Last updated: 11/07/2018 13:09:26
Assess GSK Biologicals' MMR vaccine (Priorix) when given to healthy children at the age of 12 to 18 months in Singapore.
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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.
Trial description: 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).
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
150
Primary completion date:
2001-30-04
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Lim FS et al. (2007) Safety, reactogenicity and immunogenicity of the live attenuated combined measles, mumps and rubella vaccine containing the RIT 4385 mumps strain in healthy Singaporean children. Ann Acad Med Singapore. 36 (12): 969-973.
Medical condition
Rubella, Mumps, Measles
Product
Measles, Mumps, Rubella Vaccine
Collaborators
Not applicable
Study date(s)
November 2000 to April 2001
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
12 - 18 months
Accepts healthy volunteers
Yes
- 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.
- 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
Inclusion and exclusion 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.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2001-30-04
Actual study completion date
2001-30-04
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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