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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Hepatitis A

Treatments: Biological: Hepatitis A vaccine AVAXIM 80U; Biological: Hepatitis A vaccine (HAVRIX 720)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00483470

HAF78

Details and patient eligibility

About

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

Enrollment: 720 patients

Sex: All

Ages: 12 months to 15 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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720 participants in 2 patient groups

1

Experimental group

Treatment:

Biological: Hepatitis A vaccine AVAXIM 80U

2

Active Comparator group

Treatment:

Biological: Hepatitis A vaccine (HAVRIX 720)