Skip to main content
OpenTrials
Completed

NCT Number: NCT00388440

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rubella Infections Measles Mononegavirales Infections Morbillivirus Infections Mouth Diseases Mumps Paramyxoviridae Infections Parotid Diseases Parotitis RNA Virus Infections Rubivirus Infections Rubulavirus Infections Salivary Gland Diseases Stomatognathic Diseases Togaviridae Infections Virus Diseases

Age range

12 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MMR vaccine (Priorix)

Biological

Primary outcomes

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

Secondary outcomes

  1. Antibody concentration to all vaccine antigens after vaccination

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Phase IV Open Study to Assess the Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Live Attenuated Measles-Mumps-Rubella (MMR) Vaccine When Given to Healthy Children at the Age of 12 to 18 Months in Singapore.

Important dates

Study start
2000
Primary completion
2001
Study completion
2001
First posted
Oct 16, 2006
Registry last updated
Sep 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.