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Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Infants and Children
This study is ongoing, but not recruiting participants.
Study NCT00391391   Information provided by Sanofi-Aventis
First Received: October 23, 2006   Last Updated: May 14, 2008   History of Changes

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
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP