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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00313950
First received: April 11, 2006
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Measles
Mumps
Rubella
Hepatitis A
Biological: Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella
Biological: Attenuated Measles Mumps Rubella; Inactivated Hep A vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • To provide information concerning the immunogenicity of Hepatitis A Vaccine in subjects receiving Pediatric vaccines. [ Time Frame: Day 7 - Day 196 ] [ Designated as safety issue: No ]

Enrollment: 470
Study Start Date: September 2006
Study Completion Date: April 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 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™
Experimental: Group 2 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™
Experimental: Group 3 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™

  Eligibility

Ages Eligible for Study:   12 Months to 13 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00313950

Locations
Turkey
Izmir, Turkey
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00313950     History of Changes
Other Study ID Numbers: HAF65
Study First Received: April 11, 2006
Last Updated: January 17, 2014
Health Authority: Turkey: Ministry of Health

Keywords provided by Sanofi:
measles
rubella
mumps
hepatitis A

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Measles
Mumps
Rubella
Digestive System Diseases
Enterovirus Infections
Hepatitis, Viral, Human
Liver Diseases
Mononegavirales Infections
Morbillivirus Infections
Mouth Diseases
Paramyxoviridae Infections
Parotid Diseases
Parotitis
Picornaviridae Infections
RNA Virus Infections
Rubivirus Infections
Rubulavirus Infections
Salivary Gland Diseases
Stomatognathic Diseases
Togaviridae Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014