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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002973-39 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aQIV/aQIV | Experimental | Subjects previously vaccinated with aQIV followed one year later by aQIV |
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| aQIV/QIV | Experimental | Subjects previously vaccinated with aQIV followed one year later by QIV |
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| QIV/aQIV | Experimental | Subjects previously vaccinated with QIV followed one year later by aQIV |
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| QIV/QIV | Experimental | Subjects previously vaccinated with QIV followed one year later by QIV |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjuvanted QIV (aQIV) | Biological | Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 22 |
| 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. | Day 22 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 22 |
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Inclusion Criteria:
In order to participate in this study, all subjects must meet ALL of the inclusion criteria described.
Exclusion Criteria:
Additional eligibility criteria may be discussed by contacting the site.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Program Director | Seqirus | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site- 001 | Espoo | Etelä-Suomen Lääni | 02230 | Finland | ||
| Investigational Site- 002 |
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All enrolled subjects were included in the study.
This study was conducted at 17 sites in total; 9 sites in Finland, 4 sites in the Philippines and 4 sites in Thailand.
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| ID | Title | Description |
|---|---|---|
| FG000 | aQIV/aQIV | Subjects previously vaccinated with aQIV followed one year later by aQIV Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV) |
| FG001 | aQIV/QIV |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Non-adjuvanted QIV | Biological | Non-adjuvanted Quadrivalent Influenza Vaccine (QIV) |
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| 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. | Day 181 |
| 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. | Day 1, Day 22 |
| 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. | Day 22, Day 181 |
| 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. | Day 22, Day 181 |
| 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. | Day 22 |
| 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. | Day 1, Day 22, Day 181 |
| 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. | Day 22/Day 1 and Day 181/Day 1 |
| 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. | Day 22, Day 181 |
| 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. | Day 1, Day 22, Day 181 |
| 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. | Day 22/Day 1 and Day 181/Day 1 |
| 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. | Day 1, Day 22, Day 181 |
| 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. | Day 22/Day 1 and Day 181/Day 1 |
| 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. | Day 1 to Day 7 after vaccination |
| 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). | 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. | 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. | Day 1 to Day 366 |
| 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. | Day 1 to Day 366 |
| 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. | Day 1 to Day 366 |
| 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. | Day 22, Day 181 |
| 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. | Day 22, Day 181 |
| Helsinki |
| Etelä-Suomen Lääni |
| 00100 |
| Finland |
| Investigational Site- 003 | Helsinki | Etelä-Suomen Lääni | 00100 | Finland |
| Investigational Site- 004 | Jarvenpaa | Etelä-Suomen Lääni | 04400 | Finland |
| Investigational Site- 005 | Kokkola | Länsi-Suomen Lääni | 67100 | Finland |
| Investigational Site- 007 | Pori | Länsi-Suomen Lääni | 28100 | Finland |
| Investigational Site- 009 | Tampere | Länsi-Suomen Lääni | 33100 | Finland |
| Investigational Site- 010 | Turku | Länsi-Suomen Lääni | 20520 | Finland |
| Investigational Site- 006 | Oulu | 90220 | Finland |
| Investigational Site- 303 | Laguna | Matro Manila | 1781 | Philippines |
| Investigational Site- 304 | Muntinlupa | National Capital Region | 1781 | Philippines |
| Investigational Site- 305 | Muntinlupa | National Capital Region | 1781 | Philippines |
| Investigational Site- 306 | Cavite | 4114 | Philippines |
| Investigational Site- 325 | Pathum Thani | Bangkok | 12120 | Thailand |
| Investigational Site- 320 | Bangkok | Changwat Samut Prakan | 10400 | Thailand |
| Investigational Site- 327 | Bangkok | Krung Thep Maha Nakhon [Bangko | 10400 | Thailand |
| Investigational Site- 323 | Bangkok | 10330 | Thailand |
Subjects previously vaccinated with aQIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
| FG002 | QIV/aQIV | Subjects previously vaccinated with QIV followed one year later by aQIV Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV) |
| FG003 | QIV/QIV | Subjects previously vaccinated with QIV followed one year later by QIV Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV) |
| Exposed |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | aQIV/aQIV | Subjects previously vaccinated with aQIV followed one year later by aQIV Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV) |
| BG001 | aQIV/QIV | Subjects previously vaccinated with aQIV followed one year later by QIV Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV) |
| BG002 | QIV/aQIV | Subjects previously vaccinated with QIV followed one year later by aQIV Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV) |
| BG003 | QIV/QIV | Subjects previously vaccinated with QIV followed one year later by QIV Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV) |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Risk Status | Subjects with underlying conditions that posed high risk of influenza complications (at risk/not at risk) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | titer | Day 22 |
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| Primary | 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | titer | Day 22 |
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| Secondary | 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | titer | Day 22 |
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| Secondary | 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | titer | Day 181 |
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| Secondary | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of subjects | Day 1, Day 22 |
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| Secondary | 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | ratio | Day 22, Day 181 |
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| Secondary | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of subjects | Day 22, Day 181 |
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| Secondary | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of subjects | Day 22 |
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| Secondary | 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | titer | Day 1, Day 22, Day 181 |
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| Secondary | 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | ratio | Day 22/Day 1 and Day 181/Day 1 |
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| Secondary | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of subjects | Day 22, Day 181 |
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| Secondary | 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | titer | Day 1, Day 22, Day 181 |
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| Secondary | 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | ratio | Day 22/Day 1 and Day 181/Day 1 |
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| Secondary | 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | titer | Day 1, Day 22, Day 181 |
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| Secondary | 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | ratio | Day 22/Day 1 and Day 181/Day 1 |
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| Secondary | 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. | The solicited safety set consisting of all subjects who received a study vaccination with evaluable solicited AE data recorded on a diary card. | Posted | Number | percentage of subjects | Day 1 to Day 7 after vaccination |
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| Secondary | 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). | 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). | Posted | Number | percentage of subjects | Day 1 to Day 366 |
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| Secondary | 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. | 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). | Posted | Number | percentage of subjects | Day 1 to Day 366 |
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| Secondary | 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. | 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). | Posted | Number | percentage of subjects | Day 1 to Day 366 |
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| Secondary | 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. | 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). | Posted | Number | percentage of subjects | Day 1 to Day 366 |
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| Secondary | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of subjects | Day 22, Day 181 |
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| Secondary | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of subjects | Day 22, Day 181 |
|
Day 1 - Day 366
The overall safety set included all subjects who were in the solicited safety set and/or in the unsolicited safety set.
Assessment of revaccination safety included:
SAEs collected between Day 1 to Day 366 Non-serious AEs included solicited AEs collected between Day 1 to Day 7 after last vaccination, and unsolicited AEs collected between Day 1 to Day 366 after last vaccination
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | aQIV-aQIV | Subjects previously vaccinated with aQIV followed one year later by aQIV Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV) | 0 | 403 | 10 | 403 | 289 | 403 |
| EG001 | aQIV-QIV | Subjects previously vaccinated with aQIV followed one year later by QIV Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV) | 0 | 403 | 11 | 403 | 269 | 403 |
| EG002 | QIV-aQIV | Subjects previously vaccinated with QIV followed one year later by aQIV Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV) | 0 | 402 | 7 | 402 | 274 | 402 |
| EG003 | QIV-QIV | Subjects previously vaccinated with QIV followed one year later by QIV Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV) | 0 | 393 | 8 | 393 | 229 | 393 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron Deficiency Anaemia | Blood and lymphatic system disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| Spina Bifida Occulta | Congenital, familial and genetic disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| Aphthous Ulcer | Gastrointestinal disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| Anaphylactic Reaction | Immune system disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| Amoebic Dysentery | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
| |
| Appendiceal Abscess | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
| |
| Dengue Fever | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
| |
| External Ear Cellulitis | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
| |
| Herpangina | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
| |
| Animal Bite | Injury, poisoning and procedural complications | MedDRA version 19.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA version 19.1 | Systematic Assessment |
| |
| Jaw Fracture | Injury, poisoning and procedural complications | MedDRA version 19.1 | Systematic Assessment |
| |
| Wound Secretion | Injury, poisoning and procedural complications | MedDRA version 19.1 | Systematic Assessment |
| |
| Febrile Convulsion | Nervous system disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| Kawasaki's Disease | Vascular disorders | MedDRA version 19.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| Influenza Like Illness | General disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| Injection Site Erythema | General disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| Injection Site Induration | General disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| Injection Site Pain | General disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| Eating Disorder | Psychiatric disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA version 19.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Seqirus Clinical Trial Disclosure Manager | Seqirus | Phone: 1-855-358-8966 | Seqirus.ClinicalTrials@Seqirus.com |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| Other |
|
| Finland |
|
| Thailand |
|
| Not at risk |
|
| B/Yamagata |
|
| B/Victoria |
|
Comparison performed for strain A/H3N2.
| GMT ratio |
| 0.93 |
| 2-Sided |
| 95 |
| 0.9 |
| 1.0 |
| Non-Inferiority |
Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667. |
| Comparison performed for strain B/Yamagata. | GMT ratio | 1.19 | 2-Sided | 95 | 1.1 | 1.3 | Non-Inferiority | Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667. |
| Comparison performed for strain B/Victoria. | GMT ratio | 1.18 | 2-Sided | 95 | 1.1 | 1.3 | Non-Inferiority | Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667. |
|
|
|
|
|
| OG003 | QIV/QIV | Subjects previously vaccinated with QIV followed one year later by QIV Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV) |
|
|
|
| OG002 |
| QIV/aQIV |
Subjects previously vaccinated with QIV followed one year later by aQIV Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV) |
| OG003 | QIV/QIV | Subjects previously vaccinated with QIV followed one year later by QIV Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV) |
|
|
|
Subjects previously vaccinated with QIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
| OG003 | QIV/QIV | Subjects previously vaccinated with QIV followed one year later by QIV Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV) |
|
|
| OG003 | QIV/QIV | Subjects previously vaccinated with QIV followed one year later by QIV Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV) |
|
|
| OG003 | QIV/QIV | Subjects previously vaccinated with QIV followed one year later by QIV Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV) |
|
|
| OG003 | QIV/QIV | Subjects previously vaccinated with QIV followed one year later by QIV Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV) |
|
|
Subjects previously vaccinated with QIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
| OG003 | QIV/QIV | Subjects previously vaccinated with QIV followed one year later by QIV Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV) |
|
|
| OG002 | QIV/aQIV | Subjects previously vaccinated with QIV followed one year later by aQIV Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV) |
| OG003 | QIV/QIV | Subjects previously vaccinated with QIV followed one year later by QIV Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV) |
|
|
| OG003 | QIV/QIV | Subjects previously vaccinated with QIV followed one year later by QIV Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV) |
|
|
Subjects previously vaccinated with QIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
| OG003 | QIV/QIV | Subjects previously vaccinated with QIV followed one year later by QIV Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV) |
|
|
| OG003 | QIV/QIV | Subjects previously vaccinated with QIV followed one year later by QIV Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV) |
|
|
Subjects previously vaccinated with QIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
| OG003 | QIV/QIV | Subjects previously vaccinated with QIV followed one year later by QIV Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV) |
|
|
Subjects previously vaccinated with QIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
|
Subjects previously vaccinated with QIV followed one year later by QIV Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV) |
|
|
| QIV/aQIV |
Subjects previously vaccinated with QIV followed one year later by aQIV Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV) |
| OG003 | QIV/QIV | Subjects previously vaccinated with QIV followed one year later by QIV Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV) |
|
|
| QIV/QIV |
Subjects previously vaccinated with QIV followed one year later by QIV Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV) |
|
|
| OG003 |
| QIV/QIV |
Subjects previously vaccinated with QIV followed one year later by QIV Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV) |
|
|
Subjects previously vaccinated with QIV followed one year later by aQIV Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV) |
| OG003 | QIV/QIV | Subjects previously vaccinated with QIV followed one year later by QIV Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV) |
|
|
Subjects previously vaccinated with QIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
| OG003 | QIV/QIV | Subjects previously vaccinated with QIV followed one year later by QIV Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV) |
|
|