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

May 28, 2014 updated by: Jiangsu Province Centers for Disease Control and Prevention

A Phase 3, Randomized, Controlled, and Blinded Clinical Trial to Evaluate Safety and Immunogenicity of 10µg/0.5ml Hepatitis B Vaccine for Infants and Other Age Groups.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1537

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Jiangsu Provincial Center for Disease Control and Prevention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria (For Infant Group):

  • Healthy full-term infant after birth, Apgar score ≥7.
  • Guardian signed informed consent.
  • Guardian can comply with the requirements of the clinical trial.
  • Without administering immunoglobulin during the following period.
  • Axillary temperature ≤37.0 ℃.

Inclusion Criteria (For Other Age Groups):

  • More than 1 month old healthy people, without the history of hepatitis B infection.
  • Subjects or their guardians signed informed consent.
  • After questioning medical history, physical examination and being judged as healthy subject.
  • Without the history of hepatitis B vaccination.
  • Subjects or their guardians can comply with requirements of the clinical trail.
  • Without other prevention drugs or immunoglobulin administered within two weeks before the clinical trail or during the following period.
  • Axillary temperature ≤37.0 ℃.

Exclusion Criteria (For Infant Group):

  • Apgar score of infant after birth <7.
  • With nervous system damage after birth, or with the family history of mental illness, epilepsy or encephalopathy.
  • With immune system dysfunction.
  • With vitamin deficiency.
  • With acute febrile diseases, or infectious diseases.
  • With congenital malformations, developmental disorders or serious chronic illness.
  • With thrombocytopenia or other coagulation disorders.
  • Administered immunoglobulin during the period of the clinical trail, especially administered Hepatitis B immunoglobulin to the infant of Hepatitis B infected mother.
  • With endemic disease.
  • Participate another clinical trial during the period of the clinical trail.
  • Any circumstance that may affect clinical trail evaluation.

Exclusion Criteria (For Other Age Groups):

  • With allergies, seizures, epilepsy, encephalopathy or with family history of mental illness.
  • Allergic to any component of the study vaccine.
  • With immune system dysfunction.
  • Hepatitis B infected people.
  • Anti-HBs was positive screened by ELISA kit.
  • Either anti-HBs ≥10mIU/ml or HBsAg was positive screened by Radioimmunoassay method.
  • With acute febrile diseases or infectious diseases.
  • With congenital malformations, developmental disorders or serious chronic illness.
  • With thrombocytopenia or other coagulation disorders.
  • With the history of severe allergic reactions.
  • Administered other prevention drugs or immunoglobulin within two weeks before the clinical trail or during the following period.
  • With any acute illness that requires antibiotics or anti-viral treatment within 7 days before the clinical trail.
  • With vitamin deficiency.
  • With the history of febrile convulsion.
  • Axillary temperature ≥38.0 ℃ within 3 days before the clinical trail.
  • Participate another clinical trial during the period of the clinical trail.
  • Pregnant woman.
  • Any circumstance that may affect clinical trail evaluation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Biological: 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 were administered intramuscular injection at 0, 1, 6 momth interval.
Active Comparator: 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.
Biological: 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 were administered intramuscular injection at 0, 1, 6 momth interval.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects with adverse events
Time Frame: 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.
Within 28 days after hepatitis B vaccination
Geometric mean concentration of anti-hepatitis B virus surface antigen antibody
Time Frame: 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.
The 28th day after whole course of hepatitis B vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of hepatitis B virus perinatal transmission
Time Frame: 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.
The 28th day 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
Time Frame: 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.
The 28th day after the second of hepatitis B vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Province Centers for Disease Control and Prevention

Collaborators

Beijing Tiantan Biological Products Co., Ltd.

Investigators

  • Principal Investigator: Fubao Ma, Doctor, Jiangsu Provincial Center for Disease Control and Prevention

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

May 19, 2014

First Submitted That Met QC Criteria

May 28, 2014

First Posted (Estimate)

June 2, 2014

Study Record Updates

Last Update Posted (Estimate)

June 2, 2014

Last Update Submitted That Met QC Criteria

May 28, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JSEPI-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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