Study of Evaluating Safety and Immunogenicity of 10µg/0.5ml Hepatitis B Vaccine

Phase 3

Completed

• Conditions: Hepatitis B
• Interventions: Biological: 3 dose of 10µg/0.5ml hepatitis B vaccine; Biological: 3 dose of 5µg/0.5ml hepatitis B vaccine

• Registration Number: NCT02152709
• Lead Sponsor: Jiangsu Province Centers for Disease Control and Prevention

Brief Summary

The main objective of this study was to evaluate the safety and immunogenicity of 10µg/0.5ml and 5µg/0.5ml hepatitis B vaccine made by recombinant deoxyribonudeic acid techniques in saccharomyces cereviside yeast for infants and other age groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2010-03
• Study Completion: 2010-10
• Status Verified: 2014-05
• Study First Submitted: 2014-05-19
• Study First Submitted QC: 2014-05-28
• Last Update Submitted: 2014-05-28
• Study First Posted: 2014-06-02
• Last Update Posted: 2014-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1537

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10µg/0.5ml hepatitis B vaccine	3 dose of 10µg/0.5ml hepatitis B vaccine	3 dose of 10µg/0.5ml hepatitis B vaccine made by recombinant deoxyribonudeic acid techniques in saccharomyces cereviside.Produced by Beijing Tiantan Biological Products Co., Ltd. Lot number: YHB2008063S1.
5µg/0.5ml hepatitis B vaccine	3 dose of 5µg/0.5ml hepatitis B vaccine	3 dose of 5µg/0.5ml hepatitis B vaccine made by recombinant deoxyribonudeic acid techniques in saccharomyces cereviside.Produced by Beijing Tiantan Biological Products Co., Ltd. Lot number:20080603.

Primary Outcome Measures

Name	Time	Method
Number of subjects with adverse events	Within 28 days after hepatitis B vaccination	To analyze the number of subjects with adverse events within 28 days after administered each of hepatitis B vaccine.
Geometric mean concentration of anti-hepatitis B virus surface antigen antibody	The 28th day after whole course of hepatitis B vaccination	Geometric mean concentration of anti-hepatitis B virus surface antigen antibody was measured by chemiluminescence assay and expressed with mIU/mL.

Secondary Outcome Measures

Name	Time	Method
The rate of hepatitis B virus perinatal transmission	The 28th day after whole course of hepatitis B vaccination	To analyze the rate of hepatitis B virus perinatal transmission after whole course of hepatitis B vaccination.
Geometric mean concentration of anti-hepatitis B virus surface antigen antibody after the second dose of hepatitis B vaccination	The 28th day after the second of hepatitis B vaccination	Geometric mean concentration of anti-hepatitis B virus surface antigen antibody was measured by chemiluminescence assay and expressed with mIU/mL.

Trial Locations

Locations (1)

Jiangsu Provincial Center for Disease Control and Prevention; 🇨🇳 Nanjing, Jiangsu, China