Phase IV Trial to Collect Safety Data and Sera for Immunogenicity Testing in Healthy Children Given Fluzone® Vaccine

Study Overview
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Brief Summary
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To provide Centers for Biologic Evaluation and Research (CBER) with sera collected from healthy children receiving the 2007-2008 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study.

Official Title
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Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2007-2008 Formulation)

Conditions
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Influenza

Intervention / Treatment
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* Biological: 2007-2008 Influenza Virus Vaccine
* Biological: 2007-2008 Influenza Virus Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is aged ≥ 6 months (24 weeks) to < 36 months (3rd birthday). Participant is considered to be in good health on the basis of reported medical history and limited physical examination. Participant is available for the duration of the study. Parent/legal acceptable representative is willing and able to provide informed consent. Parent/legal acceptable representative is willing and able to meet protocol requirements. Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg (5.5 lbs). Exclusion Criteria: Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine. An acute illness with or without fever (For infants/toddlers: temperature ≥ 100.4°F rectal; For children: temperature ≥ 99.5°F oral/axillary) in the 72 hours preceding enrollment in the trial (Enrollment may be deferred). Clinically significant findings in vital signs or review of systems (Investigator judgment; defer or exclude). Participation in any other interventional clinical trial within 30 days prior to enrollment or planned participation in the 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. Known human immunodeficiency virus (HIV)-positive mother. Prior personal 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. Received any vaccinations within the preceding 14 days (enrollment may be deferred).

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 35 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Influenza vaccine Naive/Inadequately Primed<br>Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14. | Biological: 2007-2008 Influenza Virus Vaccine<br>* 0.25 mL, Intramuscular<br>* Other names: Fluzone®;|
| Experimental: Influenza Vaccine Primed<br>Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0. | Biological: 2007-2008 Influenza Virus Vaccine<br>* 0.25 mL, Intramuscular<br>* Other names: Fluzone®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Solicited injection site reactions: Erythema, swelling, pain/tenderness; Solicited systemic reactions: (for infants/toddlers) - fever, irritability, abnormal crying, drowsiness, lost appetite, vomiting; (for children) - fever, headache, malaise, myalgia) Note: Influenza-primed group received only dose 1. | Days 0-3 post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza Vaccine, Influenza Virus, Orthomyxoviridae Infections, Fluzone®