| Primary | Safety Endpoint: Number of Subjects With SAEs, AEs Leading to Withdrawal From the Study, NOCDs, AESIs and Medically Attended AEs. | Safety was assessed in terms of number of subjects between 12 months and 7 years of age reporting unsolicited events up to 12 months after last vaccination with either aQIV or QIV (comparator): serious adverse events (SAEs), AEs leading to study withdrawal, new onset chronic disease (NOCDs), adverse events of special interest (AESIs) and medically attended AEs after vaccination. | The Unsolicited Safety Set consisting of subjects who received a study vaccination and who had any AE assessments (ie, a subject did not have to have an AE to be included in this population) was used for analysis. | Posted | | Count of Participants | | Participants | | Day 1 through Day 356 | | | | ID | Title | Description |
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| OG000 | aQIV | Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118_05 received aQIV in study V118_05E1. | | OG001 | Comparator QIV | Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118_05 received QIV in study V118_05E1. |
| | | Title | Denominators | Categories |
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| SAEs | | | | At least possibly related SAEs | | |
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| Primary | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Differences in Percentage of Subjects Achieving Seroconversion for Homologous Influenza Strains (Day 22) | The percentage of subjects achieving seroconversion at Day 22 after vaccination is reported for homologous strains; Seroconversion is defined as hemagglutination inhibition (HI) ≥1:40 for subjects negative at baseline [<1:10]; or a minimum 4-fold increase in HI titer for subjects positive at baseline [HI ≥1:10]; Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab | The Full Analysis Set for Immunogenicity consisting of all enrolled subjects who received a study vaccination and provided evaluable serum samples (homologous strains) for both before (baseline) and after vaccination (ie, Day 22 and/or Day 181). Day 22 analyses are reported for the 302 and 257 (256 for the A/H3N2 strain) participants in the aQIV and Comparator QIV groups, respectively, who had immunogenicity data at both Day 1 and Day 22. | Posted | | Number | 95% Confidence Interval | Percentage of subjects | | Day 1, Day 22 | | | | ID | Title | Description |
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| OG000 | aQIV | Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118_05 received aQIV in study V118_05E1. | | OG001 | Comparator QIV | Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118_05 received QIV in study V118_05E1. |
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| Primary | Immunogenicity Endpoint: Percentage of Subjects Achieving HI Titer ≥ 1:40 and and Differences in Percentage of Subjects Achieving HI Titer ≥ 1:40 for Homologous Influenza Strains (Day 22). | The percentage of subjects achieving HI titer ≥1:40 at Day 22 after vaccination is reported for homologous strains. Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab | The Full Analysis Set for Immunogenicity consisting of all enrolled subjects who received a study vaccination and provided evaluable serum samples (homologous strains) for both before (baseline) and after vaccination (ie, Day 22 and/or Day 181). Day 22 analyses are reported for the 302 and 257 (256 for the A/H3N2 strain) participants in the aQIV and Comparator QIV groups, respectively, who had immunogenicity data at both Day 1 and Day 22. | Posted | | Number | 95% Confidence Interval | Percentage of subjects | | Day 1, Day 22 | | | | ID | Title | Description |
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| OG000 | Adjuvanted Quadrivalent Influenza Vaccine (aQIV) | Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118_05 received aQIV in study V118_05E1. | | OG001 | Comparator Quadrivalent Influenza Vaccine (QIV) | Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118_05 received QIV in the study V118_05E1. |
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| Secondary | Safety Endpoint: Number of Subjects With a Diagnosis of Failure to Thrive or Short Stature | Short stature was defined as a height/length that was 2 or more standard deviations below the mean for age and gender within a population and was assessed as being below the 2nd z-score (worse outcome) on the length/height-for-age scale. Failure-to-thrive was defined by inadequate weight gain and physical growth and assessed through 2 or more of the following criteria: height/length-for-age, weight-for-age or weight-for-height/length below the 2nd z-score, a child's growth line crossing a z-score line, a sharp change in growth curve or a curve that remains flat. The observations were made for 2 or more time points each divided by at least 2 months. | The Unsolicited Safety Set consisting of subjects who received a study vaccination and who had any AE assessments (ie, a subject did not have to have an AE to be included in this population) was used for analysis. | Posted | | Number | | participants | | Day 1 through Day 366 (Day 1, Day 22, Day 181, Day 366) | | | | ID | Title | Description |
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| OG000 | aQIV | Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118_05 received aQIV in study V118_05E1. | | OG001 | Comparator QIV | Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118_05 received QIV in study V118_05E1. |
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| Secondary | Safety Endpoint: Number of Subjects With Any Unsolicited AEs | Safety was assessed in terms of number of subjects between 12 months and 7 years of age reporting unsolicited events up to 12 months after last vaccination with either aQIV or QIV (comparator). | The Unsolicited Safety Set consisting of subjects who received a study vaccination and who had any AE assessments (ie, a subject did not have to have an AE to be included in this population) was used for analysis. | Posted | | Count of Participants | | Participants | | Day 1 through Day 22 | | | | ID | Title | Description |
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| OG000 | aQIV | Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118_05 received aQIV in study V118_05E1. | | OG001 | Comparator QIV | Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118_05 received QIV in the present study V118_05E1. |
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| Secondary | Safety Endpoint: Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Safety was assessed in terms of number of subjects between 12 months and 7 years of age reporting solicited local and systemic AEs, day 1 to day 7 after vaccination with either aQIV or QIV (comparator). | The Solicited Safety Set consisting of subjects who received a study vaccination and had any assessment of local and systemic reactions and/or assessment of any use of analgesics/antipyretics was used for analysis. | Posted | | Count of Participants | | Participants | | Up to 7 days following vaccination | | | | ID | Title | Description |
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| OG000 | aQIV | Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118_05 received aQIV in study V118_05E1. | | OG001 | Comparator QIV | Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118_05 received QIV in study V118_05E1. |
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| Secondary | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Differences in Percentage of Subjects Achieving Seroconversion for Homologous Influenza Strains (Day 181) | The percentage of subjects achieving seroconversion at Day 181 after vaccination is reported for homologous strains. Seroconversion is defined as HI ≥1:40 for subjects negative at baseline [<1:10]; or a minimum 4-fold increase in HI titer for subjects positive at baseline [HI ≥1:10]; Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab. | The Full Analysis Set for Immunogenicity consisting of all enrolled subjects who received a study vaccination and provided evaluable serum samples (homologous strains) for both before (baseline) and after vaccination (ie, Day 22 and/or Day 181). Day 181 analyses are reported for the 289 and 251 participants in the aQIV and Comparator QIV groups, respectively, who had immunogenicity data at both Day 1 and Day 181. | Posted | | Number | 95% Confidence Interval | Percentage of subjects | | Day 1, Day 181 | | | | ID | Title | Description |
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| OG000 | Adjuvanted Quadrivalent Influenza Vaccine (aQIV) | Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118_05 received aQIV in the study V118_05E1. | | OG001 | Comparator Quadrivalent Influenza Vaccine (QIV) | |
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| Secondary | Immunogenicity Endpoint: Percentage of Subjects Achieving HI Titer ≥ 1:40 and Difference in Percentage of Subjects Achieving HI Titer ≥ 1:40 for Homologous Influenza Strains (Day 181) | The percentage of subjects achieving HI titer ≥1:40 at Day 181 after vaccination is reported for homologous strains; Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab | The Full Analysis Set for Immunogenicity consisting of all enrolled subjects who received a study vaccination and provided evaluable serum samples (homologous strains) for both before (baseline) and after vaccination (ie, Day 22 and/or Day 181). Day 181 analyses are reported for the 289 and 251 participants in the aQIV and Comparator QIV groups, respectively, who had immunogenicity data at both Day 1 and Day 181. | Posted | | Number | 95% Confidence Interval | Percentage of subjects | | Day 1, Day 181 | | | | ID | Title | Description |
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| OG000 | Adjuvanted Quadrivalent Influenza Vaccine (aQIV) | Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118_05 received aQIV in study V118_05E1. | | OG001 | Comparator Quadrivalent Influenza Vaccine (QIV) | Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118_05 received QIV in study V118_05E1. |
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| Secondary | Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) and GMT Ratios for Homologous Influenza Strains (Day 1, Day 22, Day 181) | Adjusted GMT, GMR and 95% confidence interval (CI) were analyzed using ANCOVA with study specific covariates. Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab | The Full Analysis Set for Immunogenicity consisting of all enrolled subjects who received a study vaccination and provided evaluable serum samples (homologous strains) for both before (baseline) and after vaccination (ie, Day 22 and/or Day 181). Day 22 analyses are reported for 302 and 257 (256 for the A/H3N2 strain) participants in the aQIV and Comparator QIV groups, respectively. Day 181 analyses are reported for 289 and 251 participants in the aQIV and Comparator QIV groups, respectively. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Day 1, Day 22, Day 181 | | | | ID | Title | Description |
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| OG000 | Adjuvanted Quadrivalent Influenza Vaccine (aQIV) | Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118_05 received aQIV in study V118_05E1. | | OG001 | Comparator Quadrivalent Influenza Vaccine (QIV) | Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118_05 received QIV in study V118_05E1. |
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| Secondary | Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Homologous Influenza Strains | The GMR is the geometric mean of the fold increase in HI titer from Day 1 to Day 22 or Day 181. Adjusted GMT, GMR and 95% CI were analyzed using ANCOVA with study specific covariates. Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab | The Full Analysis Set for Immunogenicity consisting of all enrolled subjects who received a study vaccination and provided evaluable serum samples (homologous strains) for both before (baseline) and after vaccination (ie, Day 22 and/or Day 181). Note: Subjects may be included in the Day 181 analyses but not the Day 22 analyses (and vice versa). | Posted | | Geometric Mean | 95% Confidence Interval | ratio | | Day 1, Day 22, and Day 181 | | | | ID | Title | Description |
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| OG000 | Adjuvanted Quadrivalent Influenza Vaccine (aQIV) | Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118_05 received aQIV in study V118_05E1. | | OG001 | Comparator Quadrivalent Influenza Vaccine (QIV) | Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118_05 received QIV in study V118_05E1. |
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| Secondary | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Difference in Percentage of Subjects Achieving Seroconversion for Heterologous Influenza Strains (Day 181) | The percentage of subjects achieving seroconversion at Day 181 after vaccination is reported for homologous strains. Seroconversion is defined as HI ≥1:40 for subjects negative at baseline [<1:10]; or a minimum 4-fold increase in HI titer for subjects positive at baseline [HI ≥1:10]; Strains tested: A/H3N2 is Influenza A H3N2 Hong Kong/2014 Ab; B/Yamagata is Influenza B Phuket/2013 Ab | The Full Analysis Set for Immunogenicity consisting of all enrolled subjects who received a study vaccination and provided evaluable serum samples (heterologous strains) for both before (baseline) and after vaccination. | Posted | | Number | 95% Confidence Interval | Percentage of subjects | | Day 1, Day 181 | | | | ID | Title | Description |
|---|
| OG000 | Adjuvanted Quadrivalent Influenza Vaccine (aQIV) | Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118_05 received aQIV in study V118_05E1. | | OG001 | Comparator Quadrivalent Influenza Vaccine (QIV) | Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118_05 received QIV in study V118_05E1. |
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| Secondary | Immunogenicity Endpoint: Percentage of Subjects Achieving HI Titer ≥ 1:40 and Difference in Percentage of Subjects Achieving HI Titer ≥ 1:40 for Heterologous Influenza Strains (Day 181) | The percentage of subjects achieving HI titer ≥1:40 at Day 181 after vaccination is reported for homologous strains; Strains tested: A/H3N2 is Influenza A H3N2 Hong Kong/2014 Ab; B/Yamagata is Influenza B Phuket/2013 Ab | The Full Analysis Set for Immunogenicity consisting of all enrolled subjects who received a study vaccination and provided evaluable serum samples (heterologous strains) for both before (baseline) and after vaccination. | Posted | | Number | 95% Confidence Interval | Percentage of subjects | | Day 1, Day 181 | | | | ID | Title | Description |
|---|
| OG000 | Adjuvanted Quadrivalent Influenza Vaccine (aQIV) | Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118_05 received aQIV in study V118_05E1. | | OG001 | Comparator Quadrivalent Influenza Vaccine (QIV) | Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118_05 received QIV in study V118_05E1. |
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| Secondary | Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) for Heterologous Influenza Strains (Day 1, Day 22, Day 181) | Adjusted GMT, GMR and 95% CI were analyzed using ANCOVA with study specific covariates. Strains tested: A/H3N2 is Influenza A H3N2 Hong Kong/2014 Ab; B/Yamagata is Influenza B Phuket/2013 Ab | The Full Analysis Set for Immunogenicity consisting of all enrolled subjects who received a study vaccination and provided evaluable serum samples (heterologous strains) for both before (baseline) and after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Day 1, Day 22, Day 181 | | | | ID | Title | Description |
|---|
| OG000 | Adjuvanted Quadrivalent Influenza Vaccine (aQIV) | Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118_05 received aQIV in study V118_05E1. | | OG001 | Comparator Quadrivalent Influenza Vaccine (QIV) | Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118_05 received QIV in study V118_05E1. |
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| Secondary | Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Heterologous Influenza Strains | The GMR is the geometric mean of the fold increase in HI titer from Day 1 to Day 22 or Day 181. Adjusted GMT, GMR and 95% CI were analyzed using ANCOVA with study specific covariates. Strains tested: A/H3N2 is Influenza A H3N2 Hong Kong/2014 Ab; B/Yamagata is Influenza B Phuket/2013 Ab | The Full Analysis Set for Immunogenicity consisting of all enrolled subjects who received a study vaccination and provided evaluable serum samples (heterologous strains) for both before (baseline) and after vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | ratio | | Day 1, Day 22, and Day 181 | | | | ID | Title | Description |
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| OG000 | Adjuvanted Quadrivalent Influenza Vaccine (aQIV) | Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118_05 received aQIV in study V118_05E1. | | OG001 | Comparator Quadrivalent Influenza Vaccine (QIV) | Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118_05 received QIV in study V118_05E1. |
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