Clinical trial NCT00313950: Immunogenicity and Safety of Hepatitis A Vaccine Given at the Same Time of Measles, Mumps, Rubella Combined Vaccine
Official title: Immunogenicity and Safety of AVAXIM™ 80U-Pediatric Administered Alone or Concomitantly With TRIMOVAX™ in 12-13 Months Old Healthy Hepatitis A Seronegative Turkish Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Measles
Mumps
Rubella
Hepatitis A
Keywords: measles
rubella
mumps
hepatitis A
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-04-12
Enrollment: 470
Sex: ALL
Minimum age (years): 12
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 different site will interfere on immunogenicity for the four valences Hepatitis A, Measles, Mumps, and Rubella.


Eligibility criteria: 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

Primary outcomes:
measure: To provide information concerning the immunogenicity of Hepatitis A Vaccine in subjects receiving Pediatric vaccines.
timeFrame: Day 7 - Day 196
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
Study officials:
affiliation: Sanofi Pasteur Inc
name: Medical Director
role: STUDY_DIRECTOR
References: