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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment
Mumps; Rubella; Measles; Varicella	Biological: Priorix-Tetra™; Other: Safety data collection

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 Design

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Study Type :	Observational
Actual Enrollment :	0 participants
Observational Model:	Cohort
Time Perspective:	Prospective
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 Start Date :	August 2013
Estimated Primary Completion Date :	March 2016
Estimated Study Completion Date :	March 2016

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Primary Outcome Measures :

1. Occurrence of Grade 3 adverse events (AEs) with a causal relationship to vaccination [ Time Frame: Between Day 0 and Day 42 ]

Secondary Outcome Measures :

1. Occurrence of Grade 3 AEs [ Time Frame: Between Day 0 and Day 42 ]
2. Occurrence of medically-attended AEs [ Time Frame: Between Day 0 and Day 42 ]
3. Occurrence of Serious Adverse Events (SAEs) [ Time Frame: From the time of vaccination (Week 0) to study end (Week 6) ]
4. Occurrence of febrile convulsions [ Time Frame: Between Day 0 and Day 42 ]

Eligibility Criteria

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Ages Eligible for Study:	12 Months to 12 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
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.

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.

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01738841 History of Changes
Other Study ID Numbers:	114229
First Posted:	November 30, 2012
Last Update Posted:	July 22, 2013
Last Verified:	July 2013

Keywords provided by GlaxoSmithKline:

Combined measles-mumps-rubella-varicella vaccine; Priorix-Tetra™; MMRV	children; Post-marketing surveillance; Philippines

Additional relevant MeSH terms:

Measles; Chickenpox; Herpes Zoster; Rubella; Mumps; Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Herpesviridae Infections; DNA Virus Infections; Rubivirus Infections; Togaviridae Infections; Rubulavirus Infections	Parotitis; Parotid Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Vaccines; Tetracycline; Immunologic Factors; Physiological Effects of Drugs; Anti-Bacterial Agents; Anti-Infective Agents; Protein Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action