Clincosm LogoSign in Get a demo

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

Sponsor
Sanofi Pasteur, a Sanofi Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00483470
Collaborator
(none)
720
Enrollment
3
Locations
2
Arms
14
Duration (Months)
240
Patients Per Site
17.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Biological: Hepatitis A vaccine AVAXIM 80U
  • Biological: Hepatitis A vaccine (HAVRIX 720)
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
720 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Study Start Date :
Jun 1, 2007
Actual Primary Completion Date :
May 1, 2008
Actual Study Completion Date :
Aug 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Biological: Hepatitis A vaccine AVAXIM 80U
0.5 mL, Intramuscular
Other Names:
  • AVAXIM 80U Pediatric vaccine

    		•
    Active Comparator: 2

    Biological: Hepatitis A vaccine (HAVRIX 720)
    0.5 mL, Intramuscular

    Outcome Measures

    Primary Outcome Measures

    1. To provide information concerning the immunogenicity of AVAXIM 80U Pediatric vaccine [1 month post-vaccination]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Months to 15 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    1. 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

    1. 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)

    2. Able to attend all scheduled visits and to comply with all trial procedures

    3. Subject anti-HAV seronegative (IgG) according to the screening results (assay performed with local kit)

    4. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Guilin City Guangxi China 541001
    2 Nanning Guangxi China 530021
    3 Yongfu Country Guangxi China 541800

    Sponsors and Collaborators

    • Sanofi Pasteur, a Sanofi Company

    Investigators

    • Study Director: Medical Director, Sanofi Pasteur Inc

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Sanofi Pasteur, a Sanofi Company
    ClinicalTrials.gov Identifier:
    NCT00483470
    Other Study ID Numbers:
    • HAF78
    First Posted:
    Jun 7, 2007
    Last Update Posted:
    Jan 22, 2014
    Last Verified:
    Jan 1, 2014
    Keywords provided by Sanofi Pasteur, a Sanofi Company
    Hepatitis A
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis
    Vaccines

    Study Results

    No Results Posted as of Jan 22, 2014