DV2-HBV-27: Observational Pregnancy Registry

Dynavax Technologies Corporation300 enrolled

Overview

Purpose of the study is to evaluate pregnancy outcomes among women who received a dose of HEPLISAV-B within 28 days prior to conception or at any time during pregnancy

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Pregnant

Interventions

HEPLISAV-BBIOLOGICAL

This study is strictly observational. Administration of HEPLISAV-B, the schedule of office visits and all treatment regimens will be determined by the treating health care provider in the context of routine clinical care.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years and older * HEPLISAV-B exposure within 28 days prior to conception or at any time during pregnancy Exclusion Criteria: * Less than 18 years of age * HEPLISAV-B exposure greater than 28 days prior to conception

Locations (1)

PPD Registry Office, Recruiting Nationwide

Wilmington, North Carolina, United States

Outcomes

Primary Outcomes

Rate of Major Congenital Malformations in Live-Born Infants.

Time frame: Live-born infants will be followed to 12 months of age

Rate of Still Births, Pre-Term, or Fetal Loss (Including Spontaneous Abortion) of any Gestational Age

Time frame: Follow-up will end at the time of pregnancy outcome up to 9 months

Data from ClinicalTrials.gov

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