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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Crucell Holland BV
ClinicalTrials.gov Identifier:
NCT01349283
First received: May 5, 2011
Last updated: March 3, 2014
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Hepatitis B
Biological: HepavaxGene (thiomersal free)
Biological: Engerix B
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Crucell Holland BV:

Primary Outcome Measures:
  • Seroconversion rate for subjects in Stratum 2 [ Time Frame: Month 7 ] [ Designated as safety issue: No ]
    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.

  • Positivity for HBsAg for subjects in Stratum 1 [ Time Frame: Month 2, Month 7 and Month 12 ] [ Designated as safety issue: No ]
    The presence of hepatitis B surface antigen (HBsAg), as determined by ELISA, for subjects whose mothers are positive for chronic hepatitis B


Secondary Outcome Measures:
  • Seroconversion rate for subjects in Stratum 1 [ Time Frame: Month 7 ] [ Designated as safety issue: No ]
    Seroconversion rate is defined as HBsAb concentrations from ELISA ≥10 mIU/mL

  • Solicited adverse events [ Time Frame: Days 1 to 4 ] [ Designated as safety issue: Yes ]
    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]

  • Seroconversion rate for subjects in Stratum 1 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Seroconversion rate is defined as HBsAb concentrations from ELISA ≥10 mIU/mL

  • Positivity for HBsAg for subjects in Stratum 2 [ Time Frame: Months 2, 7 and 12 ] [ Designated as safety issue: No ]

Enrollment: 1738
Study Start Date: May 2011
Study Completion Date: November 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 1 Day
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01349283

Locations
China, Jiangsu
Center for Disease Control and Prevention Jiangsu Province
Nanjing, Jiangsu, China
Sponsors and Collaborators
Crucell Holland BV
Investigators
Principal Investigator: Zhu Fencai, MD Jiangsu Provincial Center for Disease Prevention and Control, China
  More Information

No publications provided

Responsible Party: Crucell Holland BV
ClinicalTrials.gov Identifier: NCT01349283     History of Changes
Other Study ID Numbers: HVG-V-A002
Study First Received: May 5, 2011
Last Updated: March 3, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Crucell Holland BV:
Hepatitis B Vaccine
Hepatitis B Virus
Antigen
Antibody
Vaccination

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on October 19, 2014