Study of Safety and Immunogenicity of Fluzone® in Healthy Children

Study Overview
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Brief Summary
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To describe the safety of the 2004-2005 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to < 36 months. To describe the immunogenicity of the 2004-2005 inactivated, split-virion influenza vaccine Fluzone®, administered in a two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to < 36 months

Detailed Description
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To provide the Centers for Biologic Evaluation and Research (CBER) with sera collected from healthy children receiving the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study by the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO).

Official Title
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Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Influenza Virus Vaccine Fluzone® 2004-2005

Conditions
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Influenza

Intervention / Treatment
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* Biological: Influenza Vaccine 2004-2005 Paediatric Formulation
* Biological: Influenza Vaccine 2004-2005 Paediatric Formulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria : Participant is aged ≥ 6 months to < 36 months. 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/guardian is willing and able to provide informed consent. Parent/guardian is willing and able to meet protocol requirements. Exclusion Criteria : Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine. Previous history of influenza vaccination or documented history of influenza infection. An acute illness with or without fever (temperature > 100.4 °F rectal) in the 72 hours preceding enrollment in the trial (defer enrollment). Clinically significant findings in vital signs or review of systems (investigator judgment; defer or exclude). Participation in any other clinical trial within 30 days prior to enrollment up to termination of the subject's 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 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. Any vaccination in the 14 days preceding enrollment in the study or scheduled between Visit 1 and Visit 3.

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: Infants <12 Months<br>Participants aged ≥ 6 to < 12 months at enrollment and received 2 doses of Fluzone® Vaccine | Biological: Influenza Vaccine 2004-2005 Paediatric Formulation<br>* 0.25 mL (Day 0 and Day 28), Intramuscular<br>* Other names: Fluzone®;|
| Experimental: Toddlers ≥12 Months<br>Participants aged ≥ 12 to < 36 months at enrollment and received 2 doses of Fluzone® vaccine | Biological: Influenza Vaccine 2004-2005 Paediatric Formulation<br>* 0.25 mL (Day 0 and Day 28), 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 With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Solicited local reactions: Erythema, bruising, induration, pain at injection site. Solicited systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, diarrhea, vomiting, rash collected daily for four days after each injection. | 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, Fluzone® vaccine, Infants, Toddlers