At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 353 enrolled

Drug / intervention

Hepatitis B vaccinebiological

Likely dose

Hepatitis B vaccine 60 μgfrom 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/NCT02203357

NCT02203357Phase 4Completed

Compare CT.gov

A Randomized, Opened, Parallel-group Clinical Trial of Hepatitis B Vaccine With Different Dosages and Schedules in Healthy Young Adults

Peking University·interventional·Posted Jul 29, 2014·Updated Oct 18, 2019

In Brief

A Phase 4 clinical trial evaluating Hepatitis B vaccine for Hepatitis B. Completed, enrolled 353 participants across 1 site.

Detailed Summary

The objective of this study is to evaluate the immunogenicity and Anti-HBV antibody persistence of hepatitis B vaccine with different doses and schedules. Hepatitis B vaccine with the regimens of 20μg, 0-1-6 mon and 60μg,0-1 or 0-2 mon will be administered to young adults, and the comparative immunogenicity among the three groups will be measured at 1 mon post-a series vaccination, 1- and 2-year after the first dose of the regimen. Furthermore, the safety of hepatitis B vaccine with different doses and schedules will also be evaluated.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHepatitis B

CountriesChina

CollaboratorsGuangxi Center for Disease Control and Prevention, Liuzhou City Center for disease control and prevention, Shenzhen Kangtai Biological Products Co., LTD

Timeline

Phase 4CompletedFinished

2014201520162017201820192020202120222023202420252026

Enrollment StartMar 2014

First PostedJul 2014

Primary CompletionJun 2016

Study CompletionDec 2016

TodayJul 2026

First PostedJul 29, 2014

Enrollment StartMar 1, 2014

Primary CompletionJun 1, 2016

Study CompletionDec 1, 2016

TodayJul 2, 2026

Enrollment to primary: 2.3 yearsPosted 11.9 years ago

Interventions

Hepatitis B vaccinebiological

Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.