Twinrix Pregnancy Registry

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Hepatitis

Treatments: Other: Data Collection

Study type: Observational

Funder types: Industry

Identifiers

NCT03619590

201339

Details and patient eligibility

About

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.

Full 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.

Enrollment: 245 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

245 participants in 1 patient group

Exposure Group

Description:

Pregnant women who were exposed to Twinrix within 28 days prior to conception or at any time during pregnancy. Reporting of exposed pregnancies is voluntary and prospective.

Treatment:

Other: Data Collection