Last updated: 11/03/2018 19:03:07

Post-marketing safety study of GlaxoSmithKline (GSK) Biologicals' Synflorix™ vaccine, in healthy infants and children in Sri Lanka

GSK study ID
116290
Clinicaltrials.gov ID
NCT01803425
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 (PMS) of GlaxoSmithKline Biologicals’ 10-valent pneumococcal conjugate vaccine (Synflorix™) when administered to healthy infants and children according to the Prescribing Information in Sri Lanka
Trial description: This PMS study aims to collect safety and reactogenicity data of Synflorix™ in healthy infants and children of the local population as per the licensing requirement of the Sri Lankan regulatory authority.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Occurrence of solicited local (any intensity) and general (any intensity and causally related) adverse events (AEs)

Timeframe: During the 4-day follow-up period (Day 0 to Day 3) following any dose of Synflorix™ and overall

Occurrence of unsolicited AEs

Timeframe: During the 31-day period (Day 0 to Day 30) following any dose of Synflorix™ and overall

Occurrence of Serious Adverse Events (SAEs)

Timeframe: Throughout the PMS study period, starting at Dose 1 (Visit 1) and ending 31 days (Day 0 to Day 30) after the last dose of Synflorix™ for each subject in the PMS study

Secondary outcomes:
Not applicable
Interventions:
  • Other: Synflorix™ data collection
    • Enrollment:
    0
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Immunisation against Streptococcus pneumoniae
    Product
    GSK1024850A, GSK2647154A
    Collaborators
    Not applicable
    Study date(s)
    April 2013 to April 2014
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    6 weeks - 5 years
    Accepts healthy volunteers
    Yes
    • Subjects who the investigator believes that their parent(s)/ LAR(s) can and will comply with the requirements of the protocol should be enrolled in the PMS study.
    • Infants aged 6 weeks and above and children.
    • Subjects with contraindications according to the locally approved PI.
    • Child in care.
    Inclusion and exclusion criteria
    Inclusion criteria:

      Subjects who the investigator believes that their parent(s)/ LAR(s) can and will comply with the requirements of the protocol should be enrolled in the PMS study.

      • Infants aged 6 weeks and above and children.
      • Written, signed or thumb-printed informed consent obtained from the parent(s)/LAR(s) of the child. Where subject’s parent(s)/LAR(s) are illiterate, the consent form will be countersigned by an impartial witness. Note: Consent for this PMS study is solely for collection of safety and reactogenicity data and not for vaccination that is per routine practice. Data for demography, medical history and previous vaccination history, and concomitant medication/vaccination will also be collected.
    Exclusion criteria:

      Subjects with contraindications according to the locally approved PI.

      • Child in care.
      • Previous administration of three doses of Synflorix™.
      • Previous vaccination with a pneumococcal vaccine other than Synflorix™.
      • Planned administration of another pneumococcal vaccine other than Synflorix™ during the PMS study.

    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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