Assess GSK Biologicals' MMR Vaccine (Priorix) When Given to Healthy Children at the Age of 12 to 18 Months in Singapore.

This study has been completed.

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00388440

Purpose

To evaluate the safety and immunogenicity of GSK Biologicals’ live attenuated MMR vaccine (Priorix) in a local population in Singapore. The vaccine was administered as a single dose to healthy children (12-18 months of age) and blood samples were collected at two time points (before vaccination and after vaccination).

Condition	Intervention	Phase
Measles Mumps Rubella	Biological: MMR vaccine (Priorix)	Phase IV

MedlinePlus related topics: Measles Mumps Rubella

Drug Information available for: Measles-Mumps-Rubella Vaccine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Study to Assess the Safety and Immunogenicity of GSK Biologicals' Live Attenuated Measles-Mumps-Rubella (MMR) Vaccine (Priorix) When Given to Healthy Children at the Age of 12 to 18 Months in Singapore.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Solicited symptoms (Day 0-3); unsolicited AEs (Day 0-42); SAEs (full study)

Secondary Outcome Measures:

Antibody concentration to all vaccine antigens after vaccination

Estimated Enrollment:	150
Study Start Date:	November 2000

Eligibility

Ages Eligible for Study:	12 Months to 18 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

A male or female infant between 12 and 18 months of age at the time of the vaccination
Written informed consent obtained from the parents or guardians of the subject.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the dose of study vaccine
Previous vaccination against mumps and/or rubella
History of, or intercurrent, measles, mumps, and/or rubella disease
Known exposure to measles, mumps or rubella within 30 days prior to the start of the study
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00388440

Locations

Singapore
GSK Clinical Trials Call Center
Singapore, Singapore, 688846

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

Clinical Trials

GlaxoSmithKline

More Information

Study ID Numbers:	209762/147
Study First Received:	October 13, 2006
Last Updated:	October 13, 2006
ClinicalTrials.gov Identifier:	NCT00388440
Health Authority:	Singapore: Health Sciences Authority

Keywords provided by GlaxoSmithKline:

Measles
Mumps
Rubella
Singapore

Study placed in the following topic categories:

Mouth Diseases
Virus Diseases
Paramyxoviridae Infections
Measles
Healthy

Stomatognathic Diseases
Salivary Gland Diseases
Rubella
Togaviridae Infections
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