Immunogenicity and Safety of Sanofi Pasteur's AVAXIM 80U Pediatric Vaccine Followed by Booster Dose
Information source: Sanofi
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis A
Intervention: Hepatitis A vaccine AVAXIM 80U (Biological); Hepatitis A vaccine (HAVRIX 720) (Biological)
Phase: Phase 3
Status: Completed
Sponsored by: Sanofi Pasteur, a Sanofi Company Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Sanofi Pasteur Inc
Summary
As per request by the Heath Authorities, the present clinical study will assess the
immunogenicity and safety
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: To provide information concerning the immunogenicity of AVAXIM 80U Pediatric vaccine
Eligibility
Minimum age: 12 Months.
Maximum age: 15 Years.
Gender(s): Both.
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
Locations and Contacts
Guilin City, Guangxi 541001, China
Nanning, Guangxi 530021, China
Yongfu Country, Guangxi 541800, China
Additional Information
Starting date: June 2007
Last updated: January 17, 2014
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