Phase IV Trial to Collect Safety Data and Sera in Healthy Children Given Fluzone Vaccine

Study Overview
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Brief Summary
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To provide serum to the Food and Drug Administration (FDA) for use by FDA, the Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO) for characterization of circulating influenza strains. Observational Objectives: To describe the safety of the 2005-2006 pediatric formulation of Fluzone vaccine, 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 2005-2006 pediatric formulation of Fluzone vaccine, administered in a two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to < 36 months.

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 (2005-2006 Formulation)

Conditions
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Influenza

Intervention / Treatment
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* Biological: Influenza Virus Vaccine (Fluzone®)
* Biological: Influenza Virus Vaccine (Fluzone®)


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. Exclusion Criteria: Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine. 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 (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 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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 36 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 Virus Vaccine Naïve<br>Subjects have never received Influenza virus vaccine in the past | Biological: Influenza Virus Vaccine (Fluzone®)<br>* 0.25 mL, Intramuscular (Day 0 and Day 28)<br>* Other names: Fluzone®;|
| Experimental: Influenza Virus Vaccine-primed<br>Subjects have received Influenza virus vaccine in the past | Biological: Influenza Virus Vaccine (Fluzone®)<br>* 0.25 mL, Intramuscular (Day 0)<br>* Other names: Fluzone®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Titer (GMT) of Hemagglutination Inhibition Antibodies Pre-vaccination and 14 Days Post-vaccination | GMTs and their 95% Confidence interval are presented for each of the 3 antigens in the Fluzone® vaccine 2005-2006 Pediatric formulation. Post-dose 1 (Influenza vaccine Primed group); post-dose 2 (Influenza vaccine Naive group) | Day 14 post-vaccination | 

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