Clinical trial NCT03619590: Twinrix Pregnancy Registry
Official title: Twinrix [Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine] Pregnancy Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis
Keywords: Teratogenicity
Pregnancy
Hepatitis B
Twinrix
Prenatal exposure
Hepatitis A
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2018-08-08
Enrollment: 245
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes pregnant women who were exposed to Twinrix within 28 days prior to conception or at any time during pregnancy.

Brief summary: 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.

Detailed description: The Twinrix Pregnancy Registry will be maintained by GSK Vaccines Clinical Safety and Pharmacovigilance. Enrolment in the Registry will begin at the time of commercial launch of Twinrix in the United States (US). At the time of initiation of the Registry, pre-existing reports of pregnancy from clinical trials will be evaluated and enrolled when the criteria for registration are met. Reporting of exposed pregnancies is voluntary. Pregnancies will be registered following maternal exposure to Twinrix within 28 days prior to conception or during pregnancy. Registration of pregnancies is prospective, i.e., reported during pregnancy before the pregnancy outcome is known. Retrospective reports, in which the pregnancy outcomes are known at the time of reporting, will also be reviewed to assist in the detection of any unusual patterns that may exist among the reported birth defects. However, because there is no denominator from which risk can be calculated, these reports will be excluded from the analysis.

Eligibility 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.

Exclusion Criteria:

-

Primary outcomes:
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: