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

Inclusion criteria

Inclusion criteria

to be checked at the screening visit (SC):

• 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

• 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):

• 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

• 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)
• Able to attend all scheduled visits and to comply with all trial procedures
• Subject anti-HAV seronegative (IgG) according to the screening results (assay performed with local kit)
• 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):

• Participation in another clinical trial in the 4 weeks preceding trial vaccination
• Planned participation in another clinical trial during the present trial period
• Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
• 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
• Chronic illness at a stage that could interfere with trial conduct or completion
• Blood or blood-derived products received in the past 3 months
• Any vaccination in the 4 weeks preceding the trial vaccination
• Any vaccination planned in the 4 weeks following the trial vaccination
• History of hepatitis A infection (confirmed either clinically or serologically )
• Previous vaccination against hepatitis A with the trial vaccine or another hepatitis A vaccine
• Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
• History of /current seizures
• Clinical or serological evidence of systemic illness including Hepatitis C and HIV
• Febrile (axillary temperature ≥ 37.1°C) or acute illness