Safety Study of Measles-Mumps-Rubella-Varicella (MMRV) Vaccine, Priorix-Tetra™ in Children Living in the Philippines

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 2016

Detailed Description

The participating physicians will enroll only those subjects for whom they would prescribe Priorix-Tetra in the course of their normal clinical practice.

Interventions

  • Biological: Priorix-Tetra™
    • Single dose, subcutaneous injection
  • Other: Safety data collection
    • Recording of adverse events, using diary cards

Arms, Groups and Cohorts

  • Cohort Group
    • Children aged 12 months to 12 years will receive Priorix-Tetra as prescribed by the physician.

Clinical Trial Outcome Measures

Primary Measures

  • Occurrence of Grade 3 adverse events (AEs) with a causal relationship to vaccination
    • Time Frame: Between Day 0 and Day 42

Secondary Measures

  • 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

Participating in This Clinical Trial

Inclusion Criteria

  • Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol. – Written informed consent obtained from the parent(s)/LAR(s) of the subject. – Male or female subjects living in the Philippines between, and including, the ages of 12 months and 12 years at the time of the vaccination. – Female subjects of child bearing potential may be enrolled in the study, if the subject: – has agreed to be abstinent or practiced adequate contraception for 30 days prior to vaccination, and – has a negative pregnancy test on the day of vaccination, and – has agreed to continue adequate contraception during the entire treatment period and for 3 months after completion of the vaccination. Exclusion Criteria:

  • 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.

Gender Eligibility: All

Minimum Age: 12 Months

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • GlaxoSmithKline
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • GSK Clinical Trials, Study Director, GlaxoSmithKline

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