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

Phase 4

Completed

• Conditions: Measles; Rubella; Mumps; Hepatitis A
• Interventions: Biological: Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella; Biological: Attenuated Measles Mumps Rubella; Inactivated Hep A vaccine

• Registration Number: NCT00313950
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-04-11
• Study First Submitted QC: 2006-04-11
• Study First Posted: 2006-04-12
• Study Start: 2006-09
• Primary Completion: 2009-12
• Study Completion: 2010-04
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-17
• Last Update Posted: 2014-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 470

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella	-
Group 2	Attenuated Measles Mumps Rubella; Inactivated Hep A vaccine	-
Group 3	Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella	-

Primary Outcome Measures

Name	Time	Method
To provide information concerning the immunogenicity of Hepatitis A Vaccine in subjects receiving Pediatric vaccines.	Day 7 - Day 196