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

May 5, 2011
March 3, 2014
May 2011
November 2012   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01349283 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Immunogenicity and Safety of the Hepatitis B Vaccine Hepavax-Gene TF and a Comparator Hepatitis B Vaccine in Newborns
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Hepatitis B
  • Biological: HepavaxGene (thiomersal free)
    10 µg/0.5 mL, intramuscular injection on Day 1, Month 1, Month 6
  • Biological: Engerix B
    10 µg/0.5 mL, intramuscular injection on Day 1, Month 1, Month 6
  • Experimental: HepavaxGene Stratum 1a
    Subjects of mothers with chronic hepatitis B (positive for both HBsAg and hepatitis B envelope antigen - HBeAg)
    Intervention: Biological: HepavaxGene (thiomersal free)
  • Active Comparator: Comparator vaccine Stratum 1a
    Subjects of mothers with chronic hepatitis B (positive for both HBsAg and HBeAg)
    Intervention: Biological: Engerix B
  • Experimental: HepavaxGene Stratum 1b
    Subjects of mothers with chronic hepatitis B (positive for HBsAg only)
    Intervention: Biological: HepavaxGene (thiomersal free)
  • Active Comparator: Comparator vaccine Stratum 1b
    Subjects of mothers with chronic hepatitis B (positive for HBsAg only)
    Intervention: Biological: Engerix B
  • Experimental: HepavaxGene Stratum 2
    Subjects of mothers without chronic hepatitis B (negative for both HBsAg and HBeAg)
    Intervention: Biological: HepavaxGene (thiomersal free)
  • Active Comparator: Comparator vaccine Stratum 2
    Subjects of mothers without chronic hepatitis B (negative for both HBsAg and HBeAg)
    Intervention: Biological: Engerix B
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1738
November 2013
November 2012   (final data collection date for primary outcome measure)

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.
Both
up to 1 Day
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01349283
HVG-V-A002
No
Crucell Holland BV
Crucell Holland BV
Not Provided
Principal Investigator: Zhu Fencai, MD Jiangsu Provincial Center for Disease Prevention and Control, China
Crucell Holland BV
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP