Immunogenicity and Safety of Sanofi Pasteur's AVAXIM 80U Pediatric Vaccine Followed by Booster Dose

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00483470
First received: June 5, 2007
Last updated: January 17, 2014
Last verified: January 2014

June 5, 2007
January 17, 2014
June 2007
May 2008   (final data collection date for primary outcome measure)
To provide information concerning the immunogenicity of AVAXIM 80U Pediatric vaccine [ Time Frame: 1 month post-vaccination ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00483470 on ClinicalTrials.gov Archive Site
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Immunogenicity and Safety of Sanofi Pasteur's AVAXIM 80U Pediatric Vaccine Followed by Booster Dose
Not Provided

As per request by the Heath Authorities, the present clinical study will assess the immunogenicity and safety

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Hepatitis A
  • Biological: Hepatitis A vaccine AVAXIM 80U
    0.5 mL, Intramuscular
    Other Name: AVAXIM 80U Pediatric vaccine
  • Biological: Hepatitis A vaccine (HAVRIX 720)
    0.5 mL, Intramuscular
    Other Name: Hepatitis A vaccine (HAVRIX 720)
  • Experimental: 1
    Intervention: Biological: Hepatitis A vaccine AVAXIM 80U
  • Active Comparator: 2
    Intervention: Biological: Hepatitis A vaccine (HAVRIX 720)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
720
August 2008
May 2008   (final data collection date for primary outcome measure)

Inclusion Criteria :

Inclusion criteria to be checked at the screening visit (SC):

  1. Toddlers, children and adolescents:

    Sub-Group 1: from 12 months to 3 years of age on the day of inclusion

    Sub-Group 2: from 4 to 6 years of age on the day of inclusion

    Sub-Group 3: from 7 to 9 years of age on the day of inclusion

    Sub-Group 4: from 10 to 12 years of age on the day of inclusion

    Sub-Group 5: from 13 to 15 years of age on the day of inclusion

  2. Screening informed consent form signed by the parent(s) or other legal representative for all the subjects and by the adolescents (sub-group 5 only)

Inclusion criteria to be checked at the inclusion visit (V01):

  1. Toddlers, children and adolescents:

    Sub-Group 1: from 12 months to 3 years of age on the day of inclusion

    Sub-Group 2: from 4 to 6 years of age on the day of inclusion

    Sub-Group 3: from 7 to 9 years of age on the day of inclusion

    Sub-Group 4: from 10 to 12 years of age on the day of inclusion

    Sub-Group 5: from 13 to 15 years of age on the day of inclusion

  2. Inclusion informed consent form signed by the parent(s) or other legal representative for all the subjects and by the adolescents (sub-group 5 only)
  3. Able to attend all scheduled visits and to comply with all trial procedures
  4. Subject anti-HAV seronegative (IgG) according to the screening results (assay performed with local kit)
  5. Subject HBsAg seronegative and ALT <40 IU/l according to the screening results

Exclusion Criteria :

Exclusion criteria to be checked at the inclusion visit (V01):

  1. Participation in another clinical trial in the 4 weeks preceding trial vaccination
  2. Planned participation in another clinical trial during the present trial period
  3. Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
  4. Systemic hypersensitivity to any of the vaccines components or history of a life-threatening reaction to the trial vaccines or a vaccine containing the same substances
  5. Chronic illness at a stage that could interfere with trial conduct or completion
  6. Blood or blood-derived products received in the past 3 months
  7. Any vaccination in the 4 weeks preceding the trial vaccination
  8. Any vaccination planned in the 4 weeks following the trial vaccination
  9. History of hepatitis A infection (confirmed either clinically or serologically )
  10. Previous vaccination against hepatitis A with the trial vaccine or another hepatitis A vaccine
  11. Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
  12. History of /current seizures
  13. Clinical or serological evidence of systemic illness including Hepatitis C and HIV
  14. Febrile (axillary temperature ≥ 37.1°C) or acute illness
Both
12 Months to 15 Years
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00483470
HAF78
Not Provided
Sanofi ( Sanofi Pasteur, a Sanofi Company )
Sanofi Pasteur, a Sanofi Company
Not Provided
Study Director: Medical Director Sanofi Pasteur Inc
Sanofi
January 2014

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