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

July 18, 2013 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children aged 12 months to 12 years living in Philippines will receive Priorix-Tetra as prescribed by the physician.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort Group
Children aged 12 months to 12 years will receive Priorix-Tetra as prescribed by the physician.
Biological: Priorix-Tetra™
Single dose, subcutaneous injection
Other: Safety data collection
Recording of adverse events, using diary cards

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence of Grade 3 AEs
Time Frame: Between Day 0 and Day 42
Between Day 0 and Day 42
Occurrence of medically-attended AEs
Time Frame: Between Day 0 and Day 42
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)
From the time of vaccination (Week 0) to study end (Week 6)
Occurrence of febrile convulsions
Time Frame: Between Day 0 and Day 42
Between Day 0 and Day 42

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

November 28, 2012

First Submitted That Met QC Criteria

November 29, 2012

First Posted (Estimate)

November 30, 2012

Study Record Updates

Last Update Posted (Estimate)

July 22, 2013

Last Update Submitted That Met QC Criteria

July 18, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 114229

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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