Safety and Immunogenicity Testing of Influenza Vaccine in Healthy Children 2 Months and 6 Months of Age

Study Overview
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Brief Summary
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Primary Objective: To describe the safety of the 2004-2005 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule (described in the package insert for vaccine-naïve young children) to the investigational and control groups. Observational Objective: To describe the percentage of protective Hemagglutination Inhibition (HAI) antibody titers (following a 2-dose Fluzone® immunization series) to each of the 3 vaccine antigens among the investigational and control groups.

Detailed Description
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This is an observational and descriptive study that will provide preliminary comparative information about the safety and immunogenicity of Fluzone® vaccine among children aged 6 to 12 weeks (the investigational group, also referred to as the 2-month-old group) versus children aged 24 to 36 weeks (the control group, also referred to as the 6-month-old group). The study is not designed to achieve any preset statistical power, and no hypotheses will be tested.

Official Title
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Proof of Concept Study of the Safety and Immunogenicity of Influenza Virus Vaccine Fluzone® 2004-2005 Among Healthy Children 2 Months vs 6 Months of Age

Conditions
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Influenza

Intervention / Treatment
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* Biological: Influenza virus vaccine (2004-2005 Formulation)
* Biological: Influenza virus vaccine (2004-2005 Formulation)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria : Aged 42 to 84 days (6 to 12 weeks) or 24 to 36 weeks on the day of inclusion. Born at full term of pregnancy (≥ 36 weeks) with a birth weight ≥ 2.5 kg. Considered to be in good health on the basis of reported medical history and history-directed physical examination. Available for the duration of the study. Parent/guardian willing and able to provide informed consent. Parent/guardian able to attend all scheduled visits and comply with all trial procedures. Willingness to permit venipuncture or heel stick for purposes of collecting a blood sample. 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. Receipt of any vaccine in the 7 days prior to enrollment. An acute illness with fever (rectal temperature ≥ 38.0 °C [or ≥ 100.4 °F]) in the 72 hours preceding enrollment in the trial (defer enrollment). Known bleeding disorder. Participation in any other clinical trial within 30 days prior to enrollment, or planned participation in another clinical trial prior to termination of the subject's participation in this 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 that could interfere with trial conduct or completion. Known HIV-positive or HBsAg-positive mother. Known HIV, hepatitis B (HBsAg), or hepatitis C infection. Blood or blood-derived products received in the past 2 months. 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: 2 Months
Maximum Age: 9 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Participants aged 6 to 12 Weeks at enrollment | Biological: Influenza virus vaccine (2004-2005 Formulation)<br>* 0.25 mL, Intramuscular<br>* Other names: Fluzone® Preservative-free;|
| Experimental: Group 2<br>Participants aged 24 to 36 Weeks at enrollment | Biological: Influenza virus vaccine (2004-2005 Formulation)<br>* 0.25 mL, Intramuscular<br>* Other names: Fluzone® Preservative-free;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Solicited local (injection site) reactions: Tenderness, erythema (redness), and swelling Solicited systemic reactions: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Loss of Appetite, and Irritability. | Day 0 to Day 7 post-vaccination | 

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