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

Sponsored by:	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

MedlinePlus related topics: Hepatitis Hepatitis A Measles Mumps Rubella

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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

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 ]

Estimated Enrollment:	470
Study Start Date:	September 2006
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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)
2: Experimental	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)
3: Experimental	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)

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

Contacts

Contact: Public Registry Sanofi Pasteur

RegistryContactUs@sanofipasteur.com

Locations

Turkey
	Recruiting
Izmir, Turkey

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Medical Director

Sanofi Pasteur Inc

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Sanofi Pasteur Inc. ( Medical Director )
Study ID Numbers:	HAF65
Study First Received:	April 11, 2006
Last Updated:	October 2, 2008
ClinicalTrials.gov Identifier:	NCT00313950
Health Authority:	Turkey: Ministry of Health

Keywords provided by Sanofi-Aventis:

measles
rubella
mumps
hepatitis A

Study placed in the following topic categories:

Mouth Diseases
Liver Diseases
Paramyxoviridae Infections
Measles
Hepatitis, Viral, Human
Picornaviridae Infections
Healthy
Rubella
Togaviridae Infections

Hepatitis
Virus Diseases
Digestive System Diseases
Hepatitis A
Stomatognathic Diseases
Enterovirus Infections
Salivary Gland Diseases
Mumps

Additional relevant MeSH terms:

Rubivirus Infections
Parotid Diseases
RNA Virus Infections
Morbillivirus Infections

Rubulavirus Infections
Parotitis
Mononegavirales Infections

ClinicalTrials.gov processed this record on January 16, 2009