NCT03664648

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 10, 2018

Completed
2.5 years until next milestone

Study Start

First participant enrolled

February 21, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

September 18, 2023

Status Verified

September 1, 2023

Enrollment Period

3.5 years

First QC Date

July 18, 2018

Last Update Submit

September 15, 2023

Conditions

Pregnant

Keywords

PregnantConceivedHBV VaccineHepatitis BHepatitis B vaccineHBVHepatitisRegistryPreventionFemale volunteers

Outcome Measures

Primary Outcomes (2)

  • Rate of Major Congenital Malformations in Live-Born Infants.

    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

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

Study Arms (1)

Adult Pregnant Women Exposed to HEPLISAV-B

Adult women who received a dose of HEPLISAV-B within 28 days prior to conception or at any time during pregnancy.

Biological: HEPLISAV-B

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.

Adult Pregnant Women Exposed to HEPLISAV-B

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant Women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Women 18 years of age or older exposed to HEPLISAV-B within 28 days of conception or at any time during pregnancy.

You may qualify if:

  • years and older
  • HEPLISAV-B exposure within 28 days prior to conception or at any time during pregnancy

You may not qualify if:

  • Less than 18 years of age
  • HEPLISAV-B exposure greater than 28 days prior to conception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PPD Registry Office, Recruiting Nationwide

Wilmington, North Carolina, 28401, United States

Location

MeSH Terms

Conditions

Hepatitis BHepatitis

Interventions

Heplisav-B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanLiver DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2018

First Posted

September 10, 2018

Study Start

February 21, 2021

Primary Completion

September 1, 2024

Study Completion

December 1, 2024

Last Updated

September 18, 2023

Record last verified: 2023-09

Locations

US(1)