Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Infants and Children

Completed · Phase 2

Conditions studied: Orthomyxoviridae Infection, Influenza, Myxovirus Infection

In brief

Primary Objective: To evaluate for each influenza strain the non-inferiority of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years. Secondary Objectives: * To describe the immunogenicity of of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years. * To describe the safety of of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.

Key facts

Study ID

NCT00391391

Run by

Sanofi

People needed

520

Starts

2006-10-01

Expected to finish

2007-10-01

Last updated by the study team

2011-12-01

Who can join

Age: 1 and older, up to 8. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Aged 6 months to 8 years but not yet 9 years on the day of inclusion.
• Subject is healthy, as determined by medical history.
• Institution Review Board (IRB)-approved informed assent form signed by eligible subject (if required by local regulations) and/or an IRB-approved informed consent form signed by the subject's parent(s) or legal representative (and by an independent witness if required by local regulations).
• Parent or legal guardian willing and able to attend (bring subject) to all scheduled visits and comply with all trial procedures.

You may not qualify if…

• Participation in another clinical trial in the 4 weeks preceding the trial vaccination.
• Planned participation in another clinical trial during the present trial period.
• Personal or family history of Guillain-Barré Syndrome.
• Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy 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.
• Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a vaccine containing the same substances.
• Chronic illness at a stage that could interfere with trial conduct or completion
• Received blood or blood-derived products in the previous 3 months.
• Any vaccination in the 4 weeks preceding or following the trial vaccinations (Subjects can take standard childhood vaccination(s) following Visit 3 blood draw).
• Known current human immunodeficiency virus (HIV), hepatitis B (HBsAg) or hepatitis C infection or seropositivity.
• Known thrombocytopenia or bleeding disorder contraindicating IM vaccination.
• Acute medical illness, with or without fever, within the last 72 hours or an oral temperature ≥ 37.5 °C (99.5 °F) or rectal temperature of ≥ 38°C (100.4 °F) at the time of enrollment.
• History of seizures.
• Received antibiotics therapy within 72 hours preceding the trial vaccination.
• Received any allergy shots in the 7-day period preceding trial vaccination and/or scheduled to receive any allergy shots in the 7-day period after trial vaccination.
• Any condition, which in the opinion of the investigator would pose a health risk to the participant.

Where it is running

• Study site — Harrisburg, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Trumann, Arkansas, United States
• Study site — Bellflower, California, United States
• Study site — Downey, California, United States
• Study site — Fountain Valley, California, United States
• Study site — Paramount, California, United States
• Study site — Owensboro, Kentucky, United States
• Study site — Bossier City, Louisiana, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Brainerd, Minnesota, United States
• Study site — Cleveland, Ohio, United States
• Study site — Erie, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Uniontown, Pennsylvania, United States
• Study site — Wexford, Pennsylvania, United States
• Study site — Fort Worth, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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