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 2016/2017 Quadrivalent Influenza Vaccine (comparator QIV) in a healthy pediatric population 6 months through 59 months of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
2,250
The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2016/2017 influenza season). Subjects will receive one or two doses according to the recommendations of the Advisory Committee on Immunization Practices for the United States 2016-17 Influenza Season. Preferred sites for intramuscular injection are the anterolateral aspect of the thigh in infants 6 months through 11 months of age, the anterolateral aspect of the thigh (or the deltoid muscle of the arm if muscle mass is adequate) in children 12 months through 35 months of age.
The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2016/2017 influenza season. Subjects will receive one or two doses according to the recommendations of the Advisory Committee on Immunization Practices for the United States 2016-17 Influenza Season. Preferred sites for intramuscular injection of the non-dominant arm in children 36 months through 59 months of age.
The Geometric Mean Titer (GMT) Ratio of Each Virus Strain.
Noninferiority of Seqirus QIV compared to comparator QIV was assessed by hemagglutination inhibition (HI) antibody geometric mean titer (GMT) 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. B/VIC = B/Victoria B/YAM = B/Yamagata
Time frame: Postvaccination (28 days after last vaccination)
The Difference in Seroconversion Rate (SCR) for Each Virus Strain.
Noninferiority of Seqirus QIV compared to comparator QIV will be assessed by seroconversion rate (SCR) for each viral strain. 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 vaccine (for each strain) will be determined.
Time frame: Postvaccination (28 days after last vaccination)
Number of Participants With Solicited Local Adverse Reactions and Solicited Systemic Adverse Events (AE)
Frequency and severity of solicited local adverse reactions and systemic AEs for 7 days after each vaccination dose
Time frame: Postvaccination (up to 7 days after vaccination)
Number of Participants With Cellulitis-like Reactions
Frequency of cellulitis-like reactions for at least 28 days after each vaccination dose
Time frame: Postvaccination (up to 28 days after each vaccination)
Number of Participants With Unsolicited AEs
Frequency and severity of unsolicited AEs for at least 28 days after each vaccination dose
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Site 434
Birmingham, Alabama, United States
Site 442
Mobile, Alabama, United States
Site 430
Anaheim, California, United States
Site 437
Anaheim, California, United States
Site 423
Downey, California, United States
Site 397
Ontario, California, United States
Site 445
Paramount, California, United States
Site 402
Sacramento, California, United States
Site 425
San Diego, California, United States
Site 418
Miami, Florida, United States
...and 29 more locations
Time frame: Postvaccination (up to 28 days after vaccination)
Number of Participants With Serious Adverse Events (SAE)
Frequency of SAEs for 180 days after the last vaccination dose. SAE = serious adverse events, AESI = adverse event of special interest
Time frame: 180 days after the last vaccination dose.
Geometric Mean of Hemagglutination Titers (HI GMTs) Prevaccination (Day 1) and Postvaccination (Study Exit Visit) of Each Virus Strain
The humoral immune response will be assessed for Seqirus QIV \& comparator QIV. Serum HI titers against the 4 influenza vaccine strains will be used to calculate geometric mean of HI titers prevaccination \& postvaccination.
Time frame: 28 days after last vaccination.
Seroconversion Rates (SCRs) of Each Virus Strain
The humoral immune response will be assessed for Seqirus QIV \& comparator QIV. Serum HI titers against the 4 influenza vaccine strains will be used to calculate SCRs defined as the % 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
Seroprotection Rates of Each Virus Strain
The humoral immune response will be assessed for Seqirus QIV \& comparator QIV. Serum HI titers against the 4 influenza vaccine strains will be used to calculate the percentage of subjects with a titer ≥40 (seroprotection rates) at Day 1 and at Study Exit Visit.
Time frame: 28 days after last vaccination.
Geometric Mean Fold Increase (GMFI) of Each Virus Strain
The humoral immune response will be assessed for Seqirus QIV \& comparator QIV. Serum HI titers against the 4 influenza vaccine strains will be used to calculate GMFIs, defined as the geometric mean fold titer change (rise) from Day 1 to Study Exit Visit.
Time frame: Prevaccination (Day 1) and Postvaccination (28 days after last vaccination)