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The Safety and Immunogenicity of Recombinant Hepatitis B Vaccines in the Health Neonates

NCT01183611 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1740

Last updated 2010-09-17

No results posted yet for this study

Summary

The primary safety objective of this study is to assess the safety of 10 mcg recombinant hepatitis B vaccine in the Chinese health neonates. The primary immunogenicity objective is to assess the antibody response following 3 doses immunization of the 10 mcg experimental dose and 10 or 5 mcg control dose, Participants will include up to 1740 healthy neonates. This is a randomized, double-blinded, Phase III study. This study is designed to investigate the safety, reactogenicity, and immunogenicity of 10ug recombinant hepatitis B vaccine (yeast). Subjects will be stratified by the mother with positive for both HBsAg and HBeAg, positive for the surface antigen but negative for HBeAg, negative for the HBsAg and HBeAg and HBeAb and HBcAb.

* Stratified 1: There are 180 neonates born to the mother with positive for both HBsAg and HBeAg will be randomized into two groups according to the ratio of 2:1. 120 subjects will receive the 10 mcg experimental vaccine and 60 subjects will receive 10 mcg control vaccine respectively.
* Stratified 2: There are 360 neonates born to the mother with positive for HBsAg but negative for HBeAg will be randomized into two groups according to the ratio of 2:1. 240 subjects will receive the 10 mcg experimental vaccine and 120 subjects will receive 10 mcg control vaccine respectively.
* Stratified 3: There are 1200 neonates born to the mother with negative for the HBsAg and HBeAg and HBeAb and HBcAb will be randomized into 3 groups. 600 of them will receive the 10mcg experimental vaccine. 300 subjects will receive 10mcg control vaccine. And the other 300 subjects will receive 5mcg control vaccine.

The recombinant hepatitis B vaccine will be administered at m0, 1 and 6. Following each immunization, safety will be measured by assessment of adverse events through 30 days following each vaccination, serious adverse events and new-onset chronic medical conditions through 6 months post the final vaccination (Day 180 after last vaccination). For the immunogenicity testing will apply the chemiluminescence immunoassay on serum obtained on the day 0, 210 and 360 after born.

Conditions

  • Virus Disease
  • DNA Virus Infections
  • Hepadnaviridae Infections

Interventions

BIOLOGICAL

Experimental recombinant hepatitis B vaccine, HBIG

Experimental 10mcg/0.5 ml recombinant hepatitis B vaccine and 200IU HBIG

BIOLOGICAL

Active Comparator hepatitis B vaccine

Active Comparator 10mcg/0.5 ml of recombinant hepatitis B vaccine，200IU HBIG

BIOLOGICAL

Experimental recombinant hepatitis B vaccine

Experimental 10mcg/0.5 ml of recombinant hepatitis B vaccine

BIOLOGICAL

Active Comparator recombinant hepatitis B vaccine.

Active Comparator 10mcg/0.5 ml of recombinant hepatitis B vaccine.

BIOLOGICAL

Placebo Comparator recombinant hepatitis B vaccine

Placebo Comparator 10mcg/0.5 ml of recombinant hepatitis B vaccine.

Sponsors & Collaborators

  • Jiangsu Province Centers for Disease Control and Prevention

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
24 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2010-06-30
Completion
2010-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01183611 on ClinicalTrials.gov