Influenza
Conditions
Keywords
Influenza Vaccine, MF59 adjuvant
Brief summary
Safety, Immunogenicity of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children Previously vaccinated in Trial V118\_05. Subjects will receive either the Same or Alternate Type of Vaccine.
Interventions
Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
Sponsors
Study design
Eligibility
Inclusion criteria
In order to participate in this study, all subjects must meet ALL of the inclusion criteria described. * Subject's parent/legal guardian has voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. * Male or female subject who has completed their Visit 13 (Study Day 366 for non-naïve subjects) or clinic Visit 15 (Day 390 for naïve subjects) in parent trial V118\_05. * For naïve subjects in parent trial V118\_05 to have received two doses of the same study vaccine (i.e. 2 doses of aQIV or 2 doses of QIV).
Exclusion criteria
* Previous immunization with any influenza vaccine (licensed or investigational) within 6 months prior to enrollment. * Subjects with a clinical condition representing a contraindication to intramuscular vaccination or blood draws. * Unwillingness of the parent(s)/ legal guardian(s) of the subject to refuse to participate in another clinical trial while enrolled in V118-05E3. Additional eligibility criteria may be discussed by contacting the site.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio as Determined by Hemagglutination Inhibition (HI) Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Noninferiority Analysis | Day 22 | GMT and 95% confidence interval (CI) were analyzed for Day 22 against homologous strains using ANCOVA with study specific covariates. Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013. |
| Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Superiority Analysis | Day 22 | GMT and 95% CI were analyzed for Day 22 against homologous strains using ANCOVA with study specific covariates. Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity Endpoint: Seroconversion Rate (SCR) on Day 22 Against Homologous Strains (aQIV-primed and QIV-primed Comparison) | Day 1, Day 22 | The percentage of subjects achieving seroconversion at Day 22 after vaccination is reported against homologous strains. Seroconversion was defined in subjects seronegative at baseline (i.e. HI titer \<1:10 on Day 1) as postvaccination HI titer ≥1:40 and defined in subjects seropositive at baseline (i.e. HI titer ≥1:10 on Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer. Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013. |
| Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains | Day 22, Day 181 | The GMR is the geometric mean of the fold increase in HI titer from Day 1 to Day 22 or Day 181. GMR and 95% CI were analyzed against homologous strains using ANCOVA with study specific covariates. Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013. |
| Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains | Day 22, Day 181 | The percentage of subjects achieving HI titer ≥1:40 at Day 22 and Day 181 after vaccination is reported against homologous strains. Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013. |
| Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | Day 22 | The percentage of subjects achieving HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 at Day 22 after vaccination is reported against homologous strains. Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013. |
| Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains | Day 1, Day 22, Day 181 | GMT and 95% CI were analyzed for Day 22 for the heterologous strains using ANCOVA with study specific covariates. The two heterologous strains selected for HI testing in this study were the H3N2 strain, A/Hong Kong/4801/2014 (X-263B), and the B/ Victoria lineage strain, B/Malaysia/2506/2004. |
| Immunogenicity Endpoint: GMR as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 Against Heterologous Strains | Day 22/Day 1 and Day 181/Day 1 | The GMR is the geometric mean of the fold increase in HI titer from Day 1 to Day 22 or Day 181. GMR and 95% CI were analyzed for the heterologous strains using ANCOVA with study specific covariates. The two heterologous strains selected for HI testing in this study were the H3N2 strain, A/Hong Kong/4801/2014 (X-263B), and the B Victoria lineage strain, B/Malaysia/2506/2004. |
| Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains | Day 22, Day 181 | The percentage of subjects achieving HI titer ≥1:40 at Day 22 and Day 181 after vaccination and the percentage of subject who experienced seroconversion is reported for homologous strains. Seroconversion was defined in subjects seronegative at baseline (i.e. HI titer \<1:10 on Day 1) as post-vaccination HI titer ≥1:40 and defined in subjects seropositive at baseline (i.e. HI titer ≥1:10 on Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer. The two heterologous strains selected for HI testing in this study were the H3N2 strain, A/Hong Kong/4801/2014 (X-263B), and the B/Victoria lineage strain, B/Malaysia/2506/2004. |
| Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | Day 1, Day 22, Day 181 | To further characterize immune response, MN GMT and 95% CI were analyzed for Day 1, Day 22, and Day 181 against homologous strains. Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013. |
| Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | Day 22/Day 1 and Day 181/Day 1 | The GMR is the geometric mean of the fold increase in MN titer from Day 1 to Day 22 or Day 181. GMR and 95% CI were analyzed for the homologous strains using ANCOVA with study specific covariates. Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013. |
| Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (QIV-primed Comparison) | Day 22 | GMT and 95% CI were analyzed for Day 22 against homologous strains using ANCOVA with study specific covariates. Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013. |
| Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | Day 22/Day 1 and Day 181/Day 1 | The GMR is the geometric mean of the fold increase in anti-NA titer from Day 1 to Day 22 or Day 181. GMR and 95% CI were analyzed against homologous strains using ANCOVA with study specific covariates. Strains tested: N1 (PR8 H6N1 California/07/2009), N2 (PR8 H6N2 Switzerl/9715293/2013); B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013. |
| Safety Endpoint: Percentage of Subjects With Solicited AEs | Day 1 to Day 7 after vaccination | Safety of revaccination was assessed in terms of percentage of subjects reporting solicited AEs up to 7 days after vaccination. |
| Safety Endpoint: Percentage of Subjects With Unsolicited AEs | Day 1 to Day 366 | Safety of revaccination was assessed in terms of percentage of subjects reporting unsolicited AEs during the overall study period (Day 1 to Day 366). |
| Safety Endpoint: Percentage of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), AE of Special Interest (AESI), and Medically Attended AE. | Day 1 to Day 366 | Safety of revaccination was assessed in terms of percentage of subjects reporting SAEs, AEs leading to withdrawal, NOCD, AESI and medically attended AE. Each subject was followed for a period of 12 months after receipt of the study vaccine. NOCDs include AEs that represents a new diagnosis of a chronic medical condition that was not present or suspected in a subject prior to study enrollment. AESIs include potentially immune-mediated disorders which were reported by the investigators. |
| Safety Endpoint: Percentage of Subjects With Diagnosis of Failure to Thrive or Short Stature | Day 1 to Day 366 | Safety of revaccination was assessed in terms of percentage of subjects reporting diagnosis of failure to thrive or short stature up to 12 months after last vaccination. |
| Safety Endpoint: Percentage of Subjects With Otitis Media, or Pneumonia, or Influenza-like Illness | Day 1 to Day 366 | Safety of revaccination was assessed in terms of percentage of subjects reporting otitis media, or pneumonia, or influenza-like illness up to 12 months after last vaccination. |
| Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | Day 22, Day 181 | The percentage of subjects achieving MN titer ≥1:20, ≥1:40, ≥1:80 ≥1:160, ≥1:320 and ≥1:640 at Day 22 and Day 181 after vaccination is reported against homologous strains. Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013. |
| Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | Day 22, Day 181 | The percentage of subjects achieving anti-NA titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 after vaccination is reported against homologous strains Strains tested: N1 (PR8 H6N1 California/07/2009), N2 (PR8 H6N2 Switzerl/9715293/2013); B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013. |
| Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | Day 1, Day 22, Day 181 | To further characterize immune response, adjusted anti-NA GMT and 95% CI were analyzed for Day 1, Day 22, and Day 181 against homologous strains. Strains tested: N1 (PR8 H6N1 California/07/2009), N2 (PR8 H6N2 Switzerl/9715293/2013); B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013. |
| Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 181 Against Homologous Strains (aQIV-primed and QIV-primed Comparison) | Day 181 | GMT and 95% CI were analyzed for Day 181 against homologous strains using ANCOVA with study specific covariates. Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013. |
Countries
Finland, Philippines, Thailand
Participant flow
Recruitment details
This study was conducted at 17 sites in total; 9 sites in Finland, 4 sites in the Philippines and 4 sites in Thailand.
Pre-assignment details
All enrolled subjects were included in the study.
Participants by arm
| Arm | Count |
|---|---|
| aQIV/aQIV Subjects previously vaccinated with aQIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV) | 403 |
| aQIV/QIV Subjects previously vaccinated with aQIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV) | 403 |
| QIV/aQIV Subjects previously vaccinated with QIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV) | 402 |
| QIV/QIV Subjects previously vaccinated with QIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV) | 393 |
| Total | 1,601 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Administrative/Other | 2 | 0 | 1 | 2 |
| Overall Study | Lost to Follow-up | 1 | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | aQIV/aQIV | aQIV/QIV | QIV/aQIV | QIV/QIV | Total |
|---|---|---|---|---|---|
| Age, Continuous | 54.4 months STANDARD_DEVIATION 17.12 | 52.3 months STANDARD_DEVIATION 17.02 | 53.4 months STANDARD_DEVIATION 17.32 | 53.3 months STANDARD_DEVIATION 17.3 | 53.0 months STANDARD_DEVIATION 16.91 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 402 Participants | 403 Participants | 402 Participants | 392 Participants | 1599 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 364 Participants | 364 Participants | 362 Participants | 355 Participants | 1445 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 3 Participants | 3 Participants | 3 Participants | 10 Participants |
| Race/Ethnicity, Customized White | 38 Participants | 36 Participants | 37 Participants | 35 Participants | 146 Participants |
| Region of Enrollment Finland | 39 Participants | 39 Participants | 39 Participants | 38 Participants | 155 Participants |
| Region of Enrollment Philippines | 210 Participants | 211 Participants | 213 Participants | 212 Participants | 846 Participants |
| Region of Enrollment Thailand | 154 Participants | 153 Participants | 150 Participants | 143 Participants | 600 Participants |
| Risk Status At risk | 10 Participants | 20 Participants | 18 Participants | 13 Participants | 61 Participants |
| Risk Status Not at risk | 393 Participants | 383 Participants | 384 Participants | 380 Participants | 1540 Participants |
| Sex: Female, Male Female | 197 Participants | 189 Participants | 206 Participants | 178 Participants | 770 Participants |
| Sex: Female, Male Male | 206 Participants | 214 Participants | 196 Participants | 215 Participants | 831 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 403 | 0 / 403 | 0 / 402 | 0 / 393 |
| other Total, other adverse events | 289 / 403 | 269 / 403 | 274 / 402 | 229 / 393 |
| serious Total, serious adverse events | 10 / 403 | 11 / 403 | 7 / 402 | 8 / 393 |
Outcome results
Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio as Determined by Hemagglutination Inhibition (HI) Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Noninferiority Analysis
GMT and 95% confidence interval (CI) were analyzed for Day 22 against homologous strains using ANCOVA with study specific covariates. Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Time frame: Day 22
Population: Immunogenicity per protocol set (PPS) consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop reverse transcription polymerase chain reaction(RT-PCR) confirmed influenza infection between baseline and Visit 2.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| aQIV/aQIV | Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio as Determined by Hemagglutination Inhibition (HI) Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Noninferiority Analysis | A/H1N1 | 1219.00 titer |
| aQIV/aQIV | Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio as Determined by Hemagglutination Inhibition (HI) Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Noninferiority Analysis | A/H3N2 | 2355.52 titer |
| aQIV/aQIV | Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio as Determined by Hemagglutination Inhibition (HI) Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Noninferiority Analysis | B/Yamagata | 276.23 titer |
| aQIV/aQIV | Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio as Determined by Hemagglutination Inhibition (HI) Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Noninferiority Analysis | B/Victoria | 388.35 titer |
| aQIV/QIV | Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio as Determined by Hemagglutination Inhibition (HI) Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Noninferiority Analysis | B/Victoria | 328.42 titer |
| aQIV/QIV | Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio as Determined by Hemagglutination Inhibition (HI) Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Noninferiority Analysis | A/H1N1 | 1020.89 titer |
| aQIV/QIV | Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio as Determined by Hemagglutination Inhibition (HI) Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Noninferiority Analysis | B/Yamagata | 232.82 titer |
| aQIV/QIV | Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio as Determined by Hemagglutination Inhibition (HI) Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Noninferiority Analysis | A/H3N2 | 2529.83 titer |
Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Superiority Analysis
GMT and 95% CI were analyzed for Day 22 against homologous strains using ANCOVA with study specific covariates. Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Time frame: Day 22
Population: The immunogenicity full analysis set (FAS) consisting of all subjects who received a study vaccination and provided immunogenicity data at both Visit 1 (baseline) and at least one post-vaccination visit.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| aQIV/aQIV | Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Superiority Analysis | A/H1N1 | 1218.91 titer |
| aQIV/aQIV | Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Superiority Analysis | A/H3N2 | 2345.71 titer |
| aQIV/aQIV | Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Superiority Analysis | B/Yamagata | 274.75 titer |
| aQIV/aQIV | Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Superiority Analysis | B/Victoria | 387.35 titer |
| aQIV/QIV | Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Superiority Analysis | B/Victoria | 326.68 titer |
| aQIV/QIV | Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Superiority Analysis | A/H1N1 | 1023.37 titer |
| aQIV/QIV | Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Superiority Analysis | B/Yamagata | 230.51 titer |
| aQIV/QIV | Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Superiority Analysis | A/H3N2 | 2521.60 titer |
Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains
The GMR is the geometric mean of the fold increase in anti-NA titer from Day 1 to Day 22 or Day 181. GMR and 95% CI were analyzed against homologous strains using ANCOVA with study specific covariates. Strains tested: N1 (PR8 H6N1 California/07/2009), N2 (PR8 H6N2 Switzerl/9715293/2013); B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Time frame: Day 22/Day 1 and Day 181/Day 1
Population: The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| aQIV/aQIV | Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | N1 (Day 22/Day 1) | 5.40 ratio |
| aQIV/aQIV | Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | N1 (Day 181/Day 1) | 3.95 ratio |
| aQIV/aQIV | Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | N2 (Day 22/Day 1) | 4.51 ratio |
| aQIV/aQIV | Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | N2 (Day 181/Day 1) | 2.45 ratio |
| aQIV/aQIV | Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | B/Yamagata (Day 22/Day 1) | 5.75 ratio |
| aQIV/aQIV | Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | B/Yamagata (Day 181/Day 1) | 3.29 ratio |
| aQIV/aQIV | Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | B/Victoria (Day 22/Day 1) | 6.81 ratio |
| aQIV/aQIV | Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | B/Victoria (Day 181/Day 1) | 3.05 ratio |
| aQIV/QIV | Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | B/Yamagata (Day 181/Day 1) | 2.70 ratio |
| aQIV/QIV | Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | B/Yamagata (Day 22/Day 1) | 5.59 ratio |
| aQIV/QIV | Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | N1 (Day 181/Day 1) | 2.63 ratio |
| aQIV/QIV | Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | B/Victoria (Day 181/Day 1) | 3.40 ratio |
| aQIV/QIV | Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | B/Victoria (Day 22/Day 1) | 7.15 ratio |
| aQIV/QIV | Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | N2 (Day 181/Day 1) | 2.74 ratio |
| aQIV/QIV | Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | N2 (Day 22/Day 1) | 5.18 ratio |
| aQIV/QIV | Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | N1 (Day 22/Day 1) | 5.02 ratio |
| QIV/aQIV | Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | B/Victoria (Day 22/Day 1) | 7.14 ratio |
| QIV/aQIV | Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | N2 (Day 22/Day 1) | 6.13 ratio |
| QIV/aQIV | Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | N2 (Day 181/Day 1) | 2.50 ratio |
| QIV/aQIV | Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | B/Yamagata (Day 22/Day 1) | 5.69 ratio |
| QIV/aQIV | Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | B/Yamagata (Day 181/Day 1) | 2.32 ratio |
| QIV/aQIV | Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | B/Victoria (Day 181/Day 1) | 3.09 ratio |
| QIV/aQIV | Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | N1 (Day 22/Day 1) | 5.70 ratio |
| QIV/aQIV | Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | N1 (Day 181/Day 1) | 3.22 ratio |
| QIV/QIV | Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | N2 (Day 22/Day 1) | 4.84 ratio |
| QIV/QIV | Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | N2 (Day 181/Day 1) | 1.79 ratio |
| QIV/QIV | Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | N1 (Day 181/Day 1) | 1.39 ratio |
| QIV/QIV | Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | N1 (Day 22/Day 1) | 3.83 ratio |
| QIV/QIV | Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | B/Yamagata (Day 22/Day 1) | 3.95 ratio |
| QIV/QIV | Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | B/Victoria (Day 181/Day 1) | 2.21 ratio |
| QIV/QIV | Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | B/Victoria (Day 22/Day 1) | 5.18 ratio |
| QIV/QIV | Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | B/Yamagata (Day 181/Day 1) | 1.77 ratio |
Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains
To further characterize immune response, adjusted anti-NA GMT and 95% CI were analyzed for Day 1, Day 22, and Day 181 against homologous strains. Strains tested: N1 (PR8 H6N1 California/07/2009), N2 (PR8 H6N2 Switzerl/9715293/2013); B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Time frame: Day 1, Day 22, Day 181
Population: The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| aQIV/aQIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Yamagata (Day 1) | 290.06 titer |
| aQIV/aQIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Yamagata (Day 181) | 727.17 titer |
| aQIV/aQIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Victoria (Day 22) | 3175.99 titer |
| aQIV/aQIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | N1 (Day 1) | 1174.69 titer |
| aQIV/aQIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Victoria (Day 181) | 1424.38 titer |
| aQIV/aQIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | N1 (Day 181) | 2477.65 titer |
| aQIV/aQIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | N2 (Day 1) | 204.59 titer |
| aQIV/aQIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | N1 (Day 22) | 3403.72 titer |
| aQIV/aQIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Yamagata (Day 22) | 1288.67 titer |
| aQIV/aQIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | N2 (Day 22) | 915.19 titer |
| aQIV/aQIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | N2 (Day 181) | 505.91 titer |
| aQIV/aQIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Victoria (Day 1) | 497.11 titer |
| aQIV/QIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | N1 (Day 22) | 3161.01 titer |
| aQIV/QIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Victoria (Day 1) | 548.92 titer |
| aQIV/QIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | N2 (Day 1) | 289.86 titer |
| aQIV/QIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Victoria (Day 181) | 1587.86 titer |
| aQIV/QIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Yamagata (Day 1) | 282.17 titer |
| aQIV/QIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Victoria (Day 22) | 3336.65 titer |
| aQIV/QIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | N1 (Day 1) | 1209.21 titer |
| aQIV/QIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | N2 (Day 181) | 565.69 titer |
| aQIV/QIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | N2 (Day 22) | 1050.44 titer |
| aQIV/QIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | N1 (Day 181) | 1649.89 titer |
| aQIV/QIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Yamagata (Day 181) | 596.62 titer |
| aQIV/QIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Yamagata (Day 22) | 1250.88 titer |
| QIV/aQIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Victoria (Day 22) | 3331.87 titer |
| QIV/aQIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | N1 (Day 1) | 230.09 titer |
| QIV/aQIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | N1 (Day 22) | 3588.43 titer |
| QIV/aQIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | N1 (Day 181) | 2018.32 titer |
| QIV/aQIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | N2 (Day 1) | 86.08 titer |
| QIV/aQIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | N2 (Day 22) | 1242.36 titer |
| QIV/aQIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | N2 (Day 181) | 516.51 titer |
| QIV/aQIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Victoria (Day 1) | 306.48 titer |
| QIV/aQIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Victoria (Day 181) | 1443.37 titer |
| QIV/aQIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Yamagata (Day 1) | 148.35 titer |
| QIV/aQIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Yamagata (Day 22) | 1275.06 titer |
| QIV/aQIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Yamagata (Day 181) | 511.73 titer |
| QIV/QIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | N2 (Day 181) | 369.04 titer |
| QIV/QIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | N2 (Day 22) | 980.87 titer |
| QIV/QIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | N1 (Day 1) | 182.80 titer |
| QIV/QIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Yamagata (Day 1) | 126.07 titer |
| QIV/QIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | N2 (Day 1) | 86.34 titer |
| QIV/QIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | N1 (Day 181) | 870.73 titer |
| QIV/QIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Yamagata (Day 181) | 391.23 titer |
| QIV/QIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Yamagata (Day 22) | 883.66 titer |
| QIV/QIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Victoria (Day 22) | 2418.50 titer |
| QIV/QIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Victoria (Day 1) | 237.96 titer |
| QIV/QIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | N1 (Day 22) | 2410.65 titer |
| QIV/QIV | Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Victoria (Day 181) | 1030.77 titer |
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains
The GMR is the geometric mean of the fold increase in HI titer from Day 1 to Day 22 or Day 181. GMR and 95% CI were analyzed against homologous strains using ANCOVA with study specific covariates. Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Time frame: Day 22, Day 181
Population: The immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| aQIV/aQIV | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains | A/H1N1 (Day 22/Day 1) | 7.69 ratio |
| aQIV/aQIV | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains | A/H1N1 (Day 181/Day 1) | 3.11 ratio |
| aQIV/aQIV | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains | A/H3N2 (Day 22/Day 1) | 9.02 ratio |
| aQIV/aQIV | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains | A/H3N2 (Day 181/Day 1) | 5.44 ratio |
| aQIV/aQIV | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains | B/Yamagata (Day 22/Day 1) | 7.81 ratio |
| aQIV/aQIV | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains | B/Yamagata (Day 181/Day 1) | 2.74 ratio |
| aQIV/aQIV | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains | B/Victoria (Day 22/Day 1) | 7.86 ratio |
| aQIV/aQIV | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains | B/Victoria (Day 181/Day 1) | 2.59 ratio |
| aQIV/QIV | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains | B/Yamagata (Day 181/Day 1) | 2.44 ratio |
| aQIV/QIV | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains | B/Yamagata (Day 22/Day 1) | 6.58 ratio |
| aQIV/QIV | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains | A/H1N1 (Day 181/Day 1) | 2.61 ratio |
| aQIV/QIV | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains | B/Victoria (Day 181/Day 1) | 2.33 ratio |
| aQIV/QIV | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains | B/Victoria (Day 22/Day 1) | 6.64 ratio |
| aQIV/QIV | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains | A/H3N2 (Day 181/Day 1) | 5.50 ratio |
| aQIV/QIV | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains | A/H3N2 (Day 22/Day 1) | 9.69 ratio |
| aQIV/QIV | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains | A/H1N1 (Day 22/Day 1) | 6.44 ratio |
| QIV/aQIV | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains | B/Victoria (Day 22/Day 1) | 6.70 ratio |
| QIV/aQIV | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains | A/H3N2 (Day 22/Day 1) | 9.08 ratio |
| QIV/aQIV | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains | A/H3N2 (Day 181/Day 1) | 4.72 ratio |
| QIV/aQIV | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains | B/Yamagata (Day 22/Day 1) | 6.26 ratio |
| QIV/aQIV | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains | B/Yamagata (Day 181/Day 1) | 2.07 ratio |
| QIV/aQIV | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains | B/Victoria (Day 181/Day 1) | 2.12 ratio |
| QIV/aQIV | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains | A/H1N1 (Day 22/Day 1) | 7.61 ratio |
| QIV/aQIV | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains | A/H1N1 (Day 181/Day 1) | 2.72 ratio |
| QIV/QIV | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains | A/H3N2 (Day 22/Day 1) | 8.54 ratio |
| QIV/QIV | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains | A/H3N2 (Day 181/Day 1) | 4.67 ratio |
| QIV/QIV | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains | A/H1N1 (Day 181/Day 1) | 1.95 ratio |
| QIV/QIV | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains | A/H1N1 (Day 22/Day 1) | 5.47 ratio |
| QIV/QIV | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains | B/Yamagata (Day 22/Day 1) | 4.41 ratio |
| QIV/QIV | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains | B/Victoria (Day 181/Day 1) | 1.61 ratio |
| QIV/QIV | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains | B/Victoria (Day 22/Day 1) | 4.94 ratio |
| QIV/QIV | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains | B/Yamagata (Day 181/Day 1) | 1.60 ratio |
Immunogenicity Endpoint: GMR as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 Against Heterologous Strains
The GMR is the geometric mean of the fold increase in HI titer from Day 1 to Day 22 or Day 181. GMR and 95% CI were analyzed for the heterologous strains using ANCOVA with study specific covariates. The two heterologous strains selected for HI testing in this study were the H3N2 strain, A/Hong Kong/4801/2014 (X-263B), and the B Victoria lineage strain, B/Malaysia/2506/2004.
Time frame: Day 22/Day 1 and Day 181/Day 1
Population: The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| aQIV/aQIV | Immunogenicity Endpoint: GMR as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 Against Heterologous Strains | A/H3N2 (Day 22/Day 1) | 14.67 ratio |
| aQIV/aQIV | Immunogenicity Endpoint: GMR as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 Against Heterologous Strains | A/H3N2 (Day 181/Day 1) | 5.31 ratio |
| aQIV/aQIV | Immunogenicity Endpoint: GMR as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 Against Heterologous Strains | B/Victoria (Day 181/Day 1) | 4.38 ratio |
| aQIV/aQIV | Immunogenicity Endpoint: GMR as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 Against Heterologous Strains | B/Victoria (Day 22/Day 1) | 13.40 ratio |
| aQIV/QIV | Immunogenicity Endpoint: GMR as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 Against Heterologous Strains | A/H3N2 (Day 181/Day 1) | 5.42 ratio |
| aQIV/QIV | Immunogenicity Endpoint: GMR as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 Against Heterologous Strains | A/H3N2 (Day 22/Day 1) | 14.55 ratio |
| aQIV/QIV | Immunogenicity Endpoint: GMR as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 Against Heterologous Strains | B/Victoria (Day 22/Day 1) | 10.18 ratio |
| aQIV/QIV | Immunogenicity Endpoint: GMR as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 Against Heterologous Strains | B/Victoria (Day 181/Day 1) | 3.50 ratio |
| QIV/aQIV | Immunogenicity Endpoint: GMR as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 Against Heterologous Strains | A/H3N2 (Day 181/Day 1) | 5.63 ratio |
| QIV/aQIV | Immunogenicity Endpoint: GMR as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 Against Heterologous Strains | B/Victoria (Day 22/Day 1) | 11.60 ratio |
| QIV/aQIV | Immunogenicity Endpoint: GMR as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 Against Heterologous Strains | A/H3N2 (Day 22/Day 1) | 13.40 ratio |
| QIV/aQIV | Immunogenicity Endpoint: GMR as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 Against Heterologous Strains | B/Victoria (Day 181/Day 1) | 3.17 ratio |
| QIV/QIV | Immunogenicity Endpoint: GMR as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 Against Heterologous Strains | A/H3N2 (Day 22/Day 1) | 12.63 ratio |
| QIV/QIV | Immunogenicity Endpoint: GMR as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 Against Heterologous Strains | A/H3N2 (Day 181/Day 1) | 4.68 ratio |
| QIV/QIV | Immunogenicity Endpoint: GMR as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 Against Heterologous Strains | B/Victoria (Day 22/Day 1) | 8.39 ratio |
| QIV/QIV | Immunogenicity Endpoint: GMR as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 Against Heterologous Strains | B/Victoria (Day 181/Day 1) | 2.29 ratio |
Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains
The GMR is the geometric mean of the fold increase in MN titer from Day 1 to Day 22 or Day 181. GMR and 95% CI were analyzed for the homologous strains using ANCOVA with study specific covariates. Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Time frame: Day 22/Day 1 and Day 181/Day 1
Population: The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| aQIV/aQIV | Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | A/H1N1 (Day 22/Day 1) | 11.85 ratio |
| aQIV/aQIV | Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | A/H1N1 (Day 181/Day 1) | 3.67 ratio |
| aQIV/aQIV | Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | A/H3N2 (Day 22/Day 1) | 28.19 ratio |
| aQIV/aQIV | Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | A/H3N2 (Day 181/Day 1) | 10.63 ratio |
| aQIV/aQIV | Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | B/Yamagata (Day 22/Day 1) | 14.11 ratio |
| aQIV/aQIV | Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | B/Yamagata (Day 181/Day 1) | 3.97 ratio |
| aQIV/aQIV | Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | B/Victoria (Day 22/Day 1) | 9.43 ratio |
| aQIV/aQIV | Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | B/Victoria (Day 181/Day 1) | 3.25 ratio |
| aQIV/QIV | Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | A/H3N2 (Day 181/Day 1) | 10.93 ratio |
| aQIV/QIV | Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | A/H1N1 (Day 22/Day 1) | 12.07 ratio |
| aQIV/QIV | Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | B/Victoria (Day 22/Day 1) | 9.20 ratio |
| aQIV/QIV | Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | A/H1N1 (Day 181/Day 1) | 3.66 ratio |
| aQIV/QIV | Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | B/Victoria (Day 181/Day 1) | 2.77 ratio |
| aQIV/QIV | Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | B/Yamagata (Day 22/Day 1) | 10.95 ratio |
| aQIV/QIV | Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | A/H3N2 (Day 22/Day 1) | 33.88 ratio |
| aQIV/QIV | Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | B/Yamagata (Day 181/Day 1) | 3.84 ratio |
| QIV/aQIV | Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | B/Victoria (Day 181/Day 1) | 2.51 ratio |
| QIV/aQIV | Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | B/Victoria (Day 22/Day 1) | 8.97 ratio |
| QIV/aQIV | Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | A/H1N1 (Day 22/Day 1) | 15.73 ratio |
| QIV/aQIV | Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | A/H3N2 (Day 181/Day 1) | 10.99 ratio |
| QIV/aQIV | Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | B/Yamagata (Day 22/Day 1) | 8.99 ratio |
| QIV/aQIV | Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | B/Yamagata (Day 181/Day 1) | 3.07 ratio |
| QIV/aQIV | Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | A/H1N1 (Day 181/Day 1) | 3.47 ratio |
| QIV/aQIV | Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | A/H3N2 (Day 22/Day 1) | 25.57 ratio |
| QIV/QIV | Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | A/H1N1 (Day 181/Day 1) | 2.08 ratio |
| QIV/QIV | Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | A/H3N2 (Day 22/Day 1) | 23.93 ratio |
| QIV/QIV | Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | A/H3N2 (Day 181/Day 1) | 8.72 ratio |
| QIV/QIV | Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | B/Yamagata (Day 22/Day 1) | 7.18 ratio |
| QIV/QIV | Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | B/Yamagata (Day 181/Day 1) | 2.08 ratio |
| QIV/QIV | Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | B/Victoria (Day 181/Day 1) | 1.58 ratio |
| QIV/QIV | Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | A/H1N1 (Day 22/Day 1) | 8.11 ratio |
| QIV/QIV | Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains | B/Victoria (Day 22/Day 1) | 5.12 ratio |
Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 181 Against Homologous Strains (aQIV-primed and QIV-primed Comparison)
GMT and 95% CI were analyzed for Day 181 against homologous strains using ANCOVA with study specific covariates. Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Time frame: Day 181
Population: The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| aQIV/aQIV | Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 181 Against Homologous Strains (aQIV-primed and QIV-primed Comparison) | A/H1N1 | 489.45 titer |
| aQIV/aQIV | Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 181 Against Homologous Strains (aQIV-primed and QIV-primed Comparison) | A/H3N2 | 1423.38 titer |
| aQIV/aQIV | Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 181 Against Homologous Strains (aQIV-primed and QIV-primed Comparison) | B/Yamagata | 97.01 titer |
| aQIV/aQIV | Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 181 Against Homologous Strains (aQIV-primed and QIV-primed Comparison) | B/Victoria | 128.32 titer |
| aQIV/QIV | Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 181 Against Homologous Strains (aQIV-primed and QIV-primed Comparison) | A/H3N2 | 1438.40 titer |
| aQIV/QIV | Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 181 Against Homologous Strains (aQIV-primed and QIV-primed Comparison) | B/Yamagata | 86.43 titer |
| aQIV/QIV | Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 181 Against Homologous Strains (aQIV-primed and QIV-primed Comparison) | B/Victoria | 115.26 titer |
| aQIV/QIV | Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 181 Against Homologous Strains (aQIV-primed and QIV-primed Comparison) | A/H1N1 | 411.72 titer |
| QIV/aQIV | Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 181 Against Homologous Strains (aQIV-primed and QIV-primed Comparison) | B/Yamagata | 73.37 titer |
| QIV/aQIV | Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 181 Against Homologous Strains (aQIV-primed and QIV-primed Comparison) | A/H3N2 | 1233.84 titer |
| QIV/aQIV | Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 181 Against Homologous Strains (aQIV-primed and QIV-primed Comparison) | B/Victoria | 104.93 titer |
| QIV/aQIV | Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 181 Against Homologous Strains (aQIV-primed and QIV-primed Comparison) | A/H1N1 | 429.06 titer |
| QIV/QIV | Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 181 Against Homologous Strains (aQIV-primed and QIV-primed Comparison) | B/Victoria | 79.76 titer |
| QIV/QIV | Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 181 Against Homologous Strains (aQIV-primed and QIV-primed Comparison) | A/H3N2 | 1222.21 titer |
| QIV/QIV | Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 181 Against Homologous Strains (aQIV-primed and QIV-primed Comparison) | A/H1N1 | 307.36 titer |
| QIV/QIV | Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 181 Against Homologous Strains (aQIV-primed and QIV-primed Comparison) | B/Yamagata | 56.57 titer |
Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (QIV-primed Comparison)
GMT and 95% CI were analyzed for Day 22 against homologous strains using ANCOVA with study specific covariates. Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Time frame: Day 22
Population: The immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| aQIV/aQIV | Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (QIV-primed Comparison) | A/H1N1 | 1206.20 titer |
| aQIV/aQIV | Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (QIV-primed Comparison) | A/H3N2 | 2369.95 titer |
| aQIV/aQIV | Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (QIV-primed Comparison) | B/Yamagata | 221.54 titer |
| aQIV/aQIV | Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (QIV-primed Comparison) | B/Victoria | 330.94 titer |
| aQIV/QIV | Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (QIV-primed Comparison) | B/Victoria | 244.03 titer |
| aQIV/QIV | Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (QIV-primed Comparison) | A/H1N1 | 866.51 titer |
| aQIV/QIV | Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (QIV-primed Comparison) | B/Yamagata | 156.01 titer |
| aQIV/QIV | Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (QIV-primed Comparison) | A/H3N2 | 2229.48 titer |
Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains
GMT and 95% CI were analyzed for Day 22 for the heterologous strains using ANCOVA with study specific covariates. The two heterologous strains selected for HI testing in this study were the H3N2 strain, A/Hong Kong/4801/2014 (X-263B), and the B/ Victoria lineage strain, B/Malaysia/2506/2004.
Time frame: Day 1, Day 22, Day 181
Population: The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| aQIV/aQIV | Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains | A/H3N2 (Day 1) | 97.7 titer |
| aQIV/aQIV | Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains | A/H3N2 (Day 22) | 2436.1 titer |
| aQIV/aQIV | Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains | A/H3N2 (Day 181) | 898.1 titer |
| aQIV/aQIV | Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains | B/Victoria (Day 1) | 33.4 titer |
| aQIV/aQIV | Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains | B/Victoria (Day 22) | 327.1 titer |
| aQIV/aQIV | Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains | B/Victoria (Day 181) | 107.1 titer |
| aQIV/QIV | Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains | B/Victoria (Day 181) | 85.6 titer |
| aQIV/QIV | Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains | B/Victoria (Day 1) | 23.8 titer |
| aQIV/QIV | Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains | A/H3N2 (Day 1) | 156.6 titer |
| aQIV/QIV | Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains | A/H3N2 (Day 181) | 917.6 titer |
| aQIV/QIV | Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains | A/H3N2 (Day 22) | 2415.2 titer |
| aQIV/QIV | Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains | B/Victoria (Day 22) | 248.4 titer |
| QIV/aQIV | Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains | A/H3N2 (Day 22) | 2225.1 titer |
| QIV/aQIV | Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains | A/H3N2 (Day 181) | 953.2 titer |
| QIV/aQIV | Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains | B/Victoria (Day 1) | 15.8 titer |
| QIV/aQIV | Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains | B/Victoria (Day 181) | 77.5 titer |
| QIV/aQIV | Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains | B/Victoria (Day 22) | 283.2 titer |
| QIV/aQIV | Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains | A/H3N2 (Day 1) | 40.9 titer |
| QIV/QIV | Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains | B/Victoria (Day 22) | 204.8 titer |
| QIV/QIV | Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains | B/Victoria (Day 181) | 56.0 titer |
| QIV/QIV | Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains | A/H3N2 (Day 22) | 2097.2 titer |
| QIV/QIV | Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains | B/Victoria (Day 1) | 15.9 titer |
| QIV/QIV | Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains | A/H3N2 (Day 1) | 91.6 titer |
| QIV/QIV | Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains | A/H3N2 (Day 181) | 791.7 titer |
Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains
To further characterize immune response, MN GMT and 95% CI were analyzed for Day 1, Day 22, and Day 181 against homologous strains. Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Time frame: Day 1, Day 22, Day 181
Population: The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| aQIV/aQIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Victoria (Day 1) | 43.66 titer |
| aQIV/aQIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Victoria (Day 181) | 124.31 titer |
| aQIV/aQIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Yamagata (Day 22) | 388.29 titer |
| aQIV/aQIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | A/H1N1 (Day 1) | 264.36 titer |
| aQIV/aQIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Yamagata (Day 181) | 107.05 titer |
| aQIV/aQIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | A/H1N1 (Day 181) | 727.04 titer |
| aQIV/aQIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | A/H3N2 (Day 1) | 160.88 titer |
| aQIV/aQIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | A/H1N1 (Day 22) | 2253.81 titer |
| aQIV/aQIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Victoria (Day 22) | 355.63 titer |
| aQIV/aQIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | A/H3N2 (Day 22) | 5532.06 titer |
| aQIV/aQIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | A/H3N2 (Day 181) | 2069.22 titer |
| aQIV/aQIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Yamagata (Day 1) | 29.82 titer |
| aQIV/QIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | A/H1N1 (Day 22) | 2295.46 titer |
| aQIV/QIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Yamagata (Day 1) | 37.99 titer |
| aQIV/QIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | A/H3N2 (Day 1) | 113.74 titer |
| aQIV/QIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Yamagata (Day 181) | 103.59 titer |
| aQIV/QIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Victoria (Day 1) | 43.13 titer |
| aQIV/QIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Yamagata (Day 22) | 301.39 titer |
| aQIV/QIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | A/H1N1 (Day 1) | 198.13 titer |
| aQIV/QIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | A/H3N2 (Day 181) | 2127.88 titer |
| aQIV/QIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | A/H3N2 (Day 22) | 6649.94 titer |
| aQIV/QIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | A/H1N1 (Day 181) | 725.35 titer |
| aQIV/QIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Victoria (Day 181) | 106.08 titer |
| aQIV/QIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Victoria (Day 22) | 346.99 titer |
| QIV/aQIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Yamagata (Day 22) | 247.31 titer |
| QIV/aQIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | A/H1N1 (Day 1) | 104.28 titer |
| QIV/aQIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | A/H1N1 (Day 22) | 2992.29 titer |
| QIV/aQIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | A/H1N1 (Day 181) | 686.98 titer |
| QIV/aQIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | A/H3N2 (Day 1) | 133.25 titer |
| QIV/aQIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | A/H3N2 (Day 22) | 5019.51 titer |
| QIV/aQIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | A/H3N2 (Day 181) | 2138.80 titer |
| QIV/aQIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Yamagata (Day 1) | 21.57 titer |
| QIV/aQIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Yamagata (Day 181) | 82.90 titer |
| QIV/aQIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Victoria (Day 1) | 27.96 titer |
| QIV/aQIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Victoria (Day 22) | 338.49 titer |
| QIV/aQIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Victoria (Day 181) | 95.87 titer |
| QIV/QIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | A/H3N2 (Day 181) | 1696.57 titer |
| QIV/QIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | A/H3N2 (Day 22) | 4696.37 titer |
| QIV/QIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | A/H1N1 (Day 1) | 140.38 titer |
| QIV/QIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Victoria (Day 1) | 33.14 titer |
| QIV/QIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | A/H3N2 (Day 1) | 97.47 titer |
| QIV/QIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | A/H1N1 (Day 181) | 412.34 titer |
| QIV/QIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Victoria (Day 181) | 60.54 titer |
| QIV/QIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Victoria (Day 22) | 193.09 titer |
| QIV/QIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Yamagata (Day 22) | 197.51 titer |
| QIV/QIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Yamagata (Day 1) | 21.07 titer |
| QIV/QIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | A/H1N1 (Day 22) | 1543.54 titer |
| QIV/QIV | Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains | B/Yamagata (Day 181) | 56.03 titer |
Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains
The percentage of subjects achieving anti-NA titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 after vaccination is reported against homologous strains Strains tested: N1 (PR8 H6N1 California/07/2009), N2 (PR8 H6N2 Switzerl/9715293/2013); B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Time frame: Day 22, Day 181
Population: The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:320 (Day 22) | 98.21 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:20 (Day 181) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:640 (Day 22) | 85.71 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:40 (Day 181) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:160 (Day 181) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:320 (Day 22) | 94.64 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:160 (Day 22) | 98.21 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:80 (Day 181) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:320 (Day 22) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:80 (Day 22) | 98.21 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:40 (Day 22) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:160 (Day 181) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:160 (Day 22) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:20 (Day 22) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:640 (Day 181) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:320 (Day 181) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:640 (Day 22) | 91.07 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:40 (Day 181) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:80 (Day 22) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:40 (Day 22) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:20 (Day 181) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:640 (Day 181) | 89.09 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:20 (Day 22) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:20 (Day 22) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:80 (Day 181) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:640 (Day 181) | 72.73 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:320 (Day 181) | 92.73 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:40 (Day 22) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:40 (Day 181) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:160 (Day 181) | 98.18 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:160 (Day 22) | 98.21 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:80 (Day 22) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:80 (Day 181) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:80 (Day 22) | 98.21 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:40 (Day 22) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:160 (Day 22) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:320 (Day 181) | 94.55 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:20 (Day 22) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:640 (Day 181) | 70.91 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:320 (Day 22) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:20 (Day 181) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:320 (Day 181) | 80.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:160 (Day 181) | 85.45 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1,≥1:640 (Day 22) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:640 (Day 22) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:80 (Day 181) | 94.55 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:40 (Day 181) | 98.18 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:20 (Day 181) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:20 (Day 181) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:40 (Day 181) | 98.33 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:80 (Day 181) | 98.33 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:320 (Day 22) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:640 (Day 22) | 91.80 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:20 (Day 181) | 98.33 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:20 (Day 22) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:40 (Day 22) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:80 (Day 22) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:160 (Day 22) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:320 (Day 22) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1,≥1:640 (Day 22) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:160 (Day 22) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:40 (Day 181) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:80 (Day 181) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:160 (Day 181) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:320 (Day 181) | 96.72 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:640 (Day 181) | 93.44 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:20 (Day 22) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:40 (Day 22) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:80 (Day 22) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:160 (Day 22) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:320 (Day 22) | 96.77 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:640 (Day 22) | 88.71 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:20 (Day 181) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:40 (Day 181) | 98.33 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:80 (Day 181) | 98.33 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:160 (Day 181) | 95.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:320 (Day 181) | 85.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:640 (Day 181) | 81.67 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:20 (Day 22) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:40 (Day 22) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:80 (Day 22) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:160 (Day 181) | 96.67 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:320 (Day 181) | 86.67 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:640 (Day 181) | 61.67 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:20 (Day 22) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:40 (Day 22) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:80 (Day 22) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:160 (Day 22) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:320 (Day 22) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:640 (Day 22) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:20 (Day 181) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:40 (Day 181) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:80 (Day 181) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:160 (Day 181) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:320 (Day 181) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:640 (Day 181) | 95.08 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:160 (Day 181) | 96.55 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:20 (Day 181) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:320 (Day 181) | 95.55 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:40 (Day 181) | 89.66 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1,≥1:640 (Day 22) | 98.31 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:20 (Day 181) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:80 (Day 181) | 86.21 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:160 (Day 181) | 81.03 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:320 (Day 22) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:320 (Day 181) | 67.24 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:640 (Day 181) | 55.17 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:160 (Day 22) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:40 (Day 181) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:20 (Day 22) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:40 (Day 22) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:80 (Day 22) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:40 (Day 181) | 98.28 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:80 (Day 22) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:40 (Day 22) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:160 (Day 22) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:160 (Day 181) | 91.38 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:80 (Day 181) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:320 (Day 181) | 84.48 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:20 (Day 22) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:640 (Day 181) | 51.72 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:20 (Day 181) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:20 (Day 22) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:40 (Day 22) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:640 (Day 22) | 89.83 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:160 (Day 181) | 96.55 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:80 (Day 22) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:160 (Day 22) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:320 (Day 22) | 96.61 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:320 (Day 181) | 93.10 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:640 (Day 181) | 72.41 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:80 (Day 181) | 96.55 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:320 (Day 22) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:20 (Day 22) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:40 (Day 22) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:80 (Day 181) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:80 (Day 22) | 98.31 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:640 (Day 181) | 81.03 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:160 (Day 22) | 98.31 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:40 (Day 181) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:640 (Day 22) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:320 (Day 22) | 94.92 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:640 (Day 22) | 79.66 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:20 (Day 181) | 100.00 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:320 (Day 22) | 85.00 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:20 (Day 181) | 100.00 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:20 (Day 181) | 90.00 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1,≥1:640 (Day 22) | 85.00 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:20 (Day 22) | 100.00 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:20 (Day 22) | 100.00 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:40 (Day 181) | 88.33 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:640 (Day 22) | 66.67 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:640 (Day 181) | 70.00 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:80 (Day 181) | 86.67 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:80 (Day 181) | 80.00 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:320 (Day 22) | 88.33 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:20 (Day 181) | 100.00 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:40 (Day 22) | 100.00 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:160 (Day 181) | 70.00 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:320 (Day 22) | 98.33 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:40 (Day 181) | 96.67 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:160 (Day 22) | 90.00 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:320 (Day 181) | 61.67 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:160 (Day 22) | 93.33 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:320 (Day 181) | 83.33 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:40 (Day 22) | 100.00 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:640 (Day 181) | 50.00 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:80 (Day 22) | 100.00 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:320 (Day 22) | 88.33 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:160 (Day 181) | 96.67 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:20 (Day 22) | 100.00 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:80 (Day 22) | 98.33 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:40 (Day 181) | 100.00 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:20 (Day 181) | 93.33 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:40 (Day 22) | 100.00 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:160 (Day 22) | 100.00 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:80 (Day 181) | 90.00 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:640 (Day 22) | 91.67 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:80 (Day 22) | 100.00 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:40 (Day 22) | 98.33 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:320 (Day 181) | 70.00 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:160 (Day 181) | 81.67 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:160 (Day 22) | 98.33 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:160 (Day 181) | 81.67 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:20 (Day 22) | 100.00 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:80 (Day 22) | 96.67 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:640 (Day 181) | 51.67 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:320 (Day 181) | 65.00 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N1, ≥1:40 (Day 181) | 91.67 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Victoria, ≥1:80 (Day 181) | 100.00 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | N2, ≥1:640 (Day 22) | 68.33 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains | B/Yamagata, ≥1:640 (Day 181) | 40.00 percentage of subjects |
Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains
The percentage of subjects achieving HI titer ≥1:40 at Day 22 and Day 181 after vaccination and the percentage of subject who experienced seroconversion is reported for homologous strains. Seroconversion was defined in subjects seronegative at baseline (i.e. HI titer \<1:10 on Day 1) as post-vaccination HI titer ≥1:40 and defined in subjects seropositive at baseline (i.e. HI titer ≥1:10 on Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer. The two heterologous strains selected for HI testing in this study were the H3N2 strain, A/Hong Kong/4801/2014 (X-263B), and the B/Victoria lineage strain, B/Malaysia/2506/2004.
Time frame: Day 22, Day 181
Population: The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains | A/H3N2, SCR (Day 22) | 78.3 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains | A/ H3N2, HI titer ≥1:40 (Day 22) | 100 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains | A/ H3N2, HI titer ≥1:40 (Day 181) | 100 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains | B/Victoria, SCR (Day 22) | 75.0 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains | B/Victoria, HI titer ≥1:40 (Day 22) | 98.3 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains | B/ Victoria, HI titer ≥1:40 (Day 181) | 91.4 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains | B/ Victoria, HI titer ≥1:40 (Day 181) | 83.6 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains | B/Victoria, SCR (Day 22) | 82.1 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains | A/H3N2, SCR (Day 22) | 73.7 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains | A/ H3N2, HI titer ≥1:40 (Day 181) | 100 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains | A/ H3N2, HI titer ≥1:40 (Day 22) | 100 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains | B/Victoria, HI titer ≥1:40 (Day 22) | 100 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains | A/ H3N2, HI titer ≥1:40 (Day 22) | 100 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains | A/ H3N2, HI titer ≥1:40 (Day 181) | 100 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains | B/Victoria, SCR (Day 22) | 81.4 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains | B/ Victoria, HI titer ≥1:40 (Day 181) | 74.1 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains | B/Victoria, HI titer ≥1:40 (Day 22) | 96.6 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains | A/H3N2, SCR (Day 22) | 83.1 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains | B/Victoria, HI titer ≥1:40 (Day 22) | 98.3 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains | B/ Victoria, HI titer ≥1:40 (Day 181) | 64.3 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains | A/ H3N2, HI titer ≥1:40 (Day 22) | 100 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains | B/Victoria, SCR (Day 22) | 77.6 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains | A/H3N2, SCR (Day 22) | 69.0 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains | A/ H3N2, HI titer ≥1:40 (Day 181) | 98.2 percentage of subjects |
Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains
The percentage of subjects achieving HI titer ≥1:40 at Day 22 and Day 181 after vaccination is reported against homologous strains. Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Time frame: Day 22, Day 181
Population: The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains | A/H1N1 (Day 22) | 100 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains | A/H1N1 (Day 181) | 100 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains | A/H3N2 (Day 22) | 100 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains | A/H3N2 (Day 181) | 99.8 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata (Day 22) | 98.5 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata (Day 181) | 94.3 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains | B/Victoria (Day 22) | 99.9 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains | B/Victoria (Day 181) | 95.3 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata (Day 181) | 93.9 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata (Day 22) | 98.7 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains | A/H1N1 (Day 181) | 99.2 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains | B/Victoria (Day 181) | 93.9 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains | B/Victoria (Day 22) | 100 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains | A/H3N2 (Day 181) | 100 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains | A/H3N2 (Day 22) | 100 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains | A/H1N1 (Day 22) | 100 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains | B/Victoria (Day 22) | 99.5 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains | A/H3N2 (Day 22) | 100 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains | A/H3N2 (Day 181) | 100 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata (Day 22) | 98.5 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata (Day 181) | 83.9 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains | B/Victoria (Day 181) | 86.7 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains | A/H1N1 (Day 22) | 100 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains | A/H1N1 (Day 181) | 99.2 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains | A/H3N2 (Day 22) | 100 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains | A/H3N2 (Day 181) | 98.7 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains | A/H1N1 (Day 181) | 95.9 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains | A/H1N1 (Day 22) | 99.7 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata (Day 22) | 96.6 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains | B/Victoria (Day 181) | 76.9 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains | B/Victoria (Day 22) | 97.9 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata (Day 181) | 76.1 percentage of subjects |
Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains
The percentage of subjects achieving MN titer ≥1:20, ≥1:40, ≥1:80 ≥1:160, ≥1:320 and ≥1:640 at Day 22 and Day 181 after vaccination is reported against homologous strains. Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Time frame: Day 22, Day 181
Population: The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data (MN titer ≥1:20, ≥1:40, ≥1:80, \>four-fold rise), and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:20 (Day 22) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/ H1N1, ≥1:40 (Day 22) | 98.31 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H1N1, ≥1:80 (Day 22) | 98.31 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H1N1, ≥1:160 (Day 22) | 98.31 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H1N1, ≥1:320 (Day 22) | 96.61 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H1N1, ≥1:640 (Day 22) | 96.61 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H1N1, ≥1:20 (Day 181) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H1N1, ≥1:40 (Day 181) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H1N1, ≥1:80 (Day 181) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H1N1, ≥1:160 (Day 181) | 96.67 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H1N1, ≥1:320 (Day 181) | 91.67 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H1N1, ≥1:640 (Day 181) | 80.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/ H1N1, ≥1:20 (Day 22) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:40 (Day 22) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:80 (Day 22) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:160 (Day 22) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:320 (Day 22) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:640 (Day 22) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:20 (Day 181) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:40 (Day 181) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:80 (Day 181) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:160 (Day 181) | 96.67 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:320 (Day 181) | 91.67 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:640 (Day 181) | 86.67 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:20 (Day 22) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:40 (Day 22) | 98.33 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:80 (Day 22) | 95.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:160 (Day 22) | 91.67 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:320 (Day 22) | 75.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:640 (Day 22) | 58.33 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:20 (Day 181) | 98.33 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:40 (Day 181) | 93.33 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:80 (Day 181) | 71.67 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:160 (Day 181) | 45.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:320 (Day 181) | 25.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:640 (Day 181) | 3.33 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:20 (Day 22) | 98.31 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:40 (Day 22) | 94.92 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:80 (Day 22) | 91.53 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:160 (Day 22) | 86.44 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:320 (Day 22) | 74.58 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:640 (Day 22) | 49.15 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:20 (Day 181) | 100.00 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:40 (Day 181) | 86.67 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:80 (Day 181) | 78.33 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:160 (Day 181) | 58.33 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:320 (Day 181) | 31.67 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:640 (Day 181) | 8.33 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:20 (Day 22) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:20 (Day 22) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:320 (Day 22) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:640 (Day 181) | 15.52 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:20 (Day 181) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:40 (Day 22) | 98.31 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H1N1, ≥1:40 (Day 181) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:640 (Day 181) | 8.62 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H1N1, ≥1:20 (Day 181) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:80 (Day 22) | 96.61 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:320 (Day 22) | 67.80 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:320 (Day 181) | 24.14 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:160 (Day 181) | 48.28 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:160 (Day 22) | 86.44 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:640 (Day 22) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:80 (Day 181) | 63.79 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:80 (Day 181) | 72.41 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:320 (Day 22) | 72.88 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H1N1, ≥1:320 (Day 181) | 91.38 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:40 (Day 181) | 93.10 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:40 (Day 181) | 87.93 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:640 (Day 22) | 47.46 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H1N1, ≥1:640 (Day 22) | 98.31 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:20 (Day 181) | 96.55 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H1N1, ≥1:640 (Day 181) | 63.79 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:20 (Day 181) | 98.28 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:80 (Day 22) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:40 (Day 22) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H1N1, ≥1:320 (Day 22) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:40 (Day 181) | 98.28 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:160 (Day 22) | 86.44 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:160 (Day 181) | 43.10 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:320 (Day 181) | 20.69 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:80 (Day 181) | 98.28 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H1N1, ≥1:160 (Day 181) | 98.28 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H1N1, ≥1:160 (Day 22) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:640 (Day 22) | 42.37 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:160 (Day 181) | 98.28 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:80 (Day 22) | 96.61 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H1N1, ≥1:80 (Day 22) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:160 (Day 22) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:320 (Day 181) | 94.83 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:40 (Day 22) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/ H1N1, ≥1:40 (Day 22) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:20 (Day 22) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:640 (Day 181) | 86.21 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H1N1, ≥1:80 (Day 181) | 100.00 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/ H1N1, ≥1:20 (Day 22) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:320 (Day 22) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:20 (Day 22) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:40 (Day 22) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:160 (Day 22) | 81.67 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:80 (Day 22) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:160 (Day 22) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:640 (Day 181) | 12.07 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:640 (Day 22) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:320 (Day 22) | 58.33 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:20 (Day 181) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:40 (Day 181) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:80 (Day 181) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:160 (Day 181) | 96.55 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:640 (Day 22) | 33.33 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:320 (Day 181) | 93.10 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:640 (Day 181) | 84.48 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:320 (Day 181) | 18.97 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:20 (Day 22) | 96.67 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:40 (Day 22) | 96.67 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:20 (Day 181) | 98.28 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:80 (Day 22) | 95.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:160 (Day 22) | 78.33 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:320 (Day 22) | 65.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:640 (Day 22) | 31.67 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:40 (Day 181) | 74.14 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:20 (Day 181) | 93.10 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:40 (Day 181) | 79.31 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:80 (Day 181) | 56.90 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:160 (Day 181) | 32.76 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:80 (Day 181) | 44.83 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:320 (Day 181) | 15.52 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:640 (Day 181) | 5.17 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/ H1N1, ≥1:20 (Day 22) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/ H1N1, ≥1:40 (Day 22) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:20 (Day 22) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H1N1, ≥1:80 (Day 22) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H1N1, ≥1:160 (Day 22) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H1N1, ≥1:320 (Day 22) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H1N1, ≥1:640 (Day 22) | 91.67 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:40 (Day 22) | 96.67 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H1N1, ≥1:20 (Day 181) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H1N1, ≥1:40 (Day 181) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:160 (Day 181) | 27.59 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H1N1, ≥1:80 (Day 181) | 100.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H1N1, ≥1:160 (Day 181) | 94.83 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:80 (Day 22) | 90.00 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H1N1, ≥1:320 (Day 181) | 84.48 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H1N1, ≥1:640 (Day 181) | 55.17 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:20 (Day 22) | 96.55 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:640 (Day 181) | 83.93 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H1N1, ≥1:640 (Day 181) | 48.28 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/ H1N1, ≥1:20 (Day 22) | 100.00 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:640 (Day 22) | 22.03 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:320 (Day 181) | 85.71 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:160 (Day 22) | 98.28 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/ H1N1, ≥1:40 (Day 22) | 100.00 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H1N1, ≥1:320 (Day 181) | 63.79 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:160 (Day 181) | 89.29 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H1N1, ≥1:80 (Day 181) | 93.10 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H1N1, ≥1:80 (Day 22) | 98.31 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:20 (Day 22) | 98.31 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:80 (Day 181) | 91.07 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:160 (Day 22) | 69.49 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H1N1, ≥1:160 (Day 22) | 94.92 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:40 (Day 181) | 96.43 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:320 (Day 22) | 35.59 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:80 (Day 22) | 98.28 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H1N1, ≥1:320 (Day 22) | 94.92 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:20 (Day 181) | 98.21 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:640 (Day 22) | 98.28 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:80 (Day 22) | 84.75 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H1N1, ≥1:640 (Day 22) | 81.36 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H1N1, ≥1:160 (Day 181) | 81.03 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:640 (Day 22) | 24.14 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:320 (Day 22) | 98.28 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:20 (Day 181) | 80.36 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:40 (Day 181) | 60.71 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:320 (Day 22) | 50.00 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:20 (Day 22) | 98.28 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:40 (Day 181) | 71.43 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:640 (Day 181) | 5.36 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:320 (Day 181) | 8.93 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H1N1, ≥1:20 (Day 181) | 98.28 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:80 (Day 181) | 46.43 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:160 (Day 22) | 70.69 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:20 (Day 181) | 96.43 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:40 (Day 22) | 93.22 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:160 (Day 181) | 17.86 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:160 (Day 181) | 23.21 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:80 (Day 22) | 89.66 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H3N2, ≥1:40 (Day 22) | 98.28 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:320 (Day 181) | 7.14 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Victoria, ≥1:80 (Day 181) | 41.07 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:40 (Day 22) | 93.10 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | A/H1N1, ≥1:40 (Day 181) | 96.55 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains | B/Yamagata, ≥1:640 (Day 181) | 3.57 percentage of subjects |
Immunogenicity Endpoint: Seroconversion Rate (SCR) on Day 22 Against Homologous Strains (aQIV-primed and QIV-primed Comparison)
The percentage of subjects achieving seroconversion at Day 22 after vaccination is reported against homologous strains. Seroconversion was defined in subjects seronegative at baseline (i.e. HI titer \<1:10 on Day 1) as postvaccination HI titer ≥1:40 and defined in subjects seropositive at baseline (i.e. HI titer ≥1:10 on Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer. Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Time frame: Day 1, Day 22
Population: The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| aQIV/aQIV | Immunogenicity Endpoint: Seroconversion Rate (SCR) on Day 22 Against Homologous Strains (aQIV-primed and QIV-primed Comparison) | A/H1N1 | 62.7 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Seroconversion Rate (SCR) on Day 22 Against Homologous Strains (aQIV-primed and QIV-primed Comparison) | A/H3N2 | 68.9 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Seroconversion Rate (SCR) on Day 22 Against Homologous Strains (aQIV-primed and QIV-primed Comparison) | B/Yamagata | 76.4 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoint: Seroconversion Rate (SCR) on Day 22 Against Homologous Strains (aQIV-primed and QIV-primed Comparison) | B/Victoria | 77.4 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Seroconversion Rate (SCR) on Day 22 Against Homologous Strains (aQIV-primed and QIV-primed Comparison) | A/H3N2 | 68.0 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Seroconversion Rate (SCR) on Day 22 Against Homologous Strains (aQIV-primed and QIV-primed Comparison) | B/Yamagata | 72.0 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Seroconversion Rate (SCR) on Day 22 Against Homologous Strains (aQIV-primed and QIV-primed Comparison) | B/Victoria | 74.8 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoint: Seroconversion Rate (SCR) on Day 22 Against Homologous Strains (aQIV-primed and QIV-primed Comparison) | A/H1N1 | 60.9 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Seroconversion Rate (SCR) on Day 22 Against Homologous Strains (aQIV-primed and QIV-primed Comparison) | B/Yamagata | 79.44 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Seroconversion Rate (SCR) on Day 22 Against Homologous Strains (aQIV-primed and QIV-primed Comparison) | A/H3N2 | 72.80 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Seroconversion Rate (SCR) on Day 22 Against Homologous Strains (aQIV-primed and QIV-primed Comparison) | B/Victoria | 77.92 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoint: Seroconversion Rate (SCR) on Day 22 Against Homologous Strains (aQIV-primed and QIV-primed Comparison) | A/H1N1 | 72.04 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Seroconversion Rate (SCR) on Day 22 Against Homologous Strains (aQIV-primed and QIV-primed Comparison) | B/Victoria | 69.55 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Seroconversion Rate (SCR) on Day 22 Against Homologous Strains (aQIV-primed and QIV-primed Comparison) | A/H3N2 | 76.74 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Seroconversion Rate (SCR) on Day 22 Against Homologous Strains (aQIV-primed and QIV-primed Comparison) | A/H1N1 | 62.37 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoint: Seroconversion Rate (SCR) on Day 22 Against Homologous Strains (aQIV-primed and QIV-primed Comparison) | B/Yamagata | 66.49 percentage of subjects |
Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains
The percentage of subjects achieving HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 at Day 22 after vaccination is reported against homologous strains. Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Time frame: Day 22
Population: The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| aQIV/aQIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | B/Victoria, HI ≥1:110 | 93.0 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | B/Yamagata, HI ≥1:151 | 87.6 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | A/H1N1, HI ≥1:330 | 97.3 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | B/Yamagata, HI ≥1:629 | 27.9 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | B/Yamagata, HI ≥1:215 | 69.9 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | A/H1N1, HI ≥1:110 | 100.0 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | B/Yamagata, HI ≥1:330 | 44.0 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | A/H1N1, HI ≥1:151 | 100.0 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | B/Victoria, HI ≥1:330 | 58.7 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | A/ H1N1 ≥1:629 | 94.8 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | A/H3N2, HI ≥1:110 | 99.8 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | B/Victoria, HI ≥1:215 | 79.6 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | A/H3N2, HI ≥1:151 | 99.8 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | B/Victoria, HI ≥1:629 | 45.3 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | A/H3N2, HI ≥1:215 | 99.5 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | A/H1N1, HI ≥1:215 | 99.8 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | B/Victoria, HI ≥1:151 | 91.3 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | A/H3N2, HI ≥1:330 | 99.3 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | A/H3N2, HI ≥1:629 | 99.0 percentage of subjects |
| aQIV/aQIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | B/Yamagata, HI ≥1:110 | 90.8 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | B/Victoria, HI ≥1:110 | 89.9 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | B/Yamagata, HI ≥1:110 | 88.4 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | B/Victoria, HI ≥1:330 | 48.7 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | B/Yamagata, HI ≥1:629 | 20.9 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | A/H3N2, HI ≥1:110 | 100.0 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | B/Yamagata, HI ≥1:151 | 81.6 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | A/H1N1, HI ≥1:110 | 100.0 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | B/Victoria, HI ≥1:629 | 37.6 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | A/H3N2, HI ≥1:629 | 99.7 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | B/Yamagata, HI ≥1:215 | 64.2 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | A/H3N2, HI ≥1:151 | 100.0 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | B/Yamagata, HI ≥1:330 | 34.3 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | A/H3N2, HI ≥1:330 | 99.7 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | A/H1N1, HI ≥1:330 | 93.7 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | B/Victoria, HI ≥1:151 | 87.9 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | A/H1N1, HI ≥1:215 | 99.2 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | A/H3N2, HI ≥1:215 | 100.0 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | A/ H1N1 ≥1:629 | 87.6 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | A/H1N1, HI ≥1:151 | 100.0 percentage of subjects |
| aQIV/QIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | B/Victoria, HI ≥1:215 | 73.4 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | B/Yamagata, HI ≥1:215 | 53.3 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | A/H1N1, HI ≥1:110 | 99.7 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | A/H1N1, HI ≥1:151 | 99.5 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | A/H1N1, HI ≥1:215 | 97.5 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | A/H1N1, HI ≥1:330 | 93.2 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | A/ H1N1 ≥1:629 | 87.9 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | A/H3N2, HI ≥1:110 | 100.0 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | A/H3N2, HI ≥1:151 | 100.0 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | A/H3N2, HI ≥1:215 | 100.0 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | A/H3N2, HI ≥1:330 | 99.5 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | A/H3N2, HI ≥1:629 | 99.2 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | B/Yamagata, HI ≥1:110 | 82.7 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | B/Yamagata, HI ≥1:151 | 75.9 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | B/Yamagata, HI ≥1:330 | 25.1 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | B/Yamagata, HI ≥1:629 | 14.2 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | B/Victoria, HI ≥1:110 | 86.0 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | B/Victoria, HI ≥1:151 | 83.0 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | B/Victoria, HI ≥1:215 | 67.5 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | B/Victoria, HI ≥1:330 | 41.9 percentage of subjects |
| QIV/aQIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | B/Victoria, HI ≥1:629 | 34.3 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | A/H3N2, HI ≥1:629 | 95.1 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | A/H3N2, HI ≥1:330 | 95.9 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | B/Victoria, HI ≥1:330 | 32.0 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | B/Victoria, HI ≥1:110 | 76.1 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | A/H3N2, HI ≥1:215 | 97.7 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | A/H3N2, HI ≥1:151 | 99.5 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | A/H1N1, HI ≥1:151 | 97.4 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | B/Victoria, HI ≥1:151 | 70.6 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | A/H3N2, HI ≥1:110 | 99.5 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | A/ H1N1 ≥1:629 | 74.2 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | A/H1N1, HI ≥1:110 | 97.7 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | B/Victoria, HI ≥1:215 | 53.0 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | A/H1N1, HI ≥1:330 | 82.5 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | B/Yamagata, HI ≥1:215 | 38.5 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | A/H1N1, HI ≥1:215 | 93.8 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | B/Yamagata, HI ≥1:330 | 14.9 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | B/Yamagata, HI ≥1:151 | 59.9 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | B/Yamagata, HI ≥1:110 | 68.3 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | B/Victoria, HI ≥1:629 | 24.1 percentage of subjects |
| QIV/QIV | Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains | B/Yamagata, HI ≥1:629 | 7.3 percentage of subjects |
Safety Endpoint: Percentage of Subjects With Diagnosis of Failure to Thrive or Short Stature
Safety of revaccination was assessed in terms of percentage of subjects reporting diagnosis of failure to thrive or short stature up to 12 months after last vaccination.
Time frame: Day 1 to Day 366
Population: The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| aQIV/aQIV | Safety Endpoint: Percentage of Subjects With Diagnosis of Failure to Thrive or Short Stature | 0.25 percentage of subjects |
| aQIV/QIV | Safety Endpoint: Percentage of Subjects With Diagnosis of Failure to Thrive or Short Stature | 0.74 percentage of subjects |
| QIV/aQIV | Safety Endpoint: Percentage of Subjects With Diagnosis of Failure to Thrive or Short Stature | 0.25 percentage of subjects |
| QIV/QIV | Safety Endpoint: Percentage of Subjects With Diagnosis of Failure to Thrive or Short Stature | 0.76 percentage of subjects |
Safety Endpoint: Percentage of Subjects With Otitis Media, or Pneumonia, or Influenza-like Illness
Safety of revaccination was assessed in terms of percentage of subjects reporting otitis media, or pneumonia, or influenza-like illness up to 12 months after last vaccination.
Time frame: Day 1 to Day 366
Population: The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| aQIV/aQIV | Safety Endpoint: Percentage of Subjects With Otitis Media, or Pneumonia, or Influenza-like Illness | otitis media, any event | 3.23 percentage of subjects |
| aQIV/aQIV | Safety Endpoint: Percentage of Subjects With Otitis Media, or Pneumonia, or Influenza-like Illness | influenza-like illness | 7.94 percentage of subjects |
| aQIV/aQIV | Safety Endpoint: Percentage of Subjects With Otitis Media, or Pneumonia, or Influenza-like Illness | pneumonia, any event | 1.49 percentage of subjects |
| aQIV/QIV | Safety Endpoint: Percentage of Subjects With Otitis Media, or Pneumonia, or Influenza-like Illness | otitis media, any event | 3.47 percentage of subjects |
| aQIV/QIV | Safety Endpoint: Percentage of Subjects With Otitis Media, or Pneumonia, or Influenza-like Illness | influenza-like illness | 10.17 percentage of subjects |
| aQIV/QIV | Safety Endpoint: Percentage of Subjects With Otitis Media, or Pneumonia, or Influenza-like Illness | pneumonia, any event | 1.49 percentage of subjects |
| QIV/aQIV | Safety Endpoint: Percentage of Subjects With Otitis Media, or Pneumonia, or Influenza-like Illness | pneumonia, any event | 0.75 percentage of subjects |
| QIV/aQIV | Safety Endpoint: Percentage of Subjects With Otitis Media, or Pneumonia, or Influenza-like Illness | otitis media, any event | 3.73 percentage of subjects |
| QIV/aQIV | Safety Endpoint: Percentage of Subjects With Otitis Media, or Pneumonia, or Influenza-like Illness | influenza-like illness | 9.20 percentage of subjects |
| QIV/QIV | Safety Endpoint: Percentage of Subjects With Otitis Media, or Pneumonia, or Influenza-like Illness | otitis media, any event | 2.80 percentage of subjects |
| QIV/QIV | Safety Endpoint: Percentage of Subjects With Otitis Media, or Pneumonia, or Influenza-like Illness | influenza-like illness | 7.89 percentage of subjects |
| QIV/QIV | Safety Endpoint: Percentage of Subjects With Otitis Media, or Pneumonia, or Influenza-like Illness | pneumonia, any event | 1.78 percentage of subjects |
Safety Endpoint: Percentage of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), AE of Special Interest (AESI), and Medically Attended AE.
Safety of revaccination was assessed in terms of percentage of subjects reporting SAEs, AEs leading to withdrawal, NOCD, AESI and medically attended AE. Each subject was followed for a period of 12 months after receipt of the study vaccine. NOCDs include AEs that represents a new diagnosis of a chronic medical condition that was not present or suspected in a subject prior to study enrollment. AESIs include potentially immune-mediated disorders which were reported by the investigators.
Time frame: Day 1 to Day 366
Population: The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited adverse event (AE) data (including those where it was reported/confirmed that no events had occurred).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| aQIV/aQIV | Safety Endpoint: Percentage of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), AE of Special Interest (AESI), and Medically Attended AE. | NOCD | 0.50 percentage of subjects |
| aQIV/aQIV | Safety Endpoint: Percentage of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), AE of Special Interest (AESI), and Medically Attended AE. | SAE | 2.48 percentage of subjects |
| aQIV/aQIV | Safety Endpoint: Percentage of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), AE of Special Interest (AESI), and Medically Attended AE. | AESI | 0 percentage of subjects |
| aQIV/aQIV | Safety Endpoint: Percentage of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), AE of Special Interest (AESI), and Medically Attended AE. | AE leading to withdrawal | 0 percentage of subjects |
| aQIV/aQIV | Safety Endpoint: Percentage of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), AE of Special Interest (AESI), and Medically Attended AE. | Medically attended AE | 51.61 percentage of subjects |
| aQIV/QIV | Safety Endpoint: Percentage of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), AE of Special Interest (AESI), and Medically Attended AE. | AE leading to withdrawal | 0 percentage of subjects |
| aQIV/QIV | Safety Endpoint: Percentage of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), AE of Special Interest (AESI), and Medically Attended AE. | NOCD | 0 percentage of subjects |
| aQIV/QIV | Safety Endpoint: Percentage of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), AE of Special Interest (AESI), and Medically Attended AE. | AESI | 0 percentage of subjects |
| aQIV/QIV | Safety Endpoint: Percentage of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), AE of Special Interest (AESI), and Medically Attended AE. | SAE | 2.73 percentage of subjects |
| aQIV/QIV | Safety Endpoint: Percentage of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), AE of Special Interest (AESI), and Medically Attended AE. | Medically attended AE | 54.34 percentage of subjects |
| QIV/aQIV | Safety Endpoint: Percentage of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), AE of Special Interest (AESI), and Medically Attended AE. | AE leading to withdrawal | 0 percentage of subjects |
| QIV/aQIV | Safety Endpoint: Percentage of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), AE of Special Interest (AESI), and Medically Attended AE. | Medically attended AE | 53.98 percentage of subjects |
| QIV/aQIV | Safety Endpoint: Percentage of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), AE of Special Interest (AESI), and Medically Attended AE. | SAE | 1.74 percentage of subjects |
| QIV/aQIV | Safety Endpoint: Percentage of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), AE of Special Interest (AESI), and Medically Attended AE. | NOCD | 0 percentage of subjects |
| QIV/aQIV | Safety Endpoint: Percentage of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), AE of Special Interest (AESI), and Medically Attended AE. | AESI | 0 percentage of subjects |
| QIV/QIV | Safety Endpoint: Percentage of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), AE of Special Interest (AESI), and Medically Attended AE. | NOCD | 0 percentage of subjects |
| QIV/QIV | Safety Endpoint: Percentage of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), AE of Special Interest (AESI), and Medically Attended AE. | SAE | 2.04 percentage of subjects |
| QIV/QIV | Safety Endpoint: Percentage of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), AE of Special Interest (AESI), and Medically Attended AE. | Medically attended AE | 48.60 percentage of subjects |
| QIV/QIV | Safety Endpoint: Percentage of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), AE of Special Interest (AESI), and Medically Attended AE. | AE leading to withdrawal | 0 percentage of subjects |
| QIV/QIV | Safety Endpoint: Percentage of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), AE of Special Interest (AESI), and Medically Attended AE. | AESI | 0.25 percentage of subjects |
Safety Endpoint: Percentage of Subjects With Solicited AEs
Safety of revaccination was assessed in terms of percentage of subjects reporting solicited AEs up to 7 days after vaccination.
Time frame: Day 1 to Day 7 after vaccination
Population: The solicited safety set consisting of all subjects who received a study vaccination with evaluable solicited AE data recorded on a diary card.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| aQIV/aQIV | Safety Endpoint: Percentage of Subjects With Solicited AEs | Solicited Systemic AE | 39.21 percentage of subjects |
| aQIV/aQIV | Safety Endpoint: Percentage of Subjects With Solicited AEs | Solicited Local AE | 44.67 percentage of subjects |
| aQIV/aQIV | Safety Endpoint: Percentage of Subjects With Solicited AEs | Other (analgesic/antipyretic use) | 27.54 percentage of subjects |
| aQIV/aQIV | Safety Endpoint: Percentage of Subjects With Solicited AEs | Any Solicited AE | 64.76 percentage of subjects |
| aQIV/QIV | Safety Endpoint: Percentage of Subjects With Solicited AEs | Solicited Local AE | 37.97 percentage of subjects |
| aQIV/QIV | Safety Endpoint: Percentage of Subjects With Solicited AEs | Other (analgesic/antipyretic use) | 10.17 percentage of subjects |
| aQIV/QIV | Safety Endpoint: Percentage of Subjects With Solicited AEs | Any Solicited AE | 50.12 percentage of subjects |
| aQIV/QIV | Safety Endpoint: Percentage of Subjects With Solicited AEs | Solicited Systemic AE | 24.81 percentage of subjects |
| QIV/aQIV | Safety Endpoint: Percentage of Subjects With Solicited AEs | Any Solicited AE | 53.48 percentage of subjects |
| QIV/aQIV | Safety Endpoint: Percentage of Subjects With Solicited AEs | Other (analgesic/antipyretic use) | 16.92 percentage of subjects |
| QIV/aQIV | Safety Endpoint: Percentage of Subjects With Solicited AEs | Solicited Systemic AE | 30.85 percentage of subjects |
| QIV/aQIV | Safety Endpoint: Percentage of Subjects With Solicited AEs | Solicited Local AE | 36.82 percentage of subjects |
| QIV/QIV | Safety Endpoint: Percentage of Subjects With Solicited AEs | Other (analgesic/antipyretic use) | 10.43 percentage of subjects |
| QIV/QIV | Safety Endpoint: Percentage of Subjects With Solicited AEs | Any Solicited AE | 40.71 percentage of subjects |
| QIV/QIV | Safety Endpoint: Percentage of Subjects With Solicited AEs | Solicited Local AE | 29.52 percentage of subjects |
| QIV/QIV | Safety Endpoint: Percentage of Subjects With Solicited AEs | Solicited Systemic AE | 18.83 percentage of subjects |
Safety Endpoint: Percentage of Subjects With Unsolicited AEs
Safety of revaccination was assessed in terms of percentage of subjects reporting unsolicited AEs during the overall study period (Day 1 to Day 366).
Time frame: Day 1 to Day 366
Population: The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| aQIV/aQIV | Safety Endpoint: Percentage of Subjects With Unsolicited AEs | Any Unsolicited AE | 54.09 percentage of subjects |
| aQIV/aQIV | Safety Endpoint: Percentage of Subjects With Unsolicited AEs | Related Unsolicited AE | 6.20 percentage of subjects |
| aQIV/QIV | Safety Endpoint: Percentage of Subjects With Unsolicited AEs | Related Unsolicited AE | 3.97 percentage of subjects |
| aQIV/QIV | Safety Endpoint: Percentage of Subjects With Unsolicited AEs | Any Unsolicited AE | 55.33 percentage of subjects |
| QIV/aQIV | Safety Endpoint: Percentage of Subjects With Unsolicited AEs | Any Unsolicited AE | 55.97 percentage of subjects |
| QIV/aQIV | Safety Endpoint: Percentage of Subjects With Unsolicited AEs | Related Unsolicited AE | 5.72 percentage of subjects |
| QIV/QIV | Safety Endpoint: Percentage of Subjects With Unsolicited AEs | Any Unsolicited AE | 52.16 percentage of subjects |
| QIV/QIV | Safety Endpoint: Percentage of Subjects With Unsolicited AEs | Related Unsolicited AE | 3.82 percentage of subjects |