Influenza Vaccine Dose-Response in Infants and Toddlers: Immunogenicity and Reactogenicity
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Inactivated Influenza Vaccine Trivalent Types A and B (Split Virion)
Intervention description: Arm 1 (experimental group) received two spaced injections of the 0.5 mL (full) dose while arm 2 (comparison group) received the currently recommended two spaced injections of 0.25mL (half) dose of trivalent inactivated split virion influenza vaccine (VAXIGRIP®) manufactured by Sanofi Pasteur, Lyon, France.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 262.0
Sex: All
Minimum age: 6 Months
Maximum age: 23 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza Vaccines; Infant; Dose-Response Relationship, Immunologic

Summary:

      The purpose of this study is to compare the antibody response and reaction rates in children
      age 6-23 months when they are given either the currently recommended schedule of two 0.25ml
      doses of influenza vaccine one month apart or two 0.5ml doses of influenza vaccine, one month
      apart.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Child healthy (stable chronic conditions acceptable) as established by health
             assessment interview and verbal history-directed health examination

          -  Child between and including 6 months of age and 23 months of age (up to and including
             the day before 24 months of age)

          -  Child is available and can complete all relevant procedures during the entire study
             period

          -  Parent or legal guardian is available and can be reached by phone during the entire
             study period

          -  Parent/guardian provides written informed consent

          -  Parent/guardian is fluent in English

        Exclusion Criteria:

          -  Child has history of laboratory-confirmed influenza

          -  Child has history of any prior influenza immunization

          -  Child has history of anaphylactic reaction to any component of the vaccine (i.e. egg)

          -  Child has received immune globulin or other blood products within the prior six weeks

          -  Child has received injected or oral steroids within the prior six weeks (inhaled or
             topical steroids allowed)

          -  Child has a bleeding diathesis or condition associated with prolonged bleeding time
             that would contraindicate intramuscular injection (thrombocytopenia, coagulation
             disorder, anti-coagulant therapy)

          -  Child is or will be enrolled in any other clinical trial of a drug, vaccine or medical
             device during the study period

          -  Child is scheduled to receive a live vaccine (notably measles, mumps, rubella or
             varicella vaccines) during the study period

          -  Child has a health condition which, in the opinion of the investigator, would
             interfere with the evaluation or pose a health risk to the child