Influenza Immunization
Conditions
Brief summary
The purpose of this study was to demonstrate the non-inferior HAI immune response of quadrivalent recombinant influenza vaccine (RIV4) vs licensed Egg-Based Quadrivalent Influenza Vaccine (IIV4) for the 4 strains based on the egg-derived antigen in all participants aged 3 to 8 years and to describe the immunogenicity and safety profile of RIV4 compared to IIV4 in participants aged 3 to 8 years.
Detailed description
Participants were enrolled on the day of their first vaccination and received 1 or 2 doses 28 days apart of either RIV4 or IIV4; depending on if they were previously vaccinated against influenza or previously unvaccinated against influenza, respectively; and were followed for 6 months after the last vaccination.
Interventions
BIOLOGICALRecombinant influenza vaccine (RIV4)
Pharmaceutical form: solution for injection Route of administration: intramuscular
BIOLOGICALQuadrivalent influenza vaccine (IIV4)
Pharmaceutical form: suspension for injection Route of administration: intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Modified double-blind (participant, Sponsor, and Investigator blinded)
Eligibility
Sex/Gender
ALL
Age
3 Years to 8 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 3 to 8 years on the day of inclusion * Assent form has been signed and dated by the participant (according to local regulations), and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative and by an independent witness, if required by local regulations
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 is 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) of Influenza Vaccine Antibodies 28 Days After the Last Vaccination | Day 29 [participants previously vaccinated] or Day 57 [participants previously unvaccinated] | GMTs of influenza vaccine antibodies were measured using individual hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1 strain, A/H3N2 strain, B/Victoria lineage strain, and B/Yamagata lineage strain. |
| Percentage of Participants With Seroconversion (SC) Against Antigens 28 Days After the Last Vaccination | Day 29 [participants previously vaccinated] or Day 57 [participants previously unvaccinated] | Anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1 strain, A/H3N2 strain, B/Victoria lineage strain, and B/Yamagata lineage strain. SC was defined as either a pre-vaccination HAI titer less than (\<) 10 (1/dilution) and a post-vaccination titer greater than or equal to (≥) 40 (1/dilution) or a pre-vaccination titer ≥ 10 (1/dilution) and a ≥ 4-fold increase in post-vaccination titer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies | Day 1 (all participants) and Day 29 (participants previously vaccinated) or Day 57 (participants previously unvaccinated) | GMTR was the ratio of the individual titers post-vaccination over pre-vaccination. The GMTs of influenza vaccine antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1 strain, A/H3N2 strain, B/Victoria lineage strain, and B/Yamagata lineage strain. |
| Number of Participants With Immediate Unsolicited Adverse Events (AEs) | Within 30 minutes post-vaccination on Day 1 (all participants) and Day 29 (participants previously unvaccinated) | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the case report form (CRF) in terms of diagnosis and onset window post-vaccination. Immediate events were recorded to capture medically relevant unsolicited systemic AEs which occurred within the first 30 minutes after vaccination. |
| Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Day 1 to Day 8 (all participants); Day 29 to Day 36 (participants previously unvaccinated) | Solicited injection site reactions were reactions at and around the injection/administration site of the investigational medicinal product (IMP) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF and considered as being related to the IMP administered at that site. Solicited systemic reactions were systemic AEs observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF, and those occurring during the specified collection period were always considered related to the IMP even if there was evidence of alternative etiology. |
| GMTs of Influenza Vaccine Antibodies at Day 1 | Pre-vaccination on Day 1 | GMTs of influenza vaccine antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1 strain, A/H3N2 strain, B/Victoria lineage strain, and B/Yamagata lineage strain. |
| Number of Participants With Medically Attended Adverse Events (MAAEs) | Up to Day 29 (all participants); Up to Day 57 (participants previously unvaccinated) | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An MAAE was a new onset or a worsening of a condition that prompted the participant or participant's parent/legally acceptable representative to seek unplanned medical advice at a physician's office or emergency department. |
| Number of Participants With Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI) | From the first vaccination up to 6 months after the last vaccination, 209 days | An SAE was defined as any adverse event 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 other medically important event. An AESI was defined as one of scientific and medical concern specific to the Sponsor's study intervention or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. |
| Number of Participants With Unsolicited AEs | Up to Day 29 (all participants); Up to Day 57 (participants previously unvaccinated) | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the CRF in terms of diagnosis and onset window post-vaccination. |
| Percentage of Participants With Detectable HAI Titer ≥ 10 and ≥ 40 for Influenza Vaccine Antibodies at Day 1 and 28 Days After the Last Vaccination | Day 1 (all participants) and Day 29 (participants previously vaccinated) or Day 57 (participants previously unvaccinated) | Antibody titers were measured using HAI assay for 4 influenza virus strains: A/H1N1 strain, A/H3N2 strain, B/Victoria lineage strain, and B/Yamagata lineage strain. |
Countries
Poland, Spain, United States
Participant flow
Recruitment details
This study was conducted at 31 investigational sites in 3 countries between 10 November 2022 to 03 October 2023.
Pre-assignment details
A total of 366 participants were enrolled in this study and randomized in a 1:1 ratio to receive quadrivalent recombinant influenza vaccine (RIV4) or quadrivalent inactivated influenza vaccine (IIV4). These participants were stratified according to their previous influenza vaccination status and their age.
Participants by arm
| Arm | Count |
|---|---|
| RIV4 Participants who were previously vaccinated against influenza received a single IM injection of RIV4 0.5 mL on Day 1. Participants who were previously unvaccinated against influenza received a single IM injection of RIV4 0.5 mL on Day 1 and Day 29. | 183 |
| IIV4 Participants who were previously vaccinated against influenza received a single IM injection of IIV4 0.5 mL on Day 1. Participants who were previously unvaccinated against influenza received a single IM injection of IIV4 0.5 mL on Day 1 and Day 29. | 183 |
| Total | 366 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Protocol Deviation | 0 | 1 |
| Overall Study | Withdrawal by Parent/Guardian | 2 | 2 |
| Overall Study | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | RIV4 | IIV4 | Total |
|---|---|---|---|
| Age, Continuous | 5.73 years STANDARD_DEVIATION 1.72 | 5.48 years STANDARD_DEVIATION 1.64 | 5.60 years STANDARD_DEVIATION 1.68 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 3 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Black | 31 Participants | 33 Participants | 64 Participants |
| Race/Ethnicity, Customized Mixed origin | 4 Participants | 13 Participants | 17 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 144 Participants | 136 Participants | 280 Participants |
| Sex: Female, Male Female | 95 Participants | 93 Participants | 188 Participants |
| Sex: Female, Male Male | 88 Participants | 90 Participants | 178 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 181 | 0 / 181 |
| other Total, other adverse events | 86 / 181 | 98 / 181 |
| serious Total, serious adverse events | 0 / 181 | 1 / 181 |
Outcome results
Primary
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies 28 Days After the Last Vaccination
GMTs of influenza vaccine antibodies were measured using individual hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1 strain, A/H3N2 strain, B/Victoria lineage strain, and B/Yamagata lineage strain.
Time frame: Day 29 [participants previously vaccinated] or Day 57 [participants previously unvaccinated]
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. Only participants with data collected for each category at Day 29 \[participants previously vaccinated\] or Day 57 \[participants previously unvaccinated\] are reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RIV4 | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies 28 Days After the Last Vaccination | B/Yamagata | 789 titer |
| RIV4 | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies 28 Days After the Last Vaccination | A/H1N1 | 998 titer |
| RIV4 | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies 28 Days After the Last Vaccination | A/H3N2 | 2398 titer |
| RIV4 | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies 28 Days After the Last Vaccination | B/Victoria | 337 titer |
| IIV4 | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies 28 Days After the Last Vaccination | B/Victoria | 605 titer |
| IIV4 | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies 28 Days After the Last Vaccination | B/Yamagata | 708 titer |
| IIV4 | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies 28 Days After the Last Vaccination | A/H3N2 | 889 titer |
| IIV4 | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies 28 Days After the Last Vaccination | A/H1N1 | 640 titer |
Comparison: Statistical analysis for A/H1N195% CI: [0.948, 1.73]
Comparison: Statistical analysis for A/H3N295% CI: [1.93, 3.3]
Comparison: Statistical analysis for B/Victoria95% CI: [0.397, 0.668]
Comparison: Statistical analysis for B/Yamagata95% CI: [0.799, 1.3]
Primary
Percentage of Participants With Seroconversion (SC) Against Antigens 28 Days After the Last Vaccination
Anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1 strain, A/H3N2 strain, B/Victoria lineage strain, and B/Yamagata lineage strain. SC was defined as either a pre-vaccination HAI titer less than (\<) 10 (1/dilution) and a post-vaccination titer greater than or equal to (≥) 40 (1/dilution) or a pre-vaccination titer ≥ 10 (1/dilution) and a ≥ 4-fold increase in post-vaccination titer.
Time frame: Day 29 [participants previously vaccinated] or Day 57 [participants previously unvaccinated]
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 \[participants previously vaccinated\] or Day 57 \[participants previously unvaccinated\] are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RIV4 | Percentage of Participants With Seroconversion (SC) Against Antigens 28 Days After the Last Vaccination | A/H1N1 | 84.8 percentage of participants |
| RIV4 | Percentage of Participants With Seroconversion (SC) Against Antigens 28 Days After the Last Vaccination | A/H3N2 | 82.3 percentage of participants |
| RIV4 | Percentage of Participants With Seroconversion (SC) Against Antigens 28 Days After the Last Vaccination | B/Victoria | 85.4 percentage of participants |
| RIV4 | Percentage of Participants With Seroconversion (SC) Against Antigens 28 Days After the Last Vaccination | B/Yamagata | 88.6 percentage of participants |
| IIV4 | Percentage of Participants With Seroconversion (SC) Against Antigens 28 Days After the Last Vaccination | B/Yamagata | 82.8 percentage of participants |
| IIV4 | Percentage of Participants With Seroconversion (SC) Against Antigens 28 Days After the Last Vaccination | A/H1N1 | 77.7 percentage of participants |
| IIV4 | Percentage of Participants With Seroconversion (SC) Against Antigens 28 Days After the Last Vaccination | B/Victoria | 92.4 percentage of participants |
| IIV4 | Percentage of Participants With Seroconversion (SC) Against Antigens 28 Days After the Last Vaccination | A/H3N2 | 66.9 percentage of participants |
Comparison: Statistical analysis for A/H1N195% CI: [-1.55, 15.7]
Comparison: Statistical analysis for A/H3N295% CI: [5.8, 24.7]
Comparison: Statistical analysis for B/Victoria95% CI: [-14.02, 0.1]
Comparison: Statistical analysis for B/Yamagata95% CI: [-1.99, 13.6]
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 of influenza vaccine antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1 strain, A/H3N2 strain, B/Victoria lineage strain, and B/Yamagata lineage strain.
Time frame: Day 1 (all participants) and Day 29 (participants previously vaccinated) or Day 57 (participants previously unvaccinated)
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 and Day 29 \[participants previously vaccinated\] or Day 57 \[participants previously unvaccinated\] are reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RIV4 | Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies | A/H1N1 | 14.2 ratio |
| RIV4 | Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies | A/H3N2 | 17.1 ratio |
| RIV4 | Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies | B/Victoria | 16.0 ratio |
| RIV4 | Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies | B/Yamagata | 12.2 ratio |
| IIV4 | Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies | B/Yamagata | 13.1 ratio |
| IIV4 | Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies | A/H1N1 | 13.8 ratio |
| IIV4 | Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies | B/Victoria | 32.7 ratio |
| IIV4 | Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies | A/H3N2 | 7.86 ratio |
Secondary
GMTs of Influenza Vaccine Antibodies at Day 1
GMTs of influenza vaccine antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1 strain, A/H3N2 strain, B/Victoria lineage strain, and B/Yamagata lineage strain.
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) |
|---|---|---|---|
| RIV4 | GMTs of Influenza Vaccine Antibodies at Day 1 | A/H3N2 | 141 titer |
| RIV4 | GMTs of Influenza Vaccine Antibodies at Day 1 | A/H1N1 | 70.5 titer |
| RIV4 | GMTs of Influenza Vaccine Antibodies at Day 1 | B/Yamagata | 65.2 titer |
| RIV4 | GMTs of Influenza Vaccine Antibodies at Day 1 | B/Victoria | 20.9 titer |
| IIV4 | GMTs of Influenza Vaccine Antibodies at Day 1 | B/Yamagata | 54.7 titer |
| IIV4 | GMTs of Influenza Vaccine Antibodies at Day 1 | A/H1N1 | 46.5 titer |
| IIV4 | GMTs of Influenza Vaccine Antibodies at Day 1 | B/Victoria | 18.4 titer |
| IIV4 | GMTs of Influenza Vaccine Antibodies at Day 1 | A/H3N2 | 112 titer |
Secondary
Number of Participants With Immediate Unsolicited Adverse Events (AEs)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the case report form (CRF) in terms of diagnosis and onset window post-vaccination. Immediate events were recorded to capture medically relevant unsolicited systemic AEs which occurred within the first 30 minutes after vaccination.
Time frame: Within 30 minutes post-vaccination on Day 1 (all participants) and Day 29 (participants previously unvaccinated)
Population: Safety analysis set included participants who received at least 1 dose of the study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RIV4 | Number of Participants With Immediate Unsolicited Adverse Events (AEs) | 0 Participants |
| IIV4 | Number of Participants With Immediate Unsolicited Adverse Events (AEs) | 0 Participants |
Secondary
Number of Participants With Medically Attended Adverse Events (MAAEs)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An MAAE was a new onset or a worsening of a condition that prompted the participant or participant's parent/legally acceptable representative to seek unplanned medical advice at a physician's office or emergency department.
Time frame: Up to Day 29 (all participants); Up to Day 57 (participants previously unvaccinated)
Population: Safety analysis set included participants who received at least 1 dose of the study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RIV4 | Number of Participants With Medically Attended Adverse Events (MAAEs) | 18 Participants |
| IIV4 | Number of Participants With Medically Attended Adverse Events (MAAEs) | 12 Participants |
Secondary
Number of Participants With Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI)
An SAE was defined as any adverse event 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 other medically important event. An AESI was defined as one of scientific and medical concern specific to the Sponsor's study intervention or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate.
Time frame: From the first vaccination up to 6 months after the last vaccination, 209 days
Population: Safety analysis set included participants who received at least 1 dose of the study vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RIV4 | Number of Participants With Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI) | AESIs | 0 Participants |
| RIV4 | Number of Participants With Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI) | SAEs | 0 Participants |
| IIV4 | Number of Participants With Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI) | SAEs | 1 Participants |
| IIV4 | Number of Participants With Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI) | AESIs | 0 Participants |
Secondary
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions
Solicited injection site reactions were reactions at and around the injection/administration site of the investigational medicinal product (IMP) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF and considered as being related to the IMP administered at that site. Solicited systemic reactions were systemic AEs observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF, and those occurring during the specified collection period were always considered related to the IMP even if there was evidence of alternative etiology.
Time frame: Day 1 to Day 8 (all participants); Day 29 to Day 36 (participants previously unvaccinated)
Population: Safety analysis set included participants who received at least 1 dose of the study vaccine. Only participants with data collected for each category up to 7 days post vaccination are reported.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RIV4 | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Solicited injection site reactions | 70 Participants |
| RIV4 | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Solicited systemic reactions | 50 Participants |
| IIV4 | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Solicited systemic reactions | 66 Participants |
| IIV4 | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Solicited injection site reactions | 76 Participants |
Secondary
Number of Participants With Unsolicited AEs
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the CRF in terms of diagnosis and onset window post-vaccination.
Time frame: Up to Day 29 (all participants); Up to Day 57 (participants previously unvaccinated)
Population: Safety analysis set included participants who received at least 1 dose of the study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RIV4 | Number of Participants With Unsolicited AEs | 44 Participants |
| IIV4 | Number of Participants With Unsolicited AEs | 47 Participants |
Secondary
Percentage of Participants With Detectable HAI Titer ≥ 10 and ≥ 40 for Influenza Vaccine Antibodies at Day 1 and 28 Days After the Last Vaccination
Antibody titers were measured using HAI assay for 4 influenza virus strains: A/H1N1 strain, A/H3N2 strain, B/Victoria lineage strain, and B/Yamagata lineage strain.
Time frame: Day 1 (all participants) and Day 29 (participants previously vaccinated) or Day 57 (participants previously unvaccinated)
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 and Day 29 \[participants previously vaccinated\] or Day 57 \[participants previously unvaccinated\] are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RIV4 | Percentage of Participants With Detectable HAI Titer ≥ 10 and ≥ 40 for Influenza Vaccine Antibodies at Day 1 and 28 Days After the Last Vaccination | Titer ≥ 40: B/Victoria: Day 29 or Day 57 | 92.5 percentage of participants |
| RIV4 | Percentage of Participants With Detectable HAI Titer ≥ 10 and ≥ 40 for Influenza Vaccine Antibodies at Day 1 and 28 Days After the Last Vaccination | Titer ≥ 10: B/Yamagata: Day 29 or Day 57 | 100 percentage of participants |
| RIV4 | Percentage of Participants With Detectable HAI Titer ≥ 10 and ≥ 40 for Influenza Vaccine Antibodies at Day 1 and 28 Days After the Last Vaccination | Titer ≥ 10: A/H3N2: Day 29 or Day 57 | 100 percentage of participants |
| RIV4 | Percentage of Participants With Detectable HAI Titer ≥ 10 and ≥ 40 for Influenza Vaccine Antibodies at Day 1 and 28 Days After the Last Vaccination | Titer ≥ 40: A/H1N1: Day 1 | 65.4 percentage of participants |
| RIV4 | Percentage of Participants With Detectable HAI Titer ≥ 10 and ≥ 40 for Influenza Vaccine Antibodies at Day 1 and 28 Days After the Last Vaccination | Titer ≥ 10: A/H1N1: Day 29 or Day 57 | 98.7 percentage of participants |
| RIV4 | Percentage of Participants With Detectable HAI Titer ≥ 10 and ≥ 40 for Influenza Vaccine Antibodies at Day 1 and 28 Days After the Last Vaccination | Titer ≥ 40: A/H1N1: Day 29 or Day 57 | 97.5 percentage of participants |
| RIV4 | Percentage of Participants With Detectable HAI Titer ≥ 10 and ≥ 40 for Influenza Vaccine Antibodies at Day 1 and 28 Days After the Last Vaccination | Titer ≥ 10: B/Victoria: Day 1 | 69.8 percentage of participants |
| RIV4 | Percentage of Participants With Detectable HAI Titer ≥ 10 and ≥ 40 for Influenza Vaccine Antibodies at Day 1 and 28 Days After the Last Vaccination | Titer ≥ 40: A/H3N2: Day 1 | 76.1 percentage of participants |
| RIV4 | Percentage of Participants With Detectable HAI Titer ≥ 10 and ≥ 40 for Influenza Vaccine Antibodies at Day 1 and 28 Days After the Last Vaccination | Titer ≥ 10: A/H1N1: Day 1 | 78.6 percentage of participants |
| RIV4 | Percentage of Participants With Detectable HAI Titer ≥ 10 and ≥ 40 for Influenza Vaccine Antibodies at Day 1 and 28 Days After the Last Vaccination | Titer ≥ 40: A/H3N2: Day 29 or Day 57 | 98.1 percentage of participants |
| RIV4 | Percentage of Participants With Detectable HAI Titer ≥ 10 and ≥ 40 for Influenza Vaccine Antibodies at Day 1 and 28 Days After the Last Vaccination | Titer ≥ 10: A/H3N2: Day 1 | 87.4 percentage of participants |
| RIV4 | Percentage of Participants With Detectable HAI Titer ≥ 10 and ≥ 40 for Influenza Vaccine Antibodies at Day 1 and 28 Days After the Last Vaccination | Titer ≥ 40: B/Victoria: Day 1 | 35.8 percentage of participants |
| RIV4 | Percentage of Participants With Detectable HAI Titer ≥ 10 and ≥ 40 for Influenza Vaccine Antibodies at Day 1 and 28 Days After the Last Vaccination | Titer ≥ 40: B/Yamagata: Day 1 | 69.8 percentage of participants |
| RIV4 | Percentage of Participants With Detectable HAI Titer ≥ 10 and ≥ 40 for Influenza Vaccine Antibodies at Day 1 and 28 Days After the Last Vaccination | Titer ≥ 10: B/Yamagata: Day 1 | 85.5 percentage of participants |
| RIV4 | Percentage of Participants With Detectable HAI Titer ≥ 10 and ≥ 40 for Influenza Vaccine Antibodies at Day 1 and 28 Days After the Last Vaccination | Titer ≥ 40: B/Yamagata: Day 29 or Day 57 | 99.4 percentage of participants |
| RIV4 | Percentage of Participants With Detectable HAI Titer ≥ 10 and ≥ 40 for Influenza Vaccine Antibodies at Day 1 and 28 Days After the Last Vaccination | Titer ≥ 10: B/Victoria: Day 29 or Day 57 | 99.4 percentage of participants |
| IIV4 | Percentage of Participants With Detectable HAI Titer ≥ 10 and ≥ 40 for Influenza Vaccine Antibodies at Day 1 and 28 Days After the Last Vaccination | Titer ≥ 40: B/Yamagata: Day 29 or Day 57 | 99.4 percentage of participants |
| IIV4 | Percentage of Participants With Detectable HAI Titer ≥ 10 and ≥ 40 for Influenza Vaccine Antibodies at Day 1 and 28 Days After the Last Vaccination | Titer ≥ 40: B/Victoria: Day 1 | 33.8 percentage of participants |
| IIV4 | Percentage of Participants With Detectable HAI Titer ≥ 10 and ≥ 40 for Influenza Vaccine Antibodies at Day 1 and 28 Days After the Last Vaccination | Titer ≥ 40: B/Victoria: Day 29 or Day 57 | 96.8 percentage of participants |
| IIV4 | Percentage of Participants With Detectable HAI Titer ≥ 10 and ≥ 40 for Influenza Vaccine Antibodies at Day 1 and 28 Days After the Last Vaccination | Titer ≥ 10: A/H1N1: Day 1 | 70.7 percentage of participants |
| IIV4 | Percentage of Participants With Detectable HAI Titer ≥ 10 and ≥ 40 for Influenza Vaccine Antibodies at Day 1 and 28 Days After the Last Vaccination | Titer ≥ 10: A/H1N1: Day 29 or Day 57 | 98.1 percentage of participants |
| IIV4 | Percentage of Participants With Detectable HAI Titer ≥ 10 and ≥ 40 for Influenza Vaccine Antibodies at Day 1 and 28 Days After the Last Vaccination | Titer ≥ 10: A/H3N2: Day 1 | 81.5 percentage of participants |
| IIV4 | Percentage of Participants With Detectable HAI Titer ≥ 10 and ≥ 40 for Influenza Vaccine Antibodies at Day 1 and 28 Days After the Last Vaccination | Titer ≥ 10: A/H3N2: Day 29 or Day 57 | 99.4 percentage of participants |
| IIV4 | Percentage of Participants With Detectable HAI Titer ≥ 10 and ≥ 40 for Influenza Vaccine Antibodies at Day 1 and 28 Days After the Last Vaccination | Titer ≥ 10: B/Victoria: Day 1 | 63.1 percentage of participants |
| IIV4 | Percentage of Participants With Detectable HAI Titer ≥ 10 and ≥ 40 for Influenza Vaccine Antibodies at Day 1 and 28 Days After the Last Vaccination | Titer ≥ 10: B/Victoria: Day 29 or Day 57 | 100 percentage of participants |
| IIV4 | Percentage of Participants With Detectable HAI Titer ≥ 10 and ≥ 40 for Influenza Vaccine Antibodies at Day 1 and 28 Days After the Last Vaccination | Titer ≥ 10: B/Yamagata: Day 1 | 87.3 percentage of participants |
| IIV4 | Percentage of Participants With Detectable HAI Titer ≥ 10 and ≥ 40 for Influenza Vaccine Antibodies at Day 1 and 28 Days After the Last Vaccination | Titer ≥ 10: B/Yamagata: Day 29 or Day 57 | 100 percentage of participants |
| IIV4 | Percentage of Participants With Detectable HAI Titer ≥ 10 and ≥ 40 for Influenza Vaccine Antibodies at Day 1 and 28 Days After the Last Vaccination | Titer ≥ 40: A/H1N1: Day 1 | 54.8 percentage of participants |
| IIV4 | Percentage of Participants With Detectable HAI Titer ≥ 10 and ≥ 40 for Influenza Vaccine Antibodies at Day 1 and 28 Days After the Last Vaccination | Titer ≥ 40: A/H1N1: Day 29 or Day 57 | 96.2 percentage of participants |
| IIV4 | Percentage of Participants With Detectable HAI Titer ≥ 10 and ≥ 40 for Influenza Vaccine Antibodies at Day 1 and 28 Days After the Last Vaccination | Titer ≥ 40: A/H3N2: Day 1 | 70.1 percentage of participants |
| IIV4 | Percentage of Participants With Detectable HAI Titer ≥ 10 and ≥ 40 for Influenza Vaccine Antibodies at Day 1 and 28 Days After the Last Vaccination | Titer ≥ 40: A/H3N2: Day 29 or Day 57 | 98.1 percentage of participants |
| IIV4 | Percentage of Participants With Detectable HAI Titer ≥ 10 and ≥ 40 for Influenza Vaccine Antibodies at Day 1 and 28 Days After the Last Vaccination | Titer ≥ 40: B/Yamagata: Day 1 | 66.2 percentage of participants |