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

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00388440

Enrollment

150

Registered

2006-10-16

Start date

2000-11-30

Completion date

2001-04-30

Last updated

2016-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Measles, Mumps, Rubella

Keywords

Mumps, Singapore, Rubella, Measles

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).

Interventions

BIOLOGICALMMR vaccine (Priorix)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Months to 18 Months

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Solicited symptoms (Day 0-3); unsolicited AEs (Day 0-42); SAEs (full study)	—

Secondary

Measure	Time frame
Antibody concentration to all vaccine antigens after vaccination	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026