Safety Study of Measles-Mumps-Rubella-Varicella (MMRV) Vaccine, Priorix-Tetra™ in Children Living in the Philippines
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01738841 |
Recruitment Status
:
Withdrawn
(Local authorities no longer require routine PMS studies; GSK does not believe the study would add meaningfully to the safety data already available for MMRV.)
First Posted
: November 30, 2012
Last Update Posted
: July 22, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Mumps Rubella Measles Varicella | Biological: Priorix-Tetra™ Other: Safety data collection |
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 |

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
|
- Occurrence of Grade 3 adverse events (AEs) with a causal relationship to vaccination [ Time Frame: Between Day 0 and Day 42 ]
- Occurrence of Grade 3 AEs [ Time Frame: Between Day 0 and Day 42 ]
- Occurrence of medically-attended AEs [ Time Frame: Between Day 0 and Day 42 ]
- Occurrence of Serious Adverse Events (SAEs) [ Time Frame: From the time of vaccination (Week 0) to study end (Week 6) ]
- Occurrence of febrile convulsions [ Time Frame: Between Day 0 and Day 42 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 12 Months to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01738841
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT01738841 History of Changes |
Other Study ID Numbers: |
114229 |
First Posted: | November 30, 2012 Key Record Dates |
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 |