Influenza Immunization
Conditions
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
Pharmaceutical form: Solution for injection Route of administration: intramuscular
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29 | 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. |
| Percentage of Participants With Seroconversion for Influenza Vaccine Antibodies at Day 29 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies | On Days 1 and 29 | 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. |
| Number of Participants With Immediate Unsolicited Adverse Events (AEs) | Within 30 minutes post-vaccination on Day 1 | 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. |
| Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | From 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 1 | Pre-vaccination on 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. |
| 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 days | 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. |
| Number of Participants With Unsolicited AEs | From 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 29 | On 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. |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 1,308 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 |
| Overall Study | Lost to Follow-up | 9 | 11 |
| Overall Study | Protocol Violation | 6 | 3 |
| Overall Study | Withdrawal by parent/guardian | 2 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 9 |
Baseline characteristics
| Characteristic | Cohort 1: Participants Aged 9 to 17 Years | Cohort 2: Participants Aged 18 to 49 Years | Total |
|---|---|---|---|
| Age, Continuous | 13.0 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 Participants | 1 Participants | 6 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 6 Participants | 7 Participants |
| Race/Ethnicity, Customized Black or African American | 157 Participants | 98 Participants | 255 Participants |
| Race/Ethnicity, Customized Multiple | 16 Participants | 13 Participants | 29 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 467 Participants | 536 Participants | 1003 Participants |
| Sex: Female, Male Female | 312 Participants | 395 Participants | 707 Participants |
| Sex: Female, Male Male | 336 Participants | 265 Participants | 601 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 641 | 0 / 658 |
| other Total, other adverse events | 263 / 641 | 336 / 658 |
| serious Total, serious adverse events | 3 / 641 | 7 / 658 |
Outcome results
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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: Participants Aged 9 to 17 Years | Geometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29 | A/H1N1 | 1946 titer |
| Cohort 1: Participants Aged 9 to 17 Years | Geometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29 | A/H3N2 | 1975 titer |
| Cohort 1: Participants Aged 9 to 17 Years | Geometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29 | B/Victoria | 405 titer |
| Cohort 1: Participants Aged 9 to 17 Years | Geometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29 | B/Yamagata | 1941 titer |
| Cohort 2: Participants Aged 18 to 49 Years | Geometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29 | B/Yamagata | 1593 titer |
| Cohort 2: Participants Aged 18 to 49 Years | Geometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29 | A/H1N1 | 982 titer |
| Cohort 2: Participants Aged 18 to 49 Years | Geometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29 | B/Victoria | 258 titer |
| Cohort 2: Participants Aged 18 to 49 Years | Geometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29 | A/H3N2 | 604 titer |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: Participants Aged 9 to 17 Years | Percentage of Participants With Seroconversion for Influenza Vaccine Antibodies at Day 29 | A/H1N1 | 78.3 percentage of participants |
| Cohort 1: Participants Aged 9 to 17 Years | Percentage of Participants With Seroconversion for Influenza Vaccine Antibodies at Day 29 | A/H3N2 | 86.5 percentage of participants |
| Cohort 1: Participants Aged 9 to 17 Years | Percentage of Participants With Seroconversion for Influenza Vaccine Antibodies at Day 29 | B/Victoria | 76.8 percentage of participants |
| Cohort 1: Participants Aged 9 to 17 Years | Percentage of Participants With Seroconversion for Influenza Vaccine Antibodies at Day 29 | B/Yamagata | 77.2 percentage of participants |
| Cohort 2: Participants Aged 18 to 49 Years | Percentage of Participants With Seroconversion for Influenza Vaccine Antibodies at Day 29 | B/Yamagata | 62.9 percentage of participants |
| Cohort 2: Participants Aged 18 to 49 Years | Percentage of Participants With Seroconversion for Influenza Vaccine Antibodies at Day 29 | A/H1N1 | 76.4 percentage of participants |
| Cohort 2: Participants Aged 18 to 49 Years | Percentage of Participants With Seroconversion for Influenza Vaccine Antibodies at Day 29 | B/Victoria | 73.6 percentage of participants |
| Cohort 2: Participants Aged 18 to 49 Years | Percentage of Participants With Seroconversion for Influenza Vaccine Antibodies at Day 29 | A/H3N2 | 87.1 percentage of participants |
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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: Participants Aged 9 to 17 Years | Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies | A/H1N1 | 12.7 ratio |
| Cohort 1: Participants Aged 9 to 17 Years | Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies | A/H3N2 | 17.9 ratio |
| Cohort 1: Participants Aged 9 to 17 Years | Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies | B/Victoria | 8.41 ratio |
| Cohort 1: Participants Aged 9 to 17 Years | Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies | B/Yamagata | 7.13 ratio |
| Cohort 2: Participants Aged 18 to 49 Years | Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies | B/Yamagata | 5.31 ratio |
| Cohort 2: Participants Aged 18 to 49 Years | Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies | A/H1N1 | 13.1 ratio |
| Cohort 2: Participants Aged 18 to 49 Years | Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies | B/Victoria | 6.91 ratio |
| Cohort 2: Participants Aged 18 to 49 Years | Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies | A/H3N2 | 20.8 ratio |
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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: Participants Aged 9 to 17 Years | GMTs Against Influenza Vaccine Antibodies at Day 1 | B/Yamagata | 272 titer |
| Cohort 1: Participants Aged 9 to 17 Years | GMTs Against Influenza Vaccine Antibodies at Day 1 | A/H3N2 | 111 titer |
| Cohort 1: Participants Aged 9 to 17 Years | GMTs Against Influenza Vaccine Antibodies at Day 1 | B/Victoria | 48.1 titer |
| Cohort 1: Participants Aged 9 to 17 Years | GMTs Against Influenza Vaccine Antibodies at Day 1 | A/H1N1 | 154 titer |
| Cohort 2: Participants Aged 18 to 49 Years | GMTs Against Influenza Vaccine Antibodies at Day 1 | B/Victoria | 37.3 titer |
| Cohort 2: Participants Aged 18 to 49 Years | GMTs Against Influenza Vaccine Antibodies at Day 1 | A/H3N2 | 29.0 titer |
| Cohort 2: Participants Aged 18 to 49 Years | GMTs Against Influenza Vaccine Antibodies at Day 1 | B/Yamagata | 300 titer |
| Cohort 2: Participants Aged 18 to 49 Years | GMTs Against Influenza Vaccine Antibodies at Day 1 | A/H1N1 | 74.9 titer |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Participants Aged 9 to 17 Years | Number of Participants With Immediate Unsolicited Adverse Events (AEs) | 1 Participants |
| Cohort 2: Participants Aged 18 to 49 Years | Number of Participants With Immediate Unsolicited Adverse Events (AEs) | 0 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Participants Aged 9 to 17 Years | Number of Participants With Medically Attended Adverse Events (MAAEs) | 27 Participants |
| Cohort 2: Participants Aged 18 to 49 Years | Number of Participants With Medically Attended Adverse Events (MAAEs) | 35 Participants |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Participants Aged 9 to 17 Years | Number of Participants With Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI) | SAE | 3 Participants |
| Cohort 1: Participants Aged 9 to 17 Years | Number of Participants With Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI) | AESI | 0 Participants |
| Cohort 2: Participants Aged 18 to 49 Years | Number of Participants With Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI) | SAE | 7 Participants |
| Cohort 2: Participants Aged 18 to 49 Years | Number of Participants With Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI) | AESI | 0 Participants |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Participants Aged 9 to 17 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Solicited injection site reaction | 220 Participants |
| Cohort 1: Participants Aged 9 to 17 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Solicited systemic reaction | 182 Participants |
| Cohort 2: Participants Aged 18 to 49 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Solicited injection site reaction | 259 Participants |
| Cohort 2: Participants Aged 18 to 49 Years | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Solicited systemic reaction | 230 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Participants Aged 9 to 17 Years | Number of Participants With Unsolicited AEs | 93 Participants |
| Cohort 2: Participants Aged 18 to 49 Years | Number of Participants With Unsolicited AEs | 119 Participants |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: Participants Aged 9 to 17 Years | Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 | Titer >=10: A/H1N1: Day 29 | 100 percentage of participants |
| Cohort 1: Participants Aged 9 to 17 Years | Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 | Titer >=10: B/Victoria: Day 1 | 92.1 percentage of participants |
| Cohort 1: Participants Aged 9 to 17 Years | Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 | Titer >=10: A/H3N2: Day 1 | 89.2 percentage of participants |
| Cohort 1: Participants Aged 9 to 17 Years | Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 | Titer >=10: B/Victoria: Day 29 | 99.5 percentage of participants |
| Cohort 1: Participants Aged 9 to 17 Years | Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 | Titer >=10: A/H1N1: Day 1 | 97.0 percentage of participants |
| Cohort 1: Participants Aged 9 to 17 Years | Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 | Titer >=40: B/Victoria: Day 1 | 61.4 percentage of participants |
| Cohort 1: Participants Aged 9 to 17 Years | Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 | Titer >=10: A/H3N2: Day 29 | 100 percentage of participants |
| Cohort 1: Participants Aged 9 to 17 Years | Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 | Titer >=40: B/Victoria: Day 29 | 95.6 percentage of participants |
| Cohort 1: Participants Aged 9 to 17 Years | Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 | Titer >=40: A/H1N1: Day 1 | 87.2 percentage of participants |
| Cohort 1: Participants Aged 9 to 17 Years | Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 | Titer >=40: A/H3N2: Day 1 | 74.7 percentage of participants |
| Cohort 1: Participants Aged 9 to 17 Years | Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 | Titer >=10: B/Yamagata: Day 29 | 100 percentage of participants |
| Cohort 1: Participants Aged 9 to 17 Years | Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 | Titer >=10: B/Yamagata: Day 1 | 97.9 percentage of participants |
| Cohort 1: Participants Aged 9 to 17 Years | Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 | Titer >=40: B/Yamagata: Day 1 | 93.1 percentage of participants |
| Cohort 1: Participants Aged 9 to 17 Years | Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 | Titer >=40: A/H3N2: Day 29 | 99.0 percentage of participants |
| Cohort 1: Participants Aged 9 to 17 Years | Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 | Titer >=40: B/Yamagata: Day 29 | 99.5 percentage of participants |
| Cohort 1: Participants Aged 9 to 17 Years | Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 | Titer >=40: A/H1N1: Day 29 | 99.7 percentage of participants |
| Cohort 2: Participants Aged 18 to 49 Years | Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 | Titer >=40: B/Yamagata: Day 29 | 100 percentage of participants |
| Cohort 2: Participants Aged 18 to 49 Years | Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 | Titer >=10: A/H1N1: Day 1 | 89.8 percentage of participants |
| Cohort 2: Participants Aged 18 to 49 Years | Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 | Titer >=10: A/H1N1: Day 29 | 99.3 percentage of participants |
| Cohort 2: Participants Aged 18 to 49 Years | Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 | Titer >=40: A/H1N1: Day 1 | 71.8 percentage of participants |
| Cohort 2: Participants Aged 18 to 49 Years | Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 | Titer >=40: A/H1N1: Day 29 | 97.5 percentage of participants |
| Cohort 2: Participants Aged 18 to 49 Years | Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 | Titer >=10: A/H3N2: Day 1 | 77.7 percentage of participants |
| Cohort 2: Participants Aged 18 to 49 Years | Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 | Titer >=10: A/H3N2: Day 29 | 99.7 percentage of participants |
| Cohort 2: Participants Aged 18 to 49 Years | Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 | Titer >=40: A/H3N2: Day 1 | 45.0 percentage of participants |
| Cohort 2: Participants Aged 18 to 49 Years | Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 | Titer >=40: A/H3N2: Day 29 | 95.0 percentage of participants |
| Cohort 2: Participants Aged 18 to 49 Years | Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 | Titer >=10: B/Victoria: Day 1 | 91.7 percentage of participants |
| Cohort 2: Participants Aged 18 to 49 Years | Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 | Titer >=10: B/Victoria: Day 29 | 99.8 percentage of participants |
| Cohort 2: Participants Aged 18 to 49 Years | Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 | Titer >=40: B/Victoria: Day 1 | 59.8 percentage of participants |
| Cohort 2: Participants Aged 18 to 49 Years | Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 | Titer >=40: B/Victoria: Day 29 | 97.0 percentage of participants |
| Cohort 2: Participants Aged 18 to 49 Years | Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 | Titer >=10: B/Yamagata: Day 1 | 99.5 percentage of participants |
| Cohort 2: Participants Aged 18 to 49 Years | Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 | Titer >=10: B/Yamagata: Day 29 | 100 percentage of participants |
| Cohort 2: Participants Aged 18 to 49 Years | Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 | Titer >=40: B/Yamagata: Day 1 | 95.2 percentage of participants |