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

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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Recruitment Status : Withdrawn (Local authorities no longer require routine PMS studies; GSK does not believe the study would add meaningfully to the safety data already available for MMRV.)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
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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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Information from the National Library of Medicine

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


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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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