Status:
COMPLETED
Annual Study for Serum Collection for Immunogenicity and Safety Evaluation in Healthy Children Receiving Fluzone®
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Influenza
Orthomyxoviridae Infections
Eligibility:
All Genders
6-5 years
Phase:
PHASE4
Brief Summary
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 in...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00755274
Start Date
September 1 2008
End Date
January 1 2009
Last Update
April 14 2016
Active Locations (1)
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1
Norfolk, Virginia, United States, 23510