | 2.3 Fold Rise |
| SSA: qIRV (Dose Level 1) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A2 | 4.6 Fold Rise |
| SSA: qIRV (Dose Level 1) + QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B2 | 1.4 Fold Rise |
| SSA: qIRV - Licensed QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B2 | 1.4 Fold Rise |
| SSA: qIRV - Licensed QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A2 | 1.4 Fold Rise |
| SSA: qIRV - Licensed QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B2 | 1.6 Fold Rise |
| SSA: qIRV - Licensed QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 4.8 Fold Rise |
| SSA: qIRV - Licensed QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 1.9 Fold Rise |
| SSA: qIRV - Licensed QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 5.5 Fold Rise |
| SSA: qIRV - Licensed QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 7.4 Fold Rise |
| SSA: qIRV - Licensed QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A2 | 1.2 Fold Rise |
| SSA: qIRV - Licensed QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A2 | 2.3 Fold Rise |
| SSA: qIRV - Licensed QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B2 | 1.8 Fold Rise |
| SSA: qIRV - Licensed QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 1.9 Fold Rise |
| SSA: qIRV - Licensed QIV | Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 1.6 Fold Rise |
Secondary
Geometric Mean Ratio (GMR) of HAI Titers for Each Strain at 4 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A
GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution) and were reported in the descriptive section. GMRs were estimated by the ratio of the GMTs between vaccine groups, using licensed QIV group as reference and were reported in the statistical analysis section.
Time frame: 4 weeks After vaccination 1
Population: Vaccination 1 EIP included all eligible participants who received vaccination 1; had blood drawn for assay testing within the specified time frame (26-35 days) after Vaccination 1; had at least 1 valid and determinate assay result at the 4-week post-vaccination 1 visit and had no major protocol deviations before Vaccination 2.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Geometric Mean Ratio (GMR) of HAI Titers for Each Strain at 4 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A | B1 | 21.0 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | Geometric Mean Ratio (GMR) of HAI Titers for Each Strain at 4 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A | A1 | 176.7 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | Geometric Mean Ratio (GMR) of HAI Titers for Each Strain at 4 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A | B2 | 17.2 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | Geometric Mean Ratio (GMR) of HAI Titers for Each Strain at 4 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A | A2 | 88.3 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | Geometric Mean Ratio (GMR) of HAI Titers for Each Strain at 4 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A | B2 | 31.7 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | Geometric Mean Ratio (GMR) of HAI Titers for Each Strain at 4 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A | B1 | 21.9 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | Geometric Mean Ratio (GMR) of HAI Titers for Each Strain at 4 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A | A2 | 57.9 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | Geometric Mean Ratio (GMR) of HAI Titers for Each Strain at 4 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A | A1 | 204.6 Titers |
Comparison: Strain: A195% CI: [0.34, 2.2]
Comparison: Strain: A295% CI: [0.86, 2.7]
Comparison: Strain: B195% CI: [0.4, 2.28]
Comparison: Strain: B295% CI: [0.25, 1.18]
Secondary
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A
GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the lower limit of quantitation (LLOQ) were set to 0.5\*LLQ.
Time frame: Weeks 1, 4 and 8 after vaccination 1
Population: Vaccination 1 evaluable immunogenicity population (EIP) included all eligible participants who received vaccination 1; had blood drawn for assay testing within the specified time frame (26-35 days) after vaccination 1; had at least 1 valid and determinate assay result at the 4-week post-vaccination 1 visit and had no major protocol deviations before vaccination 2. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 109.6 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 70.5 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 51.5 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 137.1 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 80.0 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 205.4 Titers |
| SSA: mIRV A (Dose Level 3) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 117.6 Titers |
| SSA: mIRV A (Dose Level 3) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 186.6 Titers |
| SSA: mIRV A (Dose Level 3) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 63.5 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 80.0 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 162.8 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 314.0 Titers |
| SSA: mIRV A - Licensed QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 122.6 Titers |
| SSA: mIRV A - Licensed QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 40.0 Titers |
| SSA: mIRV A - Licensed QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 68.2 Titers |
| SSA: mIRV B (Dose Level 1) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 48.8 Titers |
| SSA: mIRV B (Dose Level 1) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 37.9 Titers |
| SSA: mIRV B (Dose Level 1) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 69.0 Titers |
| SSA: mIRV B (Dose Level 2) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 22.3 Titers |
| SSA: mIRV B (Dose Level 2) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 27.5 Titers |
| SSA: mIRV B (Dose Level 2) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 37.9 Titers |
| SSA: mIRV B (Dose Level 3) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 42.6 Titers |
| SSA: mIRV B (Dose Level 3) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 66.2 Titers |
| SSA: mIRV B (Dose Level 3) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 29.2 Titers |
| SSA: mIRV B (Dose Level 4) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 72.5 Titers |
| SSA: mIRV B (Dose Level 4) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 46.4 Titers |
| SSA: mIRV B (Dose Level 4) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 56.6 Titers |
| SSA: mIRV B - Licensed QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 22.7 Titers |
| SSA: mIRV B - Licensed QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 29.2 Titers |
| SSA: mIRV B - Licensed QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 20.0 Titers |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 197.0 Titers |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 66.2 Titers |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 37.3 Titers |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 287.9 Titers |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 35.3 Titers |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 80.0 Titers |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 31.7 Titers |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 115.8 Titers |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 24.1 Titers |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 192.5 Titers |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 115.8 Titers |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 17.4 Titers |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 75.5 Titers |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 137.1 Titers |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 108.8 Titers |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 33.6 Titers |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 17.8 Titers |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 20.0 Titers |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 68.2 Titers |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 40.0 Titers |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 129.3 Titers |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 27.5 Titers |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 32.3 Titers |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 89.0 Titers |
| SSA: bIRV AB-Licensed QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 134.5 Titers |
| SSA: bIRV AB-Licensed QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 22.4 Titers |
| SSA: bIRV AB-Licensed QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 127.0 Titers |
| SSA: bIRV AB-Licensed QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 31.7 Titers |
| SSA: bIRV AB-Licensed QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 95.1 Titers |
| SSA: bIRV AB-Licensed QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 42.4 Titers |
| SSA: qIRV (Dose Level 1) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A2 | 160.0 Titers |
| SSA: qIRV (Dose Level 1) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B2 | 17.2 Titers |
| SSA: qIRV (Dose Level 1) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 176.7 Titers |
| SSA: qIRV (Dose Level 1) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 69.0 Titers |
| SSA: qIRV (Dose Level 1) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 21.0 Titers |
| SSA: qIRV (Dose Level 1) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 104.4 Titers |
| SSA: qIRV (Dose Level 1) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 19.0 Titers |
| SSA: qIRV (Dose Level 1) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B2 | 14.5 Titers |
| SSA: qIRV (Dose Level 1) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 16.2 Titers |
| SSA: qIRV (Dose Level 1) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A2 | 88.3 Titers |
| SSA: qIRV (Dose Level 1) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A2 | 84.4 Titers |
| SSA: qIRV (Dose Level 1) + QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B2 | 12.8 Titers |
| SSA: qIRV - Licensed QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 20.0 Titers |
| SSA: qIRV - Licensed QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 100.8 Titers |
| SSA: qIRV - Licensed QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A2 | 87.7 Titers |
| SSA: qIRV - Licensed QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 21.9 Titers |
| SSA: qIRV - Licensed QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A2 | 57.9 Titers |
| SSA: qIRV - Licensed QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B2 | 23.0 Titers |
| SSA: qIRV - Licensed QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A2 | 45.9 Titers |
| SSA: qIRV - Licensed QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 204.6 Titers |
| SSA: qIRV - Licensed QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 17.4 Titers |
| SSA: qIRV - Licensed QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 133.0 Titers |
| SSA: qIRV - Licensed QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B2 | 31.7 Titers |
| SSA: qIRV - Licensed QIV | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B2 | 24.1 Titers |
Secondary
HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ. When prevaccination assay results were lower than the LLOQ and the postvaccination results were greater than or equal to the LLOQ, the prevaccination assay results were set to LLOQ for the GMFR calculation.
Time frame: From before vaccination 1 to prior to vaccination 2, 1, 4, and 8 weeks after the last vaccination (i.e., vaccination 1 and 2 for 1-visit schedule and 2 visit schedule, respectively)
Population: EIP included all eligible participants who received vaccination; had blood drawn for assay testing within the specified time frame (26-35 days) after last vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.Here,'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A2 | 6.5 Fold Rise |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A2 | 5.7 Fold Rise |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B1 | 2.3 Fold Rise |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A1 | 13.0 Fold Rise |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B2 | 1.3 Fold Rise |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: A2 | 5.7 Fold Rise |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 14.6 Fold Rise |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 3.5 Fold Rise |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: A1 | 17.1 Fold Rise |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: B2 | 1.4 Fold Rise |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B2 | 1.6 Fold Rise |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B1 | 2.5 Fold Rise |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A1 | 24.8 Fold Rise |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 1.7 Fold Rise |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B1 | 3.2 Fold Rise |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: B1 | 1.7 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 2.1 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: B2 | 2.1 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B1 | 1.4 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: A1 | 6.5 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A1 | 4.6 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B2 | 1.5 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B1 | 2.0 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B1 | 2.1 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B2 | 2.0 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: A2 | 2.5 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 8.0 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A1 | 7.0 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: B1 | 2.0 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A2 | 3.7 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 2.5 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A2 | 4.0 Fold Rise |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: B1 | 2.9 Fold Rise |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: A1 | 7.1 Fold Rise |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 10.3 Fold Rise |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 3.5 Fold Rise |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B2 | 2.1 Fold Rise |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 1.5 Fold Rise |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A2 | 4.0 Fold Rise |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A1 | 5.5 Fold Rise |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B1 | 2.6 Fold Rise |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A2 | 5.7 Fold Rise |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B1 | 2.3 Fold Rise |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A1 | 10.3 Fold Rise |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: B2 | 2.1 Fold Rise |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B1 | 1.9 Fold Rise |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: A2 | 2.9 Fold Rise |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B2 | 1.6 Fold Rise |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 3.0 Fold Rise |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: B1 | 3.2 Fold Rise |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: A1 | 6.0 Fold Rise |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: B2 | 4.0 Fold Rise |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A2 | 3.0 Fold Rise |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 5.3 Fold Rise |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A1 | 2.8 Fold Rise |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B1 | 3.4 Fold Rise |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: A2 | 4.2 Fold Rise |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A1 | 6.0 Fold Rise |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B2 | 3.4 Fold Rise |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B2 | 2.5 Fold Rise |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B1 | 2.2 Fold Rise |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 2.7 Fold Rise |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B1 | 3.2 Fold Rise |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A2 | 3.6 Fold Rise |
| SSA: mIRV A - Licensed QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 2.7 Fold Rise |
| SSA: mIRV A - Licensed QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A2 | 1.9 Fold Rise |
| SSA: mIRV A - Licensed QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B2 | 2.1 Fold Rise |
| SSA: mIRV A - Licensed QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A2 | 1.7 Fold Rise |
| SSA: mIRV A - Licensed QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B1 | 3.2 Fold Rise |
| SSA: mIRV A - Licensed QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B1 | 2.5 Fold Rise |
| SSA: mIRV A - Licensed QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 3.8 Fold Rise |
| SSA: mIRV A - Licensed QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B2 | 1.9 Fold Rise |
| SSA: mIRV A - Licensed QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A1 | 6.0 Fold Rise |
| SSA: mIRV A - Licensed QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A1 | 6.0 Fold Rise |
| SSA: mIRV A - Licensed QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B1 | 2.0 Fold Rise |
| SSA: mIRV A - Licensed QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 8.0 Fold Rise |
| SSA: mIRV B (Dose Level 1) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 3.8 Fold Rise |
| SSA: mIRV B (Dose Level 1) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B1 | 3.0 Fold Rise |
| SSA: mIRV B (Dose Level 1) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 2.4 Fold Rise |
| SSA: mIRV B (Dose Level 1) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A1 | 3.3 Fold Rise |
| SSA: mIRV B (Dose Level 1) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A2 | 2.1 Fold Rise |
| SSA: mIRV B (Dose Level 1) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B1 | 1.8 Fold Rise |
| SSA: mIRV B (Dose Level 1) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B2 | 2.4 Fold Rise |
| SSA: mIRV B (Dose Level 1) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A1 | 4.8 Fold Rise |
| SSA: mIRV B (Dose Level 1) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B1 | 2.7 Fold Rise |
| SSA: mIRV B (Dose Level 1) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A2 | 2.5 Fold Rise |
| SSA: mIRV B (Dose Level 1) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B2 | 2.1 Fold Rise |
| SSA: mIRV B (Dose Level 1) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 4.7 Fold Rise |
| SSA: mIRV B (Dose Level 2) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B1 | 1.2 Fold Rise |
| SSA: mIRV B (Dose Level 2) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B1 | 2.5 Fold Rise |
| SSA: mIRV B (Dose Level 2) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A2 | 2.3 Fold Rise |
| SSA: mIRV B (Dose Level 2) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 10.1 Fold Rise |
| SSA: mIRV B (Dose Level 2) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B2 | 1.7 Fold Rise |
| SSA: mIRV B (Dose Level 2) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 1.8 Fold Rise |
| SSA: mIRV B (Dose Level 2) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A2 | 2.3 Fold Rise |
| SSA: mIRV B (Dose Level 2) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B2 | 1.2 Fold Rise |
| SSA: mIRV B (Dose Level 2) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A1 | 3.6 Fold Rise |
| SSA: mIRV B (Dose Level 2) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 4.4 Fold Rise |
| SSA: mIRV B (Dose Level 2) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B1 | 1.0 Fold Rise |
| SSA: mIRV B (Dose Level 2) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A1 | 6.6 Fold Rise |
| SSA: mIRV B (Dose Level 3) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A1 | 2.0 Fold Rise |
| SSA: mIRV B (Dose Level 3) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B1 | 1.5 Fold Rise |
| SSA: mIRV B (Dose Level 3) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B2 | 2.2 Fold Rise |
| SSA: mIRV B (Dose Level 3) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A1 | 2.8 Fold Rise |
| SSA: mIRV B (Dose Level 3) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B1 | 1.0 Fold Rise |
| SSA: mIRV B (Dose Level 3) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 3.0 Fold Rise |
| SSA: mIRV B (Dose Level 3) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 2.1 Fold Rise |
| SSA: mIRV B (Dose Level 3) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 1.9 Fold Rise |
| SSA: mIRV B (Dose Level 3) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A2 | 0.6 Fold Rise |
| SSA: mIRV B (Dose Level 3) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A2 | 1.6 Fold Rise |
| SSA: mIRV B (Dose Level 3) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B1 | 1.7 Fold Rise |
| SSA: mIRV B (Dose Level 3) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B2 | 2.4 Fold Rise |
| SSA: mIRV B (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A2 | 4.8 Fold Rise |
| SSA: mIRV B (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B1 | 1.6 Fold Rise |
| SSA: mIRV B (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A2 | 5.0 Fold Rise |
| SSA: mIRV B (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A1 | 3.6 Fold Rise |
| SSA: mIRV B (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A1 | 5.8 Fold Rise |
| SSA: mIRV B (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 5.2 Fold Rise |
| SSA: mIRV B (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B1 | 1.6 Fold Rise |
| SSA: mIRV B (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 1.2 Fold Rise |
| SSA: mIRV B (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 5.0 Fold Rise |
| SSA: mIRV B (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B2 | 1.2 Fold Rise |
| SSA: mIRV B (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B1 | 1.7 Fold Rise |
| SSA: mIRV B (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B2 | 1.2 Fold Rise |
| SSA: mIRV B - Licensed QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B1 | 1.5 Fold Rise |
| SSA: mIRV B - Licensed QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A2 | 2.0 Fold Rise |
| SSA: mIRV B - Licensed QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B2 | 1.6 Fold Rise |
| SSA: mIRV B - Licensed QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 3.9 Fold Rise |
| SSA: mIRV B - Licensed QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A1 | 2.6 Fold Rise |
| SSA: mIRV B - Licensed QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A1 | 4.0 Fold Rise |
| SSA: mIRV B - Licensed QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B1 | 2.2 Fold Rise |
| SSA: mIRV B - Licensed QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B2 | 1.4 Fold Rise |
| SSA: mIRV B - Licensed QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B1 | 1.9 Fold Rise |
| SSA: mIRV B - Licensed QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A2 | 3.1 Fold Rise |
| SSA: mIRV B - Licensed QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 3.3 Fold Rise |
| SSA: mIRV B - Licensed QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 1.3 Fold Rise |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B1 | 1.8 Fold Rise |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B1 | 2.4 Fold Rise |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B2 | 1.4 Fold Rise |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A2 | 2.4 Fold Rise |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B2 | 1.4 Fold Rise |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 1.5 Fold Rise |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A1 | 2.8 Fold Rise |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 7.6 Fold Rise |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B1 | 2.2 Fold Rise |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A2 | 5.0 Fold Rise |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 6.6 Fold Rise |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A1 | 6.0 Fold Rise |
Secondary
HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\* LLOQ. When prevaccination assay results were lower than the LLOQ and the postvaccination results were greater than or equal to the LLOQ, the prevaccination assay results were set to LLOQ for the GMFR calculation.
Time frame: From before vaccination 2 to 1, 4, and 8 weeks after the last vaccination
Population: EIP included all eligible participants who received vaccination; had blood drawn for assay testing within the specified time frame (26-35 days) after last vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.Here,'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: B1 | 1.5 Fold Rise |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 1.3 Fold Rise |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 2.6 Fold Rise |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: B1 | 1.0 Fold Rise |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 week after last vaccination: B1 | 1.5 Fold Rise |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: A2 | 2.5 Fold Rise |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 week after last vaccination: A2 | 1.8 Fold Rise |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: B2 | 1.0 Fold Rise |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 week after last vaccination: B2 | 1.3 Fold Rise |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: A1 | 4.3 Fold Rise |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 4.0 Fold Rise |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 week after last vaccination: A1 | 2.6 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: B1 | 1.1 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: B1 | 1.7 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 week after last vaccination: A1 | 2.9 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 week after last vaccination: A2 | 2.1 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 4.9 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 3.5 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: A1 | 4.0 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: A2 | 3.3 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 1.4 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 week after last vaccination: B1 | 1.4 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: B2 | 1.0 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 week after last vaccination: B2 | 1.3 Fold Rise |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 week after last vaccination: A1 | 3.3 Fold Rise |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 week after last vaccination: B1 | 2.2 Fold Rise |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 week after last vaccination: A2 | 1.9 Fold Rise |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 week after last vaccination: B2 | 2.4 Fold Rise |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 4.1 Fold Rise |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: B1 | 2.7 Fold Rise |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 2.3 Fold Rise |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 2.8 Fold Rise |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: A1 | 2.7 Fold Rise |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: A2 | 1.1 Fold Rise |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: B1 | 1.4 Fold Rise |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: B2 | 1.8 Fold Rise |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 week after last vaccination: B2 | 1.5 Fold Rise |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 week after last vaccination: A2 | 6.0 Fold Rise |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | Prior to Vaccination 2: B1 | 1.6 Fold Rise |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: A1 | 7.8 Fold Rise |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 week after last vaccination: B1 | 2.2 Fold Rise |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 week after last vaccination: A1 | 7.6 Fold Rise |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | Prior to Vaccination 2: A2 | 5.5 Fold Rise |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: A2 | 5.0 Fold Rise |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | Prior to Vaccination 2: A1 | 5.3 Fold Rise |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | Prior to Vaccination 2: B2 | 1.2 Fold Rise |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: B2 | 1.4 Fold Rise |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 7.8 Fold Rise |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: B1 | 2.7 Fold Rise |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 7.1 Fold Rise |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: B1 | 2.2 Fold Rise |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 1.4 Fold Rise |
Secondary
HAI GMFR From Before Vaccination to 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ. When prevaccination assay results were lower than the LLOQ and the postvaccination results were greater than or equal to the LLOQ, the pre vaccination assay results were set to LLOQ for the GMFR calculation.
Time frame: Before vaccination to 1, 4, and 8 Weeks After Vaccination
Population: EIP=all eligible participants who received vaccination;had blood drawn for assay testing within specified time frame (26-35days)after Vaccination;had at least 1valid and determinate assay result at 4-week post-vaccination visit and had no major protocol deviations.All participants reported under'Overall Number of Participants Analyzed'contributed data to table;however,may not have evaluable data for every row and'Number Analyzed'signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMFR From Before Vaccination to 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 1 Week after vaccination: A1 | 4.5 Fold Rise |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMFR From Before Vaccination to 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 1 Week after vaccination: A2 | 2.7 Fold Rise |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMFR From Before Vaccination to 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 1 Week after vaccination: B1 | 1.7 Fold Rise |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMFR From Before Vaccination to 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 1 Week after vaccination: B2 | 1.2 Fold Rise |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMFR From Before Vaccination to 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 4 Weeks after vaccination: A1 | 12.3 Fold Rise |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMFR From Before Vaccination to 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 4 Weeks after vaccination: A2 | 6.8 Fold Rise |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMFR From Before Vaccination to 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 4 Weeks after vaccination: B1 | 2.4 Fold Rise |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMFR From Before Vaccination to 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 4 Weeks after vaccination: B2 | 1.4 Fold Rise |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMFR From Before Vaccination to 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 8 Weeks after vaccination: A1 | 8.9 Fold Rise |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMFR From Before Vaccination to 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 8 Weeks after vaccination: A2 | 3.9 Fold Rise |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMFR From Before Vaccination to 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 8 Weeks after vaccination: B1 | 1.7 Fold Rise |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMFR From Before Vaccination to 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 8 Weeks after vaccination: B2 | 1.3 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMFR From Before Vaccination to 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 8 Weeks after vaccination: B1 | 1.7 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMFR From Before Vaccination to 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 1 Week after vaccination: A1 | 5.7 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMFR From Before Vaccination to 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 4 Weeks after vaccination: B1 | 2.2 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMFR From Before Vaccination to 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 1 Week after vaccination: A2 | 4.4 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMFR From Before Vaccination to 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 8 Weeks after vaccination: A2 | 5.5 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMFR From Before Vaccination to 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 1 Week after vaccination: B1 | 1.8 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMFR From Before Vaccination to 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 4 Weeks after vaccination: B2 | 1.7 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMFR From Before Vaccination to 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 1 Week after vaccination: B2 | 1.4 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMFR From Before Vaccination to 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 8 Weeks after vaccination: B2 | 1.4 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMFR From Before Vaccination to 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 4 Weeks after vaccination: A1 | 12.2 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMFR From Before Vaccination to 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 8 Weeks after vaccination: A1 | 9.9 Fold Rise |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMFR From Before Vaccination to 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 4 Weeks after vaccination: A2 | 8.7 Fold Rise |
Secondary
HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B
GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.
Time frame: Before vaccination 1, 2 and, 1, 4, and 8 weeks after the last vaccination (i.e. after vaccination 1 for 1-vist schedule arms and after vaccination 2 for 2-visit schedule arms)
Population: EIP included all eligible participants who received vaccination; had blood drawn for assay testing within the specified time frame (26-35 days) after last vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.Here,'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 8 weeks after vaccination: B2 | 17.5 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 4 weeks after vaccination: A2 | 99.7 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 1 week after vaccination: B2 | 22.7 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 1 week after vaccination: B1 | 30.7 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 4 weeks after vaccination: B1 | 33.0 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | Prior to vaccination 1: B2 | 17.0 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 8 weeks after vaccination: A2 | 95.5 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | Prior to vaccination 1: A1 | 26.7 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | Prior to vaccination 1: A2 | 35.9 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 1 week after vaccination: A2 | 68.1 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 1 week after vaccination: A1 | 76.7 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | Prior to vaccination 1: B1 | 20.3 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 8 weeks after vaccination: B1 | 20.4 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 8 weeks after vaccination: A1 | 128.4 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 4 weeks after vaccination: A1 | 121.0 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 4 weeks after vaccination: B2 | 23.7 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | Prior to vaccination 1: A2 | 27.9 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 4 weeks after vaccination: B2 | 26.9 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 8 weeks after vaccination: A1 | 128.3 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 8 weeks after vaccination: A2 | 101.7 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 8 weeks after vaccination: B1 | 22.6 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | Prior to vaccination 1: B1 | 20.0 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 8 weeks after vaccination: B2 | 19.4 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 4 weeks after vaccination: B1 | 36.4 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | Prior to vaccination 1: B2 | 17.5 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 1 week after vaccination: A1 | 88.2 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 1 week after vaccination: A2 | 62.8 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 1 week after vaccination: B1 | 30.3 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | Prior to vaccination 1: A1 | 26.9 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 1 week after vaccination: B2 | 24.0 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 4 weeks after vaccination: A1 | 155.7 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 4 weeks after vaccination: A2 | 108.7 Titers |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 8 weeks after vaccination: A1 | 81.7 Titers |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 1 week after vaccination: B1 | 48.9 Titers |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 4 weeks after vaccination: B2 | 49.6 Titers |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 8 weeks after vaccination: B2 | 32.4 Titers |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 4 weeks after vaccination: A2 | 69.0 Titers |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 1 week after vaccination: B2 | 44.2 Titers |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | Prior to vaccination 1: A1 | 27.3 Titers |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 8 weeks after vaccination: B1 | 30.0 Titers |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | Prior to vaccination 1: A2 | 29.3 Titers |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 4 weeks after vaccination: A1 | 126.4 Titers |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 4 weeks after vaccination: B1 | 57.7 Titers |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 1 week after vaccination: A1 | 99.0 Titers |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 8 weeks after vaccination: A2 | 34.3 Titers |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 1 week after vaccination: A2 | 59.0 Titers |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | Prior to vaccination 1: B2 | 16.2 Titers |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | Prior to vaccination 1: B1 | 20.7 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 8 weeks after vaccination: B2 | 15.2 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | Prior to vaccination 2: A1 | 108.5 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | Prior to vaccination 2: A2 | 75.7 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | Prior to vaccination 2: B1 | 18.4 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | Prior to vaccination 2: B2 | 12.5 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | Prior to vaccination 1: A1 | 16.3 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | Prior to vaccination 1: A2 | 10.0 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | Prior to vaccination 1: B1 | 8.4 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 1 week after vaccination: A1 | 151.4 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 1 week after vaccination: A2 | 82.2 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 1 week after vaccination: B1 | 26.4 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 1 week after vaccination: B2 | 17.9 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 4 weeks after vaccination: A1 | 143.2 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 4 weeks after vaccination: A2 | 102.7 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 4 weeks after vaccination: B1 | 32.9 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 4 weeks after vaccination: B2 | 15.6 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 8 weeks after vaccination: A1 | 157.0 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 8 weeks after vaccination: A2 | 67.7 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | 8 weeks after vaccination: B1 | 26.4 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B | Prior to vaccination 1: B2 | 8.4 Titers |
Secondary
HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B
GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 × LLOQ.
Time frame: Prior to vaccination 1 and 2, and at 1, 4, and 8 weeks after the last vaccination (i.e. after vaccination 1 for 1-vist schedule arms and after vaccination 2 for 2-visit schedule arms)
Population: EIP included all eligible participants who received vaccination; had blood drawn for assay testing within the specified time frame (26-35 days) after last vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.Here,'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B1 | 45.9 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A2 | 149.3 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: B2 | 14.5 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 21.4 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 week after last vaccination: B1 | 45.9 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: B1 | 16.5 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A1 | 298.6 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 Week after last vaccination: B1 | 45.9 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B2 | 21.4 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 week after vaccination: A2 | 171.5 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 411.9 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 Week after last vaccination: A1 | 569.7 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 2: B2 | 23.0 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 2: A2 | 149.3 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: A1 | 25.2 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 week after last vaccination: B2 | 26.4 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 2: A1 | 394.0 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 130.0 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: A2 | 32.1 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 2: B1 | 34.8 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A2 | 105.6 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 2: B1 | 42.9 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 week after last vaccination: B2 | 40.0 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B2 | 28.3 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 week after vaccination: A2 | 113.1 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: A1 | 46.5 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 week after last vaccination: B1 | 42.9 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: A2 | 50.9 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 Week after last vaccination: B1 | 30.3 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A1 | 211.1 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: B1 | 20.8 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 32.5 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: B2 | 16.6 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 171.5 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B1 | 42.9 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 2: A1 | 298.6 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 2: A2 | 69.6 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 2: B2 | 42.9 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 Week after last vaccination: A1 | 320.0 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 422.2 Titers |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 Week after last vaccination: B1 | 48.3 Titers |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 2: A2 | 66.2 Titers |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 2: B1 | 75.1 Titers |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B2 | 22.7 Titers |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: B2 | 13.1 Titers |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B1 | 58.4 Titers |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 2: B2 | 33.1 Titers |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 320.0 Titers |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 week after vaccination: A2 | 90.7 Titers |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: A1 | 27.4 Titers |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 week after last vaccination: B1 | 66.2 Titers |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A1 | 170.4 Titers |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 week after last vaccination: B2 | 33.1 Titers |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 2: A1 | 219.3 Titers |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: A2 | 26.9 Titers |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 Week after last vaccination: A1 | 320.0 Titers |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: B1 | 24.7 Titers |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 124.4 Titers |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A2 | 105.6 Titers |
| SSA: mIRV A (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 22.7 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 56.6 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 Week after last vaccination: A1 | 160.0 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 119.9 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 Week after last vaccination: B1 | 44.9 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: B2 | 17.7 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 160.0 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: A1 | 26.3 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B1 | 63.5 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 2: A1 | 160.0 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A2 | 63.5 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 week after last vaccination: B1 | 67.3 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 2: B1 | 63.5 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 week after vaccination: A2 | 75.5 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 week after last vaccination: B2 | 75.5 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 2: B2 | 89.8 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B2 | 56.6 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A1 | 75.5 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: A2 | 28.5 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: B1 | 16.7 Titers |
| SSA: mIRV A (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 2: A2 | 95.1 Titers |
| SSA: mIRV A - Licensed QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 Week after last vaccination: A1 | 151.0 Titers |
| SSA: mIRV A - Licensed QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: A1 | 23.4 Titers |
| SSA: mIRV A - Licensed QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: A2 | 36.6 Titers |
| SSA: mIRV A - Licensed QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: B1 | 19.3 Titers |
| SSA: mIRV A - Licensed QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: B2 | 14.4 Titers |
| SSA: mIRV A - Licensed QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 week after last vaccination: B1 | 35.6 Titers |
| SSA: mIRV A - Licensed QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 week after vaccination: A2 | 84.8 Titers |
| SSA: mIRV A - Licensed QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 week after last vaccination: B2 | 31.7 Titers |
| SSA: mIRV A - Licensed QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 239.7 Titers |
| SSA: mIRV A - Licensed QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B1 | 63.5 Titers |
| SSA: mIRV A - Licensed QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 95.1 Titers |
| SSA: mIRV A - Licensed QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 42.4 Titers |
| SSA: mIRV A - Licensed QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A1 | 151.0 Titers |
| SSA: mIRV A - Licensed QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 Week after last vaccination: B1 | 42.4 Titers |
| SSA: mIRV A - Licensed QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A2 | 90.7 Titers |
| SSA: mIRV A - Licensed QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B2 | 33.6 Titers |
| SSA: mIRV B (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 254.0 Titers |
| SSA: mIRV B (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 week after last vaccination: B2 | 44.9 Titers |
| SSA: mIRV B (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B2 | 45.4 Titers |
| SSA: mIRV B (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: B2 | 18.2 Titers |
| SSA: mIRV B (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 week after last vaccination: B1 | 63.5 Titers |
| SSA: mIRV B (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B1 | 80.0 Titers |
| SSA: mIRV B (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 week after vaccination: A2 | 151.0 Titers |
| SSA: mIRV B (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: A2 | 66.0 Titers |
| SSA: mIRV B (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 Week after last vaccination: A1 | 326.0 Titers |
| SSA: mIRV B (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: A1 | 70.3 Titers |
| SSA: mIRV B (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 42.4 Titers |
| SSA: mIRV B (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A2 | 181.5 Titers |
| SSA: mIRV B (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 Week after last vaccination: B1 | 42.6 Titers |
| SSA: mIRV B (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 338.4 Titers |
| SSA: mIRV B (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A1 | 248.7 Titers |
| SSA: mIRV B (Dose Level 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: B1 | 25.9 Titers |
| SSA: mIRV B (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 18.2 Titers |
| SSA: mIRV B (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 Week after last vaccination: A1 | 96.2 Titers |
| SSA: mIRV B (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 Week after last vaccination: B1 | 17.4 Titers |
| SSA: mIRV B (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: A1 | 27.5 Titers |
| SSA: mIRV B (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 week after last vaccination: B1 | 18.2 Titers |
| SSA: mIRV B (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 335.1 Titers |
| SSA: mIRV B (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 week after last vaccination: B2 | 12.6 Titers |
| SSA: mIRV B (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B1 | 38.2 Titers |
| SSA: mIRV B (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: B2 | 9.1 Titers |
| SSA: mIRV B (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 145.9 Titers |
| SSA: mIRV B (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: B1 | 13.7 Titers |
| SSA: mIRV B (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B2 | 18.2 Titers |
| SSA: mIRV B (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A2 | 96.2 Titers |
| SSA: mIRV B (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A1 | 175.5 Titers |
| SSA: mIRV B (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 week after vaccination: A2 | 96.2 Titers |
| SSA: mIRV B (Dose Level 2) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: A2 | 35.5 Titers |
| SSA: mIRV B (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 week after vaccination: A2 | 88.3 Titers |
| SSA: mIRV B (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 62.5 Titers |
| SSA: mIRV B (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A2 | 31.2 Titers |
| SSA: mIRV B (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: B1 | 22.9 Titers |
| SSA: mIRV B (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 Week after last vaccination: A1 | 72.5 Titers |
| SSA: mIRV B (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 88.3 Titers |
| SSA: mIRV B (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A1 | 51.2 Titers |
| SSA: mIRV B (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: A1 | 24.3 Titers |
| SSA: mIRV B (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 31.2 Titers |
| SSA: mIRV B (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 Week after last vaccination: B1 | 23.2 Titers |
| SSA: mIRV B (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: B2 | 12.5 Titers |
| SSA: mIRV B (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: A2 | 45.8 Titers |
| SSA: mIRV B (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B1 | 40.0 Titers |
| SSA: mIRV B (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 week after last vaccination: B2 | 25.6 Titers |
| SSA: mIRV B (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 week after last vaccination: B1 | 36.2 Titers |
| SSA: mIRV B (Dose Level 3) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B2 | 23.2 Titers |
| SSA: mIRV B (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: B2 | 10.5 Titers |
| SSA: mIRV B (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 week after last vaccination: B2 | 16.2 Titers |
| SSA: mIRV B (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 week after vaccination: A2 | 113.1 Titers |
| SSA: mIRV B (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 178.0 Titers |
| SSA: mIRV B (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: A1 | 32.3 Titers |
| SSA: mIRV B (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 15.3 Titers |
| SSA: mIRV B (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 23.5 Titers |
| SSA: mIRV B (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 week after last vaccination: B1 | 23.5 Titers |
| SSA: mIRV B (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B1 | 104.4 Titers |
| SSA: mIRV B (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: B1 | 11.0 Titers |
| SSA: mIRV B (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A1 | 198.0 Titers |
| SSA: mIRV B (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B2 | 15.3 Titers |
| SSA: mIRV B (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 Week after last vaccination: A1 | 134.5 Titers |
| SSA: mIRV B (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: A2 | 20.1 Titers |
| SSA: mIRV B (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A2 | 23.5 Titers |
| SSA: mIRV B (Dose Level 4) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 Week after last vaccination: B1 | 116.2 Titers |
| SSA: mIRV B - Licensed QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A2 | 48.8 Titers |
| SSA: mIRV B - Licensed QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 week after last vaccination: B2 | 20.0 Titers |
| SSA: mIRV B - Licensed QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 164.8 Titers |
| SSA: mIRV B - Licensed QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: B2 | 11.6 Titers |
| SSA: mIRV B - Licensed QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B1 | 76.4 Titers |
| SSA: mIRV B - Licensed QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: B1 | 18.4 Titers |
| SSA: mIRV B - Licensed QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 48.8 Titers |
| SSA: mIRV B - Licensed QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 20.0 Titers |
| SSA: mIRV B - Licensed QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: A2 | 19.6 Titers |
| SSA: mIRV B - Licensed QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A1 | 176.7 Titers |
| SSA: mIRV B - Licensed QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: A1 | 39.9 Titers |
| SSA: mIRV B - Licensed QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 Week after last vaccination: B1 | 69.0 Titers |
| SSA: mIRV B - Licensed QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B2 | 19.0 Titers |
| SSA: mIRV B - Licensed QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 Week after last vaccination: A1 | 121.3 Titers |
| SSA: mIRV B - Licensed QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 week after last vaccination: B1 | 36.5 Titers |
| SSA: mIRV B - Licensed QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 week after vaccination: A2 | 45.9 Titers |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 26.7 Titers |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 37.8 Titers |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: B1 | 13.0 Titers |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: B2 | 15.7 Titers |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A2 | 37.8 Titers |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 week after last vaccination: B1 | 28.3 Titers |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B1 | 151.0 Titers |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 week after last vaccination: B2 | 23.8 Titers |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B2 | 26.7 Titers |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: A1 | 50.6 Titers |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 332.1 Titers |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 Week after last vaccination: A1 | 151.0 Titers |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 Week after last vaccination: B1 | 127.0 Titers |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A1 | 370.4 Titers |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | 1 week after vaccination: A2 | 56.6 Titers |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B | Prior to Vaccination 1: A2 | 21.0 Titers |
Secondary
HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
HAI GMT before vaccination and at 1, 4, and 8 weeks after vaccination was described in this outcome measure. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution).
Time frame: Before vaccination and 1, 4, and 8 Weeks After the Vaccination
Population: EIP=all eligible participants who received vaccination;had blood drawn for assay testing within specified time frame (26-35days)after Vaccination;had at least 1valid and determinate assay result at 4-week post-vaccination visit and had no major protocol deviations.All participants reported under'Overall Number of Participants Analyzed'contributed data to table;however,may not have evaluable data for every row and'Number Analyzed'signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | Prior to vaccination: A1 | 21.4 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | Prior to vaccination: A2 | 16.5 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | Prior to vaccination: B1 | 22.1 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | Prior to vaccination: B2 | 11.6 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 1 week after vaccination: A1 | 113.0 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 1 week after vaccination: A2 | 52.7 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 1 week after vaccination: B1 | 39.3 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 1 week after vaccination: B2 | 16.0 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 4 weeks after vaccination: A1 | 317.3 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 4 weeks after vaccination: A2 | 140.9 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 4 weeks after vaccination: B1 | 58.9 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 4 weeks after vaccination: B2 | 19.8 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 8 weeks after vaccination: A1 | 228.9 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 8 weeks after vaccination: A2 | 80.0 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 8 weeks after vaccination: B1 | 39.0 Titers |
| SSA: mIRV A (Dose Level 1) + QIV | HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 8 weeks after vaccination: B2 | 17.9 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 8 weeks after vaccination: B2 | 19.1 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | Prior to vaccination: A1 | 18.0 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 4 weeks after vaccination: A1 | 273.6 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | Prior to vaccination: A2 | 13.2 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 8 weeks after vaccination: A1 | 221.2 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | Prior to vaccination: B1 | 19.0 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 4 weeks after vaccination: A2 | 148.2 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | Prior to vaccination: B2 | 11.6 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 8 weeks after vaccination: A2 | 92.6 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 1 week after vaccination: A1 | 124.6 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 4 weeks after vaccination: B1 | 48.2 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 1 week after vaccination: A2 | 72.3 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 8 weeks after vaccination: B1 | 34.8 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 1 week after vaccination: B1 | 37.1 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 4 weeks after vaccination: B2 | 23.3 Titers |
| SSA: mIRV A (Dose Level 2) + QIV | HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 1 week after vaccination: B2 | 19.0 Titers |
Secondary
Percentage of Participants Achieving HAI Seroconversion for All Strains at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
Seroconversion was defined as an HAI titer\<1:10 prior to vaccination and\>=1:40 at the time point of interest,or an HAI titer\>=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Exact 2-sided CI was based on the Clopper and Pearson method.
Time frame: 1, 4, and 8 Weeks After Vaccination
Population: EIP=all eligible participants who received vaccination;had blood drawn for assay testing within specified time frame (26-35days)after Vaccination;had at least 1valid and determinate assay result at 4-week post-vaccination visit and had no major protocol deviations.All participants reported under'Overall Number of Participants Analyzed'contributed data to table;however,may not have evaluable data for every row and'Number Analyzed'signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 1 Week after vaccination | 1.8 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 4 Weeks after vaccination | 7.2 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 8 Weeks after vaccination | 3.9 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 1 Week after vaccination | 4.6 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 4 Weeks after vaccination | 9.3 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 8 Weeks after vaccination | 4.7 Percentage of participants |
Secondary
Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
Seroconversion was defined as an HAI titer\<1:10 prior to vaccination and\>=1:40 at the time point of interest,or an HAI titer\>=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Exact 2-sided CI was based on the Clopper and Pearson method.
Time frame: Prior to vaccination 2 (for 2-visit schedule only) and at 1, 4, and 8 weeks after last vaccination (after vaccination 1 for 1-visit schedule and after vaccination 2 for 2-visit schedule)
Population: EIP included all eligible participants who received vaccination;had blood drawn for assay testing within the specified time frame(26-35 days) after last vaccination;had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations.Here,Number Analyzed=participants evaluable for specified rows. All participants reported under 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination | 1.1 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 week after last vaccination | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination | 3.2 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 week after last vaccination | 2.9 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination | 7.7 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 week after last vaccination | 10.5 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination | 13.5 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination | 4.8 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination | 4.2 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 week after last vaccination | 4.2 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination | 12.5 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | Prior to vaccination 2 | 4.2 Percentage of participants |
Secondary
Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
Seroconversion was defined as an HAI titer\<1:10 prior to vaccination and\>=1:40 at the time point of interest,or an HAI titer\>=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Exact 2-sided CI was based on the Clopper and Pearson method.
Time frame: Prior to vaccination 2 (for 2-visit schedule only) and at 1, 4, and 8 weeks after last vaccination (after vaccination 1 for 1-visit schedule and after vaccination 2 for 2-visit schedule)
Population: EIP included all eligible participants who received vaccination;had blood drawn for assay testing within the specified time frame(26-35 days) after last vaccination;had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations.Here,Number Analyzed=participants evaluable for specified rows. All participants reported under 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination | 20.0 Percentage of Participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination | 10.0 Percentage of Participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2 | 0.0 Percentage of Participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination | 10.0 Percentage of Participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2 | 10.0 Percentage of Participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination | 0.0 Percentage of Participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination | 10.0 Percentage of Participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination | 0.0 Percentage of Participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination | 18.2 Percentage of Participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination | 9.1 Percentage of Participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2 | 18.2 Percentage of Participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination | 0.0 Percentage of Participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination | 16.7 Percentage of Participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2 | 41.7 Percentage of Participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination | 33.3 Percentage of Participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination | 25.0 Percentage of Participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination | 25.0 Percentage of Participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination | 9.1 Percentage of Participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination | 0.0 Percentage of Participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination | 18.2 Percentage of Participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination | 16.7 Percentage of Participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination | 16.7 Percentage of Participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination | 20.0 Percentage of Participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination | 0.0 Percentage of Participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination | 0.0 Percentage of Participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination | 0.0 Percentage of Participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination | 7.1 Percentage of Participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination | 14.3 Percentage of Participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination | 0.0 Percentage of Participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination | 0.0 Percentage of Participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination | 0.0 Percentage of Participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination | 0.0 Percentage of Participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination | 0.0 Percentage of Participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination | 7.7 Percentage of Participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination | 25.0 Percentage of Participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination | 16.7 Percentage of Participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination | 9.1 Percentage of Participants |
Secondary
Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A
Seroconversion was defined as an HAI titer \<1:10 prior to vaccination and \>=1:40 at the time point of interest, or an HAI titer of \>=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Time frame: At 1, 4 and 8 Weeks after vaccination 1
Population: Vaccination 1 EIP included all eligible participants who received vaccination 1; had blood drawn for assay testing within the specified time frame (26-35 days) after Vaccination 1; had at least 1 valid and determinate assay result at the 4-week post-vaccination 1 visit and had no major protocol deviations before Vaccination 2. Here, 'Number Analyzed' signifies number of participants evaluable for the specified row.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 45.5 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 36.4 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 45.5 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 75.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 58.3 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 33.3 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 66.7 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 33.3 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 66.7 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 84.6 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 69.2 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 92.3 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 53.8 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 50.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 69.2 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 35.7 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 7.7 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 78.6 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 30.8 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 7.7 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 38.5 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 63.6 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 27.3 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 45.5 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 35.7 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 42.9 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 64.3 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 20.0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 30.0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 40.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 45.5 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 40.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 90.9 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 18.2 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 70.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 90.9 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 20.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 40.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 66.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 60.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 20.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 86.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 16.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 100.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 16.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 75.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 41.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 50.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 76.9 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 7.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 7.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 30.8 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 76.9 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 76.9 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 66.7 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 50.0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 16.7 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 25.0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 66.7 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 16.7 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 92.9 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 71.4 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B2 | 7.7 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A2 | 42.9 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A2 | 57.1 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 14.3 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B2 | 21.4 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 0.0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 7.1 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 76.9 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B2 | 7.1 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A2 | 46.2 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 26.7 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 66.7 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 13.3 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A2 | 13.3 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B2 | 6.7 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 60.0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A2 | 20.0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 46.7 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 26.7 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A2 | 40.0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B2 | 20.0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B2 | 0.0 Percentage of participants |
Secondary
Percentage of Participants Achieving HAI Seroconversion for Each Strain at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
Seroconversion was defined as an HAI titer\<1:10 prior to vaccination and\>=1:40 at the time point of interest,or an HAI titer\>=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Exact 2-sided CI was based on the Clopper and Pearson method.
Time frame: 1, 4, and 8 Weeks After Vaccination
Population: EIP=all eligible participants who received vaccination;had blood drawn for assay testing within specified time frame (26-35days)after Vaccination;had at least 1valid and determinate assay result at 4-week post-vaccination visit and had no major protocol deviations.All participants reported under'Overall Number of Participants Analyzed'contributed data to table;however,may not have evaluable data for every row and'Number Analyzed'signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 1 Week after vaccination: A1 | 57.1 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 1 Week after vaccination: A2 | 51.8 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 1 Week after vaccination: B1 | 23.4 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 1 Week after vaccination: B2 | 5.4 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 4 Weeks after vaccination: A1 | 83.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 4 Weeks after vaccination: A2 | 80.4 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 4 Weeks after vaccination: B1 | 40.2 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 4 Weeks after vaccination: B2 | 11.7 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 8 Weeks after vaccination: A1 | 79.1 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 8 Weeks after vaccination: A2 | 60.6 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 8 Weeks after vaccination: B1 | 22.7 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 8 Weeks after vaccination: B2 | 9.2 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 8 Weeks after vaccination: B1 | 21.3 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 1 Week after vaccination: A1 | 65.5 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 4 Weeks after vaccination: B1 | 32.4 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 1 Week after vaccination: A2 | 58.2 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 8 Weeks after vaccination: A2 | 76.1 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 1 Week after vaccination: B1 | 26.6 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 4 Weeks after vaccination: B2 | 21.8 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 1 Week after vaccination: B2 | 12.7 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 8 Weeks after vaccination: B2 | 10.3 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 4 Weeks after vaccination: A1 | 88.9 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 8 Weeks after vaccination: A1 | 86.2 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 4 Weeks after vaccination: A2 | 89.0 Percentage of participants |
Secondary
Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
Seroconversion was defined as an HAI titer \<1:10 prior to vaccination and \>=1:40 at the time point of interest, or an HAI titer \>=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Exact 2-sided CI was based on the Clopper and Pearson method.
Time frame: Prior to vaccination 2 and at 1, 4, and 8 Weeks After last Vaccination
Population: EIP included all eligible participants who received vaccination; had blood drawn for assay testing within the specified time frame (26-35 days) after last vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. Here,'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: B1 | 11.3 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 6.3 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 40.2 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: B1 | 4.1 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 week after last vaccination: B1 | 8.4 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: A2 | 41.1 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 week after last vaccination: A2 | 22.3 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: B2 | 1.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 week after last vaccination: B2 | 3.1 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: A1 | 59.2 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 55.1 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 week after last vaccination: A1 | 40.6 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: B1 | 7.5 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: B1 | 20.4 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 week after last vaccination: A1 | 45.3 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 week after last vaccination: A2 | 31.4 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 62.6 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 58.1 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: A1 | 58.5 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: A2 | 50.5 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 12.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 week after last vaccination: B1 | 12.1 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: B2 | 1.9 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 week after last vaccination: B2 | 7.5 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 week after last vaccination: A1 | 39.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 week after last vaccination: B1 | 29.5 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 week after last vaccination: A2 | 21.9 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 week after last vaccination: B2 | 30.5 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 49.5 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: B1 | 32.4 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 29.5 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 33.7 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: A1 | 37.1 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: A2 | 17.1 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: B1 | 18.1 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: B2 | 21.9 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 week after last vaccination: B2 | 16.7 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 week after last vaccination: A2 | 25.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | Prior to vaccination 2: B1 | 12.5 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: A1 | 83.3 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 week after last vaccination: B1 | 79.2 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 week after last vaccination: A1 | 79.2 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | Prior to vaccination 2: A2 | 79.2 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: A2 | 75.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | Prior to vaccination 2: A1 | 75.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | Prior to vaccination 2: B2 | 8.3 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: B2 | 12.5 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 37.5 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: B1 | 87.5 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 75.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: B1 | 33.3 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 16.7 Percentage of participants |
Secondary
Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
Seroconversion was defined as an HAI titer\<1:10 prior to vaccination and\>=1:40 at the time point of interest,or an HAI titer\>=1:10 prior to vaccination with a 4-fold rise at the time point of interest.Exact 2-sided CI was based on the Clopper and Pearson method.
Time frame: Prior to vaccination 2 (2-visit arms only), 1, 4 and 8 weeks after last vaccination (i.e., vaccination 1 for 1 visit and vaccination 2 for 2 visit)
Population: EIP=all eligible participants who received vaccination;had blood drawn for assay testing within specified time frame (26-35days)after Vaccination;had at least 1valid and determinate assay result at 4-week post-vaccination visit and had no major protocol deviations.All participants reported under'Overall Number of Participants Analyzed'contributed data to table;however,may not have evaluable data for every row and'Number Analyzed'signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A1 | 90.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A1 | 80.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B2 | 20.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A2 | 80.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B1 | 40.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: A1 | 90.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 40.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after vaccination: B1 | 50.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B1 | 40.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 30.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 90.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: A2 | 70.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: B2 | 20.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A2 | 70.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: B1 | 10.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B2 | 20.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B2 | 20.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A1 | 60.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: B1 | 20.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: B2 | 30.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A1 | 80.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: A1 | 60.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B1 | 20.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B2 | 10.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A2 | 80.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 80.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: A2 | 50.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B1 | 10.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after vaccination: B1 | 20.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 20.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A2 | 70.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 10.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B2 | 9.1 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after vaccination: B1 | 27.3 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 18.2 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B1 | 45.5 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A2 | 80.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A2 | 63.6 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A1 | 90.9 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 45.5 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A1 | 72.7 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: B2 | 36.4 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B2 | 36.4 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: A1 | 63.6 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: A2 | 45.5 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B1 | 36.4 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: B1 | 45.5 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 90.9 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: B1 | 50.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: B2 | 50.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 41.7 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A1 | 41.7 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B2 | 41.7 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B1 | 33.3 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A1 | 58.3 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B2 | 50.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after vaccination: B1 | 50.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A2 | 41.7 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B1 | 50.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: A2 | 50.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 50.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: A1 | 58.3 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A2 | 50.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 41.7 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B1 | 33.3 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A2 | 16.7 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B2 | 25.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B1 | 50.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 58.3 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A1 | 58.3 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after vaccination: B1 | 50.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A2 | 9.1 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 25.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 58.3 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B2 | 25.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A1 | 75.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B2 | 33.3 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A1 | 50.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B1 | 36.4 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A2 | 25.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A1 | 45.5 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B2 | 45.5 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A2 | 36.4 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B1 | 33.3 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 33.3 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 50.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 58.3 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after vaccination: B1 | 41.7 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B1 | 6.7 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after vaccination: B1 | 33.3 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B2 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B1 | 6.7 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A2 | 26.7 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 73.3 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A1 | 66.7 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B2 | 20.0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A2 | 46.7 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 20.0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 80.0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A1 | 73.3 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A1 | 35.7 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A1 | 35.7 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B1 | 21.4 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A2 | 21.4 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B2 | 21.4 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 35.7 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after vaccination: B1 | 14.3 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 28.6 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 28.6 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A2 | 14.3 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B1 | 7.1 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B2 | 28.6 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 7.7 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 69.2 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after vaccination: B1 | 23.1 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B2 | 0.0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A2 | 69.2 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 84.6 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B2 | 7.7 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B1 | 15.4 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A2 | 66.7 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B1 | 7.7 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A1 | 58.3 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A1 | 84.6 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B2 | 14.3 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A1 | 57.1 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A1 | 46.7 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 60.0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 53.3 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A2 | 26.7 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B2 | 15.4 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after vaccination: B1 | 28.6 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 14.3 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B1 | 38.5 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B1 | 0.0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A2 | 64.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 25.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A2 | 83.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A1 | 50.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B2 | 16.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: A2 | 33.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B1 | 33.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: A1 | 63.6 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 83.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after last vaccination: B2 | 8.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after vaccination: B1 | 41.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after last vaccination: B1 | 25.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 58.3 Percentage of participants |
Secondary
Percentage of Participants Who Achieved HAI Seroconversion for All Strains at 1, 4, and 8 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A
Seroconversion was defined as an HAI titer \<1:10 prior to vaccination and \>=1:40 at the time point of interest, or an HAI titer of \>=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Time frame: At 1, 4, and 8 weeks After vaccination 1
Population: Vaccination 1 EIP included all eligible participants who received vaccination 1; had blood drawn for assay testing within the specified time frame (26-35 days) after vaccination 1; had at least 1 valid and determinate assay result at the 4-week post-vaccination 1 visit and had no major protocol deviations before vaccination 2. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Who Achieved HAI Seroconversion for All Strains at 1, 4, and 8 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A | 1 Week after Vaccination 1 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Who Achieved HAI Seroconversion for All Strains at 1, 4, and 8 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A | 4 Weeks after Vaccination 1 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants Who Achieved HAI Seroconversion for All Strains at 1, 4, and 8 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A | 8 Weeks after Vaccination 1 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Who Achieved HAI Seroconversion for All Strains at 1, 4, and 8 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A | 1 Week after Vaccination 1 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Who Achieved HAI Seroconversion for All Strains at 1, 4, and 8 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A | 4 Weeks after Vaccination 1 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants Who Achieved HAI Seroconversion for All Strains at 1, 4, and 8 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A | 8 Weeks after Vaccination 1 | 0.0 Percentage of participants |
Secondary
Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A
Percentage of participants with HAI titer \>=1:40 for each strain before vaccination 1 and at 1, 4 and 8 weeks after vaccination 1 is presented in this outcome measure. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Time frame: Before vaccination 1 on day 1 and 1, 4 and 8 weeks after vaccination 1
Population: Vaccination 1 EIP=all eligible participants who received vaccination (vax) 1; had blood drawn for assay testing within specified time frame (26-35 days) after vax 1; had at least 1 valid and determinate assay result at 4-week post-vax 1 visit and had no major protocol deviations before vax 2. Number Analyzed=number of participants evaluable for specified rows and all participants in 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 81.8 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 81.8 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | Prior to Vaccination 1: A1 | 54.5 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 81.8 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | Prior to Vaccination 1: A1 | 50.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 83.3 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 83.3 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 75.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 66.7 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | Prior to Vaccination 1: A1 | 55.6 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 88.9 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 100.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 84.6 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 92.3 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | Prior to Vaccination 1: A1 | 38.5 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 76.9 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 58.3 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 76.9 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 92.3 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | Prior to Vaccination 1: A1 | 46.2 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 61.5 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 92.9 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 78.6 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | Prior to Vaccination 1: B1 | 28.6 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 30.8 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 61.5 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | Prior to Vaccination 1: B1 | 15.4 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 61.5 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 63.6 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 54.5 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | Prior to Vaccination 1: B1 | 18.2 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 81.8 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | Prior to Vaccination 1: B1 | 35.7 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 85.7 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 85.7 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 71.4 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | Prior to Vaccination 1: B1 | 10.0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 27.3 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 27.3 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 36.4 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 100.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 60.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 54.5 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | Prior to Vaccination 1: A1 | 18.2 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 100.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 90.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | Prior to Vaccination 1: B1 | 27.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 72.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 100.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 100.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | Prior to Vaccination 1: A1 | 53.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 33.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 60.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 93.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 33.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 2) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | Prior to Vaccination 1: B1 | 13.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 66.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 83.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | Prior to Vaccination 1: A1 | 33.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 33.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | Prior to Vaccination 1: B1 | 16.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 25.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 83.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 3) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 100.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | Prior to Vaccination 1: A1 | 30.8 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 92.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 100.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 61.5 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 46.2 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 100.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 38.5 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 4) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | Prior to Vaccination 1: B1 | 15.4 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 100.0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | Prior to Vaccination 1: A1 | 58.3 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | Prior to Vaccination 1: B1 | 8.3 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 100.0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 66.7 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 100.0 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 33.3 Percentage of participants |
| SSA: bIRV AB-Licensed QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 41.7 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 92.9 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | Prior to Vaccination 1: A2 | 64.3 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 23.1 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 84.6 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 78.6 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | Prior to Vaccination 1: B2 | 7.1 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 28.6 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A2 | 92.9 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | Prior to Vaccination 1: B1 | 28.6 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B2 | 35.7 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B2 | 7.1 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | Prior to Vaccination 1: A1 | 42.9 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 35.7 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A2 | 100.0 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B2 | 15.4 Percentage of participants |
| SSA: qIRV (Dose Level 1) + QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A2 | 100.0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B2 | 33.3 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A1 | 80.0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B1 | 20.0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: B2 | 26.7 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 1 Week after Vaccination 1: A2 | 93.3 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A1 | 93.3 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | Prior to Vaccination 1: A1 | 40.0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | Prior to Vaccination 1: B1 | 6.7 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | Prior to Vaccination 1: B2 | 26.7 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | Prior to Vaccination 1: A2 | 73.3 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A1 | 93.3 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B1 | 40.0 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: B2 | 53.3 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 4 Weeks after Vaccination 1: A2 | 93.3 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: B1 | 33.3 Percentage of participants |
| SSA: qIRV - Licensed QIV | Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A | 8 Weeks after Vaccination 1: A2 | 86.7 Percentage of participants |
Secondary
Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccination and 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
Percentage of participants with HAI titers \>=1:40 for all strains before vaccination and 1, 4, and 8 weeks after vaccination is reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method.
Time frame: Before vaccination and 1, 4, and 8 Weeks After Vaccination
Population: EIP=all eligible participants who received vaccination;had blood drawn for assay testing within specified time frame (26-35days)after Vaccination;had at least 1valid and determinate assay result at 4-week post-vaccination visit and had no major protocol deviations.All participants reported under'Overall Number of Participants Analyzed'contributed data to table;however,may not have evaluable data for every row and'Number Analyzed'signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccination and 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | Prior to vaccination | 6.3 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccination and 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 1 Week after vaccination | 15.3 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccination and 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 4 Weeks after vaccination | 26.8 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccination and 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 8 Weeks after vaccination | 14.4 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccination and 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 8 Weeks after vaccination | 22.4 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccination and 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | Prior to vaccination | 1.8 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccination and 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 4 Weeks after vaccination | 32.7 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccination and 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 1 Week after vaccination | 20.9 Percentage of participants |
Secondary
Percentage of Participants With HAI Titers>=1:40 for All Strains Before Vaccination and at 1, 4, and 8 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A
Percentage of participants with HAI titer \>=1:40 for all strains before vaccination 1 and 1, 4 and 8 weeks after vaccination 1 is presented in this outcome measure. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Time frame: Before vaccination 1 on day 1 and 1, 4, and 8 weeks after vaccination 1
Population: Vaccination 1 EIP included all eligible participants who received vaccination 1; had blood drawn for assay testing within the specified time frame (26-35 days) after vaccination 1; had at least 1 valid and determinate assay result at the 4-week post-vaccination 1 visit and had no major protocol deviations before vaccination 2. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers>=1:40 for All Strains Before Vaccination and at 1, 4, and 8 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A | Prior to Vaccination 1 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers>=1:40 for All Strains Before Vaccination and at 1, 4, and 8 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A | 1 Week after Vaccination 1 | 7.1 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers>=1:40 for All Strains Before Vaccination and at 1, 4, and 8 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A | 4 Weeks after Vaccination 1 | 14.3 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers>=1:40 for All Strains Before Vaccination and at 1, 4, and 8 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A | 8 Weeks after Vaccination 1 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers>=1:40 for All Strains Before Vaccination and at 1, 4, and 8 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A | 8 Weeks after Vaccination 1 | 20.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers>=1:40 for All Strains Before Vaccination and at 1, 4, and 8 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A | Prior to Vaccination 1 | 6.7 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers>=1:40 for All Strains Before Vaccination and at 1, 4, and 8 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A | 4 Weeks after Vaccination 1 | 26.7 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers>=1:40 for All Strains Before Vaccination and at 1, 4, and 8 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A | 1 Week after Vaccination 1 | 0.0 Percentage of participants |
Secondary
Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
Percentage of participants with HAI titers \>=1:40 for all strains before vaccinations 1 and 2 and 1, 4, and 8 weeks after the last vaccination is reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method.
Time frame: Prior to vaccination 1 and 2, and at 1, 4, and 8 weeks after last vaccination (after vaccination 1 for 1-visit schedule and after vaccination 2 for 2-visit schedule)
Population: EIP included all eligible participants who received vaccination;had blood drawn for assay testing within the specified time frame(26-35 days) after last vaccination;had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations.Here,Number Analyzed=participants evaluable for specified rows. All participants reported under 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | Prior to vaccination 1 | 5.2 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 week after last vaccination | 24.2 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination | 27.2 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination | 13.6 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination | 13.1 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination | 36.4 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 week after last vaccination | 26.7 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | Prior to vaccination 1 | 12.1 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination | 52.3 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination | 25.9 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 week after last vaccination | 40.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | Prior to vaccination 1 | 10.5 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination | 12.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | Prior to vaccination 1 | 0.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | Prior to vaccination 2 | 12.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 week after last vaccination | 16.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination | 20.0 Percentage of participants |
Secondary
Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
Percentage of participants with HAI titers \>=1:40 for all strains before vaccinations 1 and 2 and 1, 4, and 8 weeks after the last vaccination is reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method.
Time frame: Prior to vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (after vaccination 1 for 1-visit schedule and after vaccination 2 for 2-visit schedule)
Population: EIP included all eligible participants who received vaccination;had blood drawn for assay testing within the specified time frame(26-35 days) after last vaccination;had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations.Here,Number Analyzed=participants evaluable for specified rows. All participants reported under 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 Weeks after the last vaccination | 20.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2 | 30.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1 | 10.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 Week after the last vaccination | 20.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 Weeks after the last vaccination | 20.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1 | 10.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 Weeks after the last vaccination | 40.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2 | 50.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 Week after the last vaccination | 60.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 Weeks after the last vaccination | 40.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 Week after the last vaccination | 54.5 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 Weeks after the last vaccination | 20.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2 | 54.5 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1 | 18.2 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 Weeks after the last vaccination | 36.4 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 Weeks after the last vaccination | 66.7 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 Week after the last vaccination | 66.7 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 Weeks after the last vaccination | 50.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1 | 25.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2 | 66.7 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 Weeks after the last vaccination | 45.5 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 Week after the last vaccination | 41.7 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 Weeks after the last vaccination | 50.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2 | 0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1 | 16.7 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 Week after the last vaccination | 58.3 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1 | 16.7 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 Weeks after the last vaccination | 58.3 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 Weeks after the last vaccination | 45.5 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 Week after the last vaccination | 6.7 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 Weeks after the last vaccination | 20.0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1 | 6.7 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 Weeks after the last vaccination | 33.3 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 Week after the last vaccination | 14.3 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1 | 7.1 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 Weeks after the last vaccination | 7.1 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 Weeks after the last vaccination | 21.4 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 Week after the last vaccination | 27.3 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2 | 0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 Weeks after the last vaccination | 23.1 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1 | 7.7 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 Weeks after the last vaccination | 15.4 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1 | 7.1 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 Weeks after the last vaccination | 35.7 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 Weeks after the last vaccination | 30.8 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2 | 0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 Week after the last vaccination | 13.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 Weeks after the last vaccination | 41.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 Week after the last vaccination | 41.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2 | 0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1 | 25.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 Weeks after the last vaccination | 45.5 Percentage of participants |
Secondary
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
Percentage of participants with HAI titers \>=1:40 for each strain before vaccination and 1, 4, and 8 weeks after vaccination is reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method.
Time frame: Before vaccination and 1, 4, and 8 Weeks After Vaccination
Population: EIP=all eligible participants who received vaccination;had blood drawn for assay testing within specified time frame (26-35days)after Vaccination;had at least 1valid and determinate assay result at 4-week post-vaccination visit and had no major protocol deviations.All participants reported under'Overall Number of Participants Analyzed'contributed data to table;however,may not have evaluable data for every row and'Number Analyzed'signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | Prior to vaccination: A1 | 39.3 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | Prior to vaccination: A2 | 34.8 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | Prior to vaccination: B1 | 35.7 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | Prior to vaccination: B2 | 17.9 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 1 Week after vaccination: A1 | 82.3 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 1 Week after vaccination: A2 | 75.2 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 1 Week after vaccination: B1 | 61.6 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 1 Week after vaccination: B2 | 25.9 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 4 Weeks after vaccination: A1 | 94.7 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 4 Weeks after vaccination: A2 | 98.2 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 4 Weeks after vaccination: B1 | 77.9 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 4 Weeks after vaccination: B2 | 33.9 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 8 Weeks after vaccination: A1 | 94.6 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 8 Weeks after vaccination: A2 | 86.7 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 8 Weeks after vaccination: B1 | 61.3 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 8 Weeks after vaccination: B2 | 28.2 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 8 Weeks after vaccination: B2 | 37.4 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | Prior to vaccination: A1 | 35.5 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 4 Weeks after vaccination: A1 | 96.3 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | Prior to vaccination: A2 | 24.5 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 8 Weeks after vaccination: A1 | 95.4 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | Prior to vaccination: B1 | 37.6 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 4 Weeks after vaccination: A2 | 95.4 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | Prior to vaccination: B2 | 17.3 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 8 Weeks after vaccination: B1 | 53.2 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 1 Week after vaccination: A1 | 81.8 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 4 Weeks after vaccination: B1 | 63.9 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 1 Week after vaccination: A2 | 79.1 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 8 Weeks after vaccination: A2 | 90.8 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 1 Week after vaccination: B1 | 53.6 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 4 Weeks after vaccination: B2 | 47.3 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B | 1 Week after vaccination: B2 | 35.5 Percentage of participants |
Secondary
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
Proportion of participants achieving HAI titers \>= 1:40 for each strain before vaccination and at 1, 4 and 8 weeks after vaccination is reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method.
Time frame: Before vaccination 1 and 2 and at 1, 4 and 8 weeks after last vaccination (i.e. after vaccination 1 for 1-vist schedule arms and after vaccination 2 for 2-visit schedule arms)
Population: EIP included all eligible participants who received vaccination;had blood drawn for assay testing within the specified time frame(26-35 days) after last vaccination;had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations.Here,Number Analyzed=participants evaluable for specified rows. All participants reported under 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: B1 | 54.3 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: A2: | 94.2 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 88.6 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: A1: | 89.5 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 Week after last vaccination: A1 | 82.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | Prior to vaccination 1: B1 | 30.9 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 94.3 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | Prior to vaccination 1: B2 | 23.5 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 Week after last vaccination: B1 | 53.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | Prior to vaccination 1: A1 | 48.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | Prior to vaccination 1: A2 | 67.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 39.8 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 Week after last vaccination: A2 | 86.9 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: B1: | 36.2 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: B2: | 29.5 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 Week after last vaccination: B2 | 38.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 99.1 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 Week after last vaccination: B2 | 40.2 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 92.7 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | Prior to vaccination 1: B1 | 33.3 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: B1 | 60.9 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: B2: | 29.4 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: B1: | 41.3 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | Prior to vaccination 1: B2 | 34.3 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: A2: | 91.6 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: A1: | 88.1 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 Week after last vaccination: A1 | 84.1 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | Prior to vaccination 1: A2 | 52.8 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 50.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 Week after last vaccination: B1 | 54.2 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | Prior to vaccination 1: A1 | 51.4 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 Week after last vaccination: A2 | 84.8 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: B1 | 77.8 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | Prior to vaccination 1: A1 | 47.6 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | Prior to vaccination 1: A2 | 54.3 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | Prior to vaccination 1: B1 | 33.3 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | Prior to vaccination 1: B2 | 23.8 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 Week after last vaccination: A1 | 82.9 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 Week after last vaccination: B1 | 72.4 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 Week after last vaccination: A2 | 84.8 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 Week after last vaccination: B2 | 63.8 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 86.1 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 88.9 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 66.4 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: A1: | 75.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: A2: | 58.3 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: B1: | 46.3 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: B2: | 50.9 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 Week after last vaccination: B1 | 44.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 Week after last vaccination: A1 | 96.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: B1: | 44.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: B2 | 28.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | Prior to vaccination 2: B2 | 20.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | Prior to vaccination 2: B1 | 28.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | Prior to vaccination 1: A2 | 12.5 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: A1: | 92.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | Prior to vaccination 2: A2 | 92.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | Prior to vaccination 2: A1 | 92.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | Prior to vaccination 1: A1 | 33.3 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: A2: | 92.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | Prior to vaccination 1: B2 | 8.3 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | Prior to vaccination 1: B1 | 8.3 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: A1 | 92.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: B1 | 52.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 Week after last vaccination: B2 | 28.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 1 Week after last vaccination: A2 | 92.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 8 weeks after last vaccination: B2: | 24.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B | 4 weeks after last vaccination: A2 | 92.0 Percentage of participants |
Secondary
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
Percentage of participants achieving HAI titers \>= 1:40 for each strain before vaccinations 1 and 2 and at 1, 4 and 8 weeks after last vaccination is reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method.
Time frame: Before vaccination 1 and 2 (for 2-visit only), and 1, 4 and 8 weeks after last vaccination (i.e., vaccination 1 for 1-visit arms and vaccination 2 for 2-visit arms)
Population: EIP included all eligible participants who received vaccination;had blood drawn for assay testing within the specified time frame(26-35 days) after last vaccination;had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations.Here,Number Analyzed=participants evaluable for specified rows. All participants reported under 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: B1 | 60.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: A1 | 40.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: A2 | 100.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: A1 | 100.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: A1 | 100.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: A2 | 70.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: A2 | 100.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: A2: | 100.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: B1 | 50.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: B2 | 30.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: A1: | 100.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: A1 | 100.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: B2 | 30.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: B2 | 10.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: B1 | 70.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: B2 | 30.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: A2 | 100.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: B1: | 70.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: B2: | 30.0 Percentage of participants |
| SSA: mIRV A (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: B1 | 30.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: A1 | 100.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: B2: | 50.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: B2 | 60.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: B1 | 80.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: B1 | 30.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: A1 | 100.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: A2 | 100.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: A2 | 100.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: A1 | 70.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: B1 | 70.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: A2 | 90.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: B2 | 40.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: A1 | 100.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: B2 | 60.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: A1: | 100.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: B1 | 60.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: A2: | 100.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: B2 | 20.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: A2 | 90.0 Percentage of participants |
| SSA: mIRV A (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: B1: | 50.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: A2 | 90.9 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: A2 | 100.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: B1 | 90.9 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: B2: | 27.3 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: A1 | 100.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: B2 | 36.4 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: B2 | 54.5 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: A1 | 90.9 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: B1 | 45.5 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: B2 | 54.5 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: B2 | 18.2 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: A1: | 90.9 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: B1 | 90.9 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: B1: | 90.9 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: A2: | 100.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: B1 | 90.9 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: A1 | 100.0 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: A1 | 63.6 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: A2 | 72.7 Percentage of participants |
| SSA: mIRV A (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: A2 | 100.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: A2 | 100.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: A1: | 83.3 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: B2 | 33.3 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: B2: | 75.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: B1 | 83.3 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: B1 | 91.7 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: B1 | 41.7 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: B1: | 75.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: B1 | 91.7 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: A1 | 66.7 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: A1 | 100.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: A2 | 100.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: B2 | 83.3 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: A1 | 91.7 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: A2: | 91.7 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: B2 | 66.7 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 2: B2 | 83.3 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: A2 | 75.0 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: A1 | 91.7 Percentage of participants |
| SSA: mIRV A (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: A2 | 91.7 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: A2 | 91.7 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: A1 | 100.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: B1: | 66.7 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: A2: | 90.9 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: B2 | 25.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: A1 | 50.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: A1: | 100.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: B1 | 33.3 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: B2: | 50.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: B2 | 58.3 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: A2 | 83.3 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: B1 | 91.7 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: B1 | 66.7 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: B2 | 58.3 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: A1 | 100.0 Percentage of participants |
| SSA: mIRV A - Licensed QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: A2 | 91.7 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: A1: | 100.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: B1 | 83.3 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: B2 | 66.7 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: A1 | 100.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: A2 | 100.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: B1 | 75.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: B2 | 58.3 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: A2: | 100.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: B1: | 45.5 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: B2: | 63.6 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: B2 | 33.3 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: A1 | 100.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: A2 | 100.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: A1 | 75.0 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: A2 | 83.3 Percentage of participants |
| SSA: mIRV B (Dose Level 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: B1 | 33.3 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: B1: | 33.3 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: A2 | 100.0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: B1 | 53.3 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: A1: | 100.0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: B1 | 13.3 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: B2 | 6.7 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: A2 | 100.0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: A2: | 93.3 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: B2: | 33.3 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: B2 | 33.3 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: A1 | 53.3 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: B2 | 6.7 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: A2 | 66.7 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: A1 | 100.0 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: A1 | 93.3 Percentage of participants |
| SSA: mIRV B (Dose Level 2) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: B1 | 26.7 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: A1 | 78.6 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: B1 | 71.4 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: B1: | 35.7 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: A2 | 85.7 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: A2 | 100.0 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: B2: | 28.6 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: A2: | 57.1 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: B1 | 64.3 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: A1 | 85.7 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: B2 | 21.4 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: A1: | 64.3 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: B2 | 7.1 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: A1 | 35.7 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: B2 | 35.7 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: B1 | 42.9 Percentage of participants |
| SSA: mIRV B (Dose Level 3) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: A2 | 92.9 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: A1 | 83.3 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: B1 | 38.5 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: B2: | 30.8 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: A1: | 92.3 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: B2 | 23.1 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: B2 | 30.8 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: B1 | 46.2 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: B1 | 15.4 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: A2 | 30.8 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: B1: | 46.2 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: A2 | 100.0 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: A2 | 91.7 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: A1 | 92.3 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: A1 | 69.2 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: A2: | 92.3 Percentage of participants |
| SSA: mIRV B (Dose Level 4) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: B2 | 30.8 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: A1 | 93.3 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: A2 | 40.0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: B1 | 78.6 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: B2 | 21.4 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: B2 | 42.9 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: B2: | 30.8 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: A1 | 46.7 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: A2: | 100.0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: A1: | 92.9 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: B1: | 78.6 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: B1 | 60.0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: B2 | 33.3 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: A2 | 80.0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: B1 | 46.7 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: A2 | 100.0 Percentage of participants |
| SSA: mIRV B - Licensed QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: A1 | 93.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: B1: | 58.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: B2 | 33.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: A2: | 100.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: A1: | 100.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: A2 | 83.3 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: B2 | 50.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: B1 | 66.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: A1 | 91.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: A2 | 100.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 4 weeks after the last vaccination: A1 | 100.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: B1 | 25.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: A1 | 66.7 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: B2 | 50.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | Prior to Vaccination 1: A2 | 50.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 1 week after the last vaccination: B1 | 50.0 Percentage of participants |
| SSA: bIRV AB (Dose Level Combination 1) + QIV | Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B | 8 weeks after the last vaccination: B2: | 58.3 Percentage of participants |