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

Primary Purpose

Measles, Mumps, Rubella

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella
Attenuated Measles Mumps Rubella; Inactivated Hep A vaccine
Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Measles focused on measuring measles, rubella, mumps, hepatitis A

Eligibility Criteria

12 Months - 13 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Arm Description

Outcomes

Primary Outcome Measures

To provide information concerning the immunogenicity of Hepatitis A Vaccine in subjects receiving Pediatric vaccines.

Secondary Outcome Measures

Full Information

First Posted
April 11, 2006
Last Updated
January 17, 2014
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00313950
Brief Title
Immunogenicity and Safety of Hepatitis A Vaccine Given at the Same Time of Measles, Mumps, Rubella Combined Vaccine
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 Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Measles, Mumps, Rubella, Hepatitis A
Keywords
measles, rubella, mumps, hepatitis A

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
470 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Title
Group 2
Arm Type
Experimental
Arm Title
Group 3
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella
Other Intervention Name(s)
AVAXIM™, TRIMOVAX™
Intervention Description
0.5 mL, intramuscular (IM) (HAV Day 0 and 168); 0.5 mL, IM (MMR Day 28)
Intervention Type
Biological
Intervention Name(s)
Attenuated Measles Mumps Rubella; Inactivated Hep A vaccine
Other Intervention Name(s)
TRIMOVAX™, AVAXIM™
Intervention Description
0.5 mL, IM (MMR, Day 0); 0.5 mL, IM (HAV Day 28 and 168)
Intervention Type
Biological
Intervention Name(s)
Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella
Other Intervention Name(s)
AVAXIM™, TRIMOVAX™
Intervention Description
0.5 mL, IM (HAV Day 0 and 168); 0.5 mL, IM (MMR, Day 0)
Primary Outcome Measure Information:
Title
To provide information concerning the immunogenicity of Hepatitis A Vaccine in subjects receiving Pediatric vaccines.
Time Frame
Day 7 - Day 196

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
13 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi Pasteur Inc
Official's Role
Study Director
Facility Information:
City
Izmir
Country
Turkey

12. IPD Sharing Statement

Links:
URL
http://www.sanofipasteur.com
Description
Related Info

Learn more about this trial

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

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