This is a study to assess the immune (antibody) response and safety of a Seqirus split virion, inactivated Quadrivalent Influenza Vaccine (Seqirus QIV), in comparison with a US licensed 2015/2016 Quadrivalent Influenza Vaccine (comparator QIV) in a healthy pediatric population 5 through 17 years of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
2,278
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.
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.
Site 296
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.
Time frame: 28 days after last vaccination.
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.
Time frame: 28 days after last vaccination.
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
Time frame: 7 days after each vaccination.
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
Time frame: 7 days after each vaccination.
Safety Endpoint: The Frequency of Cellulitis-like Reaction.
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Huntsville, Alabama, United States
Site 401
Madera, California, United States
Site 397
Ontario, California, United States
Site 392
Redding, California, United States
Site 402
Sacramento, California, United States
Site 398
San Jose, California, United States
Site 388
Hialeah, Florida, United States
Site 293
Melbourne, Florida, United States
Site 289
Boise, Idaho, United States
Site 294
Peoria, Illinois, United States
...and 22 more locations
Frequency of cellulitis-like reaction for at least 28 days after each vaccination dose
Time frame: 28 days after each vaccination.
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
Time frame: 28 days after each vaccination.
Safety Endpoint: The Frequency of Serious Adverse Events (SAEs).
Frequency of serious adverse events (SAEs) for 180 days after the last vaccination dose.
Time frame: 180 days after the last vaccination dose.
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
Time frame: 28 days after last vaccination.
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
Time frame: 28 days after last vaccination.
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
Time frame: 28 days after last vaccination.
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
Time frame: 28 days after last vaccination.