Clinical trial NCT01738841: Safety Study of Measles-Mumps-Rubella-Varicella (MMRV) Vaccine, Priorix-Tetra™ in Children Living in the Philippines
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 Prescribing Information in the Philippines
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Mumps
Rubella
Measles
Varicella
Keywords: Combined measles-mumps-rubella-varicella vaccine
Priorix-Tetra™
MMRV
children
Post-marketing surveillance
Philippines
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-11-30
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Occurrence of Grade 3 adverse events (AEs) with a causal relationship to vaccination
timeFrame: Between Day 0 and Day 42
Secondary outcomes:
measure: Occurrence of Grade 3 AEs
timeFrame: Between Day 0 and Day 42
measure: Occurrence of medically-attended AEs
timeFrame: Between Day 0 and Day 42
measure: Occurrence of Serious Adverse Events (SAEs)
timeFrame: From the time of vaccination (Week 0) to study end (Week 6)
measure: Occurrence of febrile convulsions
timeFrame: Between Day 0 and Day 42
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: