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

This study is not yet open for participant recruitment.
Verified February 2013 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01738841
First received: November 28, 2012
Last updated: February 28, 2013
Last verified: February 2013
History of Changes
  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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 3000
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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01738841

Contacts
Contact: US GSK Clinical Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01738841     History of Changes
Other Study ID Numbers: 114229
Study First Received: November 28, 2012
Last Updated: February 28, 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:
Herpes Zoster
Chickenpox
Measles
Mumps
Parotitis
Rubella
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Rubulavirus Infections
Parotid Diseases
 Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Sialadenitis
Rubivirus Infections
Togaviridae Infections
Tetracycline
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013