| Primary | The Geometric Mean Titer (GMT) Ratio of Each Virus Strain. | Noninferiority of Seqirus QIV compared to comparator QIV was assessed by the eight co-primary endpoints of hemagglutination inhibition (HI) antibody geometric mean titer (GMT) and seroconversion rate (SCR) for each viral strain included in the vaccines. The GMT ratio is defined as the geometric mean of the postvaccination HI titer for the US-licensed comparator QIV over the geometric mean of the postvaccination HI titer for Seqirus QIV. | The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding. | Posted | | Geometric Mean | 95% Confidence Interval | Ratio | | 28 days after last vaccination. | | | | ID | Title | Description |
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| OG000 | GMT Ratios: GMT Comparator QIV Over GMT Seqirus QIV | GMT Ratios: GMT Comparator Quadrivalent Influenza Vaccine over GMT Seqirus Quadrivalent Influenza Vaccine |
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| A/H1N1 | | | | A/H3N2 | | | | B/Yamagata | | |
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| Primary | The Difference in Seroconversion Rate (SCR) for Each Virus Strain. | Noninferiority of Seqirus QIV compared to Comparator QIV was assessed by the eight co-primary endpoints of HI geometric mean titer (GMT) and seroconversion rate (SCR) for each viral strain. The rate of SCR is defined as the percentage of subjects with either a prevaccination HI titer < 1:10 and a postvaccination HI titer ≥ 1:40, or a prevaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in postvaccination HI titer. For the SCR comparison, the difference between the SCR for each virus strain will be determined. | The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 28 days after last vaccination. | | | | ID | Title | Description |
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| OG000 | SCR Difference = Comparator QIV SCR % Minus Seqirus QIV SCR % | Seroconversion rate difference = Comparator QIV SCR percentage minus Seqirus QIV SCR percentage |
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| Secondary | Safety Endpoint: The Frequency and Severity of Solicited Local Adverse Reactions. | Frequency and severity of solicited local adverse reactions (AEs) for 7 days (ie, day of vaccination and 6 subsequent days) after each vaccination dose | The Solicited Safety Population comprises all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and provided any evaluable data on solicited events. | Posted | | Number | | participants | | 7 days after each vaccination. | | | | ID | Title | Description |
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| OG000 | Seqirus Quadrivalent Influenza Vaccine | The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season). Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe. The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination. | | OG001 | Comparator Quadrivalent Influenza Vaccine | The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season. Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe. The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination. |
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| Secondary | Safety Endpoint: The Frequency and Severity of Solicited Systemic Adverse Events (AEs). | Frequency and severity of solicited systemic adverse events (AEs) for 7 days (ie, day of vaccination and 6 subsequent days) after each vaccination dose | The Solicited Safety Population comprised all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and provided any evaluable data on solicited events. | Posted | | Number | | participants | | 7 days after each vaccination. | | | | ID | Title | Description |
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| OG000 | Seqirus Quadrivalent Influenza Vaccine | The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season). Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe. The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination. | | OG001 | Comparator Quadrivalent Influenza Vaccine | The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season. Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe. The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination. |
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| Secondary | Safety Endpoint: The Frequency of Cellulitis-like Reaction. | Frequency of cellulitis-like reaction for at least 28 days after each vaccination dose | The Solicited Safety Population comprises all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and provided any evaluable data on solicited events. | Posted | | Number | | participants | | 28 days after each vaccination. | | | | ID | Title | Description |
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| OG000 | Seqirus Quadrivalent Influenza Vaccine | The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season). Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe. The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination. | | OG001 | Comparator Quadrivalent Influenza Vaccine | The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season. Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe. The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination. |
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| Secondary | Safety Endpoint: The Frequency and Severity of Unsolicited Adverse Events (AEs). | Frequency and severity of unsolicited AEs for at least 28 days (ie, day of vaccination and 27 subsequent days) after each vaccination dose | The Overall Safety Population comprises all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and provided any evaluable follow-up safety data. | Posted | | Number | | participants | | 28 days after each vaccination. | | | | ID | Title | Description |
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| OG000 | Seqirus Quadrivalent Influenza Vaccine | The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season). Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe. The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination. | | OG001 | Comparator Quadrivalent Influenza Vaccine | The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season. Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe. The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination. |
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| Secondary | Safety Endpoint: The Frequency of Serious Adverse Events (SAEs). | Frequency of serious adverse events (SAEs) for 180 days after the last vaccination dose. | The Overall Safety Population comprises all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and provided any evaluable follow-up safety data | Posted | | Number | | participants | | 180 days after the last vaccination dose. | | | | ID | Title | Description |
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| OG000 | Seqirus Quadrivalent Influenza Vaccine | The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season). Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe. The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination. | | OG001 | Comparator Quadrivalent Influenza Vaccine | The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season. Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe. The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination. |
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| Secondary | Immunogenicity Endpoint: GMTs - Geometric Mean of HI Titers Prevaccination (Day 1) and Postvaccination (Study Exit Visit) | The humoral immune response was assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains was used to calculate: - Geometric mean of HI titers prevaccination & postvaccination | The Per-Protocol Population comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | 28 days after last vaccination. | | | | ID | Title | Description |
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| OG000 | Seqirus Quadrivalent Influenza Vaccine | The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season). Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe. The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination. | | OG001 | Comparator Quadrivalent Influenza Vaccine | The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season. Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe. The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination. |
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| Secondary | Immunogenicity Endpoint: Seroconversion Rate (SCR) | The humoral immune response was assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains was used to calculate: - SCRs: % of subjects with either a prevaccination HI titer < 1:10 and a postvaccination HI titer ≥ 1:40 or a prevaccination titer ≥ 1:10 and a ≥ 4-fold increase in postvaccination titer | The Per-Protocol Population comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 28 days after last vaccination. | | | | ID | Title | Description |
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| OG000 | Seqirus Quadrivalent Influenza Vaccine | The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season). Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe. The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination. | | OG001 | Comparator Quadrivalent Influenza Vaccine | |
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| Secondary | Immunogenicity Endpoint: Seroprotection Rate | The humoral immune response was assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains was used to calculate: - The % of subjects with a titer ≥40 (seroprotection rates) at Day 1 and at Exit Visit | The Per-Protocol Population comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results | Posted | | Number | 95% Confidence Interval | percentage of participants | | 28 days after last vaccination. | | | | ID | Title | Description |
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| OG000 | Seqirus Quadrivalent Influenza Vaccine | The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season). Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe. The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination. | | OG001 | Comparator Quadrivalent Influenza Vaccine | The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season. Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe. The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination. |
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| Secondary | Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) | The humoral immune response was assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains was used to calculate: - Geometric mean fold increase (GMFI): geometric mean fold titer rise from Day 1 to Exit Visit | The Per-Protocol Population comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results. | Posted | | Geometric Mean | 95% Confidence Interval | Fold Change Titer (GMFI) | | 28 days after last vaccination. | | | | ID | Title | Description |
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| OG000 | Seqirus Quadrivalent Influenza Vaccine | The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season). Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe. The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination. | | OG001 | Comparator Quadrivalent Influenza Vaccine | The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season. Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe. The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination. |
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