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CompletedNCT01349283Updated Mar 4, 2014

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

A Phase 3 interventional study of HepavaxGene (thiomersal free) and Engerix B in Hepatitis B, sponsored by Crucell Holland BV. Completed at 1 site in China. Open to participants aged Up to 1 Day, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-03-04.

Sponsored by Crucell Holland BV (part of Johnson & Johnson) · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
1,738
Allocation
Randomized
Ages
Up to 1 Day
Sex
All
01

Study summary

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.

02

Conditions studied

  • Hepatitis B

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Keywords

  • Hepatitis B Vaccine
  • Hepatitis B Virus
  • Antigen
  • Antibody
  • Vaccination
03

In context

Hepatitis B

1,662 studies on the registry are indexed under Hepatitis B; 192 are open to participants now.

This study's enrollment of 1,738 is above the median of 120 across 1,191 interventional studies indexed under Hepatitis B.

Browse Hepatitis B studies →

Lead sponsor

Crucell Holland BV is the lead sponsor of 37 studies on the registry; none are open to participants now.

First submitted after Crucell Holland BV became part of Johnson & Johnson.

Browse Crucell Holland BV studies →All Johnson & Johnson studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 1 Day
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
1,738 participants (actual)

Study arms

  • 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)

  • Active comparator
    Comparator vaccine Stratum 1a

    Subjects of mothers with chronic hepatitis B (positive for both HBsAg and HBeAg)

    Biological: Engerix B

  • Experimental
    HepavaxGene Stratum 1b

    Subjects of mothers with chronic hepatitis B (positive for HBsAg only)

    Biological: HepavaxGene (thiomersal free)

  • Active comparator
    Comparator vaccine Stratum 1b

    Subjects of mothers with chronic hepatitis B (positive for HBsAg only)

    Biological: Engerix B

  • Experimental
    HepavaxGene Stratum 2

    Subjects of mothers without chronic hepatitis B (negative for both HBsAg and HBeAg)

    Biological: HepavaxGene (thiomersal free)

  • Active comparator
    Comparator vaccine Stratum 2

    Subjects of mothers without chronic hepatitis B (negative for both HBsAg and HBeAg)

    Biological: Engerix B

Interventions

  • BiologicalHepavaxGene (thiomersal free)

    10 µg/0.5 mL, intramuscular injection on Day 1, Month 1, Month 6

  • BiologicalEngerix B

    10 µg/0.5 mL, intramuscular injection on Day 1, Month 1, Month 6

06

What researchers measure

Primary outcomes

  1. Seroconversion rate for subjects in Stratum 2

    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.

    Time frame: Month 7

  2. Positivity for HBsAg for subjects in Stratum 1

    The presence of hepatitis B surface antigen (HBsAg), as determined by ELISA, for subjects whose mothers are positive for chronic hepatitis B

    Time frame: Month 2, Month 7 and Month 12

Secondary outcomes

  1. Seroconversion rate for subjects in Stratum 1

    Seroconversion rate is defined as HBsAb concentrations from ELISA ≥10 mIU/mL

    Time frame: Month 7

  2. Solicited adverse events

    Local adverse events: pain, erythema, swelling at the injection site Systemic adverse events: irritability, sleepiness, change in eating/breast feeding habits, crying, fever \[body temperature ≥38°C\]

    Time frame: Days 1 to 4

  3. Seroconversion rate for subjects in Stratum 1

    Seroconversion rate is defined as HBsAb concentrations from ELISA ≥10 mIU/mL

    Time frame: Month 12

  4. Positivity for HBsAg for subjects in Stratum 2

    Time frame: Months 2, 7 and 12

07

Study locations

1 site
  • Center for Disease Control and Prevention Jiangsu Province
    Nanjing, Jiangsu, China
08

References and documents

Publications

  • Zhu F, Deckx H, Roten R, Michiels B, Sarnecki M. Comparative Efficacy, Safety and Immunogenicity of Hepavax-Gene TF and Engerix-B Recombinant Hepatitis B Vaccines in Neonates in China. Pediatr Infect Dis J. 2017 Jan;36(1):94-101. doi: 10.1097/INF.0000000000001361. PubMed 27753794 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2011, a primary completion of Nov 2012 and a completion of Nov 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 5, 2011
First posted
May 6, 2011
Start
May 2011
Primary completionActual
Nov 2012
CompletionActual
Nov 2013
Last update
Mar 4, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 4, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01349283
Lead sponsor
Crucell Holland BV
Responsible party
Sponsor
First posted
May 6, 2011
Start date
May 2011
Primary completion
Nov 2012
Completion
Nov 2013
Last update
Mar 4, 2014

Study contacts

Zhu Fencai, MD
principal investigator · Jiangsu Provincial Center for Disease Prevention and Control, China

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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