Status:
COMPLETED
Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Infants and Children
Lead Sponsor:
Sanofi
Conditions:
Orthomyxoviridae Infection
Influenza
Eligibility:
All Genders
6-8 years
Phase:
PHASE2
Brief Summary
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 year...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- 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.
- Exclusion Criteria :
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
520 Patients enrolled
Trial Details
Trial ID
NCT00391391
Start Date
October 1 2006
End Date
October 1 2007
Last Update
December 1 2011
Active Locations (19)
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1
Harrisburg, Arkansas, United States, 72432
2
Little Rock, Arkansas, United States, 72205
3
Trumann, Arkansas, United States, 72472
4
Bellflower, California, United States, 90706