NCT01738841

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2013

Typical duration for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2012

Completed
8 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

July 22, 2013

Status Verified

July 1, 2013

Enrollment Period

2.6 years

First QC Date

November 28, 2012

Last Update Submit

July 18, 2013

Conditions

MumpsRubellaMeaslesVaricella

Keywords

Combined measles-mumps-rubella-varicella vaccinePriorix-Tetra™MMRVchildrenPost-marketing surveillancePhilippines

Outcome Measures

Primary Outcomes (1)

  • Occurrence of Grade 3 adverse events (AEs) with a causal relationship to vaccination

    Between Day 0 and Day 42

Secondary Outcomes (4)

  • Occurrence of Grade 3 AEs

    Between Day 0 and Day 42

  • Occurrence of medically-attended AEs

    Between Day 0 and Day 42

  • Occurrence of Serious Adverse Events (SAEs)

    From the time of vaccination (Week 0) to study end (Week 6)

  • Occurrence of febrile convulsions

    Between Day 0 and Day 42

Study Arms (1)

Cohort Group

Children aged 12 months to 12 years will receive Priorix-Tetra as prescribed by the physician.

Biological: Priorix-Tetra™Other: Safety data collection

Interventions

Priorix-Tetra™BIOLOGICAL

Single dose, subcutaneous injection

Cohort Group
Safety data collectionOTHER

Recording of adverse events, using diary cards

Cohort Group

Eligibility Criteria

Age12 Months - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children aged 12 months to 12 years living in Philippines will receive Priorix-Tetra as prescribed by the physician.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

MumpsRubellaMeaslesChickenpox

Interventions

Priorix-Tetra vaccine

Condition Hierarchy (Ancestors)

Rubulavirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsParotitisParotid DiseasesSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesRubivirus InfectionsTogaviridae InfectionsMorbillivirus InfectionsVaricella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus Infections

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2012

First Posted

November 30, 2012

Study Start

August 1, 2013

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

July 22, 2013

Record last verified: 2013-07