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

NCT00388440 | Completed Phase 4

• 1 other identifier: 209762/147
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Rubella; Mumps; Measles

Keywords

Mumps; Singapore; Rubella; Measles

Outcome Measures

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

Interventions

MMR vaccine (Priorix) BIOLOGICAL

Eligibility Criteria

• Age: 12 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Rubella; Mumps; Measles

Interventions

Measles-Mumps-Rubella Vaccine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Measles Vaccine; Viral Vaccines; Mumps Vaccine; Rubella Vaccine

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2006
• First Posted: October 16, 2006
• Study Start: November 1, 2000
• Primary Completion: April 1, 2001
• Study Completion: April 1, 2001
• Last Updated: September 20, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share