Healthy Volunteers, Influenza Immunization
Conditions
Brief summary
The main purpose of this Phase II study was to assess the safety and immunogenicity of a dose of Fluzone High-Dose (HD) Quadrivalent vaccine and a third dose or booster dose of Moderna coronavirus disease 19 (COVID-19) vaccine administered concomitantly or singly in adults 65 years of age and older having received their second dose of the 2-dose schedule of Moderna COVID-19 vaccine at least 5 months before enrollment in the study.
Detailed description
Participants were in the study for 6 months (approximately 180 days).
Interventions
BIOLOGICALQuadrivalent Inactivated Influenza High Dose
Sterile suspension for injection in a pre-filled syringe Intramuscular injection
BIOLOGICALCOVID-19 mRNA Vaccine (nucleoside modified)
Sterile suspension (white to off-white) in multidose vial Intramuscular injection
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Aged greater than or equal to \>= 65 years of age on the day of inclusion. * In good health or with underlying medical condition(s) that were judged to be stable by the Investigator. A stable medical condition was defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment. * Participants who previously received 2 injections of Moderna COVID-19 Vaccine with the second dose received at least 5 months before Visit 1. * Abled to attend all scheduled visits and to complied with all study procedures.
Exclusion criteria
* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the 3 months preceding planned inclusion). * Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances. * Previous dermal filler injection (either lips or face fillers). * Thrombocytopenia, contraindicated IM injection. * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicated IM vaccination. * Chronic illness that, in the opinion of the Investigator, was at a stage where it might interfere with study conduct or completion. * Moderate or severe acute illness/infection (according to Investigator judgment) on the day of study intervention administration or febrile illness (temperature \>= 100.4°Fahrenheit \[F\] \[38.0° Celsius {C}\]). A prospective participant should not be included in the study until the condition had resolved or the febrile event had subsided. * History of serious adverse reaction to any influenza or COVID-19 vaccines. * Personal history of Guillain-Barré syndrome (GBS). * Personal history of clinically significant developmental delay (at the discretion of the Investigator), neurologic disorder, or seizure disorder. * Known seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C. * Any condition that in the opinion of the Investigator posed a health risk to the participant if enrolled or could interfere with the evaluation of the vaccine. * Receipt of any vaccine in the 4 weeks preceding the study intervention(s) administration or planned receipt of any vaccine in the period between Visit 01 and 4 weeks following the study intervention(s) administration. Note: Vaccination of Group 3 participants with Fluzone High-Dose Quadrivalent vaccine at the end of the study was not considered by the Sponsor as meeting this exclusion criterion. * Receipt of blood-derived immune globulins, blood, or blood-derived products in the past 3 months. * Participation at the time of study enrollment (or in the 30 days preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating vaccine, drug, medical device, or medical procedure. * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily. * Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed 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 the proposed study. * The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Immediate Unsolicited Adverse Events (AEs) | Within 30 minutes post vaccination | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report form (CRF) in terms of diagnosis and onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs that occurred during that time were recorded as immediate unsolicited AEs in the CRF. Reported AEs for each arm were presented as pre-specified in the study protocol. |
| Number of Participants With Solicited Injection Site Reactions | Within 7 days post-vaccination | A solicited reaction (SR) was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. Solicited injection site reactions included injection site pain, axillary swelling and tenderness, injection site erythema, injection site swelling, injection site induration, and injection site bruising. Reported AEs for each arm were presented as pre-specified in the study protocol. |
| Number of Participants With Solicited Systemic Reactions | Within 7 days post-vaccination | A SR was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRF. Solicited systemic reactions included fever, headache, malaise, myalgia, arthralgia, shivering, fatigue, nausea and vomiting. Reported AEs for each arm were presented as pre-specified in the study protocol. |
| Number of Participants With Unsolicited Adverse Events | Within 21 days post-vaccination | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Reported AEs for each arm were presented as pre-specified in the study protocol. |
| Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs) | From Day 1 up to 6 months post-vaccination | An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. AESIs was defined as one of scientific and medical concern specific to the sponsor's study intervention or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor was done. Reported AEs for each arm were presented as pre-specified in the study protocol. |
| Number of Participants With Medically Attended Adverse Events (MAAEs) | From Day 1 up to 6 months post-vaccination | A MAAE was a new onset or a worsening of a condition that prompted the participant or participant's parent/legally acceptable representative to seek unplanned medical advice at a physician's office or emergency department including medical advice seeking during the study visit or routine medical care. Reported AEs for each arm were presented as pre-specified in the study protocol. |
| Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 1 | Day 1 (pre-vaccination) | GMTs of anti-influenza and anti-COVID-19 antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Yamagata, and B/Victoria. Titers were expressed in terms of 1/dilution. |
| Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 22 | Day 22 (post-vaccination) | GMTs of anti-influenza and anti-COVID-19 antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Yamagata, and B/Victoria. Titers were expressed in terms of 1/dilution. |
| Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine and COVID-19 Vaccine Antibodies | Day 1 (pre-vaccination) and Day 22 (post-vaccination) | GMTs of anti-influenza and anti-COVID-19 antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 22) and pre-vaccination (on Day 1) i.e., Day 22/Day 01. |
| Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) | Day 1 (pre-vaccination) | Anti-influenza and anti-COVID 19 antibodies were measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Percentage of participants with HAI titers \>=10 (1/dilution) are reported in the outcome measure. |
| Percentage of Participants Achieving Seroconversion Against Influenza and COVID-19 Virus Antigens | Day 22 (post-vaccination) | Anti-influenza and anti-COVID-19 antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroconversion was defined as either a pre-vaccination HAI titer less than (\<)10 (1/dilution) and a post-vaccination titer \>=40 (1/dilution) or a pre-vaccination titer \>=10 (1/dilution) and a \>= four-fold increase in post-vaccination titer at Day 22. |
| Percentage of Participants With Antibody Titers >=40 (1/Dilution) | Day 1 (pre-vaccination) | Anti-influenza and anti-COVID 19 antibodies were measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Percentage of participants with HAI titers \>=40 (1/dilution) are reported in the outcome measure. |
| Geometric Mean Concentration (GMC) of Anti-S Binding Immunoglobulin G (IgG) Antibodies | Day 1 (pre-vaccination) | GMCs of Anti-S binding IgG antibodies were assessed using enzyme-linked immunosorbent assay (ELISA) method and were measured in binding antibody units/milliliter (BAU/mL). |
| Geometric Mean Concentration Ratio (GMCR) of Anti-S Binding IgG Antibodies | Day 1 (pre-vaccination) and Day 22 (post-vaccination) | GMCs of Anti-S binding IgG antibodies were assessed using ELISA method. GMCR was calculated as the ratio of GMC post-vaccination (on Day 22) and pre-vaccination (on Day 1) i.e., Day 22/Day 01. |
| Percentage of Participants With >=2-Fold and >=4-Fold Rise in Anti-S Binding IgG Antibodies | Day 22 (post-vaccination) | Percentage of participants with \>=2-fold and \>=4-fold rise in Anti-S binding IgG antibodies at Day 22 (post-vaccination) are reported in this outcome measure. Percentage of participants with \>=2-fold rise are those for whom the computed value at Day 22 was \*2 compared to the computed value at Day 1 and percentage of participants with \>=4-fold rise are those for whom the computed value at Day 22 was \*4 compared to the computed value at Day 1. |
Countries
United States
Participant flow
Recruitment details
The study was conducted at 6 sites in the United States. A total of 306 participants were enrolled between 16 July 2021 to 05 August 2021.
Pre-assignment details
A total of 296 participants were vaccinated in the study.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine Participants received an injection of 0.7 mL, fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, IM on Day 1. | 100 |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1. | 101 |
| Group 3: COVID-19 Vaccine Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1. | 105 |
| Total | 306 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 |
| Overall Study | Protocol Deviation | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 10 | 0 |
Baseline characteristics
| Characteristic | Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Group 3: COVID-19 Vaccine | Total |
|---|---|---|---|---|
| Age, Continuous | 71.3 years STANDARD_DEVIATION 4.76 | 71.7 years STANDARD_DEVIATION 5.16 | 72.0 years STANDARD_DEVIATION 4.89 | 71.7 years STANDARD_DEVIATION 4.93 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 4 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 94 Participants | 95 Participants | 103 Participants | 292 Participants |
| Sex: Female, Male Female | 55 Participants | 54 Participants | 63 Participants | 172 Participants |
| Sex: Female, Male Male | 45 Participants | 47 Participants | 42 Participants | 134 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 0 / 92 | 0 / 104 |
| other Total, other adverse events | 94 / 100 | 65 / 92 | 100 / 104 |
| serious Total, serious adverse events | 2 / 100 | 0 / 92 | 3 / 104 |
Outcome results
Primary
Geometric Mean Concentration (GMC) of Anti-S Binding Immunoglobulin G (IgG) Antibodies
GMCs of Anti-S binding IgG antibodies were assessed using enzyme-linked immunosorbent assay (ELISA) method and were measured in binding antibody units/milliliter (BAU/mL).
Time frame: Day 1 (pre-vaccination)
Population: Analysis was performed on Immunogenicity analysis set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Geometric Mean Concentration (GMC) of Anti-S Binding Immunoglobulin G (IgG) Antibodies | 565 BAU/mL |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Geometric Mean Concentration (GMC) of Anti-S Binding Immunoglobulin G (IgG) Antibodies | 462 BAU/mL |
| Group 3: COVID-19 Vaccine | Geometric Mean Concentration (GMC) of Anti-S Binding Immunoglobulin G (IgG) Antibodies | 552 BAU/mL |
Primary
Geometric Mean Concentration (GMC) of Anti-S Binding Immunoglobulin G (IgG) Antibodies
GMCs of Anti-S binding IgG antibodies were assessed using ELISA method and were measured in BAU/mL.
Time frame: Day 22 (post-vaccination)
Population: Analysis was performed on Immunogenicity analysis set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Geometric Mean Concentration (GMC) of Anti-S Binding Immunoglobulin G (IgG) Antibodies | 7634 BAU/mL |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Geometric Mean Concentration (GMC) of Anti-S Binding Immunoglobulin G (IgG) Antibodies | 395 BAU/mL |
| Group 3: COVID-19 Vaccine | Geometric Mean Concentration (GMC) of Anti-S Binding Immunoglobulin G (IgG) Antibodies | 7904 BAU/mL |
Primary
Geometric Mean Concentration Ratio (GMCR) of Anti-S Binding IgG Antibodies
GMCs of Anti-S binding IgG antibodies were assessed using ELISA method. GMCR was calculated as the ratio of GMC post-vaccination (on Day 22) and pre-vaccination (on Day 1) i.e., Day 22/Day 01.
Time frame: Day 1 (pre-vaccination) and Day 22 (post-vaccination)
Population: Analysis was performed on Immunogenicity analysis set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Geometric Mean Concentration Ratio (GMCR) of Anti-S Binding IgG Antibodies | 13.7 ratio |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Geometric Mean Concentration Ratio (GMCR) of Anti-S Binding IgG Antibodies | 0.875 ratio |
| Group 3: COVID-19 Vaccine | Geometric Mean Concentration Ratio (GMCR) of Anti-S Binding IgG Antibodies | 14.2 ratio |
Primary
Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 1
GMTs of anti-influenza and anti-COVID-19 antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Yamagata, and B/Victoria. Titers were expressed in terms of 1/dilution.
Time frame: Day 1 (pre-vaccination)
Population: Analysis was performed on Immunogenicity analysis set which included all randomized participants who received at least 1 dose of the study vaccine and analyzed according to the vaccine they actually received and study intervention group. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 1 | A/H1N1: Pre-vaccination | 55.8 titers |
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 1 | A/H3N2: Pre-vaccination | 95.0 titers |
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 1 | B/Yamagata: Pre-vaccination | 221 titers |
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 1 | B/Victoria: Pre-vaccination | 163 titers |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 1 | B/Victoria: Pre-vaccination | 155 titers |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 1 | A/H1N1: Pre-vaccination | 45.5 titers |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 1 | B/Yamagata: Pre-vaccination | 204 titers |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 1 | A/H3N2: Pre-vaccination | 85.4 titers |
| Group 3: COVID-19 Vaccine | Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 1 | B/Victoria: Pre-vaccination | 165 titers |
| Group 3: COVID-19 Vaccine | Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 1 | A/H3N2: Pre-vaccination | 80.3 titers |
| Group 3: COVID-19 Vaccine | Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 1 | B/Yamagata: Pre-vaccination | 203 titers |
| Group 3: COVID-19 Vaccine | Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 1 | A/H1N1: Pre-vaccination | 49.7 titers |
Primary
Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 22
GMTs of anti-influenza and anti-COVID-19 antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Yamagata, and B/Victoria. Titers were expressed in terms of 1/dilution.
Time frame: Day 22 (post-vaccination)
Population: Analysis was performed on Immunogenicity analysis set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 22 | A/H1N1: Post-vaccination | 363 titers |
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 22 | A/H3N2: Post-vaccination | 286 titers |
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 22 | B/Yamagata: Post-vaccination | 429 titers |
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 22 | B/Victoria: Post-vaccination | 377 titers |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 22 | B/Victoria: Post-vaccination | 390 titers |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 22 | A/H1N1: Post-vaccination | 366 titers |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 22 | B/Yamagata: Post-vaccination | 471 titers |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 22 | A/H3N2: Post-vaccination | 315 titers |
| Group 3: COVID-19 Vaccine | Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 22 | B/Victoria: Post-vaccination | 176 titers |
| Group 3: COVID-19 Vaccine | Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 22 | A/H3N2: Post-vaccination | 76.5 titers |
| Group 3: COVID-19 Vaccine | Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 22 | B/Yamagata: Post-vaccination | 198 titers |
| Group 3: COVID-19 Vaccine | Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 22 | A/H1N1: Post-vaccination | 41.2 titers |
Primary
Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine and COVID-19 Vaccine Antibodies
GMTs of anti-influenza and anti-COVID-19 antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 22) and pre-vaccination (on Day 1) i.e., Day 22/Day 01.
Time frame: Day 1 (pre-vaccination) and Day 22 (post-vaccination)
Population: Analysis was performed on Immunogenicity analysis set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine and COVID-19 Vaccine Antibodies | A/H1N1 | 6.35 ratio |
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine and COVID-19 Vaccine Antibodies | A/H3N2 | 3.06 ratio |
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine and COVID-19 Vaccine Antibodies | B/Yamagata | 1.94 ratio |
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine and COVID-19 Vaccine Antibodies | B/Victoria | 2.27 ratio |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine and COVID-19 Vaccine Antibodies | B/Victoria | 2.44 ratio |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine and COVID-19 Vaccine Antibodies | A/H1N1 | 8.10 ratio |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine and COVID-19 Vaccine Antibodies | B/Yamagata | 2.27 ratio |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine and COVID-19 Vaccine Antibodies | A/H3N2 | 3.54 ratio |
| Group 3: COVID-19 Vaccine | Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine and COVID-19 Vaccine Antibodies | B/Victoria | 1.05 ratio |
| Group 3: COVID-19 Vaccine | Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine and COVID-19 Vaccine Antibodies | A/H3N2 | 0.940 ratio |
| Group 3: COVID-19 Vaccine | Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine and COVID-19 Vaccine Antibodies | B/Yamagata | 0.983 ratio |
| Group 3: COVID-19 Vaccine | Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine and COVID-19 Vaccine Antibodies | A/H1N1 | 0.868 ratio |
Primary
Number of Participants With Immediate Unsolicited Adverse Events (AEs)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report form (CRF) in terms of diagnosis and onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs that occurred during that time were recorded as immediate unsolicited AEs in the CRF. Reported AEs for each arm were presented as pre-specified in the study protocol.
Time frame: Within 30 minutes post vaccination
Population: Analysis was performed on SafAS which included all participants who had received the study vaccine(s) and were analyzed according to the vaccine they actually received and study intervention group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Number of Participants With Immediate Unsolicited Adverse Events (AEs) | 1 Participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Number of Participants With Immediate Unsolicited Adverse Events (AEs) | 1 Participants |
| Group 3: COVID-19 Vaccine | Number of Participants With Immediate Unsolicited Adverse Events (AEs) | 0 Participants |
Primary
Number of Participants With Medically Attended Adverse Events (MAAEs)
A MAAE was a new onset or a worsening of a condition that prompted the participant or participant's parent/legally acceptable representative to seek unplanned medical advice at a physician's office or emergency department including medical advice seeking during the study visit or routine medical care. Reported AEs for each arm were presented as pre-specified in the study protocol.
Time frame: From Day 1 up to 6 months post-vaccination
Population: Analysis was performed on the SafAS population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Number of Participants With Medically Attended Adverse Events (MAAEs) | 10 Participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Number of Participants With Medically Attended Adverse Events (MAAEs) | 6 Participants |
| Group 3: COVID-19 Vaccine | Number of Participants With Medically Attended Adverse Events (MAAEs) | 17 Participants |
Primary
Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs)
An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. AESIs was defined as one of scientific and medical concern specific to the sponsor's study intervention or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor was done. Reported AEs for each arm were presented as pre-specified in the study protocol.
Time frame: From Day 1 up to 6 months post-vaccination
Population: Analysis was performed on the SafAS.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs) | SAEs | 2 Participants |
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs) | AESIs | 1 Participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs) | SAEs | 0 Participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs) | AESIs | 0 Participants |
| Group 3: COVID-19 Vaccine | Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs) | SAEs | 3 Participants |
| Group 3: COVID-19 Vaccine | Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs) | AESIs | 1 Participants |
Primary
Number of Participants With Solicited Injection Site Reactions
A solicited reaction (SR) was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. Solicited injection site reactions included injection site pain, axillary swelling and tenderness, injection site erythema, injection site swelling, injection site induration, and injection site bruising. Reported AEs for each arm were presented as pre-specified in the study protocol.
Time frame: Within 7 days post-vaccination
Population: Analysis was performed on the SafAS. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Number of Participants With Solicited Injection Site Reactions | Axillary swelling | 2 Participants |
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Number of Participants With Solicited Injection Site Reactions | Injection site swelling | 15 Participants |
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Number of Participants With Solicited Injection Site Reactions | Injection site erythema | 22 Participants |
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Number of Participants With Solicited Injection Site Reactions | Injection site pain | 82 Participants |
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Number of Participants With Solicited Injection Site Reactions | Injection site bruising | 7 Participants |
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Number of Participants With Solicited Injection Site Reactions | Injection site induration | 12 Participants |
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Number of Participants With Solicited Injection Site Reactions | Axillary tenderness | 3 Participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Number of Participants With Solicited Injection Site Reactions | Injection site erythema | 10 Participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Number of Participants With Solicited Injection Site Reactions | Injection site pain | 54 Participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Number of Participants With Solicited Injection Site Reactions | Axillary swelling | 2 Participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Number of Participants With Solicited Injection Site Reactions | Axillary tenderness | 3 Participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Number of Participants With Solicited Injection Site Reactions | Injection site swelling | 6 Participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Number of Participants With Solicited Injection Site Reactions | Injection site induration | 3 Participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Number of Participants With Solicited Injection Site Reactions | Injection site bruising | 0 Participants |
| Group 3: COVID-19 Vaccine | Number of Participants With Solicited Injection Site Reactions | Injection site swelling | 27 Participants |
| Group 3: COVID-19 Vaccine | Number of Participants With Solicited Injection Site Reactions | Axillary swelling | 1 Participants |
| Group 3: COVID-19 Vaccine | Number of Participants With Solicited Injection Site Reactions | Injection site bruising | 4 Participants |
| Group 3: COVID-19 Vaccine | Number of Participants With Solicited Injection Site Reactions | Injection site induration | 22 Participants |
| Group 3: COVID-19 Vaccine | Number of Participants With Solicited Injection Site Reactions | Injection site erythema | 32 Participants |
| Group 3: COVID-19 Vaccine | Number of Participants With Solicited Injection Site Reactions | Axillary tenderness | 3 Participants |
| Group 3: COVID-19 Vaccine | Number of Participants With Solicited Injection Site Reactions | Injection site pain | 92 Participants |
Primary
Number of Participants With Solicited Systemic Reactions
A SR was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRF. Solicited systemic reactions included fever, headache, malaise, myalgia, arthralgia, shivering, fatigue, nausea and vomiting. Reported AEs for each arm were presented as pre-specified in the study protocol.
Time frame: Within 7 days post-vaccination
Population: Analysis was performed on the SafAS. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Number of Participants With Solicited Systemic Reactions | Myalgia | 50 Participants |
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Number of Participants With Solicited Systemic Reactions | Vomiting | 4 Participants |
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Number of Participants With Solicited Systemic Reactions | Shivering | 32 Participants |
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Number of Participants With Solicited Systemic Reactions | Arthralgia | 24 Participants |
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Number of Participants With Solicited Systemic Reactions | Fever | 12 Participants |
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Number of Participants With Solicited Systemic Reactions | Nausea | 32 Participants |
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Number of Participants With Solicited Systemic Reactions | Malaise | 46 Participants |
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Number of Participants With Solicited Systemic Reactions | Headache | 52 Participants |
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Number of Participants With Solicited Systemic Reactions | Fatigue | 62 Participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Number of Participants With Solicited Systemic Reactions | Arthralgia | 8 Participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Number of Participants With Solicited Systemic Reactions | Fever | 1 Participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Number of Participants With Solicited Systemic Reactions | Headache | 18 Participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Number of Participants With Solicited Systemic Reactions | Malaise | 13 Participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Number of Participants With Solicited Systemic Reactions | Myalgia | 20 Participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Number of Participants With Solicited Systemic Reactions | Shivering | 6 Participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Number of Participants With Solicited Systemic Reactions | Fatigue | 26 Participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Number of Participants With Solicited Systemic Reactions | Nausea | 5 Participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Number of Participants With Solicited Systemic Reactions | Vomiting | 3 Participants |
| Group 3: COVID-19 Vaccine | Number of Participants With Solicited Systemic Reactions | Malaise | 59 Participants |
| Group 3: COVID-19 Vaccine | Number of Participants With Solicited Systemic Reactions | Fever | 12 Participants |
| Group 3: COVID-19 Vaccine | Number of Participants With Solicited Systemic Reactions | Fatigue | 73 Participants |
| Group 3: COVID-19 Vaccine | Number of Participants With Solicited Systemic Reactions | Headache | 55 Participants |
| Group 3: COVID-19 Vaccine | Number of Participants With Solicited Systemic Reactions | Vomiting | 1 Participants |
| Group 3: COVID-19 Vaccine | Number of Participants With Solicited Systemic Reactions | Arthralgia | 27 Participants |
| Group 3: COVID-19 Vaccine | Number of Participants With Solicited Systemic Reactions | Myalgia | 64 Participants |
| Group 3: COVID-19 Vaccine | Number of Participants With Solicited Systemic Reactions | Nausea | 27 Participants |
| Group 3: COVID-19 Vaccine | Number of Participants With Solicited Systemic Reactions | Shivering | 22 Participants |
Primary
Number of Participants With Unsolicited Adverse Events
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Reported AEs for each arm were presented as pre-specified in the study protocol.
Time frame: Within 21 days post-vaccination
Population: Analysis was performed on the SafAS.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Number of Participants With Unsolicited Adverse Events | 17 Participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Number of Participants With Unsolicited Adverse Events | 11 Participants |
| Group 3: COVID-19 Vaccine | Number of Participants With Unsolicited Adverse Events | 15 Participants |
Primary
Percentage of Participants Achieving Seroconversion Against Influenza and COVID-19 Virus Antigens
Anti-influenza and anti-COVID-19 antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroconversion was defined as either a pre-vaccination HAI titer less than (\<)10 (1/dilution) and a post-vaccination titer \>=40 (1/dilution) or a pre-vaccination titer \>=10 (1/dilution) and a \>= four-fold increase in post-vaccination titer at Day 22.
Time frame: Day 22 (post-vaccination)
Population: Analysis was performed on Immunogenicity analysis set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Percentage of Participants Achieving Seroconversion Against Influenza and COVID-19 Virus Antigens | A/H3N2 | 43.8 percentage of participants |
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Percentage of Participants Achieving Seroconversion Against Influenza and COVID-19 Virus Antigens | B/Victoria | 30.2 percentage of participants |
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Percentage of Participants Achieving Seroconversion Against Influenza and COVID-19 Virus Antigens | A/H1N1 | 68.8 percentage of participants |
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Percentage of Participants Achieving Seroconversion Against Influenza and COVID-19 Virus Antigens | B/Yamagata | 17.7 percentage of participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Percentage of Participants Achieving Seroconversion Against Influenza and COVID-19 Virus Antigens | B/Victoria | 24.4 percentage of participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Percentage of Participants Achieving Seroconversion Against Influenza and COVID-19 Virus Antigens | A/H3N2 | 47.7 percentage of participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Percentage of Participants Achieving Seroconversion Against Influenza and COVID-19 Virus Antigens | B/Yamagata | 20.9 percentage of participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Percentage of Participants Achieving Seroconversion Against Influenza and COVID-19 Virus Antigens | A/H1N1 | 72.1 percentage of participants |
| Group 3: COVID-19 Vaccine | Percentage of Participants Achieving Seroconversion Against Influenza and COVID-19 Virus Antigens | B/Yamagata | 1.0 percentage of participants |
| Group 3: COVID-19 Vaccine | Percentage of Participants Achieving Seroconversion Against Influenza and COVID-19 Virus Antigens | A/H3N2 | 0.0 percentage of participants |
| Group 3: COVID-19 Vaccine | Percentage of Participants Achieving Seroconversion Against Influenza and COVID-19 Virus Antigens | A/H1N1 | 0.0 percentage of participants |
| Group 3: COVID-19 Vaccine | Percentage of Participants Achieving Seroconversion Against Influenza and COVID-19 Virus Antigens | B/Victoria | 1.0 percentage of participants |
Primary
Percentage of Participants With >=2-Fold and >=4-Fold Rise in Anti-S Binding IgG Antibodies
Percentage of participants with \>=2-fold and \>=4-fold rise in Anti-S binding IgG antibodies at Day 22 (post-vaccination) are reported in this outcome measure. Percentage of participants with \>=2-fold rise are those for whom the computed value at Day 22 was \*2 compared to the computed value at Day 1 and percentage of participants with \>=4-fold rise are those for whom the computed value at Day 22 was \*4 compared to the computed value at Day 1.
Time frame: Day 22 (post-vaccination)
Population: Analysis was performed on immunogenicity analysis set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Percentage of Participants With >=2-Fold and >=4-Fold Rise in Anti-S Binding IgG Antibodies | >= 2-fold rise | 97.9 percentage of participants |
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Percentage of Participants With >=2-Fold and >=4-Fold Rise in Anti-S Binding IgG Antibodies | >= 4-fold rise | 92.7 percentage of participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Percentage of Participants With >=2-Fold and >=4-Fold Rise in Anti-S Binding IgG Antibodies | >= 2-fold rise | 3.5 percentage of participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Percentage of Participants With >=2-Fold and >=4-Fold Rise in Anti-S Binding IgG Antibodies | >= 4-fold rise | 2.3 percentage of participants |
| Group 3: COVID-19 Vaccine | Percentage of Participants With >=2-Fold and >=4-Fold Rise in Anti-S Binding IgG Antibodies | >= 2-fold rise | 98.0 percentage of participants |
| Group 3: COVID-19 Vaccine | Percentage of Participants With >=2-Fold and >=4-Fold Rise in Anti-S Binding IgG Antibodies | >= 4-fold rise | 95.1 percentage of participants |
Primary
Percentage of Participants With Antibody Titers >=40 (1/Dilution)
Anti-influenza and anti-COVID 19 antibodies were measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Percentage of participants with HAI titers \>=40 (1/dilution) are reported in the outcome measure.
Time frame: Day 22 (post-vaccination)
Population: Analysis was performed on Immunogenicity analysis set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Percentage of Participants With Antibody Titers >=40 (1/Dilution) | A/H1N1: Post-vaccination | 94.8 percentage of participants |
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Percentage of Participants With Antibody Titers >=40 (1/Dilution) | A/H3N2: Post-vaccination | 96.9 percentage of participants |
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Percentage of Participants With Antibody Titers >=40 (1/Dilution) | B/Yamagata: Post-vaccination | 100 percentage of participants |
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Percentage of Participants With Antibody Titers >=40 (1/Dilution) | B/Victoria: Post-vaccination | 100 percentage of participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Percentage of Participants With Antibody Titers >=40 (1/Dilution) | B/Victoria: Post-vaccination | 100 percentage of participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Percentage of Participants With Antibody Titers >=40 (1/Dilution) | A/H1N1: Post-vaccination | 95.3 percentage of participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Percentage of Participants With Antibody Titers >=40 (1/Dilution) | B/Yamagata: Post-vaccination | 98.8 percentage of participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Percentage of Participants With Antibody Titers >=40 (1/Dilution) | A/H3N2: Post-vaccination | 100 percentage of participants |
| Group 3: COVID-19 Vaccine | Percentage of Participants With Antibody Titers >=40 (1/Dilution) | B/Victoria: Post-vaccination | 96.1 percentage of participants |
| Group 3: COVID-19 Vaccine | Percentage of Participants With Antibody Titers >=40 (1/Dilution) | A/H3N2: Post-vaccination | 72.5 percentage of participants |
| Group 3: COVID-19 Vaccine | Percentage of Participants With Antibody Titers >=40 (1/Dilution) | B/Yamagata: Post-vaccination | 96.1 percentage of participants |
| Group 3: COVID-19 Vaccine | Percentage of Participants With Antibody Titers >=40 (1/Dilution) | A/H1N1: Post-vaccination | 53.9 percentage of participants |
Primary
Percentage of Participants With Antibody Titers >=40 (1/Dilution)
Anti-influenza and anti-COVID 19 antibodies were measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Percentage of participants with HAI titers \>=40 (1/dilution) are reported in the outcome measure.
Time frame: Day 1 (pre-vaccination)
Population: Analysis was performed on Immunogenicity analysis set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Percentage of Participants With Antibody Titers >=40 (1/Dilution) | A/H1N1: Pre-vaccination | 65.7 percentage of participants |
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Percentage of Participants With Antibody Titers >=40 (1/Dilution) | A/H3N2: Pre-vaccination | 83.8 percentage of participants |
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Percentage of Participants With Antibody Titers >=40 (1/Dilution) | B/Yamagata: Pre-vaccination | 97.0 percentage of participants |
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Percentage of Participants With Antibody Titers >=40 (1/Dilution) | B/Victoria: Pre-vaccination | 99.0 percentage of participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Percentage of Participants With Antibody Titers >=40 (1/Dilution) | B/Victoria: Pre-vaccination | 94.5 percentage of participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Percentage of Participants With Antibody Titers >=40 (1/Dilution) | A/H1N1: Pre-vaccination | 56.0 percentage of participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Percentage of Participants With Antibody Titers >=40 (1/Dilution) | B/Yamagata: Pre-vaccination | 90.1 percentage of participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Percentage of Participants With Antibody Titers >=40 (1/Dilution) | A/H3N2: Pre-vaccination | 79.1 percentage of participants |
| Group 3: COVID-19 Vaccine | Percentage of Participants With Antibody Titers >=40 (1/Dilution) | B/Victoria: Pre-vaccination | 95.0 percentage of participants |
| Group 3: COVID-19 Vaccine | Percentage of Participants With Antibody Titers >=40 (1/Dilution) | A/H3N2: Pre-vaccination | 77.2 percentage of participants |
| Group 3: COVID-19 Vaccine | Percentage of Participants With Antibody Titers >=40 (1/Dilution) | B/Yamagata: Pre-vaccination | 96.0 percentage of participants |
| Group 3: COVID-19 Vaccine | Percentage of Participants With Antibody Titers >=40 (1/Dilution) | A/H1N1: Pre-vaccination | 59.4 percentage of participants |
Primary
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution)
Anti-influenza and anti-COVID 19 antibodies were measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Percentage of participants with HAI titers \>=10 (1/dilution) are reported in the outcome measure.
Time frame: Day 22 (post-vaccination)
Population: Analysis was performed on Immunogenicity analysis set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) | A/H1N1: Post-vaccination | 100 percentage of participants |
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) | A/H3N2: Post-vaccination | 100 percentage of participants |
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) | B/Yamagata: Post-vaccination | 100 percentage of participants |
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) | B/Victoria: Post-vaccination | 100 percentage of participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) | B/Victoria: Post-vaccination | 100 percentage of participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) | A/H1N1: Post-vaccination | 100 percentage of participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) | B/Yamagata: Post-vaccination | 100 percentage of participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) | A/H3N2: Post-vaccination | 100 percentage of participants |
| Group 3: COVID-19 Vaccine | Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) | B/Victoria: Post-vaccination | 100 percentage of participants |
| Group 3: COVID-19 Vaccine | Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) | A/H3N2: Post-vaccination | 99.0 percentage of participants |
| Group 3: COVID-19 Vaccine | Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) | B/Yamagata: Post-vaccination | 99.0 percentage of participants |
| Group 3: COVID-19 Vaccine | Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) | A/H1N1: Post-vaccination | 91.2 percentage of participants |
Primary
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution)
Anti-influenza and anti-COVID 19 antibodies were measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Percentage of participants with HAI titers \>=10 (1/dilution) are reported in the outcome measure.
Time frame: Day 1 (pre-vaccination)
Population: Analysis was performed on Immunogenicity analysis set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) | A/H1N1: Pre-vaccination | 97.0 percentage of participants |
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) | A/H3N2: Pre-vaccination | 100 percentage of participants |
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) | B/Yamagata: Pre-vaccination | 100 percentage of participants |
| Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine | Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) | B/Victoria: Pre-vaccination | 100 percentage of participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) | B/Victoria: Pre-vaccination | 100 percentage of participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) | A/H1N1: Pre-vaccination | 94.5 percentage of participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) | B/Yamagata: Pre-vaccination | 100 percentage of participants |
| Group 2: Fluzone HD Quadrivalent Influenza Vaccine | Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) | A/H3N2: Pre-vaccination | 98.9 percentage of participants |
| Group 3: COVID-19 Vaccine | Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) | B/Victoria: Pre-vaccination | 100 percentage of participants |
| Group 3: COVID-19 Vaccine | Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) | A/H3N2: Pre-vaccination | 99.0 percentage of participants |
| Group 3: COVID-19 Vaccine | Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) | B/Yamagata: Pre-vaccination | 99.0 percentage of participants |
| Group 3: COVID-19 Vaccine | Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) | A/H1N1: Pre-vaccination | 91.1 percentage of participants |