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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00483470
Recruitment Status : Completed
First Posted : June 7, 2007
Last Update Posted : January 22, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description
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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
Hepatitis A Biological: Hepatitis A vaccine AVAXIM 80U Biological: Hepatitis A vaccine (HAVRIX 720) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 720 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : June 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. To provide information concerning the immunogenicity of AVAXIM 80U Pediatric vaccine [ Time Frame: 1 month post-vaccination ]

Eligibility Criteria
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Ages Eligible for Study:   12 Months to 15 Years   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00483470


Locations
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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
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Study Director: Medical Director Sanofi Pasteur Inc
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00483470    
Other Study ID Numbers: HAF78
First Posted: June 7, 2007    Key Record Dates
Last Update Posted: January 22, 2014
Last Verified: January 2014
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Hepatitis A
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs