| October 23, 2006 |
| May 14, 2008 |
| October 2006 |
| October 2007 (final data collection date for primary outcome measure) |
| To provide information concerning the immunogenicity of Inactivated, Split-Virion Influenza Vaccine [ Time Frame: 28 days post-vaccination ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00391391 on ClinicalTrials.gov Archive Site |
| To provide information concerning the safety of Inactivated, Split-Virion Influenza Vaccine [ Time Frame: 6 months post-vaccination ] [ Designated as safety issue: Yes ] |
| Same as current |
| |
| Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Infants and Children |
| |
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.
|
| |
| Phase II |
| Interventional |
| Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
- Orthomyxoviridae Infection
- Influenza
- Myxovirus Infection
|
- Biological: Split, Inactivated, Trivalent Influenza Vaccine
- Biological: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)
|
- Experimental: Split, Inactivated, Trivalent Influenza Vaccine
- Active Comparator: Split, Inactivated, Trivalent Influenza Vaccine
|
| |
| |
| Active, not recruiting |
| 600 |
| September 2008 |
| October 2007 (final data collection date for primary outcome measure) |
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.
|
| Both |
| 6 Months to 8 Years |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00391391 |
| sanofi pasteur, sanofi aventis |
| FID07 |
| Sanofi-Aventis |
|
| Study Director: |
Clinical Trials |
sanofi pasteur |
|
|
| Sanofi-Aventis |
| May 2008 |