Influenza
Conditions
Keywords
vaccine, safety, immunogenicity, plant-made, virus-like particle, hemagglutinin
Brief summary
This randomized, partially-blinded, active comparator-controlled was conducted at multiple sites globally. The composition of QVLP used in this study includes a mix of recombinant H1, H3, and two B hemagglutinin proteins expressed as VLPs and is based on the 2020-2021 influenza virus strains. In this study, 3 dose levels (15 μg/strain, 30 μg/strain, and 45 μg/strain) of QVLP were planned to be tested in combination with 2 dose levels of AS03 adjuvant (full and half dose) in a single-dose regimen to select a dose level of QVLP and adjuvant dose level-combination that is safe and effective for further development. Participants participated in this study for up to approximately 13 months, during which the first visit was scheduled for screening (up to 7 days in advance of vaccine administration) and the second visit on Day 0 was scheduled for vaccine administration. Telephone contacts were made on Day 1, Day 8, and monthly (starting after Day 28) until the end of the study for safety assessments, including concomitant medication use review. Blood draws at the clinic site for key safety assessments were made on Day 3, and Day 28 and for key immunogenicity assessments on Day 0, Day 28, Day 182 (6-month follow-up), and Day 365 (12-month follow-up).
Detailed description
In this study, a partially-blinded design was applied whereby the following individuals did not have access to treatment allocation (i.e. remained blind) throughout the entire study duration: the participants, the Investigators and all personnel involved in the clinical conduct of the study (except the staff involved in the preparation and administration of the study vaccine, the quality assurance auditor, and quality control reviewers), Medicago clinical staff and medical staff involved in safety evaluations (e.g. causality assessments), and all personnel involved in sample analysis at the central and testing laboratories. A total of 209 participants were randomized to the study, divided into 8 groups receiving different adjuvant dose level-combinations of QVLP or Fluzone HD Quad (60 µg/strain). The majority of participants (126 participants) received QVLP 30 μg/strain with full dose AS03 (42 participants), QVLP 30 μg/strain unadjuvanted (41 participants) or Fluzone HD Quad (43 participants), while in 5 other groups with 83 participants enrolled in total the enrollment was discontinued prematurely due to recruitment challenges caused by COVID-19 pandemic.
Interventions
BIOLOGICALInstramuscular vaccine
On Day 0, a single injection of the assigned dose of the vaccine into the deltoid region of the arm
Sponsors
Medicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Observer-blind
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Participants read, understood, and signed the informed consent form prior to participating in the study; participants also completed study-related procedures and communicated with the study staff at visits and by phone during the study; 2. Male and female participants 65 years of age and older at the Vaccination visit (Visit 2); 3. Participants had a body mass index (BMI) \< 30 kg/m2 at the Vaccination visit (Visit 2); 4. Participants were considered by the Investigator to be reliable and likely to cooperate with the assessment procedures and be available for the duration of the study; 5. Participants were non-institutionalized (e.g. not living in rehabilitation centers or old-age homes; living in an elderly community was acceptable) and had no acute or evolving medical problems prior to study participation and no clinically relevant abnormalities that could jeopardize participant safety or interfere with study assessments, as assessed by the Investigator and determined by medical history, physical examination, serology, clinical chemistry and hematology tests, urinalysis, and vital signs. Investigator discretion was permitted with this inclusion criterion; Note: Participants with a pre-existing chronic disease were allowed to participate if the disease was stable and, according to the Investigator's judgment, the condition was unlikely to confound the results of the study or pose additional risk to the participant by participating in the study. Stable disease was generally defined as no new onset or exacerbation of pre-existing chronic disease 3 months prior to vaccination. Based on the Investigator's judgment, participants with more recent stabilization of a disease were also eligible.
Exclusion criteria
1. According to the Investigator's opinion, significant acute or chronic, uncontrolled medical or neuropsychiatric illness. Acute disease was defined as presence of any moderate or severe acute illness with or without a fever within 48 hours prior to the Vaccination visit (Visit 2). Uncontrolled was defined as: * Requiring a new medical or surgical treatment during the 3 months prior to study vaccine administration; * Required any significant change in a chronic medication (i.e. drug, dose, frequency) during the 3 months prior to study vaccine administration due to uncontrolled symptoms or drug toxicity unless the innocuous nature of the medication change met the criteria outlined in inclusion criterion #5 and was appropriately justified and documented by the Investigator. Note: Investigator discretion was permitted with this exclusion criterion. 2. Any confirmed or suspected current immunosuppressive condition or immunodeficiency, including cancer, human immunodeficiency virus, hepatitis B or C infection (participants with a history of cured hepatitis B or C infection without any signs of immunodeficiency at present time were allowed). Investigator discretion was permitted with this exclusion criterion; 3. Current autoimmune disease requiring systemic treatment (such as rheumatoid arthritis, systemic lupus erythematosus, or multiple sclerosis). Investigator discretion was permitted with this exclusion criterion, and participants were eligible to participate with appropriate written justification in the source document (i.e. participants with a history of autoimmune disease who were disease-free without treatment for 3 years or more, or on stable thyroid replacement therapy, mild psoriasis \[i.e. a small number of minor plaques requiring no systemic treatment\], etc.); 4. Administration of any non-influenza vaccine within 30 days prior to the Vaccination visit (Visit 2); planned administration of any vaccine up to Day 28 of the study. Immunization on an emergency basis during the study was evaluated on case-by-case basis by the Investigator. Note: Administration of an authorized COVID-19 vaccine prior to or during the study was acceptable; 5. Administration of influenza vaccine within 6 months prior to the Vaccination visit (Visit 2) or planned administration of influenza vaccine (other than the study vaccine) up to completion of the study; 6. Administration of any adjuvanted or investigational influenza vaccine within 1 year prior to randomization or planned administration prior to the completion of the study; 7. Use of any investigational or non-registered product within 30 days or five half-lives, whichever is longer, prior to the Vaccination visit (Visit 2) or planned use during the study period. Participants who were in a prolonged post-administration observation period of another investigational or marketed drug clinical study, for which there was no ongoing exposure to the investigational or marketed product and all scheduled on-site visits were completed, were allowed to take part in this study, if all other eligibility criteria were met; 8. Administration of any medication or treatment that may alter the vaccine immune responses, such as: * Systemic glucocorticoids at a dose exceeding 10 mg of prednisone (or equivalent) per day for more than 7 consecutive days or for 10 or more days in total, within 1 month prior to the Vaccination visit (Visit 2). Inhaled, nasal, intraarticular, ophthalmic, dermatological, and other topical glucocorticoids were permitted; * Cytotoxic, antineoplastic or immunosuppressant drugs - within 36 months prior to the Vaccination visit (Visit 2); * Any immunoglobulin preparations or blood products, blood transfusion - within 6 months prior to the Vaccination visit (Visit 2); 9. Use of any prescription antiviral drugs with the intention of COVID-19 prophylaxis, including those that were thought to be effective for prevention of COVID-19 but had not been licensed for this indication, within 1 month prior to the Vaccination visit (Visit 2); 10. Participants at high risk of contracting SARS-CoV-2/COVID-19 infection, including, but not limited to, individuals with known close contact with: * anyone residing in, visiting, or working at a health care or long-term care institution (i.e. long-term care facilities, acute care hospitals, rehabilitation hospitals, mental health hospitals, emergency departments); * anyone with laboratory-confirmed SARS-CoV-2/COVID-19 infection within 2 weeks prior to vaccine administration; * anyone who traveled outside the country for any duration within 30 days before the study vaccination; 11. History of allergy to any of the constituents of QVLP, any components of Fluzone HD Quad, the adjuvant AS03, egg, or tobacco; 12. History of anaphylactic allergic reactions to plants or plants components (including fruits and nuts); 13. Participants with a history of Guillain-Barré Syndrome; 14. Personal or family (first-degree relatives) history of narcolepsy; 15. Use of prophylactic medications (e.g. antihistamines \[H1 receptor antagonists\], nonsteroidal anti-inflammatory drugs \[NSAIDs\], systemic and topical glucocorticoids, non-opioid and opioid analgesics) within 24 hours prior to the Vaccination visit (Visit 2) to prevent or pre-empt symptoms due to vaccination; 16. Had a rash, dermatological condition, tattoos, muscle mass, or any other abnormalities at the injection site that could interfere with injection site reaction rating. Investigator discretion was permitted with this exclusion criterion; 17. Participants identified as an Investigator or employee of the Investigator or clinical site with direct involvement in this study, or identified as an immediate family member (i.e. parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in this study, or any employees of Medicago.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain on Day 0 | Day 0 (pre-vaccination) | The GMTs in each treatment group were measured using an HI assay for the homologous influenza strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). |
| GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 28 | Day 28 | The GMTs in each treatment group were measured using an HI assay for the homologous influenza strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). |
| Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | Day 0 (pre-vaccination) up to Day 28 | Seroconversion rate: the percentage of participants in a given treatment group with either a ≥4-fold increase in reciprocal HI titers between Day 0 and Day 28 or a rise of undetectable HI titer (i.e. \< 10) pre-vaccination (Day 0) to an HI titer of ≥ 40 on Day 28 was measured using an HI assay for the homologous influenza strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). |
| Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | Day 0 (pre-vaccination) up to Day 28 | Seroprotection rate: the percentage of participants in a given treatment group attaining a reciprocal HI titer of ≥40 on Day 28 (the percentage of vaccine recipients with a serum HI titer of at least 1:40 following vaccination) for the homologous influenza strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). |
| Geometric Mean Fold Rise (GMFR) Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 28/Day 0) | Day 0 (pre-vaccination), Day 28 | GMFR, the geometric mean of the ratio of GMTs (Day 28/Day 0) in each treatment group was measured using an HI assay for the homologous strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). |
| Number of Participants With at Least One Immediate Adverse Event (AE) | Up to 30 minutes post-vaccination | An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. Immediate AEs were defined as any solicited (local and systemic) and unsolicited AEs that started up to 30 minutes after vaccination. Solicited local AEs included erythema, swelling, and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. |
| Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4 | Up to 30 minutes post-vaccination | An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. Immediate AEs were defined as any solicited (local and systemic) and unsolicited AEs that started up to 30 minutes after vaccination. Solicited local AEs included erythema, swelling, and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. The intensity of the AEs was graded according to the United States Food and Drug Administration Toxicity Grading Scale: mild (Grade 1), moderate (Grade 2), severe (Grade 3), or potentially life threatening (Grade 4). |
| Number of Participants With at Least One Immediate AE Related to Vaccination | 30 minutes post-vaccination | An AE is defined in OM #6. Immediate AEs were defined as any solicited (local and systemic) and unsolicited AEs that started up to 30 minutes after vaccination. Solicited local AEs included erythema, swelling and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. A related AE is an event where the investigator determined that the relationship to study vaccine was Possibly Related, Probably Related or Definitely Related. If a participant reported multiple occurrences of the same AE, only the most closely related occurrence was presented. The causal relationship of all solicited local and systemic AEs was considered related to vaccination. Participants with any related AE was reported. |
| Number of Participants With at Least One Solicited Local or Systemic AE From Day 0 up to Day 7 | Day 0 (pre-vaccination) up to Day 7 | An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. Solicited local AEs included erythema, swelling, and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. |
| Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 7 | Day 0 (pre-vaccination) up to Day 7 | An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. Solicited local AEs included erythema, swelling and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. The intensity of the AEs was graded according to the FDA Toxicity Grading Scale: mild (Grade 1), moderate (Grade 2), severe (Grade 3), or potentially life threatening (Grade 4). |
| Number of Participants With at Least One Unsolicited AE From Day 0 up to Day 28 | Day 0 (pre-vaccination) up to Day 28 | An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. |
| Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 28 | Day 0 (pre-vaccination) up to Day 28 | An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. The intensity of the AEs was graded according to the FDA Toxicity Grading Scale: mild (Grade 1), moderate (Grade 2), severe (Grade 3), or potentially life threatening (Grade 4). |
| Number of Participants With at Least One Unsolicited AE Related to Vaccination From Day 0 up to Day 28 | Day 0 (pre-vaccination) up to Day 28 | An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. A related AE was an event where the Investigator determined that the relationship to study vaccine was Possibly Related, Probably Related or Definitely Related. If a participant reported multiple occurrences of the same AE, only the most closely related occurrence was presented. Participants with any related AE were reported. |
| Number of Participants With at Least One Serious Adverse Events (SAE) From Day 1 up to Day 28 | Day 1 up to Day 28 | An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. An SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event. |
| Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 1 up to Day 28 | Day 1 up to Day 28 | An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. |
| Number of Participants With at Least One Adverse Event of Special Interest (AESI) From Day 1 up to Day 28 | Day 1 up to Day 28 | An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. AESIs included hypersensitivity reactions, narcolepsy, Potential Immune-Mediated Diseases (pIMDs), and other AESIs. Participants with any AESI were reported. |
| Number of Participants With at Least One Medically Attended AE (MAAE) From Day 1 up to Day 28 | Day 1 up to Day 28 | An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. MAAEs are defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a healthcare provider. |
| Number of Participants With at Least One New Onset Clinical Disease (NOCD) From Day 1 up to Day 28 | Day 1 up to Day 28 | All NOCDs that may plausibly have an allergic, autoimmune or inflammatory component were assessed and reported. Plausibility was interpreted broadly; the only clear exceptions were degenerative conditions such as osteoarthritis, age-related physiologic changes and life-style diseases. In this context, most cancers, cardiac conditions, and kidney diseases had to be reported. |
| Number of Participants With the Occurrence of Death From Day 1 up to Day 28 | Day 1 up to Day 28 | The number of participants in each treatment group with an occurrence of death was assessed. |
| Number of Participants With at Least One SAE From Day 29 up to Day 182 | Day 29 up to Day 182 | An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. An SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event. |
| Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 29 up to Day 182 | Day 29 up to Day 182 | An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. The number of participants with at least one AE leading to withdrawal was assessed. |
| Number of Participants With at Least One AESI From Day 29 up to Day 182 | Day 29 up to Day 182 | An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. AESIs included hypersensitivity reactions, narcolepsy, pIMDs, and other AESIs. Participants with any AESI were reported. |
| Number of Participants With at Least One MAAE From Day 29 up to Day 182 | Day 29 up to Day 182 | An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. MAAEs are defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider. |
| Number of Participants With at Least One New NOCD From Day 29 up to Day 182 | Day 29 up to Day 182 | All NOCDs that may plausibly have an allergic, autoimmune or inflammatory component were assessed and reported. Plausibility was interpreted broadly; the only clear exceptions were degenerative conditions such as osteoarthritis, age-related physiologic changes and life-style diseases. In this context, most cancers, cardiac conditions, and kidney diseases were reported. |
| Number of Participants With an Occurrence of Death From Day 29 up to Day 182 | Day 29 up to Day 182 | The number of participants in each treatment group with an occurrence of death was assessed. |
| Number of Participants With at Least One SAE From Day 183 up to Day 365 | Day 183 up to the end of study (Day 365) | An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. An SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event. |
| Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 183 up to Day 365 | Day 183 up to the end of study (Day 365) | An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. The number of participants with at least one AE leading to withdrawal was assessed. |
| Number of Participants With at Least One AESI From Day 183 up to Day 365 | Day 183 up to the end of study (Day 365) | An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. AESIs included hypersensitivity reactions, narcolepsy, pIMDs, and other AESIs. Participants with any AESI were reported. |
| Number of Participants With at Least One MAAE From Day 183 up to Day 365 | Day 183 up to the end of study (Day 365) | An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. MAAEs were defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider. |
| Number of Participants With at Least One NOCD From Day 183 up to Day 365 | Day 183 up to the end of study (Day 365) | All NOCDs that may plausibly have an allergic, autoimmune or inflammatory component were assessed and reported. Plausibility should be interpreted broadly; the only clear exceptions are degenerative conditions such as osteoarthritis, age-related physiologic changes and life-style diseases. In this context, most cancers, cardiac conditions, and kidney diseases should be reported. |
| Number of Participants With an Occurrence of Death From Day 183 up to Day 365 | Day 183 up to the end of study (Day 365) | The number of participants in each treatment group with an occurrence of death was assessed. |
| Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 0 | Day 0 (pre-vaccination) | Participants were monitored for any abnormal findings in urine parameters (urine color, glucose, occult blood, protein, specific gravity, specimen appearance, pH), hematological parameters (basophils, leukocytes, eosinophils, erythrocytes mean corpuscular hemoglobin, erythrocytes, hematocrit, hemoglobin, lymphocytes, mean platelet volume, monocytes, neutrophils, platelets), and blood chemistry parameters (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatinine, gamma glutamyl transferase, glucose, HDL and LDL cholesterol, phosphate, potassium, protein, sodium, triglycerides, urea nitrogen). Any laboratory result outside of the testing laboratory's normal range was classified as clinically significant or not clinically significant by the site investigator, with appropriate documentation. |
| Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3 | Day 3 | Participants were monitored for any abnormal findings in urine parameters (urine color, glucose, occult blood, protein, specific gravity, specimen appearance, pH), hematological parameters (basophils, leukocytes, eosinophils, erythrocytes mean corpuscular hemoglobin, erythrocytes, hematocrit, hemoglobin, lymphocytes, mean platelet volume, monocytes, neutrophils, platelets), and blood chemistry parameters (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatinine, gamma glutamyl transferase, glucose, HDL and LDL cholesterol, phosphate, potassium, protein, sodium, triglycerides, urea nitrogen). Any laboratory result outside of the testing laboratory's normal range was classified as clinically significant or not clinically significant by the site investigator, with appropriate documentation. |
| Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 28 | Day 28 | Participants were monitored for any abnormal findings in urine parameters (urine color, glucose, occult blood, protein, specific gravity, specimen appearance, and pH), hematological parameters (basophils, leukocytes, eosinophils, erythrocytes mean corpuscular hemoglobin, erythrocytes, hematocrit, hemoglobin, lymphocytes, mean platelet volume, monocytes, neutrophils, and platelets), and blood chemistry parameters (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatinine, gamma glutamyl transferase, glucose, cholesterol, phosphate, potassium, protein, sodium, triglycerides, and urea nitrogen). Any laboratory result outside of the testing laboratory's normal range was classified as clinically significant or not clinically significant by the site investigator, with appropriate documentation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With at Least One NOCD From Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365, Stratified by Prior Influenza Vaccination Status | Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365 | All NOCDs that may plausibly have an allergic, autoimmune or inflammatory component were assessed and reported. Plausibility was interpreted broadly; the only clear exceptions were degenerative conditions such as osteoarthritis, age-related physiologic changes and life-style diseases. In this context, most cancers, cardiac conditions, and kidney diseases had to be reported. It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination. |
| Number of Participants With the Occurrence of Death From Day 1 up to Day 28, From Day 29 to Day 182, and From Day 183 to Day 365, Stratified by Prior Influenza Vaccination Status | Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365 | The number of participants in each treatment group with an occurrence of death was assessed. It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination. |
| GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | Day 182, Day 365 | The GMTs in each treatment group were measured using an HI assay for the homologous influenza strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). |
| Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3, Stratified by Prior Influenza Vaccination Status | Day 3 | Participants were monitored for abnormal findings in urine parameters (urine color, glucose, occult blood, protein, specific gravity, specimen appearance, pH), hematological parameters (basophils, leukocytes, eosinophils, erythrocytes mean corpuscular hemoglobin, erythrocytes, hematocrit, hemoglobin, lymphocytes, mean platelet volume, monocytes, neutrophils, platelets), and blood chemistry parameters (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatinine, gamma glutamyl transferase, glucose, HDL and LDL cholesterol, phosphate, potassium, protein, sodium, triglycerides, urea nitrogen). Any laboratory result outside of the normal range was classified as clinically significant or not clinically significant by the site investigator. It was planned that the endpoint would be analyzed if \>25% of the participants had received a standard influenza vaccine during the 12 months prior to study vaccination. |
| Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 28, Stratified by Prior Influenza Vaccination Status | Day 28 | Participants were monitored for abnormal findings in urine parameters (urine color, glucose, occult blood, protein, specific gravity, specimen appearance, pH), hematological parameters (basophils, leukocytes, eosinophils, erythrocytes mean corpuscular hemoglobin, erythrocytes, hematocrit, hemoglobin, lymphocytes, mean platelet volume, monocytes, neutrophils, platelets), and blood chemistry parameters (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatinine, gamma glutamyl transferase, glucose, HDL and LDL cholesterol, phosphate, potassium, protein, sodium, triglycerides, urea nitrogen). Any laboratory result outside of the normal range was classified as clinically significant or not clinically significant by the site investigator. It was planned that the endpoint would be analyzed if \>25% of the participants had received a standard influenza vaccine during the 12 months prior to study vaccination. |
| Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 0, Stratified by Prior Influenza Vaccination Status | Day 0 (pre-vaccination) | Participants were monitored for abnormal findings in urine parameters (urine color, glucose, occult blood, protein, specific gravity, specimen appearance, pH), hematological parameters (basophils, leukocytes, eosinophils, erythrocytes mean corpuscular hemoglobin, erythrocytes, hematocrit, hemoglobin, lymphocytes, mean platelet volume, monocytes, neutrophils, platelets), and blood chemistry parameters (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatinine, gamma glutamyl transferase, glucose, HDL and LDL cholesterol, phosphate, potassium, protein, sodium, triglycerides, urea nitrogen). Any laboratory result outside of the normal range was classified as clinically significant or not clinically significant by the site investigator. It was planned that the endpoint would be analyzed if \>25% of the participants had received a standard influenza vaccine during the 12 months prior to study vaccination. |
| Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | Day 0 (pre-vaccination) up to Day 182 and up to Day 365 | Seroconversion rate: the percentage of participants in a given treatment group with either a ≥4-fold increase in reciprocal HI titers between Day 0 and Day 182 and Day 0 and Day 365 or a rise of undetectable HI titer (i.e. \<10) pre-vaccination (Day 0) to an HI titer of ≥40 on Day 182 and Day 365 was measured using an HI assay for the following homologous influenza strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). |
| Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | Day 0 (pre-vaccination) up to Day 182 and up to Day 365 | Seroprotection rate: the percentage of participants in a given treatment group attaining a reciprocal HI titer of ≥40 on Day 182 and on Day 365 (the percentage of vaccine recipients with a serum HI titer of at least 1:40 following vaccination) for the homologous influenza strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage) |
| GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | Day 0 (pre-vaccination), Day 182, Day 365 | GMFR: the geometric mean of the ratio of GMTs (Day 182/Day 0 and Day 365/Day 0) measured using an HI assay for the homologous strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). |
| GMTs of HI Antibody Response for Each Heterologous Influenza Strain | Day 0 (pre-vaccination), Day 28 | The GMTs in each treatment group were measured using an HI assay for the heterologous influenza strains: A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage). |
| Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Heterologous Influenza Strain | Day 0 (pre-vaccination) up to Day 28 | Seroconversion rate: the percentage of participants in a given treatment group with either a ≥4-fold increase in reciprocal HI titers between Day 0 and Day 28 or a rise of undetectable HI titer (i.e. \<10) pre-vaccination (Day 0) to an HI titer of ≥40 on Day 28 was measured using an HI assay for the heterologous influenza strains A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage). |
| Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Heterologous Influenza Strain | Day 0 (pre-vaccination) up to Day 28 | Seroprotection rate: the percentage of participants in a given treatment group attaining a reciprocal HI titer of ≥40 on Day 28 (the percentage of vaccine recipients with a serum HI titer of at least 1:40 following vaccination) for the heterologous influenza strains A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage) |
| GMFR Measured by HI Antibody Response for Each Heterologous Influenza Strain | Day 0 (pre-vaccination), Day 28 | GMFR: the geometric mean of the ratio of GMTs (Day 28/Day 0) measured using an HI assay for the heterologous strains A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage). |
| GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | Day 0 (pre-vaccination), Day 28 | The GMTs in each treatment group were measured using an MN assay for the homologous influenza strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). |
| Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain | Day 0 (pre-vaccination) up to Day 28 | Seroconversion rate: the percentage of participants in a given treatment group with either a ≥4-fold increase in reciprocal HI titers between Day 0 and Day 28 or a rise of undetectable MN titer (i.e. \<10) pre-vaccination (Day 0) to an MN titer of ≥40 on Day 28 was measured using an MN assay for the homologous influenza strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). |
| GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain | Day 0 (pre-vaccination), Day 28 | GMFR: the geometric mean of the ratio of GMTs (Day 28/Day 0) measured using an MN assay for the homologous strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). |
| GMTs of HI Antibody Response for Each Homologous Influenza Strain, Stratified by Prior Influenza Vaccination Status | Day 0 (pre-vaccination), Day 28 | The GMTs in each treatment group were measured using an HI assay for the homologous influenza strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination. |
| Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain, Stratified by Prior Influenza Vaccination Status | Day 0 (pre-vaccination) up to Day 28 | Seroconversion rate: the percentage of participants in a given treatment group with either a ≥4-fold increase in reciprocal HI titers between Day 0 and Day 28 or a rise of undetectable HI titer (i.e. \<10) pre-vaccination (Day 0) to an HI titer of ≥40 on Day 28 was measured using an HI assay for the homologous influenza strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination. |
| Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain, Stratified by Prior Influenza Vaccination Status | Day 0 (pre-vaccination) up to Day 28 | Seroprotection rate: the percentage of participants in a given treatment group attaining a reciprocal HI titer of ≥40 on Day 28 (the percentage of vaccine recipients with a serum HI titer of at least 1:40 following vaccination) for the homologous influenza strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination. |
| GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain, Stratified by Prior Influenza Vaccination Status | Day 0 (pre-vaccination), Day 28 | GMFR: the geometric mean of the ratio of GMTs (Day 28/Day 0) measured using an HI assay for the homologous strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination. |
| GMTs of HI Antibody Response for Each Heterologous Influenza Strain, Stratified by Prior Influenza Vaccination Status | Day 0 (pre-vaccination), Day 28 | The GMTs in each treatment group were measured using an HI assay for the heterologous influenza strains: A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination. It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination. |
| Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Heterologous Influenza Strain, Stratified by Prior Influenza Vaccination Status | Day 0 (pre-vaccination) up to Day 28 | Seroconversion rate: the percentage of participants in a given treatment group with either a ≥4-fold increase in reciprocal HI titers between Day 0 and Day 28 or a rise of undetectable HI titer (i.e. \<10) pre-vaccination (Day 0) to an HI titer of ≥40 on Day 28 was measured using an HI assay for the following heterologous influenza strains: A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination. |
| Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Heterologous Influenza Strain, Stratified by Prior Influenza Vaccination Status | Day 0 (pre-vaccination) up to Day 28 | Seroprotection rate: the percentage of participants in a given treatment group attaining a reciprocal HI titer of ≥40 on Day 28 (the percentage of vaccine recipients with a serum HI titer of at least 1:40 following vaccination) for the following heterologous influenza strains: A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination. |
| GMFR Measured by HI Antibody Response for Each Heterologous Influenza Strain, Stratified by Prior Influenza Vaccination Status | Day 0 (pre-vaccination), Day 28 | GMFR: the geometric mean of the ratio of GMTs (Day 28/Day 0) measured using an HI assay for the heterologous strains A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination. |
| GMTs of MN Antibody Response for Each Homologous Influenza Strain, Stratified by Prior Influenza Vaccination Status | Day 0 (pre-vaccination), Day 28 | The GMTs in each treatment group were measured using an MN assay for the following homologous influenza strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination. |
| Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain, Stratified by Prior Influenza Vaccination Status | Day 0 (pre-vaccination) up to Day 28 | Seroconversion rate: the percentage of participants in a given treatment group with either a ≥4-fold increase in reciprocal HI titers between Day 0 and Day 28 or a rise of undetectable MN titer (i.e. \<10) pre-vaccination (Day 0) to an MN titer of ≥40 on Day 28 was measured using an MN assay for the homologous influenza strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination. |
| GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain, Stratified by Prior Influenza Vaccination Status | Day 0 (pre-vaccination), Day 28 | GMFR: the geometric mean of the ratio of GMTs (Day 28/Day 0) measured using an MN assay for the strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination. |
| Number of Participants With at Least One Immediate AE, Stratified by Prior Influenza Vaccination Status | Up to 30 minutes post-vaccination | An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. Immediate AEs were defined as any solicited (local and systemic) and unsolicited AEs that started up to 30 minutes after vaccination. Solicited local AEs included erythema, swelling and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination. |
| Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4, Stratified by Prior Influenza Vaccination Status | Up to 30 minutes post-vaccination | An AE is defined in OM #6. Immediate AEs were defined as any solicited (local and systemic) and unsolicited AEs that started up to 30 minutes after vaccination. Solicited local AEs included erythema, swelling and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. The intensity of the AEs was graded according to the FDA Toxicity Grading Scale: mild (Grade 1), moderate (Grade 2), severe (Grade 3), or potentially life threatening (Grade 4). It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination. |
| Number of Participants With at Least One Immediate AE Related to Vaccination, Stratified by Prior Influenza Vaccination Status | Up to 30 minutes post-vaccination | An AE is defined in OM #6. Immediate AEs were defined as any solicited (local and systemic) and unsolicited AEs that started up to 30 minutes after vaccination. Solicited local AEs included erythema, swelling and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. A related AE is an event where the investigator determined that the relationship to study vaccine was Possibly Related, Probably Related, or Definitely Related. If a participant reported multiple occurrences of the same AE, only the most closely related occurrence was presented. It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination. |
| Number of Participants With at Least One Solicited Local or Systemic AE, Stratified by Prior Influenza Vaccination Status | Day 0 (pre-vaccination) up to Day 7 | An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. Solicited local AEs included erythema, swelling and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination. |
| Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4, Stratified by Prior Influenza Vaccination Status | Day 0 (pre-vaccination) up to Day 7 | An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. Solicited local AEs included erythema, swelling and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. The intensity of the AEs was graded according to the FDA Toxicity Grading Scale: mild (Grade 1), moderate (Grade 2), severe (Grade 3), or potentially life threatening (Grade 4). It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination. |
| Number of Participants With at Least One Unsolicited AE, Stratified by Prior Influenza Vaccination Status | Day 0 (pre-vaccination) up to Day 28 | An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination. |
| Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4, Stratified by Prior Influenza Vaccination Status | Day 0 (pre-vaccination) up to Day 28 | An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. The intensity of the AEs was graded according to the FDA Toxicity Grading Scale: mild (Grade 1), moderate (Grade 2), severe (Grade 3), or potentially life threatening (Grade 4). It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination. |
| Number of Participants With at Least One Unsolicited AE Related to Vaccination, Stratified by Prior Influenza Vaccination Status | Day 0 (pre-vaccination) up to Day 28 | An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. A related AE was an event where the Investigator determined that the relationship to study vaccine was Possibly Related, Probably Related, or Definitely Related. It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination. |
| Number of Participants With at Least One SAE From Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365, Stratified by Prior Influenza Vaccination Status | Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365 | An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. An SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event. It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination. |
| Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365, Stratified by Prior Influenza Vaccination Status | Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365 | An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination. |
| Number of Participants With at Least One AESI From Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365, Stratified by Prior Influenza Vaccination Status | Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365 | An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. AESIs included hypersensitivity reactions, narcolepsy, pIMDs, and other AESIs. It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination. |
| Number of Participants With at Least One MAAE From Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365, Stratified by Prior Influenza Vaccination Status | Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365 | An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. MAAEs are defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider. It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination. |
Countries
United States
Participant flow
Recruitment details
Participants were randomized at an equal ratio into 8 treatment groups to receive Quadrivalent Virus-Like Particles (QVLP) vaccine adjuvanted with AS03 (full and half dose), QVLP vaccine unadjuvanted or Fluzone HD Quad vaccine.
Pre-assignment details
Participants were healthy adult males and females 65 years of age and older.
Participants by arm
| Arm | Count |
|---|---|
| QVLP15+Full AS03 Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible). | 19 |
| QVLP15+Half AS03 Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible). | 9 |
| QVLP30+Full AS03 Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible). | 42 |
| QVLP30+Half AS03 Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible). | 19 |
| QVLP45+Full AS03 Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible). | 23 |
| QVLP45+Half AS03 Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible). | 13 |
| QVLP30 Unadjuvanted Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).. | 41 |
| Fluzone HD Quad Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible). | 43 |
| Total | 209 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 3 | 1 | 0 | 2 | 2 |
| Overall Study | Other than specified above | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 2 | 0 | 0 | 0 | 1 | 4 |
Baseline characteristics
| Characteristic | QVLP15+Full AS03 | QVLP15+Half AS03 | QVLP30+Full AS03 | QVLP30+Half AS03 | QVLP45+Full AS03 | QVLP45+Half AS03 | QVLP30 Unadjuvanted | Fluzone HD Quad | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized 65-74 years | 14 Participants | 7 Participants | 33 Participants | 14 Participants | 17 Participants | 10 Participants | 33 Participants | 34 Participants | 162 Participants |
| Age, Customized ≥75 years | 5 Participants | 2 Participants | 9 Participants | 5 Participants | 6 Participants | 3 Participants | 8 Participants | 9 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants | 1 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 9 Participants | 40 Participants | 19 Participants | 23 Participants | 13 Participants | 37 Participants | 42 Participants | 199 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Immunization History Both Influenza and Non-influenza | 1 Participants | 0 Participants | 9 Participants | 0 Participants | 0 Participants | 0 Participants | 5 Participants | 8 Participants | 23 Participants |
| Immunization History None | 10 Participants | 5 Participants | 15 Participants | 13 Participants | 13 Participants | 8 Participants | 18 Participants | 18 Participants | 100 Participants |
| Immunization History Only influenza | 6 Participants | 3 Participants | 16 Participants | 6 Participants | 9 Participants | 4 Participants | 15 Participants | 15 Participants | 74 Participants |
| Immunization History Only non-influenza | 2 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 3 Participants | 2 Participants | 12 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 |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 2 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 8 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 |
| 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 |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 17 Participants | 8 Participants | 40 Participants | 18 Participants | 19 Participants | 13 Participants | 39 Participants | 42 Participants | 196 Participants |
| Sex: Female, Male Female | 8 Participants | 6 Participants | 24 Participants | 10 Participants | 10 Participants | 4 Participants | 24 Participants | 29 Participants | 115 Participants |
| Sex: Female, Male Male | 11 Participants | 3 Participants | 18 Participants | 9 Participants | 13 Participants | 9 Participants | 17 Participants | 14 Participants | 94 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 |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 9 | 1 / 42 | 0 / 19 | 0 / 23 | 0 / 13 | 0 / 41 | 1 / 43 |
| other Total, other adverse events | 10 / 19 | 5 / 9 | 19 / 42 | 6 / 19 | 5 / 23 | 4 / 13 | 18 / 41 | 16 / 43 |
| serious Total, serious adverse events | 1 / 19 | 2 / 9 | 6 / 42 | 2 / 19 | 1 / 23 | 0 / 13 | 1 / 41 | 5 / 43 |
Outcome results
Primary
Geometric Mean Fold Rise (GMFR) Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 28/Day 0)
GMFR, the geometric mean of the ratio of GMTs (Day 28/Day 0) in each treatment group was measured using an HI assay for the homologous strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
Time frame: Day 0 (pre-vaccination), Day 28
Population: Participants in PP Set with available data were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| QVLP15+Full AS03 | Geometric Mean Fold Rise (GMFR) Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 28/Day 0) | H1N1 | 4.0142 ratio |
| QVLP15+Full AS03 | Geometric Mean Fold Rise (GMFR) Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 28/Day 0) | H3N2 | 4.7572 ratio |
| QVLP15+Full AS03 | Geometric Mean Fold Rise (GMFR) Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 28/Day 0) | B/Yamagata lineage | 3.3872 ratio |
| QVLP15+Full AS03 | Geometric Mean Fold Rise (GMFR) Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 28/Day 0) | B/Victoria lineage | 2.7180 ratio |
| QVLP15+Half AS03 | Geometric Mean Fold Rise (GMFR) Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 28/Day 0) | B/Victoria lineage | 2.0988 ratio |
| QVLP15+Half AS03 | Geometric Mean Fold Rise (GMFR) Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 28/Day 0) | H3N2 | 5.1509 ratio |
| QVLP15+Half AS03 | Geometric Mean Fold Rise (GMFR) Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 28/Day 0) | H1N1 | 5.9788 ratio |
| QVLP15+Half AS03 | Geometric Mean Fold Rise (GMFR) Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 28/Day 0) | B/Yamagata lineage | 2.7245 ratio |
| QVLP30+Full AS03 | Geometric Mean Fold Rise (GMFR) Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 28/Day 0) | H1N1 | 3.2024 ratio |
| QVLP30+Full AS03 | Geometric Mean Fold Rise (GMFR) Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 28/Day 0) | B/Victoria lineage | 3.0230 ratio |
| QVLP30+Full AS03 | Geometric Mean Fold Rise (GMFR) Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 28/Day 0) | H3N2 | 8.4563 ratio |
| QVLP30+Full AS03 | Geometric Mean Fold Rise (GMFR) Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 28/Day 0) | B/Yamagata lineage | 3.3189 ratio |
| QVLP30+Half AS03 | Geometric Mean Fold Rise (GMFR) Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 28/Day 0) | H1N1 | 2.5570 ratio |
| QVLP30+Half AS03 | Geometric Mean Fold Rise (GMFR) Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 28/Day 0) | H3N2 | 8.0508 ratio |
| QVLP30+Half AS03 | Geometric Mean Fold Rise (GMFR) Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 28/Day 0) | B/Yamagata lineage | 1.7591 ratio |
| QVLP30+Half AS03 | Geometric Mean Fold Rise (GMFR) Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 28/Day 0) | B/Victoria lineage | 2.9769 ratio |
| QVLP45+Full AS03 | Geometric Mean Fold Rise (GMFR) Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 28/Day 0) | B/Victoria lineage | 2.2729 ratio |
| QVLP45+Full AS03 | Geometric Mean Fold Rise (GMFR) Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 28/Day 0) | B/Yamagata lineage | 2.5016 ratio |
| QVLP45+Full AS03 | Geometric Mean Fold Rise (GMFR) Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 28/Day 0) | H3N2 | 6.3791 ratio |
| QVLP45+Full AS03 | Geometric Mean Fold Rise (GMFR) Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 28/Day 0) | H1N1 | 2.5408 ratio |
| QVLP45+Half AS03 | Geometric Mean Fold Rise (GMFR) Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 28/Day 0) | B/Victoria lineage | 2.4588 ratio |
| QVLP45+Half AS03 | Geometric Mean Fold Rise (GMFR) Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 28/Day 0) | B/Yamagata lineage | 2.3219 ratio |
| QVLP45+Half AS03 | Geometric Mean Fold Rise (GMFR) Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 28/Day 0) | H3N2 | 7.3718 ratio |
| QVLP45+Half AS03 | Geometric Mean Fold Rise (GMFR) Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 28/Day 0) | H1N1 | 3.4414 ratio |
| QVLP30 Unadjuvanted | Geometric Mean Fold Rise (GMFR) Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 28/Day 0) | B/Victoria lineage | 1.8734 ratio |
| QVLP30 Unadjuvanted | Geometric Mean Fold Rise (GMFR) Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 28/Day 0) | H1N1 | 2.3058 ratio |
| QVLP30 Unadjuvanted | Geometric Mean Fold Rise (GMFR) Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 28/Day 0) | B/Yamagata lineage | 1.8422 ratio |
| QVLP30 Unadjuvanted | Geometric Mean Fold Rise (GMFR) Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 28/Day 0) | H3N2 | 7.6527 ratio |
| Fluzone HD Quad | Geometric Mean Fold Rise (GMFR) Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 28/Day 0) | H3N2 | 7.5907 ratio |
| Fluzone HD Quad | Geometric Mean Fold Rise (GMFR) Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 28/Day 0) | B/Yamagata lineage | 4.4642 ratio |
| Fluzone HD Quad | Geometric Mean Fold Rise (GMFR) Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 28/Day 0) | B/Victoria lineage | 3.7317 ratio |
| Fluzone HD Quad | Geometric Mean Fold Rise (GMFR) Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 28/Day 0) | H1N1 | 2.9661 ratio |
Primary
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain on Day 0
The GMTs in each treatment group were measured using an HI assay for the homologous influenza strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
Time frame: Day 0 (pre-vaccination)
Population: Per protocol (PP) set included participants with a Day 0 and any post-vaccination immunogenicity assessment who completed the study with no major protocol deviations related to participant eligibility, the ability to develop a valid immune response, prohibited medication use, or the immunogenicity analyses; and who received QVLP or the active comparators.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| QVLP15+Full AS03 | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain on Day 0 | B/Yamagata lineage | 27.2713 titers |
| QVLP15+Full AS03 | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain on Day 0 | H3N2 | 42.9963 titers |
| QVLP15+Full AS03 | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain on Day 0 | B/Victoria lineage | 32.6846 titers |
| QVLP15+Full AS03 | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain on Day 0 | H1N1 | 87.5704 titers |
| QVLP15+Half AS03 | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain on Day 0 | H3N2 | 35.6256 titers |
| QVLP15+Half AS03 | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain on Day 0 | B/Yamagata lineage | 58.7285 titers |
| QVLP15+Half AS03 | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain on Day 0 | B/Victoria lineage | 38.5215 titers |
| QVLP15+Half AS03 | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain on Day 0 | H1N1 | 71.2385 titers |
| QVLP30+Full AS03 | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain on Day 0 | B/Victoria lineage | 46.6653 titers |
| QVLP30+Full AS03 | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain on Day 0 | H1N1 | 69.1840 titers |
| QVLP30+Full AS03 | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain on Day 0 | B/Yamagata lineage | 35.1259 titers |
| QVLP30+Full AS03 | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain on Day 0 | H3N2 | 53.5390 titers |
| QVLP30+Half AS03 | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain on Day 0 | B/Victoria lineage | 21.1180 titers |
| QVLP30+Half AS03 | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain on Day 0 | H1N1 | 60.7941 titers |
| QVLP30+Half AS03 | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain on Day 0 | H3N2 | 28.2789 titers |
| QVLP30+Half AS03 | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain on Day 0 | B/Yamagata lineage | 24.8494 titers |
| QVLP45+Full AS03 | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain on Day 0 | H3N2 | 26.8632 titers |
| QVLP45+Full AS03 | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain on Day 0 | B/Yamagata lineage | 23.9640 titers |
| QVLP45+Full AS03 | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain on Day 0 | H1N1 | 65.5830 titers |
| QVLP45+Full AS03 | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain on Day 0 | B/Victoria lineage | 36.7938 titers |
| QVLP45+Half AS03 | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain on Day 0 | H3N2 | 57.9959 titers |
| QVLP45+Half AS03 | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain on Day 0 | B/Victoria lineage | 61.2554 titers |
| QVLP45+Half AS03 | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain on Day 0 | H1N1 | 52.1449 titers |
| QVLP45+Half AS03 | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain on Day 0 | B/Yamagata lineage | 21.0585 titers |
| QVLP30 Unadjuvanted | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain on Day 0 | B/Yamagata lineage | 31.8921 titers |
| QVLP30 Unadjuvanted | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain on Day 0 | H1N1 | 80.6590 titers |
| QVLP30 Unadjuvanted | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain on Day 0 | B/Victoria lineage | 36.3962 titers |
| QVLP30 Unadjuvanted | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain on Day 0 | H3N2 | 53.9648 titers |
| Fluzone HD Quad | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain on Day 0 | H3N2 | 50.3624 titers |
| Fluzone HD Quad | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain on Day 0 | B/Yamagata lineage | 31.1646 titers |
| Fluzone HD Quad | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain on Day 0 | H1N1 | 71.9561 titers |
| Fluzone HD Quad | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain on Day 0 | B/Victoria lineage | 26.5681 titers |
Primary
GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 28
The GMTs in each treatment group were measured using an HI assay for the homologous influenza strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
Time frame: Day 28
Population: Participants in PP Set with available data were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| QVLP15+Full AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Yamagata lineage | 95.0432 titers |
| QVLP15+Full AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H1N1 | 296.2330 titers |
| QVLP15+Full AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H3N2 | 205.4037 titers |
| QVLP15+Full AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Victoria lineage | 91.4846 titers |
| QVLP15+Half AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Victoria lineage | 76.9675 titers |
| QVLP15+Half AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H3N2 | 217.8171 titers |
| QVLP15+Half AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H1N1 | 419.3985 titers |
| QVLP15+Half AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Yamagata lineage | 117.6911 titers |
| QVLP30+Full AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Victoria lineage | 121.7513 titers |
| QVLP30+Full AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H3N2 | 399.5021 titers |
| QVLP30+Full AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Yamagata lineage | 108.9616 titers |
| QVLP30+Full AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H1N1 | 222.1740 titers |
| QVLP30+Half AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H3N2 | 319.7171 titers |
| QVLP30+Half AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Victoria lineage | 81.3894 titers |
| QVLP30+Half AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H1N1 | 168.9548 titers |
| QVLP30+Half AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Yamagata lineage | 48.0076 titers |
| QVLP45+Full AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H3N2 | 255.5949 titers |
| QVLP45+Full AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Yamagata lineage | 67.2848 titers |
| QVLP45+Full AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H1N1 | 174.3779 titers |
| QVLP45+Full AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Victoria lineage | 81.3375 titers |
| QVLP45+Half AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Victoria lineage | 113.1054 titers |
| QVLP45+Half AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Yamagata lineage | 58.0067 titers |
| QVLP45+Half AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H1N1 | 214.6073 titers |
| QVLP45+Half AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H3N2 | 355.9261 titers |
| QVLP30 Unadjuvanted | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Yamagata lineage | 59.0477 titers |
| QVLP30 Unadjuvanted | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H1N1 | 165.0534 titers |
| QVLP30 Unadjuvanted | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Victoria lineage | 67.2196 titers |
| QVLP30 Unadjuvanted | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H3N2 | 369.0050 titers |
| Fluzone HD Quad | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H1N1 | 208.8559 titers |
| Fluzone HD Quad | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H3N2 | 352.6912 titers |
| Fluzone HD Quad | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Victoria lineage | 114.1339 titers |
| Fluzone HD Quad | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Yamagata lineage | 137.4894 titers |
Primary
Number of Participants With an Occurrence of Death From Day 183 up to Day 365
The number of participants in each treatment group with an occurrence of death was assessed.
Time frame: Day 183 up to the end of study (Day 365)
Population: SAS.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QVLP15+Full AS03 | Number of Participants With an Occurrence of Death From Day 183 up to Day 365 | 0 Participants |
| QVLP15+Half AS03 | Number of Participants With an Occurrence of Death From Day 183 up to Day 365 | 0 Participants |
| QVLP30+Full AS03 | Number of Participants With an Occurrence of Death From Day 183 up to Day 365 | 1 Participants |
| QVLP30+Half AS03 | Number of Participants With an Occurrence of Death From Day 183 up to Day 365 | 0 Participants |
| QVLP45+Full AS03 | Number of Participants With an Occurrence of Death From Day 183 up to Day 365 | 0 Participants |
| QVLP45+Half AS03 | Number of Participants With an Occurrence of Death From Day 183 up to Day 365 | 0 Participants |
| QVLP30 Unadjuvanted | Number of Participants With an Occurrence of Death From Day 183 up to Day 365 | 0 Participants |
| Fluzone HD Quad | Number of Participants With an Occurrence of Death From Day 183 up to Day 365 | 1 Participants |
Primary
Number of Participants With an Occurrence of Death From Day 29 up to Day 182
The number of participants in each treatment group with an occurrence of death was assessed.
Time frame: Day 29 up to Day 182
Population: SAS.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QVLP15+Full AS03 | Number of Participants With an Occurrence of Death From Day 29 up to Day 182 | 0 Participants |
| QVLP15+Half AS03 | Number of Participants With an Occurrence of Death From Day 29 up to Day 182 | 0 Participants |
| QVLP30+Full AS03 | Number of Participants With an Occurrence of Death From Day 29 up to Day 182 | 0 Participants |
| QVLP30+Half AS03 | Number of Participants With an Occurrence of Death From Day 29 up to Day 182 | 0 Participants |
| QVLP45+Full AS03 | Number of Participants With an Occurrence of Death From Day 29 up to Day 182 | 0 Participants |
| QVLP45+Half AS03 | Number of Participants With an Occurrence of Death From Day 29 up to Day 182 | 0 Participants |
| QVLP30 Unadjuvanted | Number of Participants With an Occurrence of Death From Day 29 up to Day 182 | 0 Participants |
| Fluzone HD Quad | Number of Participants With an Occurrence of Death From Day 29 up to Day 182 | 0 Participants |
Primary
Number of Participants With at Least One Adverse Event of Special Interest (AESI) From Day 1 up to Day 28
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. AESIs included hypersensitivity reactions, narcolepsy, Potential Immune-Mediated Diseases (pIMDs), and other AESIs. Participants with any AESI were reported.
Time frame: Day 1 up to Day 28
Population: SAS.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QVLP15+Full AS03 | Number of Participants With at Least One Adverse Event of Special Interest (AESI) From Day 1 up to Day 28 | 1 Participants |
| QVLP15+Half AS03 | Number of Participants With at Least One Adverse Event of Special Interest (AESI) From Day 1 up to Day 28 | 0 Participants |
| QVLP30+Full AS03 | Number of Participants With at Least One Adverse Event of Special Interest (AESI) From Day 1 up to Day 28 | 0 Participants |
| QVLP30+Half AS03 | Number of Participants With at Least One Adverse Event of Special Interest (AESI) From Day 1 up to Day 28 | 0 Participants |
| QVLP45+Full AS03 | Number of Participants With at Least One Adverse Event of Special Interest (AESI) From Day 1 up to Day 28 | 0 Participants |
| QVLP45+Half AS03 | Number of Participants With at Least One Adverse Event of Special Interest (AESI) From Day 1 up to Day 28 | 0 Participants |
| QVLP30 Unadjuvanted | Number of Participants With at Least One Adverse Event of Special Interest (AESI) From Day 1 up to Day 28 | 0 Participants |
| Fluzone HD Quad | Number of Participants With at Least One Adverse Event of Special Interest (AESI) From Day 1 up to Day 28 | 0 Participants |
Primary
Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 183 up to Day 365
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. The number of participants with at least one AE leading to withdrawal was assessed.
Time frame: Day 183 up to the end of study (Day 365)
Population: SAS.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QVLP15+Full AS03 | Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 183 up to Day 365 | 0 Participants |
| QVLP15+Half AS03 | Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 183 up to Day 365 | 0 Participants |
| QVLP30+Full AS03 | Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 183 up to Day 365 | 1 Participants |
| QVLP30+Half AS03 | Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 183 up to Day 365 | 0 Participants |
| QVLP45+Full AS03 | Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 183 up to Day 365 | 0 Participants |
| QVLP45+Half AS03 | Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 183 up to Day 365 | 0 Participants |
| QVLP30 Unadjuvanted | Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 183 up to Day 365 | 0 Participants |
| Fluzone HD Quad | Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 183 up to Day 365 | 1 Participants |
Primary
Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 1 up to Day 28
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product.
Time frame: Day 1 up to Day 28
Population: SAS.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QVLP15+Full AS03 | Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 1 up to Day 28 | 0 Participants |
| QVLP15+Half AS03 | Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 1 up to Day 28 | 0 Participants |
| QVLP30+Full AS03 | Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 1 up to Day 28 | 0 Participants |
| QVLP30+Half AS03 | Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 1 up to Day 28 | 0 Participants |
| QVLP45+Full AS03 | Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 1 up to Day 28 | 0 Participants |
| QVLP45+Half AS03 | Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 1 up to Day 28 | 0 Participants |
| QVLP30 Unadjuvanted | Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 1 up to Day 28 | 0 Participants |
| Fluzone HD Quad | Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 1 up to Day 28 | 0 Participants |
Primary
Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 29 up to Day 182
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. The number of participants with at least one AE leading to withdrawal was assessed.
Time frame: Day 29 up to Day 182
Population: SAS.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QVLP15+Full AS03 | Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 29 up to Day 182 | 0 Participants |
| QVLP15+Half AS03 | Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 29 up to Day 182 | 0 Participants |
| QVLP30+Full AS03 | Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 29 up to Day 182 | 0 Participants |
| QVLP30+Half AS03 | Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 29 up to Day 182 | 0 Participants |
| QVLP45+Full AS03 | Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 29 up to Day 182 | 0 Participants |
| QVLP45+Half AS03 | Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 29 up to Day 182 | 0 Participants |
| QVLP30 Unadjuvanted | Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 29 up to Day 182 | 0 Participants |
| Fluzone HD Quad | Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 29 up to Day 182 | 0 Participants |
Primary
Number of Participants With at Least One AESI From Day 183 up to Day 365
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. AESIs included hypersensitivity reactions, narcolepsy, pIMDs, and other AESIs. Participants with any AESI were reported.
Time frame: Day 183 up to the end of study (Day 365)
Population: SAS.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QVLP15+Full AS03 | Number of Participants With at Least One AESI From Day 183 up to Day 365 | 0 Participants |
| QVLP15+Half AS03 | Number of Participants With at Least One AESI From Day 183 up to Day 365 | 0 Participants |
| QVLP30+Full AS03 | Number of Participants With at Least One AESI From Day 183 up to Day 365 | 0 Participants |
| QVLP30+Half AS03 | Number of Participants With at Least One AESI From Day 183 up to Day 365 | 0 Participants |
| QVLP45+Full AS03 | Number of Participants With at Least One AESI From Day 183 up to Day 365 | 0 Participants |
| QVLP45+Half AS03 | Number of Participants With at Least One AESI From Day 183 up to Day 365 | 0 Participants |
| QVLP30 Unadjuvanted | Number of Participants With at Least One AESI From Day 183 up to Day 365 | 0 Participants |
| Fluzone HD Quad | Number of Participants With at Least One AESI From Day 183 up to Day 365 | 0 Participants |
Primary
Number of Participants With at Least One AESI From Day 29 up to Day 182
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. AESIs included hypersensitivity reactions, narcolepsy, pIMDs, and other AESIs. Participants with any AESI were reported.
Time frame: Day 29 up to Day 182
Population: SAS.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QVLP15+Full AS03 | Number of Participants With at Least One AESI From Day 29 up to Day 182 | 0 Participants |
| QVLP15+Half AS03 | Number of Participants With at Least One AESI From Day 29 up to Day 182 | 0 Participants |
| QVLP30+Full AS03 | Number of Participants With at Least One AESI From Day 29 up to Day 182 | 0 Participants |
| QVLP30+Half AS03 | Number of Participants With at Least One AESI From Day 29 up to Day 182 | 0 Participants |
| QVLP45+Full AS03 | Number of Participants With at Least One AESI From Day 29 up to Day 182 | 0 Participants |
| QVLP45+Half AS03 | Number of Participants With at Least One AESI From Day 29 up to Day 182 | 0 Participants |
| QVLP30 Unadjuvanted | Number of Participants With at Least One AESI From Day 29 up to Day 182 | 0 Participants |
| Fluzone HD Quad | Number of Participants With at Least One AESI From Day 29 up to Day 182 | 0 Participants |
Primary
Number of Participants With at Least One Immediate Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. Immediate AEs were defined as any solicited (local and systemic) and unsolicited AEs that started up to 30 minutes after vaccination. Solicited local AEs included erythema, swelling, and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck.
Time frame: Up to 30 minutes post-vaccination
Population: SAS.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QVLP15+Full AS03 | Number of Participants With at Least One Immediate Adverse Event (AE) | 1 Participants |
| QVLP15+Half AS03 | Number of Participants With at Least One Immediate Adverse Event (AE) | 0 Participants |
| QVLP30+Full AS03 | Number of Participants With at Least One Immediate Adverse Event (AE) | 4 Participants |
| QVLP30+Half AS03 | Number of Participants With at Least One Immediate Adverse Event (AE) | 3 Participants |
| QVLP45+Full AS03 | Number of Participants With at Least One Immediate Adverse Event (AE) | 5 Participants |
| QVLP45+Half AS03 | Number of Participants With at Least One Immediate Adverse Event (AE) | 1 Participants |
| QVLP30 Unadjuvanted | Number of Participants With at Least One Immediate Adverse Event (AE) | 5 Participants |
| Fluzone HD Quad | Number of Participants With at Least One Immediate Adverse Event (AE) | 4 Participants |
Primary
Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. Immediate AEs were defined as any solicited (local and systemic) and unsolicited AEs that started up to 30 minutes after vaccination. Solicited local AEs included erythema, swelling, and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. The intensity of the AEs was graded according to the United States Food and Drug Administration Toxicity Grading Scale: mild (Grade 1), moderate (Grade 2), severe (Grade 3), or potentially life threatening (Grade 4).
Time frame: Up to 30 minutes post-vaccination
Population: Participants in SAS with at least one immediate AE.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| QVLP15+Full AS03 | Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4 | Immediate solicited AE Grade 3 | 0 Participants |
| QVLP15+Full AS03 | Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4 | Immediate solicited AE Grade 4 | 0 Participants |
| QVLP15+Full AS03 | Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4 | Immediate solicited AE Grade 1 | 1 Participants |
| QVLP15+Full AS03 | Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4 | Immediate solicited AE Grade 2 | 0 Participants |
| QVLP15+Half AS03 | Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4 | Immediate solicited AE Grade 3 | 0 Participants |
| QVLP15+Half AS03 | Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4 | Immediate solicited AE Grade 2 | 0 Participants |
| QVLP15+Half AS03 | Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4 | Immediate solicited AE Grade 1 | 0 Participants |
| QVLP15+Half AS03 | Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4 | Immediate solicited AE Grade 4 | 0 Participants |
| QVLP30+Full AS03 | Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4 | Immediate solicited AE Grade 3 | 0 Participants |
| QVLP30+Full AS03 | Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4 | Immediate solicited AE Grade 2 | 0 Participants |
| QVLP30+Full AS03 | Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4 | Immediate solicited AE Grade 1 | 4 Participants |
| QVLP30+Full AS03 | Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4 | Immediate solicited AE Grade 4 | 0 Participants |
| QVLP30+Half AS03 | Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4 | Immediate solicited AE Grade 3 | 0 Participants |
| QVLP30+Half AS03 | Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4 | Immediate solicited AE Grade 1 | 3 Participants |
| QVLP30+Half AS03 | Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4 | Immediate solicited AE Grade 2 | 0 Participants |
| QVLP30+Half AS03 | Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4 | Immediate solicited AE Grade 4 | 0 Participants |
| QVLP45+Full AS03 | Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4 | Immediate solicited AE Grade 2 | 1 Participants |
| QVLP45+Full AS03 | Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4 | Immediate solicited AE Grade 3 | 0 Participants |
| QVLP45+Full AS03 | Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4 | Immediate solicited AE Grade 1 | 4 Participants |
| QVLP45+Full AS03 | Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4 | Immediate solicited AE Grade 4 | 0 Participants |
| QVLP45+Half AS03 | Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4 | Immediate solicited AE Grade 1 | 1 Participants |
| QVLP45+Half AS03 | Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4 | Immediate solicited AE Grade 4 | 0 Participants |
| QVLP45+Half AS03 | Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4 | Immediate solicited AE Grade 3 | 0 Participants |
| QVLP45+Half AS03 | Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4 | Immediate solicited AE Grade 2 | 0 Participants |
| QVLP30 Unadjuvanted | Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4 | Immediate solicited AE Grade 4 | 0 Participants |
| QVLP30 Unadjuvanted | Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4 | Immediate solicited AE Grade 1 | 4 Participants |
| QVLP30 Unadjuvanted | Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4 | Immediate solicited AE Grade 2 | 0 Participants |
| QVLP30 Unadjuvanted | Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4 | Immediate solicited AE Grade 3 | 1 Participants |
| Fluzone HD Quad | Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4 | Immediate solicited AE Grade 4 | 0 Participants |
| Fluzone HD Quad | Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4 | Immediate solicited AE Grade 1 | 4 Participants |
| Fluzone HD Quad | Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4 | Immediate solicited AE Grade 3 | 0 Participants |
| Fluzone HD Quad | Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4 | Immediate solicited AE Grade 2 | 0 Participants |
Primary
Number of Participants With at Least One Immediate AE Related to Vaccination
An AE is defined in OM #6. Immediate AEs were defined as any solicited (local and systemic) and unsolicited AEs that started up to 30 minutes after vaccination. Solicited local AEs included erythema, swelling and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. A related AE is an event where the investigator determined that the relationship to study vaccine was Possibly Related, Probably Related or Definitely Related. If a participant reported multiple occurrences of the same AE, only the most closely related occurrence was presented. The causal relationship of all solicited local and systemic AEs was considered related to vaccination. Participants with any related AE was reported.
Time frame: 30 minutes post-vaccination
Population: Participants in SAS with at least one immediate AE.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| QVLP15+Full AS03 | Number of Participants With at Least One Immediate AE Related to Vaccination | Related immediate solicited AE | 1 Participants |
| QVLP15+Full AS03 | Number of Participants With at Least One Immediate AE Related to Vaccination | Related immediate unsolicited AE | 0 Participants |
| QVLP15+Half AS03 | Number of Participants With at Least One Immediate AE Related to Vaccination | Related immediate solicited AE | 0 Participants |
| QVLP15+Half AS03 | Number of Participants With at Least One Immediate AE Related to Vaccination | Related immediate unsolicited AE | 0 Participants |
| QVLP30+Full AS03 | Number of Participants With at Least One Immediate AE Related to Vaccination | Related immediate unsolicited AE | 0 Participants |
| QVLP30+Full AS03 | Number of Participants With at Least One Immediate AE Related to Vaccination | Related immediate solicited AE | 4 Participants |
| QVLP30+Half AS03 | Number of Participants With at Least One Immediate AE Related to Vaccination | Related immediate solicited AE | 3 Participants |
| QVLP30+Half AS03 | Number of Participants With at Least One Immediate AE Related to Vaccination | Related immediate unsolicited AE | 0 Participants |
| QVLP45+Full AS03 | Number of Participants With at Least One Immediate AE Related to Vaccination | Related immediate unsolicited AE | 0 Participants |
| QVLP45+Full AS03 | Number of Participants With at Least One Immediate AE Related to Vaccination | Related immediate solicited AE | 5 Participants |
| QVLP45+Half AS03 | Number of Participants With at Least One Immediate AE Related to Vaccination | Related immediate unsolicited AE | 0 Participants |
| QVLP45+Half AS03 | Number of Participants With at Least One Immediate AE Related to Vaccination | Related immediate solicited AE | 1 Participants |
| QVLP30 Unadjuvanted | Number of Participants With at Least One Immediate AE Related to Vaccination | Related immediate solicited AE | 5 Participants |
| QVLP30 Unadjuvanted | Number of Participants With at Least One Immediate AE Related to Vaccination | Related immediate unsolicited AE | 0 Participants |
| Fluzone HD Quad | Number of Participants With at Least One Immediate AE Related to Vaccination | Related immediate unsolicited AE | 0 Participants |
| Fluzone HD Quad | Number of Participants With at Least One Immediate AE Related to Vaccination | Related immediate solicited AE | 4 Participants |
Primary
Number of Participants With at Least One MAAE From Day 183 up to Day 365
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. MAAEs were defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider.
Time frame: Day 183 up to the end of study (Day 365)
Population: SAS.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QVLP15+Full AS03 | Number of Participants With at Least One MAAE From Day 183 up to Day 365 | 3 Participants |
| QVLP15+Half AS03 | Number of Participants With at Least One MAAE From Day 183 up to Day 365 | 2 Participants |
| QVLP30+Full AS03 | Number of Participants With at Least One MAAE From Day 183 up to Day 365 | 8 Participants |
| QVLP30+Half AS03 | Number of Participants With at Least One MAAE From Day 183 up to Day 365 | 4 Participants |
| QVLP45+Full AS03 | Number of Participants With at Least One MAAE From Day 183 up to Day 365 | 0 Participants |
| QVLP45+Half AS03 | Number of Participants With at Least One MAAE From Day 183 up to Day 365 | 3 Participants |
| QVLP30 Unadjuvanted | Number of Participants With at Least One MAAE From Day 183 up to Day 365 | 5 Participants |
| Fluzone HD Quad | Number of Participants With at Least One MAAE From Day 183 up to Day 365 | 4 Participants |
Primary
Number of Participants With at Least One MAAE From Day 29 up to Day 182
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. MAAEs are defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider.
Time frame: Day 29 up to Day 182
Population: SAS.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QVLP15+Full AS03 | Number of Participants With at Least One MAAE From Day 29 up to Day 182 | 3 Participants |
| QVLP15+Half AS03 | Number of Participants With at Least One MAAE From Day 29 up to Day 182 | 1 Participants |
| QVLP30+Full AS03 | Number of Participants With at Least One MAAE From Day 29 up to Day 182 | 14 Participants |
| QVLP30+Half AS03 | Number of Participants With at Least One MAAE From Day 29 up to Day 182 | 3 Participants |
| QVLP45+Full AS03 | Number of Participants With at Least One MAAE From Day 29 up to Day 182 | 2 Participants |
| QVLP45+Half AS03 | Number of Participants With at Least One MAAE From Day 29 up to Day 182 | 2 Participants |
| QVLP30 Unadjuvanted | Number of Participants With at Least One MAAE From Day 29 up to Day 182 | 6 Participants |
| Fluzone HD Quad | Number of Participants With at Least One MAAE From Day 29 up to Day 182 | 12 Participants |
Primary
Number of Participants With at Least One Medically Attended AE (MAAE) From Day 1 up to Day 28
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. MAAEs are defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a healthcare provider.
Time frame: Day 1 up to Day 28
Population: SAS.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QVLP15+Full AS03 | Number of Participants With at Least One Medically Attended AE (MAAE) From Day 1 up to Day 28 | 2 Participants |
| QVLP15+Half AS03 | Number of Participants With at Least One Medically Attended AE (MAAE) From Day 1 up to Day 28 | 0 Participants |
| QVLP30+Full AS03 | Number of Participants With at Least One Medically Attended AE (MAAE) From Day 1 up to Day 28 | 3 Participants |
| QVLP30+Half AS03 | Number of Participants With at Least One Medically Attended AE (MAAE) From Day 1 up to Day 28 | 1 Participants |
| QVLP45+Full AS03 | Number of Participants With at Least One Medically Attended AE (MAAE) From Day 1 up to Day 28 | 1 Participants |
| QVLP45+Half AS03 | Number of Participants With at Least One Medically Attended AE (MAAE) From Day 1 up to Day 28 | 0 Participants |
| QVLP30 Unadjuvanted | Number of Participants With at Least One Medically Attended AE (MAAE) From Day 1 up to Day 28 | 7 Participants |
| Fluzone HD Quad | Number of Participants With at Least One Medically Attended AE (MAAE) From Day 1 up to Day 28 | 7 Participants |
Primary
Number of Participants With at Least One New NOCD From Day 29 up to Day 182
All NOCDs that may plausibly have an allergic, autoimmune or inflammatory component were assessed and reported. Plausibility was interpreted broadly; the only clear exceptions were degenerative conditions such as osteoarthritis, age-related physiologic changes and life-style diseases. In this context, most cancers, cardiac conditions, and kidney diseases were reported.
Time frame: Day 29 up to Day 182
Population: SAS.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QVLP15+Full AS03 | Number of Participants With at Least One New NOCD From Day 29 up to Day 182 | 0 Participants |
| QVLP15+Half AS03 | Number of Participants With at Least One New NOCD From Day 29 up to Day 182 | 0 Participants |
| QVLP30+Full AS03 | Number of Participants With at Least One New NOCD From Day 29 up to Day 182 | 2 Participants |
| QVLP30+Half AS03 | Number of Participants With at Least One New NOCD From Day 29 up to Day 182 | 0 Participants |
| QVLP45+Full AS03 | Number of Participants With at Least One New NOCD From Day 29 up to Day 182 | 1 Participants |
| QVLP45+Half AS03 | Number of Participants With at Least One New NOCD From Day 29 up to Day 182 | 0 Participants |
| QVLP30 Unadjuvanted | Number of Participants With at Least One New NOCD From Day 29 up to Day 182 | 2 Participants |
| Fluzone HD Quad | Number of Participants With at Least One New NOCD From Day 29 up to Day 182 | 0 Participants |
Primary
Number of Participants With at Least One New Onset Clinical Disease (NOCD) From Day 1 up to Day 28
All NOCDs that may plausibly have an allergic, autoimmune or inflammatory component were assessed and reported. Plausibility was interpreted broadly; the only clear exceptions were degenerative conditions such as osteoarthritis, age-related physiologic changes and life-style diseases. In this context, most cancers, cardiac conditions, and kidney diseases had to be reported.
Time frame: Day 1 up to Day 28
Population: SAS.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QVLP15+Full AS03 | Number of Participants With at Least One New Onset Clinical Disease (NOCD) From Day 1 up to Day 28 | 0 Participants |
| QVLP15+Half AS03 | Number of Participants With at Least One New Onset Clinical Disease (NOCD) From Day 1 up to Day 28 | 0 Participants |
| QVLP30+Full AS03 | Number of Participants With at Least One New Onset Clinical Disease (NOCD) From Day 1 up to Day 28 | 0 Participants |
| QVLP30+Half AS03 | Number of Participants With at Least One New Onset Clinical Disease (NOCD) From Day 1 up to Day 28 | 0 Participants |
| QVLP45+Full AS03 | Number of Participants With at Least One New Onset Clinical Disease (NOCD) From Day 1 up to Day 28 | 0 Participants |
| QVLP45+Half AS03 | Number of Participants With at Least One New Onset Clinical Disease (NOCD) From Day 1 up to Day 28 | 0 Participants |
| QVLP30 Unadjuvanted | Number of Participants With at Least One New Onset Clinical Disease (NOCD) From Day 1 up to Day 28 | 0 Participants |
| Fluzone HD Quad | Number of Participants With at Least One New Onset Clinical Disease (NOCD) From Day 1 up to Day 28 | 0 Participants |
Primary
Number of Participants With at Least One NOCD From Day 183 up to Day 365
All NOCDs that may plausibly have an allergic, autoimmune or inflammatory component were assessed and reported. Plausibility should be interpreted broadly; the only clear exceptions are degenerative conditions such as osteoarthritis, age-related physiologic changes and life-style diseases. In this context, most cancers, cardiac conditions, and kidney diseases should be reported.
Time frame: Day 183 up to the end of study (Day 365)
Population: SAS.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QVLP15+Full AS03 | Number of Participants With at Least One NOCD From Day 183 up to Day 365 | 1 Participants |
| QVLP15+Half AS03 | Number of Participants With at Least One NOCD From Day 183 up to Day 365 | 0 Participants |
| QVLP30+Full AS03 | Number of Participants With at Least One NOCD From Day 183 up to Day 365 | 1 Participants |
| QVLP30+Half AS03 | Number of Participants With at Least One NOCD From Day 183 up to Day 365 | 0 Participants |
| QVLP45+Full AS03 | Number of Participants With at Least One NOCD From Day 183 up to Day 365 | 0 Participants |
| QVLP45+Half AS03 | Number of Participants With at Least One NOCD From Day 183 up to Day 365 | 1 Participants |
| QVLP30 Unadjuvanted | Number of Participants With at Least One NOCD From Day 183 up to Day 365 | 0 Participants |
| Fluzone HD Quad | Number of Participants With at Least One NOCD From Day 183 up to Day 365 | 0 Participants |
Primary
Number of Participants With at Least One SAE From Day 183 up to Day 365
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. An SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event.
Time frame: Day 183 up to the end of study (Day 365)
Population: SAS.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QVLP15+Full AS03 | Number of Participants With at Least One SAE From Day 183 up to Day 365 | 0 Participants |
| QVLP15+Half AS03 | Number of Participants With at Least One SAE From Day 183 up to Day 365 | 1 Participants |
| QVLP30+Full AS03 | Number of Participants With at Least One SAE From Day 183 up to Day 365 | 6 Participants |
| QVLP30+Half AS03 | Number of Participants With at Least One SAE From Day 183 up to Day 365 | 1 Participants |
| QVLP45+Full AS03 | Number of Participants With at Least One SAE From Day 183 up to Day 365 | 0 Participants |
| QVLP45+Half AS03 | Number of Participants With at Least One SAE From Day 183 up to Day 365 | 0 Participants |
| QVLP30 Unadjuvanted | Number of Participants With at Least One SAE From Day 183 up to Day 365 | 1 Participants |
| Fluzone HD Quad | Number of Participants With at Least One SAE From Day 183 up to Day 365 | 2 Participants |
Primary
Number of Participants With at Least One SAE From Day 29 up to Day 182
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. An SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event.
Time frame: Day 29 up to Day 182
Population: SAS.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QVLP15+Full AS03 | Number of Participants With at Least One SAE From Day 29 up to Day 182 | 0 Participants |
| QVLP15+Half AS03 | Number of Participants With at Least One SAE From Day 29 up to Day 182 | 1 Participants |
| QVLP30+Full AS03 | Number of Participants With at Least One SAE From Day 29 up to Day 182 | 2 Participants |
| QVLP30+Half AS03 | Number of Participants With at Least One SAE From Day 29 up to Day 182 | 1 Participants |
| QVLP45+Full AS03 | Number of Participants With at Least One SAE From Day 29 up to Day 182 | 1 Participants |
| QVLP45+Half AS03 | Number of Participants With at Least One SAE From Day 29 up to Day 182 | 0 Participants |
| QVLP30 Unadjuvanted | Number of Participants With at Least One SAE From Day 29 up to Day 182 | 0 Participants |
| Fluzone HD Quad | Number of Participants With at Least One SAE From Day 29 up to Day 182 | 5 Participants |
Primary
Number of Participants With at Least One Serious Adverse Events (SAE) From Day 1 up to Day 28
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. An SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event.
Time frame: Day 1 up to Day 28
Population: SAS.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QVLP15+Full AS03 | Number of Participants With at Least One Serious Adverse Events (SAE) From Day 1 up to Day 28 | 1 Participants |
| QVLP15+Half AS03 | Number of Participants With at Least One Serious Adverse Events (SAE) From Day 1 up to Day 28 | 1 Participants |
| QVLP30+Full AS03 | Number of Participants With at Least One Serious Adverse Events (SAE) From Day 1 up to Day 28 | 0 Participants |
| QVLP30+Half AS03 | Number of Participants With at Least One Serious Adverse Events (SAE) From Day 1 up to Day 28 | 0 Participants |
| QVLP45+Full AS03 | Number of Participants With at Least One Serious Adverse Events (SAE) From Day 1 up to Day 28 | 0 Participants |
| QVLP45+Half AS03 | Number of Participants With at Least One Serious Adverse Events (SAE) From Day 1 up to Day 28 | 0 Participants |
| QVLP30 Unadjuvanted | Number of Participants With at Least One Serious Adverse Events (SAE) From Day 1 up to Day 28 | 0 Participants |
| Fluzone HD Quad | Number of Participants With at Least One Serious Adverse Events (SAE) From Day 1 up to Day 28 | 0 Participants |
Primary
Number of Participants With at Least One Solicited Local or Systemic AE From Day 0 up to Day 7
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. Solicited local AEs included erythema, swelling, and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck.
Time frame: Day 0 (pre-vaccination) up to Day 7
Population: SAS.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QVLP15+Full AS03 | Number of Participants With at Least One Solicited Local or Systemic AE From Day 0 up to Day 7 | 12 Participants |
| QVLP15+Half AS03 | Number of Participants With at Least One Solicited Local or Systemic AE From Day 0 up to Day 7 | 5 Participants |
| QVLP30+Full AS03 | Number of Participants With at Least One Solicited Local or Systemic AE From Day 0 up to Day 7 | 37 Participants |
| QVLP30+Half AS03 | Number of Participants With at Least One Solicited Local or Systemic AE From Day 0 up to Day 7 | 12 Participants |
| QVLP45+Full AS03 | Number of Participants With at Least One Solicited Local or Systemic AE From Day 0 up to Day 7 | 14 Participants |
| QVLP45+Half AS03 | Number of Participants With at Least One Solicited Local or Systemic AE From Day 0 up to Day 7 | 8 Participants |
| QVLP30 Unadjuvanted | Number of Participants With at Least One Solicited Local or Systemic AE From Day 0 up to Day 7 | 26 Participants |
| Fluzone HD Quad | Number of Participants With at Least One Solicited Local or Systemic AE From Day 0 up to Day 7 | 25 Participants |
Primary
Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 7
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. Solicited local AEs included erythema, swelling and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. The intensity of the AEs was graded according to the FDA Toxicity Grading Scale: mild (Grade 1), moderate (Grade 2), severe (Grade 3), or potentially life threatening (Grade 4).
Time frame: Day 0 (pre-vaccination) up to Day 7
Population: Participants in SAS with at least one solicited local or systemic AE.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| QVLP15+Full AS03 | Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 7 | Solicited AE of Grade 2 | 3 Participants |
| QVLP15+Full AS03 | Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 7 | Solicited AE of Grade 4 | 1 Participants |
| QVLP15+Full AS03 | Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 7 | Solicited AE of Grade 1 | 8 Participants |
| QVLP15+Full AS03 | Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 7 | Solicited AE of Grade 3 | 0 Participants |
| QVLP15+Half AS03 | Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 7 | Solicited AE of Grade 3 | 0 Participants |
| QVLP15+Half AS03 | Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 7 | Solicited AE of Grade 1 | 3 Participants |
| QVLP15+Half AS03 | Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 7 | Solicited AE of Grade 4 | 0 Participants |
| QVLP15+Half AS03 | Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 7 | Solicited AE of Grade 2 | 2 Participants |
| QVLP30+Full AS03 | Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 7 | Solicited AE of Grade 1 | 21 Participants |
| QVLP30+Full AS03 | Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 7 | Solicited AE of Grade 2 | 13 Participants |
| QVLP30+Full AS03 | Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 7 | Solicited AE of Grade 3 | 3 Participants |
| QVLP30+Full AS03 | Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 7 | Solicited AE of Grade 4 | 0 Participants |
| QVLP30+Half AS03 | Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 7 | Solicited AE of Grade 4 | 0 Participants |
| QVLP30+Half AS03 | Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 7 | Solicited AE of Grade 2 | 4 Participants |
| QVLP30+Half AS03 | Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 7 | Solicited AE of Grade 3 | 0 Participants |
| QVLP30+Half AS03 | Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 7 | Solicited AE of Grade 1 | 8 Participants |
| QVLP45+Full AS03 | Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 7 | Solicited AE of Grade 1 | 5 Participants |
| QVLP45+Full AS03 | Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 7 | Solicited AE of Grade 2 | 7 Participants |
| QVLP45+Full AS03 | Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 7 | Solicited AE of Grade 4 | 1 Participants |
| QVLP45+Full AS03 | Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 7 | Solicited AE of Grade 3 | 1 Participants |
| QVLP45+Half AS03 | Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 7 | Solicited AE of Grade 1 | 7 Participants |
| QVLP45+Half AS03 | Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 7 | Solicited AE of Grade 2 | 1 Participants |
| QVLP45+Half AS03 | Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 7 | Solicited AE of Grade 4 | 0 Participants |
| QVLP45+Half AS03 | Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 7 | Solicited AE of Grade 3 | 0 Participants |
| QVLP30 Unadjuvanted | Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 7 | Solicited AE of Grade 3 | 3 Participants |
| QVLP30 Unadjuvanted | Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 7 | Solicited AE of Grade 1 | 16 Participants |
| QVLP30 Unadjuvanted | Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 7 | Solicited AE of Grade 2 | 7 Participants |
| QVLP30 Unadjuvanted | Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 7 | Solicited AE of Grade 4 | 0 Participants |
| Fluzone HD Quad | Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 7 | Solicited AE of Grade 2 | 5 Participants |
| Fluzone HD Quad | Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 7 | Solicited AE of Grade 1 | 16 Participants |
| Fluzone HD Quad | Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 7 | Solicited AE of Grade 3 | 4 Participants |
| Fluzone HD Quad | Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 7 | Solicited AE of Grade 4 | 0 Participants |
Primary
Number of Participants With at Least One Unsolicited AE From Day 0 up to Day 28
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product.
Time frame: Day 0 (pre-vaccination) up to Day 28
Population: SAS.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QVLP15+Full AS03 | Number of Participants With at Least One Unsolicited AE From Day 0 up to Day 28 | 6 Participants |
| QVLP15+Half AS03 | Number of Participants With at Least One Unsolicited AE From Day 0 up to Day 28 | 4 Participants |
| QVLP30+Full AS03 | Number of Participants With at Least One Unsolicited AE From Day 0 up to Day 28 | 6 Participants |
| QVLP30+Half AS03 | Number of Participants With at Least One Unsolicited AE From Day 0 up to Day 28 | 3 Participants |
| QVLP45+Full AS03 | Number of Participants With at Least One Unsolicited AE From Day 0 up to Day 28 | 1 Participants |
| QVLP45+Half AS03 | Number of Participants With at Least One Unsolicited AE From Day 0 up to Day 28 | 0 Participants |
| QVLP30 Unadjuvanted | Number of Participants With at Least One Unsolicited AE From Day 0 up to Day 28 | 8 Participants |
| Fluzone HD Quad | Number of Participants With at Least One Unsolicited AE From Day 0 up to Day 28 | 7 Participants |
Primary
Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 28
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. The intensity of the AEs was graded according to the FDA Toxicity Grading Scale: mild (Grade 1), moderate (Grade 2), severe (Grade 3), or potentially life threatening (Grade 4).
Time frame: Day 0 (pre-vaccination) up to Day 28
Population: Participants in SAS with at least one unsolicited AE.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| QVLP15+Full AS03 | Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 28 | Unsolicited AE Grade 2 | 1 Participants |
| QVLP15+Full AS03 | Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 28 | Unsolicited AE Grade 4 | 0 Participants |
| QVLP15+Full AS03 | Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 28 | Unsolicited AE Grade 3 | 2 Participants |
| QVLP15+Full AS03 | Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 28 | Unsolicited AE Grade 1 | 3 Participants |
| QVLP15+Half AS03 | Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 28 | Unsolicited AE Grade 4 | 0 Participants |
| QVLP15+Half AS03 | Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 28 | Unsolicited AE Grade 2 | 0 Participants |
| QVLP15+Half AS03 | Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 28 | Unsolicited AE Grade 1 | 1 Participants |
| QVLP15+Half AS03 | Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 28 | Unsolicited AE Grade 3 | 3 Participants |
| QVLP30+Full AS03 | Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 28 | Unsolicited AE Grade 1 | 1 Participants |
| QVLP30+Full AS03 | Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 28 | Unsolicited AE Grade 4 | 0 Participants |
| QVLP30+Full AS03 | Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 28 | Unsolicited AE Grade 3 | 1 Participants |
| QVLP30+Full AS03 | Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 28 | Unsolicited AE Grade 2 | 4 Participants |
| QVLP30+Half AS03 | Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 28 | Unsolicited AE Grade 2 | 0 Participants |
| QVLP30+Half AS03 | Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 28 | Unsolicited AE Grade 4 | 0 Participants |
| QVLP30+Half AS03 | Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 28 | Unsolicited AE Grade 1 | 3 Participants |
| QVLP30+Half AS03 | Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 28 | Unsolicited AE Grade 3 | 0 Participants |
| QVLP45+Full AS03 | Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 28 | Unsolicited AE Grade 1 | 0 Participants |
| QVLP45+Full AS03 | Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 28 | Unsolicited AE Grade 3 | 0 Participants |
| QVLP45+Full AS03 | Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 28 | Unsolicited AE Grade 4 | 0 Participants |
| QVLP45+Full AS03 | Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 28 | Unsolicited AE Grade 2 | 1 Participants |
| QVLP45+Half AS03 | Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 28 | Unsolicited AE Grade 3 | 0 Participants |
| QVLP45+Half AS03 | Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 28 | Unsolicited AE Grade 2 | 0 Participants |
| QVLP45+Half AS03 | Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 28 | Unsolicited AE Grade 1 | 0 Participants |
| QVLP45+Half AS03 | Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 28 | Unsolicited AE Grade 4 | 0 Participants |
| QVLP30 Unadjuvanted | Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 28 | Unsolicited AE Grade 3 | 0 Participants |
| QVLP30 Unadjuvanted | Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 28 | Unsolicited AE Grade 4 | 0 Participants |
| QVLP30 Unadjuvanted | Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 28 | Unsolicited AE Grade 2 | 4 Participants |
| QVLP30 Unadjuvanted | Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 28 | Unsolicited AE Grade 1 | 4 Participants |
| Fluzone HD Quad | Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 28 | Unsolicited AE Grade 1 | 2 Participants |
| Fluzone HD Quad | Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 28 | Unsolicited AE Grade 2 | 4 Participants |
| Fluzone HD Quad | Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 28 | Unsolicited AE Grade 3 | 1 Participants |
| Fluzone HD Quad | Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 28 | Unsolicited AE Grade 4 | 0 Participants |
Primary
Number of Participants With at Least One Unsolicited AE Related to Vaccination From Day 0 up to Day 28
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. A related AE was an event where the Investigator determined that the relationship to study vaccine was Possibly Related, Probably Related or Definitely Related. If a participant reported multiple occurrences of the same AE, only the most closely related occurrence was presented. Participants with any related AE were reported.
Time frame: Day 0 (pre-vaccination) up to Day 28
Population: Participants in SAS with at least one unsolicited AE.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QVLP15+Full AS03 | Number of Participants With at Least One Unsolicited AE Related to Vaccination From Day 0 up to Day 28 | 3 Participants |
| QVLP15+Half AS03 | Number of Participants With at Least One Unsolicited AE Related to Vaccination From Day 0 up to Day 28 | 2 Participants |
| QVLP30+Full AS03 | Number of Participants With at Least One Unsolicited AE Related to Vaccination From Day 0 up to Day 28 | 2 Participants |
| QVLP30+Half AS03 | Number of Participants With at Least One Unsolicited AE Related to Vaccination From Day 0 up to Day 28 | 0 Participants |
| QVLP45+Full AS03 | Number of Participants With at Least One Unsolicited AE Related to Vaccination From Day 0 up to Day 28 | 0 Participants |
| QVLP45+Half AS03 | Number of Participants With at Least One Unsolicited AE Related to Vaccination From Day 0 up to Day 28 | 0 Participants |
| QVLP30 Unadjuvanted | Number of Participants With at Least One Unsolicited AE Related to Vaccination From Day 0 up to Day 28 | 0 Participants |
| Fluzone HD Quad | Number of Participants With at Least One Unsolicited AE Related to Vaccination From Day 0 up to Day 28 | 1 Participants |
Primary
Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 0
Participants were monitored for any abnormal findings in urine parameters (urine color, glucose, occult blood, protein, specific gravity, specimen appearance, pH), hematological parameters (basophils, leukocytes, eosinophils, erythrocytes mean corpuscular hemoglobin, erythrocytes, hematocrit, hemoglobin, lymphocytes, mean platelet volume, monocytes, neutrophils, platelets), and blood chemistry parameters (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatinine, gamma glutamyl transferase, glucose, HDL and LDL cholesterol, phosphate, potassium, protein, sodium, triglycerides, urea nitrogen). Any laboratory result outside of the testing laboratory's normal range was classified as clinically significant or not clinically significant by the site investigator, with appropriate documentation.
Time frame: Day 0 (pre-vaccination)
Population: SAS. Only participants with at least one clinically significant laboratory parameter are reported.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QVLP15+Full AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 0 | 0 Participants |
| QVLP15+Half AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 0 | 0 Participants |
| QVLP30+Full AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 0 | 0 Participants |
| QVLP30+Half AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 0 | 0 Participants |
| QVLP45+Full AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 0 | 0 Participants |
| QVLP45+Half AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 0 | 0 Participants |
| QVLP30 Unadjuvanted | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 0 | 0 Participants |
| Fluzone HD Quad | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 0 | 0 Participants |
Primary
Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 28
Participants were monitored for any abnormal findings in urine parameters (urine color, glucose, occult blood, protein, specific gravity, specimen appearance, and pH), hematological parameters (basophils, leukocytes, eosinophils, erythrocytes mean corpuscular hemoglobin, erythrocytes, hematocrit, hemoglobin, lymphocytes, mean platelet volume, monocytes, neutrophils, and platelets), and blood chemistry parameters (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatinine, gamma glutamyl transferase, glucose, cholesterol, phosphate, potassium, protein, sodium, triglycerides, and urea nitrogen). Any laboratory result outside of the testing laboratory's normal range was classified as clinically significant or not clinically significant by the site investigator, with appropriate documentation.
Time frame: Day 28
Population: SAS. Only participants with at least one clinically significant abnormal laboratory finding are reported.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| QVLP15+Full AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 28 | Urine specimen appearance - abnormal, clinically significant | 0 Participants |
| QVLP15+Full AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 28 | Urine protein - abnormal, clinically significant | 0 Participants |
| QVLP15+Full AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 28 | Urine occult blood - abnormal, clinically significant | 0 Participants |
| QVLP15+Half AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 28 | Urine protein - abnormal, clinically significant | 0 Participants |
| QVLP15+Half AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 28 | Urine occult blood - abnormal, clinically significant | 0 Participants |
| QVLP15+Half AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 28 | Urine specimen appearance - abnormal, clinically significant | 0 Participants |
| QVLP30+Full AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 28 | Urine occult blood - abnormal, clinically significant | 0 Participants |
| QVLP30+Full AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 28 | Urine protein - abnormal, clinically significant | 1 Participants |
| QVLP30+Full AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 28 | Urine specimen appearance - abnormal, clinically significant | 0 Participants |
| QVLP30+Half AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 28 | Urine protein - abnormal, clinically significant | 0 Participants |
| QVLP30+Half AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 28 | Urine occult blood - abnormal, clinically significant | 0 Participants |
| QVLP30+Half AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 28 | Urine specimen appearance - abnormal, clinically significant | 0 Participants |
| QVLP45+Full AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 28 | Urine specimen appearance - abnormal, clinically significant | 0 Participants |
| QVLP45+Full AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 28 | Urine protein - abnormal, clinically significant | 0 Participants |
| QVLP45+Full AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 28 | Urine occult blood - abnormal, clinically significant | 0 Participants |
| QVLP45+Half AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 28 | Urine protein - abnormal, clinically significant | 0 Participants |
| QVLP45+Half AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 28 | Urine occult blood - abnormal, clinically significant | 0 Participants |
| QVLP45+Half AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 28 | Urine specimen appearance - abnormal, clinically significant | 0 Participants |
| QVLP30 Unadjuvanted | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 28 | Urine protein - abnormal, clinically significant | 0 Participants |
| QVLP30 Unadjuvanted | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 28 | Urine occult blood - abnormal, clinically significant | 1 Participants |
| QVLP30 Unadjuvanted | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 28 | Urine specimen appearance - abnormal, clinically significant | 1 Participants |
| Fluzone HD Quad | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 28 | Urine occult blood - abnormal, clinically significant | 0 Participants |
| Fluzone HD Quad | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 28 | Urine specimen appearance - abnormal, clinically significant | 0 Participants |
| Fluzone HD Quad | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 28 | Urine protein - abnormal, clinically significant | 0 Participants |
Primary
Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3
Participants were monitored for any abnormal findings in urine parameters (urine color, glucose, occult blood, protein, specific gravity, specimen appearance, pH), hematological parameters (basophils, leukocytes, eosinophils, erythrocytes mean corpuscular hemoglobin, erythrocytes, hematocrit, hemoglobin, lymphocytes, mean platelet volume, monocytes, neutrophils, platelets), and blood chemistry parameters (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatinine, gamma glutamyl transferase, glucose, HDL and LDL cholesterol, phosphate, potassium, protein, sodium, triglycerides, urea nitrogen). Any laboratory result outside of the testing laboratory's normal range was classified as clinically significant or not clinically significant by the site investigator, with appropriate documentation.
Time frame: Day 3
Population: SAS. Only participants with at least one clinically significant abnormal laboratory finding are reported.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| QVLP15+Full AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3 | Urine glucose - abnormal, clinically significant | 0 Participants |
| QVLP15+Full AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3 | Urine protein - abnormal, clinically significant | 1 Participants |
| QVLP15+Full AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3 | Urine specimen appearance - abnormal, clinically significant | 0 Participants |
| QVLP15+Full AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3 | Urine occult blood - abnormal, clinically significant | 1 Participants |
| QVLP15+Half AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3 | Urine specimen appearance - abnormal, clinically significant | 0 Participants |
| QVLP15+Half AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3 | Urine protein - abnormal, clinically significant | 0 Participants |
| QVLP15+Half AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3 | Urine glucose - abnormal, clinically significant | 0 Participants |
| QVLP15+Half AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3 | Urine occult blood - abnormal, clinically significant | 0 Participants |
| QVLP30+Full AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3 | Urine protein - abnormal, clinically significant | 0 Participants |
| QVLP30+Full AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3 | Urine glucose - abnormal, clinically significant | 0 Participants |
| QVLP30+Full AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3 | Urine specimen appearance - abnormal, clinically significant | 0 Participants |
| QVLP30+Full AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3 | Urine occult blood - abnormal, clinically significant | 0 Participants |
| QVLP30+Half AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3 | Urine glucose - abnormal, clinically significant | 1 Participants |
| QVLP30+Half AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3 | Urine occult blood - abnormal, clinically significant | 0 Participants |
| QVLP30+Half AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3 | Urine protein - abnormal, clinically significant | 0 Participants |
| QVLP30+Half AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3 | Urine specimen appearance - abnormal, clinically significant | 0 Participants |
| QVLP45+Full AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3 | Urine glucose - abnormal, clinically significant | 0 Participants |
| QVLP45+Full AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3 | Urine protein - abnormal, clinically significant | 0 Participants |
| QVLP45+Full AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3 | Urine occult blood - abnormal, clinically significant | 0 Participants |
| QVLP45+Full AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3 | Urine specimen appearance - abnormal, clinically significant | 1 Participants |
| QVLP45+Half AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3 | Urine specimen appearance - abnormal, clinically significant | 0 Participants |
| QVLP45+Half AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3 | Urine protein - abnormal, clinically significant | 0 Participants |
| QVLP45+Half AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3 | Urine occult blood - abnormal, clinically significant | 0 Participants |
| QVLP45+Half AS03 | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3 | Urine glucose - abnormal, clinically significant | 0 Participants |
| QVLP30 Unadjuvanted | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3 | Urine protein - abnormal, clinically significant | 0 Participants |
| QVLP30 Unadjuvanted | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3 | Urine occult blood - abnormal, clinically significant | 0 Participants |
| QVLP30 Unadjuvanted | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3 | Urine specimen appearance - abnormal, clinically significant | 0 Participants |
| QVLP30 Unadjuvanted | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3 | Urine glucose - abnormal, clinically significant | 0 Participants |
| Fluzone HD Quad | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3 | Urine glucose - abnormal, clinically significant | 0 Participants |
| Fluzone HD Quad | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3 | Urine protein - abnormal, clinically significant | 0 Participants |
| Fluzone HD Quad | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3 | Urine specimen appearance - abnormal, clinically significant | 1 Participants |
| Fluzone HD Quad | Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3 | Urine occult blood - abnormal, clinically significant | 0 Participants |
Primary
Number of Participants With the Occurrence of Death From Day 1 up to Day 28
The number of participants in each treatment group with an occurrence of death was assessed.
Time frame: Day 1 up to Day 28
Population: SAS.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QVLP15+Full AS03 | Number of Participants With the Occurrence of Death From Day 1 up to Day 28 | 0 Participants |
| QVLP15+Half AS03 | Number of Participants With the Occurrence of Death From Day 1 up to Day 28 | 0 Participants |
| QVLP30+Full AS03 | Number of Participants With the Occurrence of Death From Day 1 up to Day 28 | 0 Participants |
| QVLP30+Half AS03 | Number of Participants With the Occurrence of Death From Day 1 up to Day 28 | 0 Participants |
| QVLP45+Full AS03 | Number of Participants With the Occurrence of Death From Day 1 up to Day 28 | 0 Participants |
| QVLP45+Half AS03 | Number of Participants With the Occurrence of Death From Day 1 up to Day 28 | 0 Participants |
| QVLP30 Unadjuvanted | Number of Participants With the Occurrence of Death From Day 1 up to Day 28 | 0 Participants |
| Fluzone HD Quad | Number of Participants With the Occurrence of Death From Day 1 up to Day 28 | 0 Participants |
Primary
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28
Seroconversion rate: the percentage of participants in a given treatment group with either a ≥4-fold increase in reciprocal HI titers between Day 0 and Day 28 or a rise of undetectable HI titer (i.e. \< 10) pre-vaccination (Day 0) to an HI titer of ≥ 40 on Day 28 was measured using an HI assay for the homologous influenza strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
Time frame: Day 0 (pre-vaccination) up to Day 28
Population: Participants in PP Set with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| QVLP15+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H3N2 | 38.9 percentage of participants |
| QVLP15+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Victoria lineage | 44.4 percentage of participants |
| QVLP15+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Yamagata lineage | 33.3 percentage of participants |
| QVLP15+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H1N1 | 38.9 percentage of participants |
| QVLP15+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Victoria lineage | 33.3 percentage of participants |
| QVLP15+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Yamagata lineage | 22.2 percentage of participants |
| QVLP15+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H1N1 | 55.6 percentage of participants |
| QVLP15+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H3N2 | 55.6 percentage of participants |
| QVLP30+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H1N1 | 36.8 percentage of participants |
| QVLP30+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Yamagata lineage | 31.6 percentage of participants |
| QVLP30+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H3N2 | 65.8 percentage of participants |
| QVLP30+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Victoria lineage | 26.3 percentage of participants |
| QVLP30+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H3N2 | 63.2 percentage of participants |
| QVLP30+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Victoria lineage | 36.8 percentage of participants |
| QVLP30+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H1N1 | 42.1 percentage of participants |
| QVLP30+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Yamagata lineage | 21.1 percentage of participants |
| QVLP45+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H1N1 | 25.0 percentage of participants |
| QVLP45+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H3N2 | 70.0 percentage of participants |
| QVLP45+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Yamagata lineage | 30.0 percentage of participants |
| QVLP45+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Victoria lineage | 30.0 percentage of participants |
| QVLP45+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H3N2 | 61.5 percentage of participants |
| QVLP45+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Yamagata lineage | 30.8 percentage of participants |
| QVLP45+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H1N1 | 30.8 percentage of participants |
| QVLP45+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Victoria lineage | 15.4 percentage of participants |
| QVLP30 Unadjuvanted | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H1N1 | 29.4 percentage of participants |
| QVLP30 Unadjuvanted | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Victoria lineage | 23.5 percentage of participants |
| QVLP30 Unadjuvanted | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Yamagata lineage | 14.7 percentage of participants |
| QVLP30 Unadjuvanted | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H3N2 | 47.1 percentage of participants |
| Fluzone HD Quad | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Yamagata lineage | 38.5 percentage of participants |
| Fluzone HD Quad | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H3N2 | 64.1 percentage of participants |
| Fluzone HD Quad | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Victoria lineage | 46.2 percentage of participants |
| Fluzone HD Quad | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H1N1 | 38.5 percentage of participants |
Primary
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28
Seroprotection rate: the percentage of participants in a given treatment group attaining a reciprocal HI titer of ≥40 on Day 28 (the percentage of vaccine recipients with a serum HI titer of at least 1:40 following vaccination) for the homologous influenza strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
Time frame: Day 0 (pre-vaccination) up to Day 28
Population: Participants in PP Set with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| QVLP15+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H1N1 | 100 percentage of participants |
| QVLP15+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H3N2 | 88.9 percentage of participants |
| QVLP15+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Victoria lineage | 88.9 percentage of participants |
| QVLP15+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Yamagata lineage | 77.8 percentage of participants |
| QVLP15+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H1N1 | 100 percentage of participants |
| QVLP15+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Yamagata lineage | 88.9 percentage of participants |
| QVLP15+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H3N2 | 88.9 percentage of participants |
| QVLP15+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Victoria lineage | 77.8 percentage of participants |
| QVLP30+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Victoria lineage | 97.4 percentage of participants |
| QVLP30+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H3N2 | 97.4 percentage of participants |
| QVLP30+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Yamagata lineage | 76.3 percentage of participants |
| QVLP30+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H1N1 | 100 percentage of participants |
| QVLP30+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H3N2 | 94.7 percentage of participants |
| QVLP30+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Yamagata lineage | 63.2 percentage of participants |
| QVLP30+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Victoria lineage | 68.4 percentage of participants |
| QVLP30+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H1N1 | 94.7 percentage of participants |
| QVLP45+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Victoria lineage | 80.0 percentage of participants |
| QVLP45+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H1N1 | 90.0 percentage of participants |
| QVLP45+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H3N2 | 100 percentage of participants |
| QVLP45+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Yamagata lineage | 80.0 percentage of participants |
| QVLP45+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Yamagata lineage | 76.9 percentage of participants |
| QVLP45+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H1N1 | 100 percentage of participants |
| QVLP45+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H3N2 | 100 percentage of participants |
| QVLP45+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Victoria lineage | 84.6 percentage of participants |
| QVLP30 Unadjuvanted | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H3N2 | 97.1 percentage of participants |
| QVLP30 Unadjuvanted | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Yamagata lineage | 67.6 percentage of participants |
| QVLP30 Unadjuvanted | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H1N1 | 100 percentage of participants |
| QVLP30 Unadjuvanted | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Victoria lineage | 82.4 percentage of participants |
| Fluzone HD Quad | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Victoria lineage | 89.7 percentage of participants |
| Fluzone HD Quad | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H1N1 | 100 percentage of participants |
| Fluzone HD Quad | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | H3N2 | 92.3 percentage of participants |
| Fluzone HD Quad | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28 | B/Yamagata lineage | 89.7 percentage of participants |
Secondary
GMFR Measured by HI Antibody Response for Each Heterologous Influenza Strain
GMFR: the geometric mean of the ratio of GMTs (Day 28/Day 0) measured using an HI assay for the heterologous strains A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage).
Time frame: Day 0 (pre-vaccination), Day 28
Population: Participants in PP Set with available data were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| QVLP15+Full AS03 | GMFR Measured by HI Antibody Response for Each Heterologous Influenza Strain | H3N2 | 2.8906 ratio |
| QVLP15+Full AS03 | GMFR Measured by HI Antibody Response for Each Heterologous Influenza Strain | B/Victoria lineage | 1.7604 ratio |
| QVLP15+Full AS03 | GMFR Measured by HI Antibody Response for Each Heterologous Influenza Strain | H1N1 | 4.6104 ratio |
| QVLP15+Half AS03 | GMFR Measured by HI Antibody Response for Each Heterologous Influenza Strain | H3N2 | 2.3315 ratio |
| QVLP15+Half AS03 | GMFR Measured by HI Antibody Response for Each Heterologous Influenza Strain | B/Victoria lineage | 1.8557 ratio |
| QVLP15+Half AS03 | GMFR Measured by HI Antibody Response for Each Heterologous Influenza Strain | H1N1 | 7.7661 ratio |
| QVLP30+Full AS03 | GMFR Measured by HI Antibody Response for Each Heterologous Influenza Strain | B/Victoria lineage | 2.2441 ratio |
| QVLP30+Full AS03 | GMFR Measured by HI Antibody Response for Each Heterologous Influenza Strain | H3N2 | 2.6710 ratio |
| QVLP30+Full AS03 | GMFR Measured by HI Antibody Response for Each Heterologous Influenza Strain | H1N1 | 3.6764 ratio |
| QVLP30+Half AS03 | GMFR Measured by HI Antibody Response for Each Heterologous Influenza Strain | H3N2 | 2.2043 ratio |
| QVLP30+Half AS03 | GMFR Measured by HI Antibody Response for Each Heterologous Influenza Strain | H1N1 | 2.4044 ratio |
| QVLP30+Half AS03 | GMFR Measured by HI Antibody Response for Each Heterologous Influenza Strain | B/Victoria lineage | 1.3040 ratio |
| QVLP45+Full AS03 | GMFR Measured by HI Antibody Response for Each Heterologous Influenza Strain | H3N2 | 1.7248 ratio |
| QVLP45+Full AS03 | GMFR Measured by HI Antibody Response for Each Heterologous Influenza Strain | H1N1 | 2.2511 ratio |
| QVLP45+Full AS03 | GMFR Measured by HI Antibody Response for Each Heterologous Influenza Strain | B/Victoria lineage | 1.6675 ratio |
| QVLP45+Half AS03 | GMFR Measured by HI Antibody Response for Each Heterologous Influenza Strain | H1N1 | 4.1198 ratio |
| QVLP45+Half AS03 | GMFR Measured by HI Antibody Response for Each Heterologous Influenza Strain | H3N2 | 1.6487 ratio |
| QVLP45+Half AS03 | GMFR Measured by HI Antibody Response for Each Heterologous Influenza Strain | B/Victoria lineage | 1.4026 ratio |
| QVLP30 Unadjuvanted | GMFR Measured by HI Antibody Response for Each Heterologous Influenza Strain | H3N2 | 3.2113 ratio |
| QVLP30 Unadjuvanted | GMFR Measured by HI Antibody Response for Each Heterologous Influenza Strain | H1N1 | 2.7513 ratio |
| QVLP30 Unadjuvanted | GMFR Measured by HI Antibody Response for Each Heterologous Influenza Strain | B/Victoria lineage | 1.7975 ratio |
| Fluzone HD Quad | GMFR Measured by HI Antibody Response for Each Heterologous Influenza Strain | H3N2 | 4.5766 ratio |
| Fluzone HD Quad | GMFR Measured by HI Antibody Response for Each Heterologous Influenza Strain | B/Victoria lineage | 3.5002 ratio |
| Fluzone HD Quad | GMFR Measured by HI Antibody Response for Each Heterologous Influenza Strain | H1N1 | 5.0566 ratio |
Secondary
GMFR Measured by HI Antibody Response for Each Heterologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
GMFR: the geometric mean of the ratio of GMTs (Day 28/Day 0) measured using an HI assay for the heterologous strains A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Time frame: Day 0 (pre-vaccination), Day 28
Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Secondary
GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0)
GMFR: the geometric mean of the ratio of GMTs (Day 182/Day 0 and Day 365/Day 0) measured using an HI assay for the homologous strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
Time frame: Day 0 (pre-vaccination), Day 182, Day 365
Population: Participants in PP Set with available data at each timepoint were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| QVLP15+Full AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | B/Yamagata lineage: Day 182/Day 0 | 1.5914 ratio |
| QVLP15+Full AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | B/Victoria lineage: Day 182/Day 0 | 0.9854 ratio |
| QVLP15+Full AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | H1N1: Day 365/Day 0 | 1.7840 ratio |
| QVLP15+Full AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | H3N2: Day 182/Day 0 | 2.7326 ratio |
| QVLP15+Full AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | H3N2: Day 365/Day 0 | 3.5029 ratio |
| QVLP15+Full AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | B/Victoria lineage: Day 365/Day 0 | 1.1788 ratio |
| QVLP15+Full AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | B/Yamagata lineage: Day 365/Day 0 | 1.3110 ratio |
| QVLP15+Full AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | H1N1: Day 182/Day 0 | 2.8586 ratio |
| QVLP15+Half AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | H3N2: Day 365/Day 0 | 5.3618 ratio |
| QVLP15+Half AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | H1N1: Day 365/Day 0 | 2.2667 ratio |
| QVLP15+Half AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | H3N2: Day 182/Day 0 | 3.7625 ratio |
| QVLP15+Half AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | B/Yamagata lineage: Day 365/Day 0 | 1.4345 ratio |
| QVLP15+Half AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | H1N1: Day 182/Day 0 | 4.6671 ratio |
| QVLP15+Half AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | B/Yamagata lineage: Day 182/Day 0 | 1.8261 ratio |
| QVLP15+Half AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | B/Victoria lineage: Day 365/Day 0 | 1.1979 ratio |
| QVLP15+Half AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | B/Victoria lineage: Day 182/Day 0 | 1.2056 ratio |
| QVLP30+Full AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | B/Victoria lineage: Day 182/Day 0 | 1.3892 ratio |
| QVLP30+Full AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | H3N2: Day 365/Day 0 | 4.0557 ratio |
| QVLP30+Full AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | B/Yamagata lineage: Day 365/Day 0 | 1.1944 ratio |
| QVLP30+Full AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | H1N1: Day 365/Day 0 | 1.6031 ratio |
| QVLP30+Full AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | B/Yamagata lineage: Day 182/Day 0 | 1.4557 ratio |
| QVLP30+Full AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | B/Victoria lineage: Day 365/Day 0 | 1.3199 ratio |
| QVLP30+Full AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | H1N1: Day 182/Day 0 | 2.4366 ratio |
| QVLP30+Full AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | H3N2: Day 182/Day 0 | 3.7985 ratio |
| QVLP30+Half AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | B/Yamagata lineage: Day 365/Day 0 | 1.2518 ratio |
| QVLP30+Half AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | H3N2: Day 365/Day 0 | 5.5988 ratio |
| QVLP30+Half AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | H3N2: Day 182/Day 0 | 3.6059 ratio |
| QVLP30+Half AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | B/Victoria lineage: Day 365/Day 0 | 1.2063 ratio |
| QVLP30+Half AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | B/Yamagata lineage: Day 182/Day 0 | 1.2508 ratio |
| QVLP30+Half AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | B/Victoria lineage: Day 182/Day 0 | 1.4917 ratio |
| QVLP30+Half AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | H1N1: Day 365/Day 0 | 1.6790 ratio |
| QVLP30+Half AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | H1N1: Day 182/Day 0 | 1.9075 ratio |
| QVLP45+Full AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | H3N2: Day 365/Day 0 | 4.0497 ratio |
| QVLP45+Full AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | B/Victoria lineage: Day 365/Day 0 | 1.1095 ratio |
| QVLP45+Full AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | H1N1: Day 365/Day 0 | 1.6075 ratio |
| QVLP45+Full AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | H3N2: Day 182/Day 0 | 2.6792 ratio |
| QVLP45+Full AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | B/Yamagata lineage: Day 182/Day 0 | 1.1448 ratio |
| QVLP45+Full AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | B/Yamagata lineage: Day 365/Day 0 | 1.1462 ratio |
| QVLP45+Full AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | B/Victoria lineage: Day 182/Day 0 | 1.1803 ratio |
| QVLP45+Full AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | H1N1: Day 182/Day 0 | 1.7392 ratio |
| QVLP45+Half AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | B/Victoria lineage: Day 182/Day 0 | 1.0689 ratio |
| QVLP45+Half AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | H1N1: Day 182/Day 0 | 1.9829 ratio |
| QVLP45+Half AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | B/Yamagata lineage: Day 365/Day 0 | 0.9986 ratio |
| QVLP45+Half AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | B/Victoria lineage: Day 365/Day 0 | 1.0238 ratio |
| QVLP45+Half AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | H3N2: Day 182/Day 0 | 4.5291 ratio |
| QVLP45+Half AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | B/Yamagata lineage: Day 182/Day 0 | 2.2374 ratio |
| QVLP45+Half AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | H1N1: Day 365/Day 0 | 2.7253 ratio |
| QVLP45+Half AS03 | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | H3N2: Day 365/Day 0 | 5.3933 ratio |
| QVLP30 Unadjuvanted | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | H3N2: Day 365/Day 0 | 5.2951 ratio |
| QVLP30 Unadjuvanted | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | H3N2: Day 182/Day 0 | 4.6788 ratio |
| QVLP30 Unadjuvanted | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | H1N1: Day 365/Day 0 | 1.5400 ratio |
| QVLP30 Unadjuvanted | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | B/Yamagata lineage: Day 365/Day 0 | 1.3226 ratio |
| QVLP30 Unadjuvanted | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | H1N1: Day 182/Day 0 | 2.1950 ratio |
| QVLP30 Unadjuvanted | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | B/Victoria lineage: Day 365/Day 0 | 1.2542 ratio |
| QVLP30 Unadjuvanted | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | B/Victoria lineage: Day 182/Day 0 | 1.1041 ratio |
| QVLP30 Unadjuvanted | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | B/Yamagata lineage: Day 182/Day 0 | 1.5232 ratio |
| Fluzone HD Quad | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | B/Victoria lineage: Day 365/Day 0 | 1.3656 ratio |
| Fluzone HD Quad | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | H1N1: Day 182/Day 0 | 1.7267 ratio |
| Fluzone HD Quad | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | H1N1: Day 365/Day 0 | 1.1081 ratio |
| Fluzone HD Quad | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | H3N2: Day 182/Day 0 | 2.7380 ratio |
| Fluzone HD Quad | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | H3N2: Day 365/Day 0 | 2.8866 ratio |
| Fluzone HD Quad | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | B/Yamagata lineage: Day 182/Day 0 | 1.5720 ratio |
| Fluzone HD Quad | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | B/Yamagata lineage: Day 365/Day 0 | 1.3422 ratio |
| Fluzone HD Quad | GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0) | B/Victoria lineage: Day 182/Day 0 | 1.4098 ratio |
Secondary
GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
GMFR: the geometric mean of the ratio of GMTs (Day 28/Day 0) measured using an HI assay for the homologous strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Time frame: Day 0 (pre-vaccination), Day 28
Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Secondary
GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain
GMFR: the geometric mean of the ratio of GMTs (Day 28/Day 0) measured using an MN assay for the homologous strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
Time frame: Day 0 (pre-vaccination), Day 28
Population: Participants in PP Set with available data were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| QVLP15+Full AS03 | GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain | H3N2 | 1.8781 ratio |
| QVLP15+Full AS03 | GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain | B/Victoria lineage | 1.7152 ratio |
| QVLP15+Full AS03 | GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain | H1N1 | 6.0914 ratio |
| QVLP15+Full AS03 | GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain | B/Yamagata lineage | 1.7366 ratio |
| QVLP15+Half AS03 | GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain | H3N2 | 2.7393 ratio |
| QVLP15+Half AS03 | GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain | H1N1 | 12.7121 ratio |
| QVLP15+Half AS03 | GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain | B/Yamagata lineage | 1.8812 ratio |
| QVLP15+Half AS03 | GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain | B/Victoria lineage | 4.4083 ratio |
| QVLP30+Full AS03 | GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain | B/Yamagata lineage | 2.3239 ratio |
| QVLP30+Full AS03 | GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain | H1N1 | 5.2592 ratio |
| QVLP30+Full AS03 | GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain | H3N2 | 2.1798 ratio |
| QVLP30+Full AS03 | GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain | B/Victoria lineage | 2.4424 ratio |
| QVLP30+Half AS03 | GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain | H3N2 | 2.0133 ratio |
| QVLP30+Half AS03 | GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain | H1N1 | 4.0415 ratio |
| QVLP30+Half AS03 | GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain | B/Victoria lineage | 2.3549 ratio |
| QVLP30+Half AS03 | GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain | B/Yamagata lineage | 1.3802 ratio |
| QVLP45+Full AS03 | GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain | B/Victoria lineage | 2.4501 ratio |
| QVLP45+Full AS03 | GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain | H1N1 | 4.0654 ratio |
| QVLP45+Full AS03 | GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain | H3N2 | 2.1935 ratio |
| QVLP45+Full AS03 | GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain | B/Yamagata lineage | 1.7651 ratio |
| QVLP45+Half AS03 | GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain | H3N2 | 1.8735 ratio |
| QVLP45+Half AS03 | GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain | B/Victoria lineage | 2.8024 ratio |
| QVLP45+Half AS03 | GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain | B/Yamagata lineage | 1.3086 ratio |
| QVLP45+Half AS03 | GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain | H1N1 | 6.3495 ratio |
| QVLP30 Unadjuvanted | GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain | H3N2 | 2.1377 ratio |
| QVLP30 Unadjuvanted | GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain | H1N1 | 3.4096 ratio |
| QVLP30 Unadjuvanted | GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain | B/Victoria lineage | 1.5535 ratio |
| QVLP30 Unadjuvanted | GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain | B/Yamagata lineage | 1.8310 ratio |
| Fluzone HD Quad | GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain | B/Victoria lineage | 3.8216 ratio |
| Fluzone HD Quad | GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain | H1N1 | 6.5345 ratio |
| Fluzone HD Quad | GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain | H3N2 | 2.8084 ratio |
| Fluzone HD Quad | GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain | B/Yamagata lineage | 3.5437 ratio |
Secondary
GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
GMFR: the geometric mean of the ratio of GMTs (Day 28/Day 0) measured using an MN assay for the strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Time frame: Day 0 (pre-vaccination), Day 28
Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Secondary
GMTs of HI Antibody Response for Each Heterologous Influenza Strain
The GMTs in each treatment group were measured using an HI assay for the heterologous influenza strains: A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage).
Time frame: Day 0 (pre-vaccination), Day 28
Population: Participants in PP Set with available data were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| QVLP15+Full AS03 | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | H3N2: Day 0 | 38.5796 titers |
| QVLP15+Full AS03 | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | H1N1: Day 0 | 90.8941 titers |
| QVLP15+Full AS03 | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | B/Victoria lineage: Day 28 | 39.2478 titers |
| QVLP15+Full AS03 | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | B/Victoria lineage: Day 0 | 22.6953 titers |
| QVLP15+Full AS03 | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | H3N2: Day 28 | 89.5835 titers |
| QVLP15+Full AS03 | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | H1N1: Day 28 | 290.5308 titers |
| QVLP15+Half AS03 | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | H3N2: Day 28 | 56.5609 titers |
| QVLP15+Half AS03 | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | H1N1: Day 28 | 418.9367 titers |
| QVLP15+Half AS03 | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | H3N2: Day 0 | 21.6012 titers |
| QVLP15+Half AS03 | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | B/Victoria lineage: Day 28 | 58.8887 titers |
| QVLP15+Half AS03 | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | B/Victoria lineage: Day 0 | 38.4838 titers |
| QVLP15+Half AS03 | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | H1N1: Day 0 | 60.8920 titers |
| QVLP30+Full AS03 | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | H1N1: Day 0 | 57.0448 titers |
| QVLP30+Full AS03 | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | H3N2: Day 0 | 32.0958 titers |
| QVLP30+Full AS03 | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | H1N1: Day 28 | 191.9608 titers |
| QVLP30+Full AS03 | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | H3N2: Day 28 | 79.9144 titers |
| QVLP30+Full AS03 | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | B/Victoria lineage: Day 0 | 34.2028 titers |
| QVLP30+Full AS03 | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | B/Victoria lineage: Day 28 | 65.9266 titers |
| QVLP30+Half AS03 | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | H1N1: Day 0 | 29.8495 titers |
| QVLP30+Half AS03 | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | B/Victoria lineage: Day 0 | 14.9040 titers |
| QVLP30+Half AS03 | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | H3N2: Day 0 | 17.5909 titers |
| QVLP30+Half AS03 | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | H3N2: Day 28 | 47.9629 titers |
| QVLP30+Half AS03 | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | H1N1: Day 28 | 90.8596 titers |
| QVLP30+Half AS03 | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | B/Victoria lineage: Day 28 | 22.2497 titers |
| QVLP45+Full AS03 | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | H1N1: Day 28 | 107.3121 titers |
| QVLP45+Full AS03 | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | B/Victoria lineage: Day 0 | 18.0797 titers |
| QVLP45+Full AS03 | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | H1N1: Day 0 | 45.6156 titers |
| QVLP45+Full AS03 | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | B/Victoria lineage: Day 28 | 31.8255 titers |
| QVLP45+Full AS03 | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | H3N2: Day 0 | 16.9318 titers |
| QVLP45+Full AS03 | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | H3N2: Day 28 | 36.6176 titers |
| QVLP45+Half AS03 | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | H1N1: Day 28 | 168.6130 titers |
| QVLP45+Half AS03 | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | H3N2: Day 0 | 30.5442 titers |
| QVLP45+Half AS03 | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | H1N1: Day 0 | 35.0221 titers |
| QVLP45+Half AS03 | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | B/Victoria lineage: Day 28 | 27.5162 titers |
| QVLP45+Half AS03 | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | H3N2: Day 28 | 48.0514 titers |
| QVLP45+Half AS03 | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | B/Victoria lineage: Day 0 | 18.4484 titers |
| QVLP30 Unadjuvanted | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | H1N1: Day 28 | 141.5521 titers |
| QVLP30 Unadjuvanted | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | H3N2: Day 28 | 108.5069 titers |
| QVLP30 Unadjuvanted | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | H1N1: Day 0 | 58.6793 titers |
| QVLP30 Unadjuvanted | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | B/Victoria lineage: Day 0 | 26.9646 titers |
| QVLP30 Unadjuvanted | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | H3N2: Day 0 | 40.3477 titers |
| QVLP30 Unadjuvanted | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | B/Victoria lineage: Day 28 | 45.6899 titers |
| Fluzone HD Quad | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | B/Victoria lineage: Day 28 | 59.6513 titers |
| Fluzone HD Quad | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | H1N1: Day 0 | 36.2950 titers |
| Fluzone HD Quad | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | B/Victoria lineage: Day 0 | 14.8765 titers |
| Fluzone HD Quad | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | H1N1: Day 28 | 210.6752 titers |
| Fluzone HD Quad | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | H3N2: Day 28 | 121.5473 titers |
| Fluzone HD Quad | GMTs of HI Antibody Response for Each Heterologous Influenza Strain | H3N2: Day 0 | 25.6289 titers |
Secondary
GMTs of HI Antibody Response for Each Heterologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
The GMTs in each treatment group were measured using an HI assay for the heterologous influenza strains: A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination. It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Time frame: Day 0 (pre-vaccination), Day 28
Population: The analysis were not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Secondary
GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365
The GMTs in each treatment group were measured using an HI assay for the homologous influenza strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
Time frame: Day 182, Day 365
Population: Participants in PP Set with available data at each time point were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| QVLP15+Full AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 182 | 45.3843 titers |
| QVLP15+Full AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 182 | 33.2709 titers |
| QVLP15+Full AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 182 | 119.5465 titers |
| QVLP15+Full AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 365 | 38.5246 titers |
| QVLP15+Full AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 365 | 40.6922 titers |
| QVLP15+Full AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 365 | 145.2654 titers |
| QVLP15+Full AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 182 | 226.2152 titers |
| QVLP15+Full AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 365 | 156.9806 titers |
| QVLP15+Half AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 365 | 217.4477 titers |
| QVLP15+Half AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 182 | 332.5919 titers |
| QVLP15+Half AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 182 | 44.8356 titers |
| QVLP15+Half AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 365 | 65.9800 titers |
| QVLP15+Half AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 365 | 44.9239 titers |
| QVLP15+Half AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 182 | 153.9351 titers |
| QVLP15+Half AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 365 | 160.1136 titers |
| QVLP15+Half AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 182 | 83.0475 titers |
| QVLP30+Full AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 365 | 32.2612 titers |
| QVLP30+Full AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 182 | 50.0023 titers |
| QVLP30+Full AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 182 | 175.6786 titers |
| QVLP30+Full AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 365 | 55.2532 titers |
| QVLP30+Full AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 365 | 97.7443 titers |
| QVLP30+Full AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 182 | 59.2611 titers |
| QVLP30+Full AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 182 | 178.9880 titers |
| QVLP30+Full AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 365 | 189.1376 titers |
| QVLP30+Half AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 182 | 39.9246 titers |
| QVLP30+Half AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 365 | 34.7689 titers |
| QVLP30+Half AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 365 | 103.0787 titers |
| QVLP30+Half AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 365 | 31.7135 titers |
| QVLP30+Half AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 182 | 33.5742 titers |
| QVLP30+Half AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 365 | 210.9250 titers |
| QVLP30+Half AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 182 | 129.4173 titers |
| QVLP30+Half AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 182 | 129.5061 titers |
| QVLP45+Full AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 365 | 109.2066 titers |
| QVLP45+Full AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 182 | 118.8437 titers |
| QVLP45+Full AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 182 | 99.1267 titers |
| QVLP45+Full AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 365 | 141.6148 titers |
| QVLP45+Full AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 182 | 30.1800 titers |
| QVLP45+Full AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 365 | 30.8130 titers |
| QVLP45+Full AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 182 | 42.7246 titers |
| QVLP45+Full AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 365 | 39.9398 titers |
| QVLP45+Half AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 365 | 24.0753 titers |
| QVLP45+Half AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 182 | 214.5054 titers |
| QVLP45+Half AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 182 | 33.1521 titers |
| QVLP45+Half AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 365 | 265.6521 titers |
| QVLP45+Half AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 365 | 156.0724 titers |
| QVLP45+Half AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 182 | 220.4298 titers |
| QVLP45+Half AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 182 | 52.2104 titers |
| QVLP45+Half AS03 | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 365 | 50.8227 titers |
| QVLP30 Unadjuvanted | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 365 | 254.8805 titers |
| QVLP30 Unadjuvanted | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 182 | 164.9504 titers |
| QVLP30 Unadjuvanted | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 365 | 124.5817 titers |
| QVLP30 Unadjuvanted | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 182 | 219.2384 titers |
| QVLP30 Unadjuvanted | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 365 | 45.4888 titers |
| QVLP30 Unadjuvanted | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 365 | 49.0601 titers |
| QVLP30 Unadjuvanted | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 182 | 46.0555 titers |
| QVLP30 Unadjuvanted | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 182 | 37.2192 titers |
| Fluzone HD Quad | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 182 | 51.3900 titers |
| Fluzone HD Quad | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 182 | 131.0605 titers |
| Fluzone HD Quad | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 365 | 45.1481 titers |
| Fluzone HD Quad | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 365 | 79.1142 titers |
| Fluzone HD Quad | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 182 | 43.4396 titers |
| Fluzone HD Quad | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 182 | 121.7951 titers |
| Fluzone HD Quad | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 365 | 39.9694 titers |
| Fluzone HD Quad | GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 365 | 135.1917 titers |
Secondary
GMTs of HI Antibody Response for Each Homologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
The GMTs in each treatment group were measured using an HI assay for the homologous influenza strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Time frame: Day 0 (pre-vaccination), Day 28
Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Secondary
GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain
The GMTs in each treatment group were measured using an MN assay for the homologous influenza strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
Time frame: Day 0 (pre-vaccination), Day 28
Population: Participants in PP Set with available data were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| QVLP15+Full AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | H3N2: Day 0 | 123.9489 titers |
| QVLP15+Full AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | B/Yamagata lineage: Day 28 | 25.7962 titers |
| QVLP15+Full AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | B/Victoria lineage: Day 0 | 25.7760 titers |
| QVLP15+Full AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | H1N1: Day 0 | 195.2871 titers |
| QVLP15+Full AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | B/Yamagata lineage: Day 0 | 16.3090 titers |
| QVLP15+Full AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | H1N1: Day 28 | 887.6906 titers |
| QVLP15+Full AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | B/Victoria lineage: Day 28 | 42.3874 titers |
| QVLP15+Full AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | H3N2: Day 28 | 198.6618 titers |
| QVLP15+Half AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | B/Yamagata lineage: Day 0 | 17.5404 titers |
| QVLP15+Half AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | H3N2: Day 0 | 107.6687 titers |
| QVLP15+Half AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | H1N1: Day 28 | 1956.7218 titers |
| QVLP15+Half AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | H3N2: Day 28 | 332.5998 titers |
| QVLP15+Half AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | B/Yamagata lineage: Day 28 | 34.2802 titers |
| QVLP15+Half AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | B/Victoria lineage: Day 0 | 25.9287 titers |
| QVLP15+Half AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | H1N1: Day 0 | 216.6401 titers |
| QVLP15+Half AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | B/Victoria lineage: Day 28 | 104.7367 titers |
| QVLP30+Full AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | B/Victoria lineage: Day 0 | 34.8450 titers |
| QVLP30+Full AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | H1N1: Day 0 | 127.4353 titers |
| QVLP30+Full AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | B/Victoria lineage: Day 28 | 70.2059 titers |
| QVLP30+Full AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | B/Yamagata lineage: Day 28 | 38.0649 titers |
| QVLP30+Full AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | B/Yamagata lineage: Day 0 | 18.9617 titers |
| QVLP30+Full AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | H3N2: Day 0 | 96.9336 titers |
| QVLP30+Full AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | H3N2: Day 28 | 205.2176 titers |
| QVLP30+Full AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | H1N1: Day 28 | 663.8670 titers |
| QVLP30+Half AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | B/Victoria lineage: Day 0 | 15.8462 titers |
| QVLP30+Half AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | H1N1: Day 0 | 137.0522 titers |
| QVLP30+Half AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | H1N1: Day 28 | 495.8821 titers |
| QVLP30+Half AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | H3N2: Day 0 | 84.7454 titers |
| QVLP30+Half AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | H3N2: Day 28 | 186.1487 titers |
| QVLP30+Half AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | B/Yamagata lineage: Day 0 | 10.7232 titers |
| QVLP30+Half AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | B/Yamagata lineage: Day 28 | 15.4893 titers |
| QVLP30+Half AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | B/Victoria lineage: Day 28 | 36.2627 titers |
| QVLP45+Full AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | H1N1: Day 0 | 122.6834 titers |
| QVLP45+Full AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | B/Yamagata lineage: Day 28 | 21.5952 titers |
| QVLP45+Full AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | B/Victoria lineage: Day 0 | 15.3550 titers |
| QVLP45+Full AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | H3N2: Day 0 | 65.5761 titers |
| QVLP45+Full AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | H1N1: Day 28 | 532.9893 titers |
| QVLP45+Full AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | B/Yamagata lineage: Day 0 | 10.8996 titers |
| QVLP45+Full AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | B/Victoria lineage: Day 28 | 45.4444 titers |
| QVLP45+Full AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | H3N2: Day 28 | 188.4193 titers |
| QVLP45+Half AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | B/Victoria lineage: Day 28 | 75.8887 titers |
| QVLP45+Half AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | H3N2: Day 28 | 196.9789 titers |
| QVLP45+Half AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | B/Victoria lineage: Day 0 | 29.8305 titers |
| QVLP45+Half AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | B/Yamagata lineage: Day 28 | 15.7214 titers |
| QVLP45+Half AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | B/Yamagata lineage: Day 0 | 10.2622 titers |
| QVLP45+Half AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | H1N1: Day 0 | 93.8593 titers |
| QVLP45+Half AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | H1N1: Day 28 | 693.3781 titers |
| QVLP45+Half AS03 | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | H3N2: Day 0 | 129.3964 titers |
| QVLP30 Unadjuvanted | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | H1N1: Day 28 | 434.8282 titers |
| QVLP30 Unadjuvanted | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | H3N2: Day 28 | 216.0005 titers |
| QVLP30 Unadjuvanted | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | H1N1: Day 0 | 141.0830 titers |
| QVLP30 Unadjuvanted | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | B/Yamagata lineage: Day 0 | 20.6308 titers |
| QVLP30 Unadjuvanted | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | B/Victoria lineage: Day 28 | 33.2720 titers |
| QVLP30 Unadjuvanted | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | B/Yamagata lineage: Day 28 | 30.5144 titers |
| QVLP30 Unadjuvanted | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | B/Victoria lineage: Day 0 | 22.2014 titers |
| QVLP30 Unadjuvanted | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | H3N2: Day 0 | 98.8487 titers |
| Fluzone HD Quad | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | B/Victoria lineage: Day 0 | 14.2585 titers |
| Fluzone HD Quad | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | B/Yamagata lineage: Day 0 | 22.3655 titers |
| Fluzone HD Quad | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | H1N1: Day 28 | 754.0606 titers |
| Fluzone HD Quad | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | B/Victoria lineage: Day 28 | 64.2444 titers |
| Fluzone HD Quad | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | H1N1: Day 0 | 89.1100 titers |
| Fluzone HD Quad | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | H3N2: Day 28 | 273.0912 titers |
| Fluzone HD Quad | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | B/Yamagata lineage: Day 28 | 64.2153 titers |
| Fluzone HD Quad | GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain | H3N2: Day 0 | 100.5515 titers |
Secondary
GMTs of MN Antibody Response for Each Homologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
The GMTs in each treatment group were measured using an MN assay for the following homologous influenza strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Time frame: Day 0 (pre-vaccination), Day 28
Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Secondary
Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365, Stratified by Prior Influenza Vaccination Status
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Time frame: Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365
Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Secondary
Number of Participants With at Least One AESI From Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365, Stratified by Prior Influenza Vaccination Status
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. AESIs included hypersensitivity reactions, narcolepsy, pIMDs, and other AESIs. It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Time frame: Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365
Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Secondary
Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4, Stratified by Prior Influenza Vaccination Status
An AE is defined in OM #6. Immediate AEs were defined as any solicited (local and systemic) and unsolicited AEs that started up to 30 minutes after vaccination. Solicited local AEs included erythema, swelling and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. The intensity of the AEs was graded according to the FDA Toxicity Grading Scale: mild (Grade 1), moderate (Grade 2), severe (Grade 3), or potentially life threatening (Grade 4). It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Time frame: Up to 30 minutes post-vaccination
Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Secondary
Number of Participants With at Least One Immediate AE Related to Vaccination, Stratified by Prior Influenza Vaccination Status
An AE is defined in OM #6. Immediate AEs were defined as any solicited (local and systemic) and unsolicited AEs that started up to 30 minutes after vaccination. Solicited local AEs included erythema, swelling and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. A related AE is an event where the investigator determined that the relationship to study vaccine was Possibly Related, Probably Related, or Definitely Related. If a participant reported multiple occurrences of the same AE, only the most closely related occurrence was presented. It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Time frame: Up to 30 minutes post-vaccination
Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Secondary
Number of Participants With at Least One Immediate AE, Stratified by Prior Influenza Vaccination Status
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. Immediate AEs were defined as any solicited (local and systemic) and unsolicited AEs that started up to 30 minutes after vaccination. Solicited local AEs included erythema, swelling and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Time frame: Up to 30 minutes post-vaccination
Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Secondary
Number of Participants With at Least One MAAE From Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365, Stratified by Prior Influenza Vaccination Status
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. MAAEs are defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider. It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Time frame: Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365
Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Secondary
Number of Participants With at Least One NOCD From Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365, Stratified by Prior Influenza Vaccination Status
All NOCDs that may plausibly have an allergic, autoimmune or inflammatory component were assessed and reported. Plausibility was interpreted broadly; the only clear exceptions were degenerative conditions such as osteoarthritis, age-related physiologic changes and life-style diseases. In this context, most cancers, cardiac conditions, and kidney diseases had to be reported. It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Time frame: Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365
Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Secondary
Number of Participants With at Least One SAE From Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365, Stratified by Prior Influenza Vaccination Status
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. An SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event. It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Time frame: Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365
Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Secondary
Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4, Stratified by Prior Influenza Vaccination Status
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. Solicited local AEs included erythema, swelling and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. The intensity of the AEs was graded according to the FDA Toxicity Grading Scale: mild (Grade 1), moderate (Grade 2), severe (Grade 3), or potentially life threatening (Grade 4). It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Time frame: Day 0 (pre-vaccination) up to Day 7
Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Secondary
Number of Participants With at Least One Solicited Local or Systemic AE, Stratified by Prior Influenza Vaccination Status
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. Solicited local AEs included erythema, swelling and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Time frame: Day 0 (pre-vaccination) up to Day 7
Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Secondary
Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4, Stratified by Prior Influenza Vaccination Status
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. The intensity of the AEs was graded according to the FDA Toxicity Grading Scale: mild (Grade 1), moderate (Grade 2), severe (Grade 3), or potentially life threatening (Grade 4). It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Time frame: Day 0 (pre-vaccination) up to Day 28
Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Secondary
Number of Participants With at Least One Unsolicited AE Related to Vaccination, Stratified by Prior Influenza Vaccination Status
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. A related AE was an event where the Investigator determined that the relationship to study vaccine was Possibly Related, Probably Related, or Definitely Related. It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Time frame: Day 0 (pre-vaccination) up to Day 28
Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Secondary
Number of Participants With at Least One Unsolicited AE, Stratified by Prior Influenza Vaccination Status
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Time frame: Day 0 (pre-vaccination) up to Day 28
Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Secondary
Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 0, Stratified by Prior Influenza Vaccination Status
Participants were monitored for abnormal findings in urine parameters (urine color, glucose, occult blood, protein, specific gravity, specimen appearance, pH), hematological parameters (basophils, leukocytes, eosinophils, erythrocytes mean corpuscular hemoglobin, erythrocytes, hematocrit, hemoglobin, lymphocytes, mean platelet volume, monocytes, neutrophils, platelets), and blood chemistry parameters (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatinine, gamma glutamyl transferase, glucose, HDL and LDL cholesterol, phosphate, potassium, protein, sodium, triglycerides, urea nitrogen). Any laboratory result outside of the normal range was classified as clinically significant or not clinically significant by the site investigator. It was planned that the endpoint would be analyzed if \>25% of the participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Time frame: Day 0 (pre-vaccination)
Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Secondary
Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 28, Stratified by Prior Influenza Vaccination Status
Participants were monitored for abnormal findings in urine parameters (urine color, glucose, occult blood, protein, specific gravity, specimen appearance, pH), hematological parameters (basophils, leukocytes, eosinophils, erythrocytes mean corpuscular hemoglobin, erythrocytes, hematocrit, hemoglobin, lymphocytes, mean platelet volume, monocytes, neutrophils, platelets), and blood chemistry parameters (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatinine, gamma glutamyl transferase, glucose, HDL and LDL cholesterol, phosphate, potassium, protein, sodium, triglycerides, urea nitrogen). Any laboratory result outside of the normal range was classified as clinically significant or not clinically significant by the site investigator. It was planned that the endpoint would be analyzed if \>25% of the participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Time frame: Day 28
Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Secondary
Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3, Stratified by Prior Influenza Vaccination Status
Participants were monitored for abnormal findings in urine parameters (urine color, glucose, occult blood, protein, specific gravity, specimen appearance, pH), hematological parameters (basophils, leukocytes, eosinophils, erythrocytes mean corpuscular hemoglobin, erythrocytes, hematocrit, hemoglobin, lymphocytes, mean platelet volume, monocytes, neutrophils, platelets), and blood chemistry parameters (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatinine, gamma glutamyl transferase, glucose, HDL and LDL cholesterol, phosphate, potassium, protein, sodium, triglycerides, urea nitrogen). Any laboratory result outside of the normal range was classified as clinically significant or not clinically significant by the site investigator. It was planned that the endpoint would be analyzed if \>25% of the participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Time frame: Day 3
Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Secondary
Number of Participants With the Occurrence of Death From Day 1 up to Day 28, From Day 29 to Day 182, and From Day 183 to Day 365, Stratified by Prior Influenza Vaccination Status
The number of participants in each treatment group with an occurrence of death was assessed. It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Time frame: Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365
Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Secondary
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Heterologous Influenza Strain
Seroconversion rate: the percentage of participants in a given treatment group with either a ≥4-fold increase in reciprocal HI titers between Day 0 and Day 28 or a rise of undetectable HI titer (i.e. \<10) pre-vaccination (Day 0) to an HI titer of ≥40 on Day 28 was measured using an HI assay for the heterologous influenza strains A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage).
Time frame: Day 0 (pre-vaccination) up to Day 28
Population: Participants in PP Set with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| QVLP15+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Heterologous Influenza Strain | H3N2 | 16.7 percentage of participants |
| QVLP15+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Heterologous Influenza Strain | B/Victoria lineage | 11.1 percentage of participants |
| QVLP15+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Heterologous Influenza Strain | H1N1 | 33.3 percentage of participants |
| QVLP15+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Heterologous Influenza Strain | H1N1 | 55.6 percentage of participants |
| QVLP15+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Heterologous Influenza Strain | B/Victoria lineage | 11.1 percentage of participants |
| QVLP15+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Heterologous Influenza Strain | H3N2 | 33.3 percentage of participants |
| QVLP30+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Heterologous Influenza Strain | H1N1 | 36.8 percentage of participants |
| QVLP30+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Heterologous Influenza Strain | H3N2 | 18.4 percentage of participants |
| QVLP30+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Heterologous Influenza Strain | B/Victoria lineage | 13.2 percentage of participants |
| QVLP30+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Heterologous Influenza Strain | H3N2 | 26.3 percentage of participants |
| QVLP30+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Heterologous Influenza Strain | H1N1 | 31.6 percentage of participants |
| QVLP30+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Heterologous Influenza Strain | B/Victoria lineage | 5.3 percentage of participants |
| QVLP45+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Heterologous Influenza Strain | B/Victoria lineage | 15.0 percentage of participants |
| QVLP45+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Heterologous Influenza Strain | H3N2 | 20.0 percentage of participants |
| QVLP45+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Heterologous Influenza Strain | H1N1 | 25.0 percentage of participants |
| QVLP45+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Heterologous Influenza Strain | H3N2 | 15.4 percentage of participants |
| QVLP45+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Heterologous Influenza Strain | B/Victoria lineage | 7.7 percentage of participants |
| QVLP45+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Heterologous Influenza Strain | H1N1 | 38.5 percentage of participants |
| QVLP30 Unadjuvanted | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Heterologous Influenza Strain | H3N2 | 29.4 percentage of participants |
| QVLP30 Unadjuvanted | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Heterologous Influenza Strain | H1N1 | 29.4 percentage of participants |
| QVLP30 Unadjuvanted | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Heterologous Influenza Strain | B/Victoria lineage | 11.8 percentage of participants |
| Fluzone HD Quad | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Heterologous Influenza Strain | H3N2 | 53.8 percentage of participants |
| Fluzone HD Quad | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Heterologous Influenza Strain | B/Victoria lineage | 46.2 percentage of participants |
| Fluzone HD Quad | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Heterologous Influenza Strain | H1N1 | 53.8 percentage of participants |
Secondary
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Heterologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
Seroconversion rate: the percentage of participants in a given treatment group with either a ≥4-fold increase in reciprocal HI titers between Day 0 and Day 28 or a rise of undetectable HI titer (i.e. \<10) pre-vaccination (Day 0) to an HI titer of ≥40 on Day 28 was measured using an HI assay for the following heterologous influenza strains: A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Time frame: Day 0 (pre-vaccination) up to Day 28
Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Secondary
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365
Seroconversion rate: the percentage of participants in a given treatment group with either a ≥4-fold increase in reciprocal HI titers between Day 0 and Day 182 and Day 0 and Day 365 or a rise of undetectable HI titer (i.e. \<10) pre-vaccination (Day 0) to an HI titer of ≥40 on Day 182 and Day 365 was measured using an HI assay for the following homologous influenza strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
Time frame: Day 0 (pre-vaccination) up to Day 182 and up to Day 365
Population: Participants in PP Set with available data at each timepoint were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| QVLP15+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 365 | 11.1 percentage of participants |
| QVLP15+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 182 | 31.6 percentage of participants |
| QVLP15+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 365 | 27.8 percentage of participants |
| QVLP15+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 182 | 15.8 percentage of participants |
| QVLP15+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 365 | 5.6 percentage of participants |
| QVLP15+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 182 | 5.3 percentage of participants |
| QVLP15+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 365 | 38.9 percentage of participants |
| QVLP15+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 182 | 36.8 percentage of participants |
| QVLP15+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 365 | 33.3 percentage of participants |
| QVLP15+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 365 | 22.2 percentage of participants |
| QVLP15+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 182 | 55.6 percentage of participants |
| QVLP15+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 182 | 55.6 percentage of participants |
| QVLP15+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 365 | 44.4 percentage of participants |
| QVLP15+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 182 | 11.1 percentage of participants |
| QVLP15+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 365 | 11.1 percentage of participants |
| QVLP15+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 182 | 22.2 percentage of participants |
| QVLP30+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 365 | 9.7 percentage of participants |
| QVLP30+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 182 | 32.4 percentage of participants |
| QVLP30+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 365 | 22.6 percentage of participants |
| QVLP30+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 365 | 38.7 percentage of participants |
| QVLP30+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 365 | 9.7 percentage of participants |
| QVLP30+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 182 | 13.5 percentage of participants |
| QVLP30+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 182 | 13.5 percentage of participants |
| QVLP30+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 182 | 16.2 percentage of participants |
| QVLP30+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 182 | 0 percentage of participants |
| QVLP30+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 365 | 6.7 percentage of participants |
| QVLP30+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 182 | 27.8 percentage of participants |
| QVLP30+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 182 | 50.0 percentage of participants |
| QVLP30+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 365 | 26.7 percentage of participants |
| QVLP30+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 182 | 22.2 percentage of participants |
| QVLP30+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 365 | 20.0 percentage of participants |
| QVLP30+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 365 | 46.7 percentage of participants |
| QVLP45+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 365 | 60.0 percentage of participants |
| QVLP45+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 182 | 42.9 percentage of participants |
| QVLP45+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 182 | 9.5 percentage of participants |
| QVLP45+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 182 | 28.6 percentage of participants |
| QVLP45+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 365 | 15.0 percentage of participants |
| QVLP45+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 182 | 19.0 percentage of participants |
| QVLP45+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 365 | 25.0 percentage of participants |
| QVLP45+Full AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 365 | 5.0 percentage of participants |
| QVLP45+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 365 | 61.5 percentage of participants |
| QVLP45+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 365 | 38.5 percentage of participants |
| QVLP45+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 182 | 38.5 percentage of participants |
| QVLP45+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 365 | 0 percentage of participants |
| QVLP45+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 182 | 7.7 percentage of participants |
| QVLP45+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 365 | 0 percentage of participants |
| QVLP45+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 182 | 0 percentage of participants |
| QVLP45+Half AS03 | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 182 | 38.5 percentage of participants |
| QVLP30 Unadjuvanted | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 182 | 17.6 percentage of participants |
| QVLP30 Unadjuvanted | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 182 | 5.9 percentage of participants |
| QVLP30 Unadjuvanted | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 365 | 3.1 percentage of participants |
| QVLP30 Unadjuvanted | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 182 | 47.1 percentage of participants |
| QVLP30 Unadjuvanted | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 365 | 12.5 percentage of participants |
| QVLP30 Unadjuvanted | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 365 | 3.1 percentage of participants |
| QVLP30 Unadjuvanted | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 365 | 53.1 percentage of participants |
| QVLP30 Unadjuvanted | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 182 | 29.4 percentage of participants |
| Fluzone HD Quad | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 182 | 24.2 percentage of participants |
| Fluzone HD Quad | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 365 | 19.4 percentage of participants |
| Fluzone HD Quad | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 365 | 16.1 percentage of participants |
| Fluzone HD Quad | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 365 | 45.2 percentage of participants |
| Fluzone HD Quad | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 182 | 45.5 percentage of participants |
| Fluzone HD Quad | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 182 | 27.3 percentage of participants |
| Fluzone HD Quad | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 182 | 21.2 percentage of participants |
| Fluzone HD Quad | Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 365 | 12.9 percentage of participants |
Secondary
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
Seroconversion rate: the percentage of participants in a given treatment group with either a ≥4-fold increase in reciprocal HI titers between Day 0 and Day 28 or a rise of undetectable HI titer (i.e. \<10) pre-vaccination (Day 0) to an HI titer of ≥40 on Day 28 was measured using an HI assay for the homologous influenza strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Time frame: Day 0 (pre-vaccination) up to Day 28
Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Secondary
Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain
Seroconversion rate: the percentage of participants in a given treatment group with either a ≥4-fold increase in reciprocal HI titers between Day 0 and Day 28 or a rise of undetectable MN titer (i.e. \<10) pre-vaccination (Day 0) to an MN titer of ≥40 on Day 28 was measured using an MN assay for the homologous influenza strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
Time frame: Day 0 (pre-vaccination) up to Day 28
Population: Participants in PP Set with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| QVLP15+Full AS03 | Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain | B/Yamagata lineage | 20.0 percentage of participants |
| QVLP15+Full AS03 | Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain | H3N2 | 12.5 percentage of participants |
| QVLP15+Full AS03 | Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain | H1N1 | 38.9 percentage of participants |
| QVLP15+Full AS03 | Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain | B/Victoria lineage | 5.6 percentage of participants |
| QVLP15+Half AS03 | Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain | B/Yamagata lineage | 12.5 percentage of participants |
| QVLP15+Half AS03 | Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain | H1N1 | 50.0 percentage of participants |
| QVLP15+Half AS03 | Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain | H3N2 | 42.9 percentage of participants |
| QVLP15+Half AS03 | Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain | B/Victoria lineage | 25.0 percentage of participants |
| QVLP30+Full AS03 | Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain | B/Yamagata lineage | 17.2 percentage of participants |
| QVLP30+Full AS03 | Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain | H3N2 | 15.6 percentage of participants |
| QVLP30+Full AS03 | Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain | B/Victoria lineage | 18.9 percentage of participants |
| QVLP30+Full AS03 | Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain | H1N1 | 55.3 percentage of participants |
| QVLP30+Half AS03 | Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain | B/Yamagata lineage | 7.1 percentage of participants |
| QVLP30+Half AS03 | Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain | B/Victoria lineage | 29.4 percentage of participants |
| QVLP30+Half AS03 | Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain | H3N2 | 26.7 percentage of participants |
| QVLP30+Half AS03 | Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain | H1N1 | 33.3 percentage of participants |
| QVLP45+Full AS03 | Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain | B/Yamagata lineage | 22.2 percentage of participants |
| QVLP45+Full AS03 | Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain | B/Victoria lineage | 26.3 percentage of participants |
| QVLP45+Full AS03 | Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain | H1N1 | 42.1 percentage of participants |
| QVLP45+Full AS03 | Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain | H3N2 | 42.1 percentage of participants |
| QVLP45+Half AS03 | Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain | H3N2 | 10.0 percentage of participants |
| QVLP45+Half AS03 | Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain | B/Victoria lineage | 30.8 percentage of participants |
| QVLP45+Half AS03 | Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain | H1N1 | 61.5 percentage of participants |
| QVLP45+Half AS03 | Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain | B/Yamagata lineage | 0 percentage of participants |
| QVLP30 Unadjuvanted | Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain | B/Yamagata lineage | 3.8 percentage of participants |
| QVLP30 Unadjuvanted | Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain | H1N1 | 33.3 percentage of participants |
| QVLP30 Unadjuvanted | Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain | B/Victoria lineage | 15.2 percentage of participants |
| QVLP30 Unadjuvanted | Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain | H3N2 | 17.2 percentage of participants |
| Fluzone HD Quad | Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain | B/Victoria lineage | 43.2 percentage of participants |
| Fluzone HD Quad | Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain | H3N2 | 35.3 percentage of participants |
| Fluzone HD Quad | Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain | H1N1 | 59.5 percentage of participants |
| Fluzone HD Quad | Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain | B/Yamagata lineage | 34.5 percentage of participants |
Secondary
Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
Seroconversion rate: the percentage of participants in a given treatment group with either a ≥4-fold increase in reciprocal HI titers between Day 0 and Day 28 or a rise of undetectable MN titer (i.e. \<10) pre-vaccination (Day 0) to an MN titer of ≥40 on Day 28 was measured using an MN assay for the homologous influenza strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Time frame: Day 0 (pre-vaccination) up to Day 28
Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Secondary
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Heterologous Influenza Strain
Seroprotection rate: the percentage of participants in a given treatment group attaining a reciprocal HI titer of ≥40 on Day 28 (the percentage of vaccine recipients with a serum HI titer of at least 1:40 following vaccination) for the heterologous influenza strains A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage)
Time frame: Day 0 (pre-vaccination) up to Day 28
Population: Participants in PP Set with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| QVLP15+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Heterologous Influenza Strain | B/Victoria lineage | 61.1 percentage of participants |
| QVLP15+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Heterologous Influenza Strain | H3N2 | 72.2 percentage of participants |
| QVLP15+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Heterologous Influenza Strain | H1N1 | 100 percentage of participants |
| QVLP15+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Heterologous Influenza Strain | B/Victoria lineage | 77.8 percentage of participants |
| QVLP15+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Heterologous Influenza Strain | H3N2 | 66.7 percentage of participants |
| QVLP15+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Heterologous Influenza Strain | H1N1 | 100 percentage of participants |
| QVLP30+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Heterologous Influenza Strain | H1N1 | 89.5 percentage of participants |
| QVLP30+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Heterologous Influenza Strain | B/Victoria lineage | 71.1 percentage of participants |
| QVLP30+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Heterologous Influenza Strain | H3N2 | 73.7 percentage of participants |
| QVLP30+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Heterologous Influenza Strain | B/Victoria lineage | 42.1 percentage of participants |
| QVLP30+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Heterologous Influenza Strain | H1N1 | 78.9 percentage of participants |
| QVLP30+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Heterologous Influenza Strain | H3N2 | 57.9 percentage of participants |
| QVLP45+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Heterologous Influenza Strain | B/Victoria lineage | 45.0 percentage of participants |
| QVLP45+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Heterologous Influenza Strain | H1N1 | 80.0 percentage of participants |
| QVLP45+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Heterologous Influenza Strain | H3N2 | 55.0 percentage of participants |
| QVLP45+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Heterologous Influenza Strain | H1N1 | 84.6 percentage of participants |
| QVLP45+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Heterologous Influenza Strain | B/Victoria lineage | 61.5 percentage of participants |
| QVLP45+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Heterologous Influenza Strain | H3N2 | 53.8 percentage of participants |
| QVLP30 Unadjuvanted | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Heterologous Influenza Strain | H3N2 | 79.4 percentage of participants |
| QVLP30 Unadjuvanted | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Heterologous Influenza Strain | H1N1 | 88.2 percentage of participants |
| QVLP30 Unadjuvanted | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Heterologous Influenza Strain | B/Victoria lineage | 64.7 percentage of participants |
| Fluzone HD Quad | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Heterologous Influenza Strain | H3N2 | 89.7 percentage of participants |
| Fluzone HD Quad | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Heterologous Influenza Strain | B/Victoria lineage | 76.9 percentage of participants |
| Fluzone HD Quad | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Heterologous Influenza Strain | H1N1 | 92.3 percentage of participants |
Secondary
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Heterologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
Seroprotection rate: the percentage of participants in a given treatment group attaining a reciprocal HI titer of ≥40 on Day 28 (the percentage of vaccine recipients with a serum HI titer of at least 1:40 following vaccination) for the following heterologous influenza strains: A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Time frame: Day 0 (pre-vaccination) up to Day 28
Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Secondary
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365
Seroprotection rate: the percentage of participants in a given treatment group attaining a reciprocal HI titer of ≥40 on Day 182 and on Day 365 (the percentage of vaccine recipients with a serum HI titer of at least 1:40 following vaccination) for the homologous influenza strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage)
Time frame: Day 0 (pre-vaccination) up to Day 182 and up to Day 365
Population: Participants in PP Set with available data at each timepoint were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| QVLP15+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 365 | 38.9 percentage of participants |
| QVLP15+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 182 | 89.5 percentage of participants |
| QVLP15+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 182 | 47.4 percentage of participants |
| QVLP15+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 365 | 11.1 percentage of participants |
| QVLP15+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 365 | 5.6 percentage of participants |
| QVLP15+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 182 | 100 percentage of participants |
| QVLP15+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 365 | 27.8 percentage of participants |
| QVLP15+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 182 | 57.9 percentage of participants |
| QVLP15+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 182 | 100 percentage of participants |
| QVLP15+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 365 | 44.4 percentage of participants |
| QVLP15+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 182 | 88.9 percentage of participants |
| QVLP15+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 182 | 77.8 percentage of participants |
| QVLP15+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 365 | 33.3 percentage of participants |
| QVLP15+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 365 | 11.1 percentage of participants |
| QVLP15+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 365 | 22.2 percentage of participants |
| QVLP15+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 182 | 88.9 percentage of participants |
| QVLP30+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 365 | 38.7 percentage of participants |
| QVLP30+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 365 | 9.7 percentage of participants |
| QVLP30+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 365 | 22.6 percentage of participants |
| QVLP30+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 182 | 94.6 percentage of participants |
| QVLP30+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 182 | 94.6 percentage of participants |
| QVLP30+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 182 | 62.2 percentage of participants |
| QVLP30+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 365 | 9.7 percentage of participants |
| QVLP30+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 182 | 75.7 percentage of participants |
| QVLP30+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 182 | 50.0 percentage of participants |
| QVLP30+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 365 | 26.7 percentage of participants |
| QVLP30+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 365 | 46.7 percentage of participants |
| QVLP30+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 182 | 50.0 percentage of participants |
| QVLP30+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 182 | 83.3 percentage of participants |
| QVLP30+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 365 | 20.0 percentage of participants |
| QVLP30+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 365 | 6.7 percentage of participants |
| QVLP30+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 182 | 94.4 percentage of participants |
| QVLP45+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 365 | 5.0 percentage of participants |
| QVLP45+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 182 | 90.5 percentage of participants |
| QVLP45+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 182 | 66.7 percentage of participants |
| QVLP45+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 365 | 25.0 percentage of participants |
| QVLP45+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 182 | 38.1 percentage of participants |
| QVLP45+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 182 | 81.0 percentage of participants |
| QVLP45+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 365 | 60.0 percentage of participants |
| QVLP45+Full AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 365 | 15.0 percentage of participants |
| QVLP45+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 365 | 38.5 percentage of participants |
| QVLP45+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 365 | 0 percentage of participants |
| QVLP45+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 365 | 61.5 percentage of participants |
| QVLP45+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 182 | 100 percentage of participants |
| QVLP45+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 182 | 100 percentage of participants |
| QVLP45+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 182 | 46.2 percentage of participants |
| QVLP45+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 182 | 69.2 percentage of participants |
| QVLP45+Half AS03 | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 365 | 0 percentage of participants |
| QVLP30 Unadjuvanted | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 182 | 91.2 percentage of participants |
| QVLP30 Unadjuvanted | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 365 | 12.5 percentage of participants |
| QVLP30 Unadjuvanted | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 365 | 53.1 percentage of participants |
| QVLP30 Unadjuvanted | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 182 | 58.8 percentage of participants |
| QVLP30 Unadjuvanted | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 365 | 3.1 percentage of participants |
| QVLP30 Unadjuvanted | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 182 | 61.8 percentage of participants |
| QVLP30 Unadjuvanted | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 365 | 3.1 percentage of participants |
| QVLP30 Unadjuvanted | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 182 | 94.1 percentage of participants |
| Fluzone HD Quad | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 365 | 16.1 percentage of participants |
| Fluzone HD Quad | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 182 | 97.0 percentage of participants |
| Fluzone HD Quad | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H1N1: Day 365 | 12.9 percentage of participants |
| Fluzone HD Quad | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 182 | 84.8 percentage of participants |
| Fluzone HD Quad | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | H3N2: Day 365 | 45.2 percentage of participants |
| Fluzone HD Quad | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 182 | 69.7 percentage of participants |
| Fluzone HD Quad | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Yamagata lineage: Day 365 | 19.4 percentage of participants |
| Fluzone HD Quad | Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365 | B/Victoria lineage: Day 182 | 66.7 percentage of participants |
Secondary
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
Seroprotection rate: the percentage of participants in a given treatment group attaining a reciprocal HI titer of ≥40 on Day 28 (the percentage of vaccine recipients with a serum HI titer of at least 1:40 following vaccination) for the homologous influenza strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if \>25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Time frame: Day 0 (pre-vaccination) up to Day 28
Population: The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.