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Study Describing the Immunogenicity and Safety of Quadrivalent Recombinant Influenza Vaccine (RIV4) Versus a Licensed Quadrivalent-inactivated Influenza Vaccine (IIV4) (Fluarix® Quadrivalent) in Participants 18 Years of Age and Older in South Korea

A Phase III Randomized, Modified Double-blind, Active-controlled, Multi-center Study to Describe the Immunogenicity and Safety of the Quadrivalent Recombinant Influenza Vaccine (RIV4) Versus a Quadrivalent-inactivated Influenza Vaccine (IIV4) (Fluarix® Quadrivalent) in Participants 18 Years of Age and Older in South Korea

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05144945
Enrollment
301
Registered
2021-12-06
Start date
2021-12-07
Completion date
2022-09-01
Last updated
2025-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza (Healthy Volunteers)

Brief summary

* To describe the immune response induced by quadrivalent recombinant influenza vaccine (RIV4) and Quadrivalent-inactivated Influenza Vaccine (IIV4) in 18-49 and greater than or equal to (\>=) 50 years of age participants by hemagglutination inhibition (HAI) measurement method. * To describe the safety profile of all participants in RIV4 and IIV4 groups.

Detailed description

The duration of each participant's participation was approximately 6 months.

Interventions

BIOLOGICALQuadrivalent Recombinant Influenza Vaccine (RIV4)

Solution for intramuscular injection

BIOLOGICALQuadrivalent inactivated influenza vaccine (IIV4)

Suspension for intramuscular injection

Sponsors

Sanofi Pasteur, a Sanofi Company
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Modified double-blind: A designated unblinded administrator administered the appropriate vaccine but was not involved in the immunogenicity and safety assessments.

Intervention model description

In each age group (18-49 and \>= 50 years of age), participants were randomized in a 1:1 ratio to each of the vaccines.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Aged \>=18 years on the day of inclusion. * Participants who were overtly healthy as determined by medical evaluation including medical history, physical examination. * Able to attend all scheduled visits and complied with all study procedures. * Informed consent form was signed and dated. * A female participant was eligible to participate if she was not pregnant or breastfeeding and one of the following conditions applies: Was of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile OR Was of childbearing potential and agreed to use an effective contraceptive method or abstinence from at least 4 weeks prior to the study intervention administration until at least 4 weeks after study intervention administration. A female participant of childbearing potential must had a negative highly sensitive pregnancy test (urine) before the first dose of study intervention.

Exclusion criteria

Participants were excluded from the study if any of the following criteria applied: * Participation at the time of study enrollment, or in the 6 months preceding the study vaccination, or planned participation during the present study period in another clinical study investigating involving an Investigational Medical Product (IMP) (vaccine, drug), medical device, or medical procedure or in any other type of medical research. * Receipt of any vaccine in the 4 weeks (28 days) preceding the study vaccination or planned receipt of any vaccine prior to Visit 2. * Previous vaccination against influenza (in the preceding 6 months) with either the study vaccine or another vaccine. * Receipt of immune globulins, blood, or blood-derived products in the past 3 months. * Known or suspected abnormal immune function: immunosuppression, suspected congenital or acquired immunodeficiency based on medical history and physical examination, 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 past 3 months). * Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances. * Thrombocytopenia or bleeding disorder, contraindicating IM vaccination based on the Investigator's judgment. * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily. * Current alcohol abuse or drug addiction that in the opinion of the Investigator might interfere with the study conduct or completion. * Chronic illness that, in the opinion of the Investigator, was at a stage where it might interfere with trial conduct or completion (Chronic illness may include, but is not limited to, cardiac disorders, renal disorders, auto-immune disorders, diabetes, psychiatric disorders, or chronic infection). * Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature \>=38.0°C). A prospective participant should not be included in the study until the condition had resolved or the febrile event had subsided. * Personal or family history of Guillain-Barré syndrome. * Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that was stable at the time of vaccination in the absence of therapy and participants who had a history of neoplastic disease and had been disease-free for \>= 5 years). * 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) 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 potential participation in a clinical trial.

Design outcomes

Primary

MeasureTime frameDescription
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 1- Per Protocol Analysis Set (PPAS)Day 1 (pre-vaccination)GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Titers were expressed in terms of 1/dilution.
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 1- Full Analysis Set (FAS)Day 1 (pre-vaccination)GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Titers were expressed in terms of 1/dilution.
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 29- PPASDay 29 (post-vaccination)GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Titers were expressed in terms of 1/dilution.
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 29- FASDay 29 (post-vaccination)GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Titers were expressed in terms of 1/dilution.
Geometric Mean Fold-rise (GMFR) for Influenza Vaccine Antibodies-PPASDay 1 (pre-vaccination) and Day 29 (post-vaccination)GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. GMFR were calculated as the ratio of GMTs post-vaccination (on Day 29) and pre-vaccination (on Day 1).
Geometric Mean Fold-rise (GMFR) for Influenza Vaccine Antibodies-FASDay 1 (pre-vaccination) and Day 29 (post-vaccination)GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. GMFR were calculated as the ratio of GMTs post-vaccination (on Day 29) and pre-vaccination (on Day 1).
Percentage of Participants Achieving Seroconversion Against Influenza Vaccine Antibodies-PPASDay 29 (post-vaccination)Anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Seroconversion was defined as either a pre-vaccination titer less than (\<) 1:10 (1/dilution) and a post-vaccination titer \>=1:40 (1/dilution) or a pre-vaccination titer \>= 1:10 (1/dilution) and a \>= four-fold increase in post-vaccination titer at Day 29.
Percentage of Participants Achieving Seroconversion Against Influenza Vaccine Antibodies-FASDay 29 (post-vaccination)Anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Seroconversion was defined as either a pre-vaccination titer less than (\<) 1:10 (1/dilution) and a post-vaccination titer \>=1:40 (1/dilution) or a pre-vaccination titer \>= 1:10 (1/dilution) and a \>= four-fold increase in post-vaccination titer at Day 29.
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 40 (1/Dilution) Against Influenza Vaccine Antibodies-PPASDay 1 (pre-vaccination) and Day 29 (post-vaccination)Antibody titers were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Percentage of participants with antibody titers \>=40 (1/dilution) against influenza vaccine antibodies at Day 1 and Day 29 were reported in this outcome measure.
Percentage of Participants With Antibody Titers >=40 (1/Dilution) Against Influenza Vaccine Antibodies-FASDay 1 (pre-vaccination) and Day 29 (post-vaccination)Antibody titers were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Percentage of participants with antibody titers \>=40 (1/dilution) against influenza vaccine antibodies at Day 1 and Day 29 were reported in this outcome measure.
Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- PPASDay 1 (pre-vaccination) and Day 29 (post-vaccination)Antibody titers were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Percentage of participants with antibody titers \>=10 (1/dilution) against influenza vaccine antibodies at Day 1 and Day 29 were reported in this outcome measure.
Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- FASDay 1 (pre-vaccination) and Day 29 (post-vaccination)Antibody titers were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Percentage of participants with antibody titers \>=10 (1/dilution) against influenza vaccine antibodies at Day 1 and Day 29 were reported in this outcome measure.
Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs)Within 30 minutes post-vaccinationAn AE was any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which did not had any casual relationship with the treatment. 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/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRF.
Number of Participants Reporting Solicited Systemic ReactionsWithin 7 days post-vaccinationA solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRF and considered as related to the study intervention administered. Solicited systemic reactions included fever, headache, malaise, myalgia, shivering, fatigue, nausea, and arthralgia.
Number of Participants Reporting Solicited Injection Site ReactionsWithin 7 days post-vaccinationA solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRF and considered as related to the study intervention administered. Solicited injection site reactions included pain, erythema, swelling, induration, bruising and tenderness.
Number of Participants Reporting Unsolicited Adverse Events (AEs)From Day 1 up to 28 days post-vaccination (i.e., up to Day 29)An AE was any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which did not had any casual relationship with the treatment. 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.
Number of Participants Reporting Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI)From Day 1 up to 6 months post-vaccination (i.e., up to Day 181)A 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. A SAE which caused death of the participant was considered as fatal SAE. An AESIs were defined as one of scientific and medical concern specific to the Sponsor's study intervention, events for which ongoing monitoring and rapid communication by the investigator to the sponsor was done.

Countries

South Korea

Participant flow

Recruitment details

The study was conducted at 3 active sites in South Korea from 07 December 2021 to 01 September 2022.

Pre-assignment details

A total of 301 participants were enrolled and randomized in the study.

Participants by arm

ArmCount
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)
Participants received a single IM injection of 0.5 mL RIV4 on Day 1.
150
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)
Participants received a single IM injection of 0.5 mL IIV4 on Day 1.
151
Total301

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrawal by Subject10

Baseline characteristics

CharacteristicGroup 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Total
Age, Continuous46.2 years
STANDARD_DEVIATION 11.9
46.1 years
STANDARD_DEVIATION 12.6
46.1 years
STANDARD_DEVIATION 12.2
Race and Ethnicity Not Collected——0 Participants
Sex: Female, Male
Female
95 Participants89 Participants184 Participants
Sex: Female, Male
Male
55 Participants62 Participants117 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1490 / 151
other
Total, other adverse events
96 / 149100 / 151
serious
Total, serious adverse events
0 / 1490 / 151

Outcome results

Primary

Geometric Mean Fold-rise (GMFR) for Influenza Vaccine Antibodies-FAS

GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. GMFR were calculated as the ratio of GMTs post-vaccination (on Day 29) and pre-vaccination (on Day 1).

Time frame: Day 1 (pre-vaccination) and Day 29 (post-vaccination)

Population: Analysis was performed on FAS population.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Geometric Mean Fold-rise (GMFR) for Influenza Vaccine Antibodies-FASB/Victoria6.14 ratio
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Geometric Mean Fold-rise (GMFR) for Influenza Vaccine Antibodies-FASA/H3N213.2 ratio
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Geometric Mean Fold-rise (GMFR) for Influenza Vaccine Antibodies-FASB/Yamagata5.31 ratio
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Geometric Mean Fold-rise (GMFR) for Influenza Vaccine Antibodies-FASA/H1N132.0 ratio
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Geometric Mean Fold-rise (GMFR) for Influenza Vaccine Antibodies-FASB/Yamagata3.47 ratio
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Geometric Mean Fold-rise (GMFR) for Influenza Vaccine Antibodies-FASB/Victoria4.74 ratio
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Geometric Mean Fold-rise (GMFR) for Influenza Vaccine Antibodies-FASA/H1N122.3 ratio
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Geometric Mean Fold-rise (GMFR) for Influenza Vaccine Antibodies-FASA/H3N28.04 ratio
Primary

Geometric Mean Fold-rise (GMFR) for Influenza Vaccine Antibodies-PPAS

GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. GMFR were calculated as the ratio of GMTs post-vaccination (on Day 29) and pre-vaccination (on Day 1).

Time frame: Day 1 (pre-vaccination) and Day 29 (post-vaccination)

Population: Analysis was performed on PPAS population.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Geometric Mean Fold-rise (GMFR) for Influenza Vaccine Antibodies-PPASB/Victoria5.95 ratio
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Geometric Mean Fold-rise (GMFR) for Influenza Vaccine Antibodies-PPASB/Yamagata5.35 ratio
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Geometric Mean Fold-rise (GMFR) for Influenza Vaccine Antibodies-PPASA/H1N131.2 ratio
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Geometric Mean Fold-rise (GMFR) for Influenza Vaccine Antibodies-PPASA/H3N212.8 ratio
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Geometric Mean Fold-rise (GMFR) for Influenza Vaccine Antibodies-PPASA/H3N27.96 ratio
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Geometric Mean Fold-rise (GMFR) for Influenza Vaccine Antibodies-PPASB/Victoria4.70 ratio
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Geometric Mean Fold-rise (GMFR) for Influenza Vaccine Antibodies-PPASA/H1N122.3 ratio
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Geometric Mean Fold-rise (GMFR) for Influenza Vaccine Antibodies-PPASB/Yamagata3.42 ratio
Primary

Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 1- Full Analysis Set (FAS)

GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Titers were expressed in terms of 1/dilution.

Time frame: Day 1 (pre-vaccination)

Population: Analysis was performed on FAS population that included all randomized participants who received a dose of the study vaccine and had a post-vaccination blood sample. Participants were analyzed according to the intervention to which they were randomized.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 1- Full Analysis Set (FAS)A/H1N129.8 titers
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 1- Full Analysis Set (FAS)A/H3N249.3 titers
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 1- Full Analysis Set (FAS)B/Victoria104 titers
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 1- Full Analysis Set (FAS)B/Yamagata239 titers
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 1- Full Analysis Set (FAS)B/Yamagata259 titers
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 1- Full Analysis Set (FAS)A/H1N138.7 titers
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 1- Full Analysis Set (FAS)B/Victoria103 titers
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 1- Full Analysis Set (FAS)A/H3N247.2 titers
Primary

Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 1- Per Protocol Analysis Set (PPAS)

GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Titers were expressed in terms of 1/dilution.

Time frame: Day 1 (pre-vaccination)

Population: Analysis was performed on PPAS population that included all randomized participants who received a dose of the study vaccine and had a post-vaccination blood sample. Participants with protocol deviations were excluded from the PPAS.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 1- Per Protocol Analysis Set (PPAS)A/H1N130.8 titers
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 1- Per Protocol Analysis Set (PPAS)A/H3N250.1 titers
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 1- Per Protocol Analysis Set (PPAS)B/Victoria109 titers
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 1- Per Protocol Analysis Set (PPAS)B/Yamagata237 titers
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 1- Per Protocol Analysis Set (PPAS)B/Yamagata262 titers
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 1- Per Protocol Analysis Set (PPAS)A/H1N138.9 titers
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 1- Per Protocol Analysis Set (PPAS)B/Victoria104 titers
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 1- Per Protocol Analysis Set (PPAS)A/H3N247.5 titers
Primary

Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 29- FAS

GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Titers were expressed in terms of 1/dilution.

Time frame: Day 29 (post-vaccination)

Population: Analysis was performed on FAS population.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 29- FASA/H1N1955 titers
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 29- FASA/H3N2649 titers
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 29- FASB/Victoria640 titers
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 29- FASB/Yamagata1268 titers
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 29- FASB/Yamagata899 titers
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 29- FASA/H1N1863 titers
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 29- FASB/Victoria486 titers
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 29- FASA/H3N2379 titers
Primary

Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 29- PPAS

GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Titers were expressed in terms of 1/dilution.

Time frame: Day 29 (post-vaccination)

Population: Analysis was performed on PPAS population.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 29- PPASA/H3N2643 titers
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 29- PPASB/Yamagata1268 titers
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 29- PPASB/Victoria646 titers
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 29- PPASA/H1N1961 titers
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 29- PPASB/Victoria490 titers
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 29- PPASA/H3N2378 titers
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 29- PPASA/H1N1868 titers
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 29- PPASB/Yamagata897 titers
Primary

Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs)

An AE was any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which did not had any casual relationship with the treatment. 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/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRF.

Time frame: Within 30 minutes post-vaccination

Population: Analysis was performed on safety analysis set that included participants who had received a dose of the study vaccine and were analyzed according to the vaccine they actually received.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs)0 Participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs)0 Participants
Primary

Number of Participants Reporting Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI)

A 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. A SAE which caused death of the participant was considered as fatal SAE. An AESIs were defined as one of scientific and medical concern specific to the Sponsor's study intervention, events for which ongoing monitoring and rapid communication by the investigator to the sponsor was done.

Time frame: From Day 1 up to 6 months post-vaccination (i.e., up to Day 181)

Population: Analysis was performed on safety analysis set.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Number of Participants Reporting Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI)SAE0 Participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Number of Participants Reporting Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI)AESI0 Participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Number of Participants Reporting Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI)SAE0 Participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Number of Participants Reporting Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI)AESI0 Participants
Primary

Number of Participants Reporting Solicited Injection Site Reactions

A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRF and considered as related to the study intervention administered. Solicited injection site reactions included pain, erythema, swelling, induration, bruising and tenderness.

Time frame: Within 7 days post-vaccination

Population: Analysis was performed on safety analysis set.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Number of Participants Reporting Solicited Injection Site ReactionsErythema1 Participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Number of Participants Reporting Solicited Injection Site ReactionsPain77 Participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Number of Participants Reporting Solicited Injection Site ReactionsBruising0 Participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Number of Participants Reporting Solicited Injection Site ReactionsSwelling2 Participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Number of Participants Reporting Solicited Injection Site ReactionsTenderness34 Participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Number of Participants Reporting Solicited Injection Site ReactionsInduration1 Participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Number of Participants Reporting Solicited Injection Site ReactionsTenderness21 Participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Number of Participants Reporting Solicited Injection Site ReactionsPain83 Participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Number of Participants Reporting Solicited Injection Site ReactionsErythema0 Participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Number of Participants Reporting Solicited Injection Site ReactionsSwelling2 Participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Number of Participants Reporting Solicited Injection Site ReactionsInduration1 Participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Number of Participants Reporting Solicited Injection Site ReactionsBruising0 Participants
Primary

Number of Participants Reporting Solicited Systemic Reactions

A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRF and considered as related to the study intervention administered. Solicited systemic reactions included fever, headache, malaise, myalgia, shivering, fatigue, nausea, and arthralgia.

Time frame: Within 7 days post-vaccination

Population: Analysis was performed on safety analysis set.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Number of Participants Reporting Solicited Systemic ReactionsFever1 Participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Number of Participants Reporting Solicited Systemic ReactionsShivering14 Participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Number of Participants Reporting Solicited Systemic ReactionsMalaise50 Participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Number of Participants Reporting Solicited Systemic ReactionsFatigue35 Participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Number of Participants Reporting Solicited Systemic ReactionsNausea7 Participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Number of Participants Reporting Solicited Systemic ReactionsMyalgia64 Participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Number of Participants Reporting Solicited Systemic ReactionsArthralgia12 Participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Number of Participants Reporting Solicited Systemic ReactionsHeadache21 Participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Number of Participants Reporting Solicited Systemic ReactionsArthralgia16 Participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Number of Participants Reporting Solicited Systemic ReactionsFever0 Participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Number of Participants Reporting Solicited Systemic ReactionsHeadache38 Participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Number of Participants Reporting Solicited Systemic ReactionsMalaise49 Participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Number of Participants Reporting Solicited Systemic ReactionsMyalgia64 Participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Number of Participants Reporting Solicited Systemic ReactionsShivering16 Participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Number of Participants Reporting Solicited Systemic ReactionsFatigue40 Participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Number of Participants Reporting Solicited Systemic ReactionsNausea6 Participants
Primary

Number of Participants Reporting Unsolicited Adverse Events (AEs)

An AE was any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which did not had any casual relationship with the treatment. 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.

Time frame: From Day 1 up to 28 days post-vaccination (i.e., up to Day 29)

Population: Analysis was performed on safety analysis set.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Number of Participants Reporting Unsolicited Adverse Events (AEs)16 Participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Number of Participants Reporting Unsolicited Adverse Events (AEs)13 Participants
Primary

Percentage of Participants Achieving Seroconversion Against Influenza Vaccine Antibodies-FAS

Anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Seroconversion was defined as either a pre-vaccination titer less than (\<) 1:10 (1/dilution) and a post-vaccination titer \>=1:40 (1/dilution) or a pre-vaccination titer \>= 1:10 (1/dilution) and a \>= four-fold increase in post-vaccination titer at Day 29.

Time frame: Day 29 (post-vaccination)

Population: Analysis was performed on FAS population. Here, 'number analyzed' = participants with available data for each specified category.

ArmMeasureGroupValue (NUMBER)
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Percentage of Participants Achieving Seroconversion Against Influenza Vaccine Antibodies-FASB/Victoria73.8 percentage of participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Percentage of Participants Achieving Seroconversion Against Influenza Vaccine Antibodies-FASA/H3N290.6 percentage of participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Percentage of Participants Achieving Seroconversion Against Influenza Vaccine Antibodies-FASB/Yamagata67.8 percentage of participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Percentage of Participants Achieving Seroconversion Against Influenza Vaccine Antibodies-FASA/H1N196.0 percentage of participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Percentage of Participants Achieving Seroconversion Against Influenza Vaccine Antibodies-FASB/Yamagata47.7 percentage of participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Percentage of Participants Achieving Seroconversion Against Influenza Vaccine Antibodies-FASA/H3N274.8 percentage of participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Percentage of Participants Achieving Seroconversion Against Influenza Vaccine Antibodies-FASB/Victoria56.3 percentage of participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Percentage of Participants Achieving Seroconversion Against Influenza Vaccine Antibodies-FASA/H1N192.1 percentage of participants
Primary

Percentage of Participants Achieving Seroconversion Against Influenza Vaccine Antibodies-PPAS

Anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Seroconversion was defined as either a pre-vaccination titer less than (\<) 1:10 (1/dilution) and a post-vaccination titer \>=1:40 (1/dilution) or a pre-vaccination titer \>= 1:10 (1/dilution) and a \>= four-fold increase in post-vaccination titer at Day 29.

Time frame: Day 29 (post-vaccination)

Population: Analysis was performed on PPAS population. Here, 'number analyzed' = participants with available data for each specified category.

ArmMeasureGroupValue (NUMBER)
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Percentage of Participants Achieving Seroconversion Against Influenza Vaccine Antibodies-PPASA/H1N195.9 percentage of participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Percentage of Participants Achieving Seroconversion Against Influenza Vaccine Antibodies-PPASA/H3N290.3 percentage of participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Percentage of Participants Achieving Seroconversion Against Influenza Vaccine Antibodies-PPASB/Victoria73.1 percentage of participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Percentage of Participants Achieving Seroconversion Against Influenza Vaccine Antibodies-PPASB/Yamagata69.0 percentage of participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Percentage of Participants Achieving Seroconversion Against Influenza Vaccine Antibodies-PPASB/Yamagata47.3 percentage of participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Percentage of Participants Achieving Seroconversion Against Influenza Vaccine Antibodies-PPASA/H1N192.0 percentage of participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Percentage of Participants Achieving Seroconversion Against Influenza Vaccine Antibodies-PPASB/Victoria56.0 percentage of participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Percentage of Participants Achieving Seroconversion Against Influenza Vaccine Antibodies-PPASA/H3N274.7 percentage of participants
Primary

Percentage of Participants With Antibody Titers >=40 (1/Dilution) Against Influenza Vaccine Antibodies-FAS

Antibody titers were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Percentage of participants with antibody titers \>=40 (1/dilution) against influenza vaccine antibodies at Day 1 and Day 29 were reported in this outcome measure.

Time frame: Day 1 (pre-vaccination) and Day 29 (post-vaccination)

Population: Analysis was performed on FAS population. Here, 'number analyzed' = participants with available data for each specified category.

ArmMeasureGroupValue (NUMBER)
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Percentage of Participants With Antibody Titers >=40 (1/Dilution) Against Influenza Vaccine Antibodies-FASA/H3N2: Day 2999.3 percentage of participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Percentage of Participants With Antibody Titers >=40 (1/Dilution) Against Influenza Vaccine Antibodies-FASA/H1N1: Day 2998.7 percentage of participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Percentage of Participants With Antibody Titers >=40 (1/Dilution) Against Influenza Vaccine Antibodies-FASA/H3N2: Day 169.1 percentage of participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Percentage of Participants With Antibody Titers >=40 (1/Dilution) Against Influenza Vaccine Antibodies-FASA/H1N1: Day 151.0 percentage of participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Percentage of Participants With Antibody Titers >=40 (1/Dilution) Against Influenza Vaccine Antibodies-FASB/Victoria: Day 2999.3 percentage of participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Percentage of Participants With Antibody Titers >=40 (1/Dilution) Against Influenza Vaccine Antibodies-FASB/Yamagata: Day 189.9 percentage of participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Percentage of Participants With Antibody Titers >=40 (1/Dilution) Against Influenza Vaccine Antibodies-FASB/Yamagata: Day 29100 percentage of participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Percentage of Participants With Antibody Titers >=40 (1/Dilution) Against Influenza Vaccine Antibodies-FASB/Victoria: Day 181.9 percentage of participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Percentage of Participants With Antibody Titers >=40 (1/Dilution) Against Influenza Vaccine Antibodies-FASB/Yamagata: Day 29100 percentage of participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Percentage of Participants With Antibody Titers >=40 (1/Dilution) Against Influenza Vaccine Antibodies-FASB/Victoria: Day 182.1 percentage of participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Percentage of Participants With Antibody Titers >=40 (1/Dilution) Against Influenza Vaccine Antibodies-FASA/H1N1: Day 157.6 percentage of participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Percentage of Participants With Antibody Titers >=40 (1/Dilution) Against Influenza Vaccine Antibodies-FASA/H3N2: Day 164.9 percentage of participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Percentage of Participants With Antibody Titers >=40 (1/Dilution) Against Influenza Vaccine Antibodies-FASB/Yamagata: Day 194.7 percentage of participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Percentage of Participants With Antibody Titers >=40 (1/Dilution) Against Influenza Vaccine Antibodies-FASA/H1N1: Day 2999.3 percentage of participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Percentage of Participants With Antibody Titers >=40 (1/Dilution) Against Influenza Vaccine Antibodies-FASA/H3N2: Day 2999.3 percentage of participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Percentage of Participants With Antibody Titers >=40 (1/Dilution) Against Influenza Vaccine Antibodies-FASB/Victoria: Day 29100 percentage of participants
Primary

Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 40 (1/Dilution) Against Influenza Vaccine Antibodies-PPAS

Antibody titers were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Percentage of participants with antibody titers \>=40 (1/dilution) against influenza vaccine antibodies at Day 1 and Day 29 were reported in this outcome measure.

Time frame: Day 1 (pre-vaccination) and Day 29 (post-vaccination)

Population: Analysis was performed on PPAS population. Here, 'number analyzed' = participants with available data for each specified category.

ArmMeasureGroupValue (NUMBER)
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 40 (1/Dilution) Against Influenza Vaccine Antibodies-PPASB/Yamagata: Day 29100 percentage of participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 40 (1/Dilution) Against Influenza Vaccine Antibodies-PPASB/Yamagata: Day 189.7 percentage of participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 40 (1/Dilution) Against Influenza Vaccine Antibodies-PPASA/H3N2: Day 169.7 percentage of participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 40 (1/Dilution) Against Influenza Vaccine Antibodies-PPASA/H1N1: Day 151.7 percentage of participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 40 (1/Dilution) Against Influenza Vaccine Antibodies-PPASA/H3N2: Day 2999.3 percentage of participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 40 (1/Dilution) Against Influenza Vaccine Antibodies-PPASB/Victoria: Day 182.8 percentage of participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 40 (1/Dilution) Against Influenza Vaccine Antibodies-PPASB/Victoria: Day 2999.3 percentage of participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 40 (1/Dilution) Against Influenza Vaccine Antibodies-PPASA/H1N1: Day 2998.6 percentage of participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 40 (1/Dilution) Against Influenza Vaccine Antibodies-PPASB/Victoria: Day 29100 percentage of participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 40 (1/Dilution) Against Influenza Vaccine Antibodies-PPASB/Yamagata: Day 29100 percentage of participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 40 (1/Dilution) Against Influenza Vaccine Antibodies-PPASA/H1N1: Day 158.0 percentage of participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 40 (1/Dilution) Against Influenza Vaccine Antibodies-PPASA/H3N2: Day 165.3 percentage of participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 40 (1/Dilution) Against Influenza Vaccine Antibodies-PPASB/Victoria: Day 182.7 percentage of participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 40 (1/Dilution) Against Influenza Vaccine Antibodies-PPASB/Yamagata: Day 194.7 percentage of participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 40 (1/Dilution) Against Influenza Vaccine Antibodies-PPASA/H1N1: Day 2999.3 percentage of participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 40 (1/Dilution) Against Influenza Vaccine Antibodies-PPASA/H3N2: Day 2999.3 percentage of participants
Primary

Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- FAS

Antibody titers were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Percentage of participants with antibody titers \>=10 (1/dilution) against influenza vaccine antibodies at Day 1 and Day 29 were reported in this outcome measure.

Time frame: Day 1 (pre-vaccination) and Day 29 (post-vaccination)

Population: Analysis was performed on FAS population. Here, 'number analyzed' = participants with available data for each specified category.

ArmMeasureGroupValue (NUMBER)
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- FASA/H1N1: Day 29100 percentage of participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- FASA/H1N1: Day 181.2 percentage of participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- FASA/H3N2: Day 29100 percentage of participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- FASB/Victoria: Day 196.0 percentage of participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- FASB/Victoria: Day 29100 percentage of participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- FASA/H3N2: Day 190.6 percentage of participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- FASB/Yamagata: Day 29100 percentage of participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- FASB/Yamagata: Day 196.6 percentage of participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- FASB/Yamagata: Day 29100 percentage of participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- FASA/H1N1: Day 190.1 percentage of participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- FASA/H3N2: Day 193.4 percentage of participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- FASB/Victoria: Day 196.0 percentage of participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- FASA/H1N1: Day 29100 percentage of participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- FASA/H3N2: Day 29100 percentage of participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- FASB/Victoria: Day 29100 percentage of participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- FASB/Yamagata: Day 199.3 percentage of participants
Primary

Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- PPAS

Antibody titers were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Percentage of participants with antibody titers \>=10 (1/dilution) against influenza vaccine antibodies at Day 1 and Day 29 were reported in this outcome measure.

Time frame: Day 1 (pre-vaccination) and Day 29 (post-vaccination)

Population: Analysis was performed on PPAS population. Here, 'number analyzed' = participants with available data for each specified category.

ArmMeasureGroupValue (NUMBER)
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- PPASA/H1N1: Day 182.1 percentage of participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- PPASA/H3N2: Day 191.0 percentage of participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- PPASB/Victoria: Day 196.6 percentage of participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- PPASB/Yamagata: Day 196.6 percentage of participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- PPASA/H1N1: Day 29100 percentage of participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- PPASA/H3N2: Day 29100 percentage of participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- PPASB/Victoria: Day 29100 percentage of participants
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- PPASB/Yamagata: Day 29100 percentage of participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- PPASB/Yamagata: Day 29100 percentage of participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- PPASA/H1N1: Day 190.0 percentage of participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- PPASA/H1N1: Day 29100 percentage of participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- PPASA/H3N2: Day 193.3 percentage of participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- PPASB/Victoria: Day 29100 percentage of participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- PPASB/Victoria: Day 196.0 percentage of participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- PPASA/H3N2: Day 29100 percentage of participants
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- PPASB/Yamagata: Day 199.3 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026