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

Measles Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00388440
• Other study ID #: 209762/147
• Status: Completed
• Phase: Phase 4
• First received: October 13, 2006
• Last updated: September 15, 2016
• Start date: November 2000
• Est. completion date: April 2001

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 2001
• Est. primary completion date: April 2001
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 18 Months

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Measles
• Mumps
• Rubella

Intervention

Biological:
• MMR vaccine (Priorix)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Solicited symptoms (Day 0-3); unsolicited AEs (Day 0-42); SAEs (full study)
Secondary	Antibody concentration to all vaccine antigens after vaccination

External Links

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