CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,091 enrolled
Drug / intervention
60mcg/1.0ml recombinant hepatitis B vaccine +2 morebiological
Likely dose
60mcg/1.0ml recombinant hepatitis B vaccinefrom 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/NCT01203319
NCT01203319Phase 3Completed
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The Immunogenicity and Safety of 60mcg and 30mcg Recombinant Hepatitis B Vaccines in People Aged 16 and Older Who Failed to Respond to Routine Administration of 10mcg Recombinant Hepatitis B Vaccines

Jiangsu Province Centers for Disease Control and Prevention·interventional·Posted Sep 16, 2010·Updated Apr 27, 2012

In Brief

A Phase 3 clinical trial evaluating 60mcg/1.0ml recombinant hepatitis B vaccine, 30mcg/1.0ml recombinant hepatitis B vaccine, and 1 other intervention for Hepatitis b. Completed, enrolled 1,091 participants.

Detailed Summary

This study is an expanded Phase 2/Phase 3 clinical trial base on the safety data obtained from the phase 1 clinical trial. The purpose of this study is to further evaluate the immunogenicity and safety of 60mcg/30mcg recombinant hepatitis B vaccines in people aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines and to explore the optimizing immunizing dose and immune procedure.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis b
Countries--
CollaboratorsShenzhen Kangtai Biological Products Co., LTD

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2010
Enrollment StartNov 1, 2006
Primary CompletionDec 1, 2010
Study CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 15.8 years ago

Interventions

60mcg/1.0ml recombinant hepatitis B vaccinebiological

to receive 60mcg/1.0ml recombinant HBV vaccines on day 0, 30 and 60

30mcg/1.0ml recombinant hepatitis B vaccinebiological

to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.

10mcg/1.0ml recombinant hepatitis B vaccinebiological

to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60