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

NCT ID: NCT01738841

Last Updated: 2013-07-22

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2016-03-31

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.

Conditions

Mumps; Rubella; Measles; Varicella

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort Group

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

Priorix-Tetra™

Intervention Type: BIOLOGICAL

Single dose, subcutaneous injection

Safety data collection

Intervention Type: OTHER

Recording of adverse events, using diary cards

Interventions

Priorix-Tetra™

Single dose, subcutaneous injection

Intervention Type: BIOLOGICAL

Safety data collection

Recording of adverse events, using diary cards

Intervention Type: OTHER

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.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

114229

Identifier Type: -

Identifier Source: org_study_id