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

Study Overview
=================
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.

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

Conditions
-----------------
Mumps, Rubella, Measles, Varicella

Intervention / Treatment
-----------------
* Biological: Priorix-Tetra™
* Other: Safety data collection


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Grade 3 AEs |  | Between Day 0 and Day 42 | 
| Occurrence of medically-attended AEs |  | Between Day 0 and Day 42 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Combined measles-mumps-rubella-varicella vaccine, Priorix-Tetra™, MMRV, children, Post-marketing surveillance, Philippines