Immunogenicity and Safety of the Hepatitis B Vaccine Hepavax-Gene TF and a Comparator Hepatitis B Vaccine in Newborns

March 3, 2014 updated by: Crucell Holland BV

A Prospective, Randomized, Double-blind, Parallel-group, Controlled Study of the Immunogenicity and Safety of the Recombinant Hepatitis B Vaccine (Hepavax-Gene TF) and a Comparator Univalent Hepatitis B Vaccine in Neonates

The primary purpose of this study is to determine whether HepavaxGene TF is non-inferior to the comparator vaccine both at impeding hepatitis B transmission from mothers positive for chronic hepatitis B (Stratum 1) to their children and also in terms of seroconversion rate in children of mothers negative for chronic hepatitis B (Stratum 2) one month after completion of the immunization schedule.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1738

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
        • Center for Disease Control and Prevention Jiangsu Province

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

No older than 1 day (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Three types of subject:

Neonates whose mothers are positive for both HBsAg and HBeAg

Neonates whose mothers are positive for only HBsAg

Neonates whose mothers are negative for both HBsAg and HBeAg

INCLUSION CRITERIA:

  • Full-term neonates with gestational age from 37 weeks to 42 weeks;
  • Apgar scores are no less than 7 at birth;
  • Neonates with standard body temperature (auxiliary temperature < 37.1°);
  • Neonates weighing ≥ 2,500 grams at birth;
  • Neonates with icteric index within the normal range (physiologic jaundice is permitted);
  • Informed consent form signed by parent/guardian;
  • The requirements of the clinical trial protocol can be observed on the basis of the opinion of the investigator.

EXCLUSION CRITERIA:

  • Subject's parent has a history of family diseases such as convulsion and brain diseases;
  • Mothers have low immunologic function or a history of organ transplantation or hemodialysis;
  • Subject's parent is allergic to any composition of Hepatitis B vaccine;
  • A family history of thrombocytopenia, or other disturbance of blood coagulation, which may result in a contraindication for intramuscular injection;
  • Known immunologic function damage;
  • Mothers had received gamma globulin or immunoglobulin injection during pregnancy;
  • Any congenital malformation
  • Known or suspected to suffer from diseases such as active infection and cardiovascular disease;
  • Any condition believed by the investigator to have possible impact on trial 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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HepavaxGene Stratum 1a
Subjects of mothers with chronic hepatitis B (positive for both HBsAg and hepatitis B envelope antigen - HBeAg)
Biological: HepavaxGene (thiomersal free)
10 µg/0.5 mL, intramuscular injection on Day 1, Month 1, Month 6
Active Comparator: Comparator vaccine Stratum 1a
Subjects of mothers with chronic hepatitis B (positive for both HBsAg and HBeAg)
Biological: Engerix B
10 µg/0.5 mL, intramuscular injection on Day 1, Month 1, Month 6
Experimental: HepavaxGene Stratum 1b
Subjects of mothers with chronic hepatitis B (positive for HBsAg only)
Biological: HepavaxGene (thiomersal free)
10 µg/0.5 mL, intramuscular injection on Day 1, Month 1, Month 6
Active Comparator: Comparator vaccine Stratum 1b
Subjects of mothers with chronic hepatitis B (positive for HBsAg only)
Biological: Engerix B
10 µg/0.5 mL, intramuscular injection on Day 1, Month 1, Month 6
Experimental: HepavaxGene Stratum 2
Subjects of mothers without chronic hepatitis B (negative for both HBsAg and HBeAg)
Biological: HepavaxGene (thiomersal free)
10 µg/0.5 mL, intramuscular injection on Day 1, Month 1, Month 6
Active Comparator: Comparator vaccine Stratum 2
Subjects of mothers without chronic hepatitis B (negative for both HBsAg and HBeAg)
Biological: Engerix B
10 µg/0.5 mL, intramuscular injection on Day 1, Month 1, Month 6

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seroconversion rate for subjects in Stratum 2
Time Frame: Month 7
Hepatitis B surface antibody (HBsAb) concentrations are measured from blood samples by standard enzyme linked immuno sorbent assay (ELISA) for subjects whose mothers are negative for chronic hepatitis B. Seroconversion rate is defined as HBsAb ≥10 mIU/mL.
Month 7
Positivity for HBsAg for subjects in Stratum 1
Time Frame: Month 2, Month 7 and Month 12
The presence of hepatitis B surface antigen (HBsAg), as determined by ELISA, for subjects whose mothers are positive for chronic hepatitis B
Month 2, Month 7 and Month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seroconversion rate for subjects in Stratum 1
Time Frame: Month 7
Seroconversion rate is defined as HBsAb concentrations from ELISA ≥10 mIU/mL
Month 7
Solicited adverse events
Time Frame: Days 1 to 4
Local adverse events: pain, erythema, swelling at the injection site Systemic adverse events: irritability, sleepiness, change in eating/breast feeding habits, crying, fever [body temperature ≥38°C]
Days 1 to 4
Seroconversion rate for subjects in Stratum 1
Time Frame: Month 12
Seroconversion rate is defined as HBsAb concentrations from ELISA ≥10 mIU/mL
Month 12
Positivity for HBsAg for subjects in Stratum 2
Time Frame: Months 2, 7 and 12
Months 2, 7 and 12

Collaborators and Investigators

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

Sponsor

Crucell Holland BV

Investigators

  • Principal Investigator: Zhu Fencai, MD, Jiangsu Provincial Center for Disease Prevention and Control, China

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

May 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

May 5, 2011

First Submitted That Met QC Criteria

May 5, 2011

First Posted (Estimate)

May 6, 2011

Study Record Updates

Last Update Posted (Estimate)

March 4, 2014

Last Update Submitted That Met QC Criteria

March 3, 2014

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HVG-V-A002

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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