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

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

Conditions
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Hepatitis A

Intervention / Treatment
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* Biological: Hepatitis A vaccine AVAXIM 80U
* Biological: Hepatitis A vaccine (HAVRIX 720)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Biological: Hepatitis A vaccine AVAXIM 80U<br>* 0.5 mL, Intramuscular<br>* Other names: AVAXIM 80U Pediatric vaccine;|
| Active Comparator: 2<br> | Biological: Hepatitis A vaccine (HAVRIX 720)<br>* 0.5 mL, Intramuscular<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To provide information concerning the immunogenicity of AVAXIM 80U Pediatric vaccine |  | 1 month post-vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis A