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

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00313950

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 IV

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:

MedlinePlus related topics: Hepatitis Hepatitis A Measles Mumps Rubella

Drug Information available for: Hepatitis A Vaccines Measles-Mumps-Rubella Vaccine

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

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, 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 IM vaccination
History of seizures
Febrile illness (axillary temperature ≥37.4°C]) on the day of inclusion

Contacts and Locations

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

Locations

Turkey

Izmir, Turkey

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Medical Director

Sanofi Pasteur Inc

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Medical Director, Sanofi Pasteur Inc.
ClinicalTrials.gov Identifier:	NCT00313950 History of Changes
Other Study ID Numbers:	HAF65
Study First Received:	April 11, 2006
Last Updated:	April 8, 2010
Health Authority:	Turkey: Ministry of Health

Keywords provided by Sanofi-Aventis:

measles
rubella
mumps
hepatitis A

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Measles
Mumps
Parotitis
Rubella
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections

RNA Virus Infections
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
Rubulavirus Infections
Parotid Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Sialadenitis
Rubivirus Infections
Togaviridae Infections

ClinicalTrials.gov processed this record on February 09, 2012