Study to Collect Sera for Immunogenicity Testing in Children Vaccinated With Fluzone®

Study Overview
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Brief Summary
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To describe the safety findings from Days 0 to 44 following injection of the 2003-2004 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 findings from Days 0 to 44 following injection of the 2003-2004 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

Detailed Description
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The study is to collect sera from healthy children being administered the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone®.

Official Title
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A Trial for the Collection of Sera in Healthy Children Receiving Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® 2003/2004

Conditions
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Influenza

Intervention / Treatment
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* Biological: Influenza virus vaccine (Pediatric formulation)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria : Aged ≥ 6 months to < 36 months. Considered to be in good health on the basis of reported medical history and limited physical examination. Available for the duration of the study (44 days +4 days). 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.

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>Participants received 2 doses of Fluzone® vaccine | Biological: Influenza virus vaccine (Pediatric formulation)<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 Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Solicited local reactions: Erythema (redness), induration, bruising and pain at the injection site. Solicited systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, diarrhea, vomiting and rash. | Day 0 to 3 post-vaccination | 

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