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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 )

Study Description
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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.

Condition or disease Intervention/treatment 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 470 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : September 2006
Actual Primary Completion Date : December 2009
Actual Study Completion Date : April 2010

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Arms and Interventions
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Arm Intervention/treatment
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™


Outcome Measures
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Primary Outcome Measures :
  1. To provide information concerning the immunogenicity of Hepatitis A Vaccine in subjects receiving Pediatric vaccines. [ Time Frame: Day 7 - Day 196 ]

Eligibility Criteria
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Ages Eligible for Study:   12 Months to 13 Months   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00313950


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

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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00313950    
Other Study ID Numbers: HAF65
First Posted: April 12, 2006    Key Record Dates
Last Update Posted: January 22, 2014
Last Verified: January 2014
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
measles
rubella
mumps
hepatitis A
Additional relevant MeSH terms:
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Hepatitis A
Measles
Rubella
Mumps
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Morbillivirus Infections
 Paramyxoviridae Infections
Mononegavirales Infections
Rubivirus Infections
Togaviridae Infections
Rubulavirus Infections
Parotitis
Parotid Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs