Evaluation of Responses to Fluzone® in Infants ≥ 6 Months of Age Who Did or Did Not Receive Fluzone® at 2 Months of Age
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Influenza Virus Vaccine; Influenza Virus Vaccine
Intervention description: 0.25 mL, Intramuscular; 0.25 mL, Intramuscular
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 242.0
Sex: All
Minimum age: 6 Months
Maximum age: 11 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Fluzone® vaccine; Influenza

Summary:

      The study is to compare the 2 Groups with respect to antibody responses to inactivated
      influenza vaccine.

      Observational Objectives:

        -  To describe the percentage of participants with protective Hemagglutinin (HAI) antibody
           titers to each of the 3 vaccine antigens in both study groups following each
           vaccination.

        -  To describe the HAI geometric mean titer (GMTs) to each of the 3 vaccine antigens in
           both study groups following each vaccination.

        -  To describe the safety of the 2005-2006 pediatric formulation of Fluzone® vaccine in
           both study groups.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant is between 6 and 10 months of age on the day of inclusion (has reached
             6-month but has not reached 11-month anniversary of birth).

          -  Available for the duration of the study.

          -  Born at full term of pregnancy (≥ 36 weeks) with a birth weight ≥ 2.5 kg

          -  Parent/legal acceptable representative willing and able to provide informed consent.

          -  Parent/legal acceptable representative able to attend all scheduled visits and comply
             with all trial procedures.

          -  Parent/legal acceptable representative willing to permit venipuncture for purposes of
             collecting a blood sample.

          -  Previously enrolled in the 2-month-old group in Study GRC27 or approved by sponsor for
             enrollment as control.

        Exclusion Criteria:

          -  Reported allergy to egg proteins, chicken proteins, or any other constituent of
             Fluzone vacccine.

          -  Previous history of influenza vaccination (Group 2 subjects only).

          -  Receipt of any vaccine in the 14 days prior to enrollment.

          -  An acute illness with or without fever (rectal temperature ≥ 38.0 °C [or ≥100.4 °F])
             in the 72 hours preceding enrollment in the trial.

          -  Known bleeding disorder.

          -  Participation in any other interventional (e.g., vaccine, drug) clinical trial (except
             Study GRC27) within 30 days prior to enrollment, or planned participation in another
             interventional clinical trial prior to termination of the subject's participation in
             this study.

          -  Known or suspected impairment of immunologic function or receipt of immunosuppressive
             therapy or immunoglobulin since birth.

          -  Personal or immediate family history of congenital immune deficiency.

          -  Developmental delay, neurologic disorder, or seizure disorder.

          -  Chronic medical, congenital or developmental disorder that could interfere with trial
             conduct or completion.

          -  Known human immunodeficiency virus (HIV)-positive or hepatitis B surface antigen
             (HBsAg)-positive mother.

          -  Known HIV, hepatitis B, or hepatitis C infection.

          -  Receipt of blood or blood-derived products within the past 2 months.

          -  Prior history of Guillain-Barré syndrome.

          -  Any condition which, in the opinion of the investigator, would pose a health risk to
             the subject or interfere with the evaluation of the vaccine.