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

Measles Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01738841
• Other study ID #: 114229
• Status: Withdrawn
• Phase: N/A
• First received: November 28, 2012
• Last updated: July 18, 2013
• Start date: August 2013
• Est. completion date: March 2016

Study information

• Verified date: July 2013
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Food and Drug Administration Philippines
• Study type: Observational

Clinical Trial 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.

Description:

The participating physicians will enroll only those subjects for whom they would prescribe Priorix-Tetra in the course of their normal clinical practice.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 12 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chickenpox
• Herpes Zoster
• Measles
• Mumps
• Rubella
• Varicella

Intervention

Biological:
• Priorix-Tetra™
Single dose, subcutaneous injection

Other:
• Safety data collection
Recording of adverse events, using diary cards

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of Grade 3 adverse events (AEs) with a causal relationship to vaccination		Between Day 0 and Day 42	No
Secondary	Occurrence of Grade 3 AEs		Between Day 0 and Day 42	No
Secondary	Occurrence of medically-attended AEs		Between Day 0 and Day 42	No
Secondary	Occurrence of Serious Adverse Events (SAEs)		From the time of vaccination (Week 0) to study end (Week 6)	No
Secondary	Occurrence of febrile convulsions		Between Day 0 and Day 42	No