Safety and Immunogenicity of Fluzone® Vaccine in Children Who Received 2 Doses of the 2005-2006 Fluzone Formulation.

Study Overview
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Brief Summary
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To compare the groups with respect to influenza immune responses following Dose 1 of Fluzone vaccine (2006-2007 formulation).

Official Title
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Safety and Immunogenicity of Fluzone® Influenza Virus Vaccine (2006-2007 Formulation) Among Healthy Children Immunized in Fall 2005 With Fluzone Vaccine or Placebo

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 : Previously enrolled in study GRC28 and received 2 vaccinations of the assigned lot. Considered to be in good health on the basis of reported medical history and history-directed physical evaluation. Available for the duration of the study. Parent/legal representative willing and able to provide informed consent. Parent/legal representative able to attend all scheduled visits and comply with all trial procedures. Parent/legal representative willing to permit venipuncture for purposes of collecting a blood sample. Exclusion Criteria : Receipt of any vaccine within the past 7 days (subjects may be deferred until after the seven days has passed.) Reported allergy to egg proteins, chicken proteins or any other constituent of the vaccine. Ever received any influenza vaccine, other than at Visits 1 and 2 of study GRC28, or known to have ever been diagnosed with laboratory-confirmed influenza. An acute illness with fever (rectal temperature ≥ 100.4°F [38.0°C]) in the 72 hours preceding enrollment in the trial (defer enrollment). Known bleeding disorder. Participation in any other interventional clinical trial within 30 days prior to enrollment, or planned participation in another interventional clinical trial prior 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 that, in the opinion of the investigator, could interfere with trial conduct or completion. Known Human Immunodeficiency Virus (HIV)-positive mother or Hepatitis B surface antigen (HBsAg)-positive mother. Known HIV, Hepatitis B, or Hepatitis C infection. Administration of immune globulin or other blood products within the last three months, or injected or oral corticosteroids or other immunomodulator therapy within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting < 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment. Prior personal history of Guillain-Barré syndrome. Any condition that, 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: 11 Months
Maximum Age: 14 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: Fluzone®-Primed Group<br>Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28, NCT00242424), will receive 2 doses of Fluzone® Pediatric 2006-2007 formulation. | Biological: Influenza Virus Vaccine, Fluzone®<br>* 0.25 mL, Intramuscular<br>* Other names: Fluzone®;|
| Experimental: Fluzone®-Naive Group<br>Participants had never received Influenza vaccine and had received two doses of placebo in the fall of 2005 (Study GRC28, NCT00242424), will receive 2 doses of Fluzone® Pediatric 2006-2007 formulation. | Biological: Influenza Virus Vaccine, Fluzone®<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 |
| --- | --- | --- |
| Percentage of Seroprotected Participants Post-vaccination With Fluzone® | Seroprotection was defined as a Post-vaccination Hemagglutination Inhibition titer of greater than or equal to 1:40. | Day 28 Post-vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone® | Antibodies against Influenza virus in Fluzone® Vaccine determined by the Hemagglutination inhibition (HAI) assay method. | Day 28 Post-vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fluzone®, Influenza, Influenza virus infection, Influenza vaccine