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Twinrix Pregnancy Registry

NCT03619590 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 245

Last updated 2019-02-04

Study results available
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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.

Conditions

  • Hepatitis

Interventions

OTHER

Data Collection

When the pregnancy is reported prospectively, the Registry will collect registration data from the reporter through telephone interview or a short registration form. In the month of the estimated date of delivery, follow-up will be sought by telephone contact or a form mailed to the health professional. Information about maternal events throughout the pregnancy, pregnancy outcome, and neonatal health is requested. Additional follow-up is not sought from subsequent health care providers.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-05-18
Primary Completion
2017-09-15
Completion
2017-09-15
FDA Drug
Yes

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03619590 on ClinicalTrials.gov