Study of Quadrivalent Influenza Vaccine Among Children
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Licensed 2010-2011 Trivalent Influenza Vaccine, No Preservative; Investigational Trivalent Influenza Vaccine with alternate B strain, No Preservative; Quadrivalent Influenza Vaccine, No Preservative
Intervention description: 0.25 mL (6 to 35 months) or 0.5 mL (3 to <9 years), Intramuscular; 0.25 mL (6 to 35 months) or 0.5 mL (3 to <9 years), Intramuscular; 0.25 mL (6 to 35 months), or 0.5 mL(3 to <9 years), Intramuscular
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 4363.0
Sex: All
Minimum age: 6 Months
Maximum age: 8 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Quadrivalent Influenza Vaccine; Trivalent Influenza Vaccine; Influenza viruses; Fluzone®

Summary:

      The aim of the study is to evaluate a prototype quadrivalent influenza vaccine (QIV), the
      licensed 2010-2011 trivalent influenza vaccine (TIV) containing the primary B strain (B1),
      and the investigational TIV containing the alternate B (B2) strain in children.

      Primary Objective:

      To demonstrate non-inferiority of antibody responses to QIV compared with licensed 2010-2011
      TIV (containing the primary B strain) and investigational TIV (containing the alternate B
      strain) as assessed by geometric mean titer (GMT) ratios for each of the four virus strains
      separately among children aged 6 months to less than 9 years of age

      Secondary Objective:

      To demonstrate superiority of antibody responses to each B strain in QIV compared with
      antibody titers following vaccination with the TIV that does not contain the corresponding B
      strain, as assessed by GMT ratios and seroconversion rates.

      Observational Objective:

      To describe the safety profile of QIV among subjects 6 months to less than 9 years of age, as
      assessed by solicited injection site and systemic adverse events (AEs) collected for 7 days
      post-vaccination, unsolicited adverse events collected from 21 days post-vaccination, and
      adverse events of special interest and serious adverse events (SAEs) collected from Visit 1
      to Visit 2.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is 6 months to < 9 years of age on the day of inclusion.

          -  Parent/guardian is willing and able to attend scheduled visits and to comply with the
             study procedures during the entire duration of the study.

          -  Subject is in reasonably good health as assessed by the Investigator.

          -  Informed consent is granted by the parent(s) or other legally acceptable
             representative; assent by subjects 7 to < 9 years of age.

          -  For subjects 6 months to < 24 months of age, born at full term of pregnancy (≥ 37
             weeks) and with a birth weight ≥ 2.5 kg (5.5 lbs).

        Exclusion Criteria:

          -  History of allergy to egg proteins or any constituents of the vaccine.

          -  History of serious adverse reaction to any influenza vaccine.

          -  Any vaccination scheduled between Visit 1 and Visit 2 (or Visit 1 and Visit 3 for
             those requiring two doses).

          -  Receipt of any vaccine in the 4 weeks preceding the first study vaccination.

          -  Participation in another interventional clinical trial investigating a vaccine, drug,
             medical device, or medical procedure in the 4 weeks preceding the first study
             vaccination or during the course of the study.

          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
             contraindicating intramuscular vaccination.

          -  Any condition that in the opinion of the Investigator would pose a health risk to the
             subject if enrolled or could interfere with the evaluation of the vaccine.

          -  Personal history of Guillain-Barré syndrome.

          -  Known or suspected congenital or acquired immunodeficiency; or receipt of
             immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within
             the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or
             equivalent for more than 2 consecutive weeks within the past 3 months).

          -  Personal or immediate family history of congenital immune deficiency.

          -  Personal developmental delay, neurologic disorder, or seizure disorder.

          -  Any chronic illness that, in the opinion of the Investigator, is not well controlled
             and may interfere with trial conduct or completion, or with assessment of adverse
             events.

          -  Known seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C.

          -  Receipt of blood or blood-derived products (including immunoglobulin therapy) in the
             past 3 months, which might interfere with assessment of the immune response.

          -  Employees of the Investigator or study center, with direct involvement in the proposed
             study or other studies under the direction of that Investigator or study center, as
             well as family members of the employees or the Investigator.