Last updated: 07/17/2024 17:08:27

Twinrix Pregnancy Registry

GSK study ID
201339
See study documents
Clinicaltrials.gov ID
NCT03619590
See results summary
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: Twinrix [Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine] Pregnancy Registry
Trial description: The purpose of the Twinrix Pregnancy Registry is to prospectively collect data describing exposure to Twinrix before or during pregnancy, potential confounding factors (such as exposure to other medications) and information related to the outcome of the pregnancy.
This is a prospective, voluntary, observational, exposure-registration study. Twinrix is designated as Food and Drug Administration (FDA) Pregnancy Category C, which means that its safety in human pregnancy has not been determined. The Registry is intended to provide an early signal of potential risks in advance of results from formal epidemiologic studies. Registry statistics can supplement animal reproductive toxicology studies and assist clinicians in evaluating the potential risks and benefits of vaccination for individual patients.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of outcomes from pregnancies with reported exposure within 28 days of last menstrual period

Timeframe: From the date of registration until the date of documentation of pregnancy outcome (up to 10 months i.e. 28 days prior to conception till the month of estimated date of delivery)

Number of outcomes from pregnancies with earliest reported exposure during the first trimester

Timeframe: From the date of registration until the date of documentation of pregnancy outcome (up to 10 months i.e. 28 days prior to conception till the month of estimated date of delivery)

Number of outcomes from pregnancies with earliest reported exposure during the second trimester

Timeframe: From the date of registration until the date of documentation of pregnancy outcome (up to 10 months i.e. 28 days prior to conception till the month of estimated date of delivery)

Number of outcomes from pregnancies with earliest reported exposure during the third trimester

Timeframe: From the date of registration until the date of documentation of pregnancy outcome (up to 10 months i.e. 28 days prior to conception till the month of estimated date of delivery)

Number of outcomes from pregnancies with reported exposure during an unspecified trimester

Timeframe: From the date of registration until the date of documentation of pregnancy outcome (up to 10 months i.e. 28 days prior to conception till the month of estimated date of delivery)

Secondary outcomes:
Not applicable
Interventions:
  • Other: Data Collection
    • Enrollment:
    245
    Primary completion date:
    2017-15-09
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Hepatitis
    Product
    SB208127
    Collaborators
    Not applicable
    Study date(s)
    May 2001 to September 2017
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female
    Age
    Not applicable
    Accepts healthy volunteers
    No
    • Documentation that Twinrix was administered ≤ 28 days before or during pregnancy;
    • Confirmation that the pregnancy is being prospectively reported;
    Inclusion and exclusion criteria
    Inclusion criteria:

      Documentation that Twinrix was administered ≤ 28 days before or during pregnancy;

      • Confirmation that the pregnancy is being prospectively reported;
      • Report made by a patient or a health care professional;
      • The timing of the prenatal exposure to Twinrix (no broader than during which trimester);
      • A patient identifier that will allow follow-up to be obtained so that the pregnancy outcome can be ascertained;
      • Whether the patient was involved in a clinical trial at the time of the exposure;
      • Full reporter contact information.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Protocol and statistical analysis plan
    Available language(s): English
    Download document(s)
    Clinical study report
    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
    2017-15-09
    Actual study completion date
    2017-15-09

    Plain language summaries

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

    Additional information about the trial

    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
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