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

Completed · Phase 4

Conditions studied: Influenza, Orthomyxoviridae Infections

In brief

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.

Key facts

Study ID

NCT00755274

Run by

Sanofi Pasteur, a Sanofi Company

People needed

32

Starts

2008-09-01

Expected to finish

2009-01-01

Last updated by the study team

2016-04-14

Who can join

Age: 1 and older, up to 5. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Study site — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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