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

Withdrawn

• Conditions: Mumps; Rubella; Measles; Varicella
• Interventions: Biological: Priorix-Tetra™; Other: Safety data collection

• Registration Number: NCT01738841
• Lead Sponsor: GlaxoSmithKline

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 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 Timeline

• Study First Submitted: 2012-11-28
• Study First Submitted QC: 2012-11-29
• Study First Posted: 2012-11-30
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-18
• Last Update Posted: 2013-07-22
• Study Start: 2013-08
• Primary Completion: 2016-03
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort Group	Priorix-Tetra™	Children aged 12 months to 12 years will receive Priorix-Tetra as prescribed by the physician.
Cohort Group	Safety data collection	Children aged 12 months to 12 years will receive Priorix-Tetra as prescribed by the physician.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Occurrence of Serious Adverse Events (SAEs)	From the time of vaccination (Week 0) to study end (Week 6)
Occurrence of febrile convulsions	Between Day 0 and Day 42
Occurrence of Grade 3 AEs	Between Day 0 and Day 42
Occurrence of medically-attended AEs	Between Day 0 and Day 42