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

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ClinicalTrials.gov Identifier: NCT00313950
Recruitment Status : Completed
First Posted : April 12, 2006
Last Update Posted : January 22, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE April 11, 2006
First Posted Date  ICMJE April 12, 2006
Last Update Posted Date January 22, 2014
Study Start Date  ICMJE September 2006
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2008)
To provide information concerning the immunogenicity of Hepatitis A Vaccine in subjects receiving Pediatric vaccines. [ Time Frame: Day 7 - Day 196 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immunogenicity and Safety of Hepatitis A Vaccine Given at the Same Time of Measles, Mumps, Rubella Combined Vaccine
Official Title  ICMJE Immunogenicity and Safety of AVAXIM™ 80U-Pediatric Administered Alone or Concomitantly With TRIMOVAX™ in 12-13 Months Old Healthy Hepatitis A Seronegative Turkish Children
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Measles
  • Mumps
  • Rubella
  • Hepatitis A
Intervention  ICMJE
  • Biological: Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella
    0.5 mL, intramuscular (IM) (HAV Day 0 and 168); 0.5 mL, IM (MMR Day 28)
    Other Names:
    • AVAXIM™
    • TRIMOVAX™
  • Biological: Attenuated Measles Mumps Rubella; Inactivated Hep A vaccine
    0.5 mL, IM (MMR, Day 0); 0.5 mL, IM (HAV Day 28 and 168)
    Other Names:
    • TRIMOVAX™
    • AVAXIM™
  • Biological: Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella
    0.5 mL, IM (HAV Day 0 and 168); 0.5 mL, IM (MMR, Day 0)
    Other Names:
    • AVAXIM™
    • TRIMOVAX™
Study Arms  ICMJE
  • Experimental: Group 1
    Intervention: Biological: Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella
  • Experimental: Group 2
    Intervention: Biological: Attenuated Measles Mumps Rubella; Inactivated Hep A vaccine
  • Experimental: Group 3
    Intervention: Biological: Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 16, 2006)
470
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Months to 13 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00313950
Other Study ID Numbers  ICMJE HAF65
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Sanofi Pasteur Inc
PRS Account Sanofi
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP