Immunogenicity and Safety of Hepatitis A Vaccine Given at the Same Time of Measles, Mumps, Rubella Combined Vaccine

Inclusion criteria

• Aged 12-13 months on the day of inclusion
• Born at full term of pregnancy (>37 weeks) with a birth weight ≥ 2.5 kg
• Informed consent form signed by the parent(s) or other legal representative
• Able to attend all scheduled visits and to comply with all trial procedures
• Subjects having received only one or no injection of vaccine against Measles
• Subjects anti-HAV seronegative according to the results obtained at the screening visit*

Exclusion criteria

• Participation in another clinical trial in the 4 weeks preceding the (first) 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 first trial vaccination
• Vaccination planned in the 4 weeks following any trial vaccination
• History of hepatitis A, Mumps, Measles and/or Rubella infection (confirmed either clinically, serologically or microbiologically)
• Previous vaccination against hepatitis A with the trial vaccine or another vaccine
• Previous vaccination against Mumps, Measles and Rubella with a Mumps, Measles and Rubella trivalent combined vaccine
• Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
• History of seizures
• Febrile illness (axillary temperature ≥37.4°C]) on the day of inclusion