Clinical Trial: Safety Study of Measles-Mumps-Rubella-Varicella (MMRV) Vaccine, Priorix-Tetra™ in Children Living in the Philippines
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Observational
Official Title: 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 Prescribin
Brief Summary: 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.
Detailed Summary: The participating physicians will enroll only those subjects for whom they would prescribe Priorix-Tetra in the course of their normal clinical practice.
Sponsor: GlaxoSmithKline
Current Primary Outcome: Occurrence of Grade 3 adverse events (AEs) with a causal relationship to vaccination [ Time Frame: Between Day 0 and Day 42 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Occurrence of Grade 3 AEs [ Time Frame: Between Day 0 and Day 42 ]
- Occurrence of medically-attended AEs [ Time Frame: Between Day 0 and Day 42 ]
- Occurrence of Serious Adverse Events (SAEs) [ Time Frame: From the time of vaccination (Week 0) to study end (Week 6) ]
- Occurrence of febrile convulsions [ Time Frame: Between Day 0 and Day 42 ]
Original Secondary Outcome: Same as current
Information By: GlaxoSmithKline
Dates:
Date Received: November 28, 2012
Date Started: August 2013
Date Completion: March 2016
Last Updated: July 18, 2013
Last Verified: July 2013
