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

Sanofi

Status and phase

Completed

Phase 4

Conditions

Rubella

Hepatitis A

Mumps

Measles

Treatments

Biological: Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella

Biological: Attenuated Measles Mumps Rubella; Inactivated Hep A vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00313950

HAF65

Details and patient eligibility

About

The present study will explore the immunogenicity of AVAXIM™ 80U-Pediatric in 12-13 months Turkish children and check if the administration of the MMR trivalent vaccine on the same day but at different site will interfere on immunogenicity for the four valences Hepatitis A, Measles, Mumps, and Rubella.

Enrollment

470 patients

Sex

All

Ages

12 to 13 months old

Volunteers

Accepts Healthy Volunteers

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