Last updated: 11/07/2018 17:17:29

Integrated Safety Summary of GSK Biologicals’ HPV-16/18 L1 VLP AS04 vaccine (Cervarix®)

GSK study ID
HPV-Meta-analysis-201110
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Integrated Safety Summary of GSK Biologicals’ HPV-16/18 L1 VLP AS04 vaccine (Cervarix®)
Trial description: The aim of this study was to update the pooled analysis of the safety of GSK Biologicals’ HPV-16/18 L1 VLP vaccine (Cervarix®), justified by a significant number of additional subjects included in ongoing clinical trials.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Occurrence of medically significant conditions (MSCs) regardless of causal relationship to vaccination and intensity

Timeframe: Throughout the follow-up period

Occurrence of any, Grade 3 and causally related to vaccination unsolicited Adverse Events (AEs)

Timeframe: Within the 30- day period (Days 0 - 29) following any vaccination

Occurrence of potential immune mediated diseases either reported as such for new studies or detected in the database by a search of MedDRA preferred terms related to immune mediated diseases regardless of causal relationship to vaccination and intensity

Timeframe: Throughout the follow-up period

Occurrence of pregnancies and pregnancy outcomes

Timeframe: Throughout the follow-up period

Occurrence of deaths, regardless of causal relationship to vaccination

Timeframe: Throughout the follow-up period

Occurrence of Serious Adverse Events (SAEs) and SAEs with causal relationship to vaccination

Timeframe: Throughout the follow-up period

Secondary outcomes:
Not applicable
Interventions:
  • Other: Data collection
    • Enrollment:
    57580
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Descamps D et al. (2009) Safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for cervical cancer prevention: A pooled analysis of 11 clinical trials. Hum Vaccin. 5(5):51-59.
    Verstraeten T et al. (2008) Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 26(51):6630–6638.
    Medical condition
    HPV infection
    Product
    Human Papillomavirus Types 16 and 18 Vaccine
    Collaborators
    Not applicable
    Study date(s)
    N/A to Invalid Date
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female
    Age
    9+ years
    Accepts healthy volunteers
    yes
    • All females from the eligible studies.
    • All interventional GSK sponsored studies of Cervarix® completed or ongoing at the time of the data lock point (DLP), 30 April 2011.
    • Subjects enrolled after 30 April 2011 in any of the ongoing studies, were excluded from the analyses.
    Inclusion and exclusion criteria
    Inclusion criteria:

      All females from the eligible studies.

      • All interventional GSK sponsored studies of Cervarix® completed or ongoing at the time of the data lock point (DLP), 30 April 2011.
    Exclusion criteria:

      Subjects enrolled after 30 April 2011 in any of the ongoing studies, were excluded from the analyses.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    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
    Participate in clinical trial
    Access to clinical trial data by researchers
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