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

January 17, 2014 updated by: Sanofi Pasteur, a Sanofi Company

Immunogenicity and Safety of AVAXIM™ 80U-Pediatric Administered Alone or Concomitantly With TRIMOVAX™ in 12-13 Months Old Healthy Hepatitis A Seronegative Turkish Children

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

470

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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™
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™
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:
  • AVAXIM™
  • TRIMOVAX™
EXPERIMENTAL: Group 3
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: 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™

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (ACTUAL)

December 1, 2009

Study Completion (ACTUAL)

April 1, 2010

Study Registration Dates

First Submitted

April 11, 2006

First Submitted That Met QC Criteria

April 11, 2006

First Posted (ESTIMATE)

April 12, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

January 22, 2014

Last Update Submitted That Met QC Criteria

January 17, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAF65

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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