Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Infants and Children
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Orthomyxoviridae Infection; Influenza; Myxovirus Infection
Intervention: Split, Inactivated, Trivalent Influenza Vaccine (Biological); Split, Inactivated, Trivalent Influenza Vaccine (Biological); Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation) (Biological); Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation) (Biological)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: sanofi pasteur
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 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.
Clinical Details
Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To provide information concerning the immunogenicity of Inactivated, Split-Virion Influenza Vaccine
Secondary outcome: To provide information concerning the safety of Inactivated, Split-Virion Influenza Vaccine
Eligibility
Minimum age: 6 Months.
Maximum age: 8 Years.
Gender(s): Both.
Criteria:
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 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.
Locations and Contacts
Little Rock, Arkansas, United States
Harrisburg, Arkansas, United States
Trumann, Arkansas, United States
Paramount, California, United States
Bellflower, California, United States
Downey, California, United States
Fountain Valley, California, United States
Owensboro, Kentucky, United States
Bossier City, Louisiana, United States
Shreveport, Louisiana, United States
Brainerd, Minnesota, United States
Cleveland, Ohio, United States
Pittsburgh, Pennsylvania, United States
Wexford, Pennsylvania, United States
Uniontown, Pennsylvania, United States
Erie, Pennsylvania, United States
Fort Worth, Texas, United States
Salt Lake City, Utah, United States
Additional Information
Starting date: October 2006
Ending date: September 2008
Last updated: May 14, 2008
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