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Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) in Participants 9 Through 49 Years of Age.

Immunogenicity and Safety of Quadrivalent Recombinant Influenza Vaccine (RIV4) in Children and Adolescents Aged 9 to 17 Years and Adults Aged 18 to 49 Years.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05513053
Enrollment
1308
Registered
2022-08-23
Start date
2022-10-27
Completion date
2023-10-27
Last updated
2025-09-09

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

Conditions

Influenza Immunization

Brief summary

The purpose of this study was to demonstrate the non-inferiority (NI) of the HAI immune response of RIV4 in participants aged 9 to 17 years vs participants aged 18 to 49 years and to describe the immunogenicity and safety profile of RIV4 in all participants.

Detailed description

The participation duration was approximately 6 months for each participant.

Interventions

BIOLOGICALQuadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NH

Pharmaceutical form: Solution for injection Route of administration: intramuscular

Sponsors

Sanofi Pasteur, a Sanofi Company
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
9 Years to 49 Years
Healthy volunteers
Yes

Inclusion criteria

* Aged 9 to 49 years on the day of inclusion * A female participant was eligible to participate if she was not pregnant or breastfeeding and one of the following conditions applies: 1) was of non-childbearing potential. To be considered of non-childbearing potential, a female should have been pre-menarche, post-menopausal for at least 1 year, or surgically sterile OR 2) was of childbearing potential and agreed to use an effective contraceptive method or abstinence from at least 4 weeks prior to the first study intervention administration until at least 4 weeks after the last study intervention administration * Assent form or informed consent form had been signed and dated by the participant (based on local regulations), and if applicable informed consent form had been signed and dated by the parent(s) or another legally acceptable representative

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 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 trial or to a vaccine containing any of the same substances * Thrombocytopenia * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination based on the Investigator's judgment * Personal or family history of Guillain-Barre Syndrome (GBS) * Personal history of clinically significant development delay (at the discretion of the Investigator), neurologic disorder, or seizure disorder NOTE: The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Design outcomes

Primary

MeasureTime frameDescription
Geometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29Day 29GMTs of anti-influenza antibodies were measured using individual hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages.
Percentage of Participants With Seroconversion for Influenza Vaccine Antibodies at Day 29Day 29Anti-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) at Day 1 and a post-vaccination titer greater than or equal to (\>=) 1: 40 (1/dilution) at Day 29 or a pre-vaccination titer \>= 1:10 at Day 1 and a \>= 4-fold increase in post-vaccination titer.

Secondary

MeasureTime frameDescription
Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine AntibodiesOn Days 1 and 29GMTR was the ratio of the individual titers post-vaccination over pre-vaccination. The GMTs were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages.
Number of Participants With Immediate Unsolicited Adverse Events (AEs)Within 30 minutes post-vaccination on Day 1An AE was any untoward medical occurrence in a clinical investigation 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 of solicited reactions, that is, prelisted in the 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.
Number of Participants With Solicited Injection Site Reactions and Systemic ReactionsFrom Day 1 up to 7 days post-vaccination (up to Day 8)A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted in the protocol and CRF and considered as related to the study intervention administered. An injection site reaction was an AR at and around the injection site and were commonly inflammatory reactions. Solicited systemic reactions were systemic AEs and those occurring during the specified collection period were always considered related to the intervention even if there was evidence of alternative etiology.
GMTs Against Influenza Vaccine Antibodies at Day 1Pre-vaccination on Day 1GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages.
Number of Participants With Medically Attended Adverse Events (MAAEs)From Day 1 up to 28 days post-vaccination (up to Day 29)An MAAE was a new onset or a worsening of a condition that prompted the participant or participant's parent/guardian to seek unplanned medical advice at a physician's office or emergency department.
Number of Participants With Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI)From Day 1 up to 6 months post-vaccination, 181 daysAn 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. An AESI was 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.
Number of Participants With Unsolicited AEsFrom Day 1 up to 28 days post-vaccination (up to Day 29)An AE was any untoward medical occurrence in a clinical investigation 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 of solicited reactions, that is, prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination.
Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29On Days 1 and 29Antibody 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 and \>=40 against influenza vaccine antibodies at Day 1 and Day 29 were reported in this outcome measure.

Countries

Czechia, Poland, Spain, United States

Participant flow

Recruitment details

This study was conducted at 36 investigational sites in 4 countries between 27 Oct 2022 to 27 Oct 2023.

Pre-assignment details

A total of 1308 participants were enrolled in this study.

Participants by arm

ArmCount
Cohort 1: Participants Aged 9 to 17 Years
Participants received a single IM injection of RIV4 0.5 mL on Day 1.
648
Cohort 2: Participants Aged 18 to 49 Years
Participants received a single IM injection of RIV4 0.5 mL on Day 1.
660
Total1,308

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAdverse Event02
Overall StudyLost to Follow-up911
Overall StudyProtocol Violation63
Overall StudyWithdrawal by parent/guardian20
Overall StudyWithdrawal by Subject29

Baseline characteristics

CharacteristicCohort 1: Participants Aged 9 to 17 YearsCohort 2: Participants Aged 18 to 49 YearsTotal
Age, Continuous13.0 years
STANDARD_DEVIATION 2.49
34.3 years
STANDARD_DEVIATION 9.21
23.7 years
STANDARD_DEVIATION 12.6
Race/Ethnicity, Customized
American Indian or Alaska Native
5 Participants1 Participants6 Participants
Race/Ethnicity, Customized
Asian
1 Participants6 Participants7 Participants
Race/Ethnicity, Customized
Black or African American
157 Participants98 Participants255 Participants
Race/Ethnicity, Customized
Multiple
16 Participants13 Participants29 Participants
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
1 Participants3 Participants4 Participants
Race/Ethnicity, Customized
Not Reported
0 Participants2 Participants2 Participants
Race/Ethnicity, Customized
Unknown
1 Participants1 Participants2 Participants
Race/Ethnicity, Customized
White
467 Participants536 Participants1003 Participants
Sex: Female, Male
Female
312 Participants395 Participants707 Participants
Sex: Female, Male
Male
336 Participants265 Participants601 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 6410 / 658
other
Total, other adverse events
263 / 641336 / 658
serious
Total, serious adverse events
3 / 6417 / 658

Outcome results

Primary

Geometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29

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

Time frame: Day 29

Population: Analysis was performed on the Per-protocol analysis set (PPAS)-subset of full analysis set (FAS) which included participants who received 1 dose of the study vaccine and had a post-vaccination blood sample.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Cohort 1: Participants Aged 9 to 17 YearsGeometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29A/H1N11946 titer
Cohort 1: Participants Aged 9 to 17 YearsGeometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29A/H3N21975 titer
Cohort 1: Participants Aged 9 to 17 YearsGeometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29B/Victoria405 titer
Cohort 1: Participants Aged 9 to 17 YearsGeometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29B/Yamagata1941 titer
Cohort 2: Participants Aged 18 to 49 YearsGeometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29B/Yamagata1593 titer
Cohort 2: Participants Aged 18 to 49 YearsGeometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29A/H1N1982 titer
Cohort 2: Participants Aged 18 to 49 YearsGeometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29B/Victoria258 titer
Cohort 2: Participants Aged 18 to 49 YearsGeometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29A/H3N2604 titer
Comparison: Statistical analysis for A/H1N195% CI: [1.73, 2.27]
Comparison: Statistical analysis for A/H3N295% CI: [2.76, 3.87]
Comparison: Statistical analysis for B/Victoria95% CI: [1.35, 1.82]
Comparison: Statistical analysis for B/Yamagata95% CI: [1.09, 1.37]
Primary

Percentage of Participants With Seroconversion for Influenza Vaccine Antibodies at Day 29

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) at Day 1 and a post-vaccination titer greater than or equal to (\>=) 1: 40 (1/dilution) at Day 29 or a pre-vaccination titer \>= 1:10 at Day 1 and a \>= 4-fold increase in post-vaccination titer.

Time frame: Day 29

Population: Analysis was performed on the PPAS-subset of FAS which included participants who received 1 dose of the study vaccine and had a post-vaccination blood sample. Only participants with data collected for each category at Day 29 are reported.

ArmMeasureGroupValue (NUMBER)
Cohort 1: Participants Aged 9 to 17 YearsPercentage of Participants With Seroconversion for Influenza Vaccine Antibodies at Day 29A/H1N178.3 percentage of participants
Cohort 1: Participants Aged 9 to 17 YearsPercentage of Participants With Seroconversion for Influenza Vaccine Antibodies at Day 29A/H3N286.5 percentage of participants
Cohort 1: Participants Aged 9 to 17 YearsPercentage of Participants With Seroconversion for Influenza Vaccine Antibodies at Day 29B/Victoria76.8 percentage of participants
Cohort 1: Participants Aged 9 to 17 YearsPercentage of Participants With Seroconversion for Influenza Vaccine Antibodies at Day 29B/Yamagata77.2 percentage of participants
Cohort 2: Participants Aged 18 to 49 YearsPercentage of Participants With Seroconversion for Influenza Vaccine Antibodies at Day 29B/Yamagata62.9 percentage of participants
Cohort 2: Participants Aged 18 to 49 YearsPercentage of Participants With Seroconversion for Influenza Vaccine Antibodies at Day 29A/H1N176.4 percentage of participants
Cohort 2: Participants Aged 18 to 49 YearsPercentage of Participants With Seroconversion for Influenza Vaccine Antibodies at Day 29B/Victoria73.6 percentage of participants
Cohort 2: Participants Aged 18 to 49 YearsPercentage of Participants With Seroconversion for Influenza Vaccine Antibodies at Day 29A/H3N287.1 percentage of participants
Comparison: Statistical analysis for A/H1N195% CI: [-2.78, 6.62]
Comparison: Statistical analysis for A/H3N295% CI: [-4.41, 3.23]
Comparison: Statistical analysis for B/Victoria95% CI: [-1.57, 8.14]
Comparison: Statistical analysis for B/Yamagata95% CI: [9.17, 19.3]
Secondary

Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies

GMTR was the ratio of the individual titers post-vaccination over pre-vaccination. The GMTs were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages.

Time frame: On Days 1 and 29

Population: Analysis was performed on the PPAS-subset of FAS which included participants who received 1 dose of the study vaccine and had a post-vaccination blood sample. Only participants with data collected for each category on Days 1 and Day 29 are reported.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Cohort 1: Participants Aged 9 to 17 YearsGeometric Mean Titer Ratio (GMTR) of Influenza Vaccine AntibodiesA/H1N112.7 ratio
Cohort 1: Participants Aged 9 to 17 YearsGeometric Mean Titer Ratio (GMTR) of Influenza Vaccine AntibodiesA/H3N217.9 ratio
Cohort 1: Participants Aged 9 to 17 YearsGeometric Mean Titer Ratio (GMTR) of Influenza Vaccine AntibodiesB/Victoria8.41 ratio
Cohort 1: Participants Aged 9 to 17 YearsGeometric Mean Titer Ratio (GMTR) of Influenza Vaccine AntibodiesB/Yamagata7.13 ratio
Cohort 2: Participants Aged 18 to 49 YearsGeometric Mean Titer Ratio (GMTR) of Influenza Vaccine AntibodiesB/Yamagata5.31 ratio
Cohort 2: Participants Aged 18 to 49 YearsGeometric Mean Titer Ratio (GMTR) of Influenza Vaccine AntibodiesA/H1N113.1 ratio
Cohort 2: Participants Aged 18 to 49 YearsGeometric Mean Titer Ratio (GMTR) of Influenza Vaccine AntibodiesB/Victoria6.91 ratio
Cohort 2: Participants Aged 18 to 49 YearsGeometric Mean Titer Ratio (GMTR) of Influenza Vaccine AntibodiesA/H3N220.8 ratio
Secondary

GMTs Against Influenza Vaccine Antibodies at Day 1

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.

Time frame: Pre-vaccination on Day 1

Population: Analysis was performed on the PPAS-subset of FAS which included participants who received 1 dose of the study vaccine and had a post-vaccination blood sample. Only participants with data collected for each category at Day 1 are reported.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Cohort 1: Participants Aged 9 to 17 YearsGMTs Against Influenza Vaccine Antibodies at Day 1B/Yamagata272 titer
Cohort 1: Participants Aged 9 to 17 YearsGMTs Against Influenza Vaccine Antibodies at Day 1A/H3N2111 titer
Cohort 1: Participants Aged 9 to 17 YearsGMTs Against Influenza Vaccine Antibodies at Day 1B/Victoria48.1 titer
Cohort 1: Participants Aged 9 to 17 YearsGMTs Against Influenza Vaccine Antibodies at Day 1A/H1N1154 titer
Cohort 2: Participants Aged 18 to 49 YearsGMTs Against Influenza Vaccine Antibodies at Day 1B/Victoria37.3 titer
Cohort 2: Participants Aged 18 to 49 YearsGMTs Against Influenza Vaccine Antibodies at Day 1A/H3N229.0 titer
Cohort 2: Participants Aged 18 to 49 YearsGMTs Against Influenza Vaccine Antibodies at Day 1B/Yamagata300 titer
Cohort 2: Participants Aged 18 to 49 YearsGMTs Against Influenza Vaccine Antibodies at Day 1A/H1N174.9 titer
Secondary

Number of Participants With Immediate Unsolicited Adverse Events (AEs)

An AE was any untoward medical occurrence in a clinical investigation 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 of solicited reactions, that is, prelisted in the 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.

Time frame: Within 30 minutes post-vaccination on Day 1

Population: Analysis was performed on the Safety analysis set which included participants who received 1 dose of the study vaccine.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Cohort 1: Participants Aged 9 to 17 YearsNumber of Participants With Immediate Unsolicited Adverse Events (AEs)1 Participants
Cohort 2: Participants Aged 18 to 49 YearsNumber of Participants With Immediate Unsolicited Adverse Events (AEs)0 Participants
Secondary

Number of Participants With Medically Attended Adverse Events (MAAEs)

An MAAE was a new onset or a worsening of a condition that prompted the participant or participant's parent/guardian to seek unplanned medical advice at a physician's office or emergency department.

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

Population: Analysis was performed on the Safety analysis set which included participants who received 1 dose of the study vaccine.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Cohort 1: Participants Aged 9 to 17 YearsNumber of Participants With Medically Attended Adverse Events (MAAEs)27 Participants
Cohort 2: Participants Aged 18 to 49 YearsNumber of Participants With Medically Attended Adverse Events (MAAEs)35 Participants
Secondary

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

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. An AESI was 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, 181 days

Population: Analysis was performed on the Safety analysis set which included participants who received 1 dose of the study vaccine.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Cohort 1: Participants Aged 9 to 17 YearsNumber of Participants With Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI)SAE3 Participants
Cohort 1: Participants Aged 9 to 17 YearsNumber of Participants With Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI)AESI0 Participants
Cohort 2: Participants Aged 18 to 49 YearsNumber of Participants With Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI)SAE7 Participants
Cohort 2: Participants Aged 18 to 49 YearsNumber of Participants With Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI)AESI0 Participants
Secondary

Number of Participants With Solicited Injection Site Reactions and Systemic Reactions

A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted in the protocol and CRF and considered as related to the study intervention administered. An injection site reaction was an AR at and around the injection site and were commonly inflammatory reactions. Solicited systemic reactions were systemic AEs and those occurring during the specified collection period were always considered related to the intervention even if there was evidence of alternative etiology.

Time frame: From Day 1 up to 7 days post-vaccination (up to Day 8)

Population: Analysis was performed on the Safety analysis set which included participants who received 1 dose of the study vaccine. Number of participants analyzed signifies those participants with data collected for this outcome measure and number analyzed signifies those participants with data collected for specified category.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Cohort 1: Participants Aged 9 to 17 YearsNumber of Participants With Solicited Injection Site Reactions and Systemic ReactionsSolicited injection site reaction220 Participants
Cohort 1: Participants Aged 9 to 17 YearsNumber of Participants With Solicited Injection Site Reactions and Systemic ReactionsSolicited systemic reaction182 Participants
Cohort 2: Participants Aged 18 to 49 YearsNumber of Participants With Solicited Injection Site Reactions and Systemic ReactionsSolicited injection site reaction259 Participants
Cohort 2: Participants Aged 18 to 49 YearsNumber of Participants With Solicited Injection Site Reactions and Systemic ReactionsSolicited systemic reaction230 Participants
Secondary

Number of Participants With Unsolicited AEs

An AE was any untoward medical occurrence in a clinical investigation 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 of solicited reactions, that is, 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 (up to Day 29)

Population: Analysis was performed on the Safety analysis set which included participants who received 1 dose of the study vaccine.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Cohort 1: Participants Aged 9 to 17 YearsNumber of Participants With Unsolicited AEs93 Participants
Cohort 2: Participants Aged 18 to 49 YearsNumber of Participants With Unsolicited AEs119 Participants
Secondary

Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29

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 and \>=40 against influenza vaccine antibodies at Day 1 and Day 29 were reported in this outcome measure.

Time frame: On Days 1 and 29

Population: Analysis was performed on the PPAS-subset of FAS which included participants who received 1 dose of the study vaccine and had a post-vaccination blood sample. Only participants with data collected for each category on Days 1 and 29 are reported.

ArmMeasureGroupValue (NUMBER)
Cohort 1: Participants Aged 9 to 17 YearsPercentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29Titer >=10: A/H1N1: Day 29100 percentage of participants
Cohort 1: Participants Aged 9 to 17 YearsPercentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29Titer >=10: B/Victoria: Day 192.1 percentage of participants
Cohort 1: Participants Aged 9 to 17 YearsPercentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29Titer >=10: A/H3N2: Day 189.2 percentage of participants
Cohort 1: Participants Aged 9 to 17 YearsPercentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29Titer >=10: B/Victoria: Day 2999.5 percentage of participants
Cohort 1: Participants Aged 9 to 17 YearsPercentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29Titer >=10: A/H1N1: Day 197.0 percentage of participants
Cohort 1: Participants Aged 9 to 17 YearsPercentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29Titer >=40: B/Victoria: Day 161.4 percentage of participants
Cohort 1: Participants Aged 9 to 17 YearsPercentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29Titer >=10: A/H3N2: Day 29100 percentage of participants
Cohort 1: Participants Aged 9 to 17 YearsPercentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29Titer >=40: B/Victoria: Day 2995.6 percentage of participants
Cohort 1: Participants Aged 9 to 17 YearsPercentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29Titer >=40: A/H1N1: Day 187.2 percentage of participants
Cohort 1: Participants Aged 9 to 17 YearsPercentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29Titer >=40: A/H3N2: Day 174.7 percentage of participants
Cohort 1: Participants Aged 9 to 17 YearsPercentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29Titer >=10: B/Yamagata: Day 29100 percentage of participants
Cohort 1: Participants Aged 9 to 17 YearsPercentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29Titer >=10: B/Yamagata: Day 197.9 percentage of participants
Cohort 1: Participants Aged 9 to 17 YearsPercentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29Titer >=40: B/Yamagata: Day 193.1 percentage of participants
Cohort 1: Participants Aged 9 to 17 YearsPercentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29Titer >=40: A/H3N2: Day 2999.0 percentage of participants
Cohort 1: Participants Aged 9 to 17 YearsPercentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29Titer >=40: B/Yamagata: Day 2999.5 percentage of participants
Cohort 1: Participants Aged 9 to 17 YearsPercentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29Titer >=40: A/H1N1: Day 2999.7 percentage of participants
Cohort 2: Participants Aged 18 to 49 YearsPercentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29Titer >=40: B/Yamagata: Day 29100 percentage of participants
Cohort 2: Participants Aged 18 to 49 YearsPercentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29Titer >=10: A/H1N1: Day 189.8 percentage of participants
Cohort 2: Participants Aged 18 to 49 YearsPercentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29Titer >=10: A/H1N1: Day 2999.3 percentage of participants
Cohort 2: Participants Aged 18 to 49 YearsPercentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29Titer >=40: A/H1N1: Day 171.8 percentage of participants
Cohort 2: Participants Aged 18 to 49 YearsPercentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29Titer >=40: A/H1N1: Day 2997.5 percentage of participants
Cohort 2: Participants Aged 18 to 49 YearsPercentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29Titer >=10: A/H3N2: Day 177.7 percentage of participants
Cohort 2: Participants Aged 18 to 49 YearsPercentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29Titer >=10: A/H3N2: Day 2999.7 percentage of participants
Cohort 2: Participants Aged 18 to 49 YearsPercentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29Titer >=40: A/H3N2: Day 145.0 percentage of participants
Cohort 2: Participants Aged 18 to 49 YearsPercentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29Titer >=40: A/H3N2: Day 2995.0 percentage of participants
Cohort 2: Participants Aged 18 to 49 YearsPercentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29Titer >=10: B/Victoria: Day 191.7 percentage of participants
Cohort 2: Participants Aged 18 to 49 YearsPercentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29Titer >=10: B/Victoria: Day 2999.8 percentage of participants
Cohort 2: Participants Aged 18 to 49 YearsPercentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29Titer >=40: B/Victoria: Day 159.8 percentage of participants
Cohort 2: Participants Aged 18 to 49 YearsPercentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29Titer >=40: B/Victoria: Day 2997.0 percentage of participants
Cohort 2: Participants Aged 18 to 49 YearsPercentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29Titer >=10: B/Yamagata: Day 199.5 percentage of participants
Cohort 2: Participants Aged 18 to 49 YearsPercentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29Titer >=10: B/Yamagata: Day 29100 percentage of participants
Cohort 2: Participants Aged 18 to 49 YearsPercentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29Titer >=40: B/Yamagata: Day 195.2 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026