Status:
COMPLETED
Immunogenicity and Safety of Hepatitis A Vaccine Given at the Same Time of Measles, Mumps, Rubella Combined Vaccine
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Measles
Mumps
Eligibility:
All Genders
12-13 years
Phase:
PHASE4
Brief Summary
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 differen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
470 Patients enrolled
Trial Details
Trial ID
NCT00313950
Start Date
September 1 2006
End Date
April 1 2010
Last Update
January 22 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Izmir, Turkey (Türkiye)