Safety Study of Measles-Mumps-Rubella-Varicella (MMRV) Vaccine, Priorix-Tetra™ in Children Living in the Philippines
This study has been withdrawn prior to enrollment.
(Local authorities no longer require routine PMS studies; GSK does not believe the study would add meaningfully to the safety data already available for MMRV.)
Information provided by (Responsible Party):
First received: November 28, 2012
Last updated: July 18, 2013
Last verified: July 2013
This study will collect data on the safety of the MMRV vaccine (Priorix-Tetra™) used in routine practice in children aged 12 months to 12 years living in the Philippines.
Other: Safety data collection
||Observational Model: Cohort
Time Perspective: Prospective
||Post-marketing Surveillance Study of GSK Biologicals' Live, Attenuated Measles, Mumps, Rubella and Varicella Vaccine, Priorix-Tetra, Following a Single Vaccine Dose Given According to Local Prescribing Information in the Philippines
Primary Outcome Measures:
- Occurrence of Grade 3 adverse events (AEs) with a causal relationship to vaccination [ Time Frame: Between Day 0 and Day 42 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Occurrence of Grade 3 AEs [ Time Frame: Between Day 0 and Day 42 ] [ Designated as safety issue: No ]
- Occurrence of medically-attended AEs [ Time Frame: Between Day 0 and Day 42 ] [ Designated as safety issue: No ]
- Occurrence of Serious Adverse Events (SAEs) [ Time Frame: From the time of vaccination (Week 0) to study end (Week 6) ] [ Designated as safety issue: No ]
- Occurrence of febrile convulsions [ Time Frame: Between Day 0 and Day 42 ] [ Designated as safety issue: No ]
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||March 2016 (Final data collection date for primary outcome measure)
Children aged 12 months to 12 years will receive Priorix-Tetra as prescribed by the physician.
Single dose, subcutaneous injection
Other: Safety data collection
Recording of adverse events, using diary cards
The participating physicians will enroll only those subjects for whom they would prescribe Priorix-Tetra in the course of their normal clinical practice.
|Ages Eligible for Study:
||12 Months to 12 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Children aged 12 months to 12 years living in Philippines will receive Priorix-Tetra as prescribed by the physician.
- Child in care.
- Any contraindications to vaccination as stated in the Prescribing Information.
- Acute, severe febrile illness at the time of enrollment. The presence of a minor infection, such as a cold, will not exclude the subject from the study.
- Previous receipt of a measles, mumps, rubella and/or varicella-virus containing vaccine less than 3 months prior to study entry.
- Previous enrolment in this trial.
- Subjects with impaired immune function, including primary or secondary immunodeficiencies based on medical history.
- History of hypersensitivity to any component of the vaccine.
- History of hypersensitivity following previous administration of measles, mumps, rubella and/or varicella-virus containing vaccines.
- Receipt of human gamma globulins or a blood transfusion within 3 months prior to study entry.
- Hypersensitivity to latex.
- Pregnant or lactating female.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01738841
||GSK Clinical Trials
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 28, 2012
||July 18, 2013
||Philippines: Food and Drug Administration Philippines
Keywords provided by GlaxoSmithKline:
Combined measles-mumps-rubella-varicella vaccine
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 25, 2014
DNA Virus Infections
RNA Virus Infections
Salivary Gland Diseases