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This study has been withdrawn prior to enrollment.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.
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 April 17, 2014
DNA Virus Infections
RNA Virus Infections
Salivary Gland Diseases
Protein Synthesis Inhibitors
Molecular Mechanisms of Pharmacological Action