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
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Condition or disease | Intervention/treatment | Phase |
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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 (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 |

Arm | Intervention/treatment |
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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:
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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:
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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:
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- To provide information concerning the immunogenicity of Hepatitis A Vaccine in subjects receiving Pediatric vaccines. [ Time Frame: Day 7 - Day 196 ]

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Ages Eligible for Study: | 12 Months to 13 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
Turkey | |
Izmir, Turkey |
Study Director: | Medical Director | Sanofi Pasteur Inc |
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 |
measles rubella mumps hepatitis A |
Hepatitis A Measles Rubella Mumps Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Infections 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 |