Last updated: 11/27/2018 21:10:26

Meta analyses on pregnancy outcomes with respect to the effect of Herpes Simplex Virus (HSV) antigen and of the adjuvant (AS04)

GSK study ID
HSV Meta analyses
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: Meta analyses on pregnancy outcomes with respect to the effect of Herpes Simplex Virus (HSV) antigen and of the adjuvant (AS04)
Trial description: The aim of this meta analyses on pregnancy outcomes was to assess the effect of HSV antigen and of the adjuvant AS04 on spontaneous abortion, as requested by GSK Vaccine Safety Monitoring Board (VSMB).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Relative risk assessment for the percentage of subjects with first pregnancy in the vaccination exposure window leading to spontaneous abortion

Timeframe: Not Applicable

Secondary outcomes:

Relative risk assessment for the percentage of subjects with first pregnancy leading to spontaneous abortion

Timeframe: Not Applicable

Relative risk assessment for the percentage of subjects with first pregnancy leading to elective termination

Timeframe: Not Applicable

Relative risk assessment for the percentage of subjects with first pregnancy the vaccination exposure window leading to elective termination

Timeframe: Not Applicable

Relative risk assessment for the percentage of subjects with pregnancy

Timeframe: Not Applicable

Interventions:
  • Other: Data Collection
    • Enrollment:
    20985
    Primary completion date:
    2010-01-09
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Herpes Simplex Virus
    Product
    Herpes Simplex Vaccine
    Collaborators
    Not applicable
    Study date(s)
    September 2010 to September 2010
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female
    Age
    13 - 45 Year
    Accepts healthy volunteers
    yes
    • All interventional GSK sponsored studies within HSV prophylactic clinical development that were completed before Sept 2010.
    • All females from the eligible studies.
    • Not applicable
    Inclusion and exclusion criteria
    Inclusion criteria:
    • All interventional GSK sponsored studies within HSV prophylactic clinical development that were completed before Sept 2010. All females from the eligible studies. Since the contribution of a study to the relative risk is contingent on the presence of the control group in the study and of at least one negative outcome, only studies meeting these conditions were used in the evaluation of relative risk.
    Exclusion criteria:
    • Not applicable

    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
    2010-01-09
    Actual study completion date
    2010-01-09

    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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