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
  Purpose

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


Condition Intervention Phase
Hepatitis A
Biological: Hepatitis A vaccine AVAXIM 80U
Biological: Hepatitis A vaccine (HAVRIX 720)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • To provide information concerning the immunogenicity of AVAXIM 80U Pediatric vaccine [ Time Frame: 1 month post-vaccination ] [ Designated as safety issue: No ]

Enrollment: 720
Study Start Date: June 2007
Study Completion Date: August 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: Hepatitis A vaccine AVAXIM 80U
0.5 mL, Intramuscular
Other Name: AVAXIM 80U Pediatric vaccine
Active Comparator: 2 Biological: Hepatitis A vaccine (HAVRIX 720)
0.5 mL, Intramuscular
Other Name: Hepatitis A vaccine (HAVRIX 720)

  Eligibility

Ages Eligible for Study:   12 Months to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483470

Locations
China, Guangxi
Guilin City, Guangxi, China, 541001
Nanning, Guangxi, China, 530021
Yongfu Country, Guangxi, China, 541800
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00483470     History of Changes
Other Study ID Numbers: HAF78
Study First Received: June 5, 2007
Last Updated: January 17, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Sanofi:
Hepatitis A

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Digestive System Diseases
Enterovirus Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014