CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 569 enrolled
Drug / intervention
Birth dose hepatitis B vaccinebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03897946
NCT03897946Phase 4Completed
CompareCT.gov

Evaluating Immunogenicity of a Birth Dose of HBV Vaccine in the DRC

University of North Carolina, Chapel Hill·interventional·Posted Apr 1, 2019·Updated Mar 3, 2021

In Brief

A Phase 4 clinical trial evaluating Birth dose hepatitis B vaccine for Hepatitis B. Completed, enrolled 569 participants across 1 site.

Detailed Summary

This project will assess the immunogenicity of a birth dose of hepatitis B vaccine in hepatitis B-exposed and hepatitis B-unexposed infants in Kinshasa, Democratic Republic of the Congo. A better understanding of the protection offered by the addition of birth dose vaccine to the EPI schedule is necessary in order to promote universal adoption of a birth dose vaccine in the DRC and throughout SSA.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B
CountriesDemocratic Republic of the Congo
CollaboratorsThe American Society of Tropical Medicine and Hygiene, Burroughs Wellcome

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedApr 1, 2019
Enrollment StartAug 20, 2019
Primary CompletionFeb 5, 2021
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 7.3 years ago

Interventions

Birth dose hepatitis B vaccinebiological

Groups A and C will receive a birth dose of hepatitis B vaccine within 24 hours of life.