Safety Study of Measles-Mumps-Rubella-Varicella (MMRV) Vaccine, Priorix-Tetra™ in Children Living in the Philippines
This study has been withdrawn prior to enrollment.
(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.)
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01738841
First received: November 28, 2012
Last updated: July 18, 2013
Last verified: July 2013
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Purpose
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 | Intervention |
|---|---|
|
Mumps Rubella Measles Varicella |
Biological: Priorix-Tetra™ Other: Safety data collection |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Occurrence of Grade 3 adverse events (AEs) with a causal relationship to vaccination [ Time Frame: Between Day 0 and Day 42 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Occurrence of Grade 3 AEs [ Time Frame: Between Day 0 and Day 42 ] [ Designated as safety issue: No ]
- Occurrence of medically-attended AEs [ Time Frame: Between Day 0 and Day 42 ] [ Designated as safety issue: No ]
- Occurrence of Serious Adverse Events (SAEs) [ Time Frame: From the time of vaccination (Week 0) to study end (Week 6) ] [ Designated as safety issue: No ]
- Occurrence of febrile convulsions [ Time Frame: Between Day 0 and Day 42 ] [ Designated as safety issue: No ]
| Enrollment: | 0 |
| Study Start Date: | August 2013 |
| Estimated Study Completion Date: | March 2016 |
| Estimated Primary Completion Date: | March 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 12 Months to 12 Years (Child) |
| Genders Eligible for Study: | Both |
| 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
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01738841
Please refer to this study by its ClinicalTrials.gov identifier: NCT01738841
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01738841 History of Changes |
| Other Study ID Numbers: | 114229 |
| Study First Received: | November 28, 2012 |
| Last Updated: | July 18, 2013 |
| Health Authority: | Philippines: Food and Drug Administration Philippines |
Keywords provided by GlaxoSmithKline:
|
Combined measles-mumps-rubella-varicella vaccine Priorix-Tetra™ MMRV |
children Post-marketing surveillance Philippines |
Additional relevant MeSH terms:
|
Measles Rubella Mumps Chickenpox Herpes Zoster Morbillivirus Infections Paramyxoviridae Infections Mononegavirales Infections RNA Virus Infections Virus Diseases Rubivirus Infections Togaviridae Infections Rubulavirus Infections Parotitis Parotid Diseases |
Salivary Gland Diseases Mouth Diseases Stomatognathic Diseases Herpesviridae Infections DNA Virus Infections Vaccines Tetracycline Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 28, 2016