Annual Study for Serum Collection for Immunogenicity and Safety Evaluation in Healthy Children Receiving Fluzone®

Study Overview
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Brief Summary
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Primary Objective: To provide the Center for Biologics Evaluation and Research (CBER) with sera collected from healthy children receiving the 2008-2009 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study. Observational Objectives: To describe the safety of the 2008-2009 pediatric formulation of Fluzone® vaccine, administered in a one- or two-dose schedule in accordance with Advisory Committee on Immunization Practices (ACIP) recommendations, in children ≥ 6 months to < 5 years of age. To describe the immunogenicity of the 2008-2009 pediatric formulation of Fluzone® vaccine, administered in a one- or two-dose schedule in accordance with ACIP recommendations, in children ≥ 6 months to < 5 years of age.

Detailed Description
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The Advisory Committee on Immunization Practices (ACIP) has in recent years recommended that all healthy children aged 6 through 59 months receive influenza vaccine. Because of the growing emphasis on influenza immunization of infants and young children, Center for Biologics Evaluation and Research (CBER) has expressed interest in receiving sera from children who have been vaccinated with the current formulation of Fluzone® vaccine. These sera will be tested to evaluate each individual's immune response to the current formulation of Fluzone® vaccine and will also be used to evaluate circulating influenza strains in order to support formulation recommendations for the subsequent year (particularly for influenza B strains, which predominantly affect the young).

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 (2008-2009 Formulation)

Conditions
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Influenza, Orthomyxoviridae Infections

Intervention / Treatment
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* Biological: Influenza Virus Vaccine No Preservative: Pediatric Dose
* Biological: Influenza Virus Vaccine No Preservative: Pediatric Dose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is ≥ 6 months to < 5 years of age. Participant is considered to be in good health on the basis of reported medical history and a limited history-directed physical examination. Parent/legal acceptable representative is willing and able to bring the subject to the scheduled visits and to comply with the study procedures during the entire duration of the study. Parent/legal acceptable representative is willing and able to provide informed consent. Subject was 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. History of severe adverse event to any influenza vaccine. Laboratory-confirmed influenza infection or vaccination against influenza in the 6 months preceding enrollment in the study. Any vaccination scheduled between Visit 1 and Visit 2. Planned participation in any other interventional clinical trial during 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. Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 5 Years

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: Group 1: Primed<br>Have received 2 or more lifetime Flu Vaccinations Prior to Visit 1 | Biological: Influenza Virus Vaccine No Preservative: Pediatric Dose<br>* 0.25 mL, IM (age 6-35 months) or 0.5 mL, IM (age 36-59 months)<br>* Other names: Fluzone®;|
| Experimental: Group 2: Naive/Inadequately Primed<br>Never Received or Received Only 1 Lifetime Flu Vaccination Prior to Visit 1 | Biological: Influenza Virus Vaccine No Preservative: Pediatric Dose<br>* 0.25 mL, IM (age 6-35 months) or 0.5 mL, IM (age 36-59 months)<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 Fluzone® Vaccination 1 | Solicited local reactions: Tenderness, pain, erythema, and swelling. Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia. | Day 0 to Day 3 post-vaccination 1 | 
| Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2 | Solicited local reactions: Tenderness, pain, erythema, and swelling. Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia. | Day 0 to Day 3 post-vaccination 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza, Orthomyxoviruses, Orthomyxoviridae Infections, Influenza vaccine