Last updated: 11/03/2018 16:21:39

Safety study of Measles-Mumps-Rubella-Varicella (MMRV) Vaccine, Priorix-Tetra™ in children living in the Philippines

GSK study ID
114229
Clinicaltrials.gov ID
NCT01738841
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

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

Timeframe: Between Day 0 and Day 42

Secondary outcomes:

Occurrence of Grade 3 AEs

Timeframe: Between Day 0 and Day 42

Occurrence of medically-attended AEs

Timeframe: Between Day 0 and Day 42

Occurrence of Serious Adverse Events (SAEs)

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

Occurrence of febrile convulsions

Timeframe: Between Day 0 and Day 42

Interventions:
  • Biological/vaccine: Priorix-Tetra™
  • Other: Safety data collection
    • Enrollment:
    0
    Primary completion date:
    2016-11-03
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Mumps, Rubella, Measles, Varicella
    Product
    SB208136
    Collaborators
    Not applicable
    Study date(s)
    August 2013 to March 2016
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    12 months - 12 years
    Accepts healthy volunteers
    Yes
    • 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.
    • Child in care.
    • Any contraindications to vaccination as stated in the Prescribing Information.
    Inclusion and exclusion 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.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    No study documents available

    Recruitment status
    Other
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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