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

• ClinicalTrials.gov Identifier: NCT00483470
• Recruitment Status: Completed
• First Posted: June 7, 2007
• Last Update Posted: January 22, 2014
• Sponsor: Sanofi Pasteur, a Sanofi Company
• Information provided by (Responsible Party): Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information

• First Submitted Date: June 5, 2007
• First Posted Date: June 7, 2007
• Last Update Posted Date: January 22, 2014
• Study Start Date: June 2007
• Actual Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 19, 2008): To provide information concerning the immunogenicity of AVAXIM 80U Pediatric vaccine [ Time Frame: 1 month post-vaccination ]
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Immunogenicity and Safety of Sanofi Pasteur's AVAXIM 80U Pediatric Vaccine Followed by Booster Dose
• Official Title: Not Provided
• Brief Summary: As per request by the Heath Authorities, the present clinical study will assess the immunogenicity and safety
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Hepatitis A

Intervention

• 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

Study Arms

• Experimental: 1
  Intervention: Biological: Hepatitis A vaccine AVAXIM 80U
• Active Comparator: 2
  Intervention: Biological: Hepatitis A vaccine (HAVRIX 720)

• Publications *: Yoon SH, Kim HW, Ahn JG, Kim IT, Kim JH, Kong KA, Kim KH. Reappraisal of the Immunogenicity and Safety of Three Hepatitis A Vaccines in Adolescents. J Korean Med Sci. 2016 Jan;31(1):73-9. doi: 10.3346/jkms.2016.31.1.73. Epub 2015 Dec 24.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 6, 2007): 720
• Original Enrollment: Same as current
• Actual Study Completion Date: August 2008
• Actual Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Months to 15 Years (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT00483470
• Other Study ID Numbers: HAF78
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
• Original Responsible Party: Not Provided
• Current Study Sponsor: Sanofi Pasteur, a Sanofi Company
• Original Study Sponsor: Sanofi
• Collaborators: Not Provided

Investigators

• Study Director: Medical Director; Sanofi Pasteur Inc

• PRS Account: Sanofi
• Verification Date: January 2014