Last updated: 11/03/2018 15:36:12

Post-marketing surveillance of GSK Biologicals’ Cervarix™ when administered to healthy females in Sri Lanka

GSK study ID
113763
Clinicaltrials.gov ID
NCT01551537
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 (GSK) Biologicals’ human papillomavirus (HPV) -16/18 vaccine, Cervarix™ when administered to healthy females according to the Prescribing Information in Sri Lanka
Trial description: This PMS study aims to collect safety and reactogenicity data of Cervarix in 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 adverse events (AEs).

Timeframe: During the 7-day period (Days 0-6) following any dose of Cervarix and overall.

Occurrence of solicited general AEs.

Timeframe: During the 7-day period (Days 0-6) following any dose of Cervarix and overall.

Occurrence of unsolicited AEs.

Timeframe: During the 30-day period (Days 0-29) following any dose of Cervarix and overall.

Occurrence of any Serious adverse events (SAEs) and SAE(s) causally related to vaccination.

Timeframe: Throughout the PMS study period (up to six months after the last dose of Cervarix).

Occurrence of potential Immune-Mediated Diseases (pIMDs).

Timeframe: Throughout the PMS study period (up to six months after the last dose of Cervarix).

Occurrence of Medically Significant Condition (MSCs).

Timeframe: Throughout the PMS study period (up to six months after the last dose of Cervarix).

Secondary outcomes:
Not applicable
Interventions:
  • Other: Cervarix data collection
  • Other: Data Collection
    • Enrollment:
    0
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Human Papillomavirus Infection
    Product
    SB580299
    Collaborators
    Not applicable
    Study date(s)
    April 2013 to April 2014
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female
    Age
    10+ years
    Accepts healthy volunteers
    Yes
    • Subjects who the investigator believes that they and/or their parent(s)/ LAR(s) can and will comply with the requirements of the protocol should be enrolled in the PMS study.
    • A female aged 10 years and above at the time of the first vaccination.
    • Subjects with contraindication according to the locally approved PI.
    • Child in care.
    Inclusion and exclusion criteria
    Inclusion criteria:

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

      • A female aged 10 years and above at the time of the first vaccination.
      • Written informed consent obtained from the subject. For subjects below the legal age of consent, written informed consent must be obtained from the parent(s)/LAR(s) of the subject and informed assent must be obtained from the subject. Where subject/subject’s parent(s)/LAR(s) are illiterate, the consent form will be countersigned by an impartial witness.
      • Subjects of childbearing potential must not be pregnant. Absence of pregnancy should be verified as per the investigator's clinical judgement.
    Exclusion criteria:

      Subjects with contraindication according to the locally approved PI.

      • Child in care.
      • Previous administration of more than two doses of Cervarix.
      • Previous vaccination with a HPV vaccine other than Cervarix.
      • Planned administration of another HPV vaccine other than Cervarix 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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