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
1 other identifier
interventional
1,738
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2011
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 5, 2011
CompletedFirst Posted
Study publicly available on registry
May 6, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedMarch 4, 2014
January 1, 2013
1.5 years
May 5, 2011
March 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Month 7
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
Month 2, Month 7 and Month 12
Secondary Outcomes (4)
Seroconversion rate for subjects in Stratum 1
Month 7
Solicited adverse events
Days 1 to 4
Seroconversion rate for subjects in Stratum 1
Month 12
Positivity for HBsAg for subjects in Stratum 2
Months 2, 7 and 12
Study Arms (6)
HepavaxGene Stratum 1a
EXPERIMENTALSubjects of mothers with chronic hepatitis B (positive for both HBsAg and hepatitis B envelope antigen - HBeAg)
Comparator vaccine Stratum 1a
ACTIVE COMPARATORSubjects of mothers with chronic hepatitis B (positive for both HBsAg and HBeAg)
HepavaxGene Stratum 1b
EXPERIMENTALSubjects of mothers with chronic hepatitis B (positive for HBsAg only)
Comparator vaccine Stratum 1b
ACTIVE COMPARATORSubjects of mothers with chronic hepatitis B (positive for HBsAg only)
HepavaxGene Stratum 2
EXPERIMENTALSubjects of mothers without chronic hepatitis B (negative for both HBsAg and HBeAg)
Comparator vaccine Stratum 2
ACTIVE COMPARATORSubjects of mothers without chronic hepatitis B (negative for both HBsAg and HBeAg)
Interventions
10 µg/0.5 mL, intramuscular injection on Day 1, Month 1, Month 6
10 µg/0.5 mL, intramuscular injection on Day 1, Month 1, Month 6
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Disease Control and Prevention Jiangsu Province
Nanjing, Jiangsu, China
Related Publications (1)
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.
PMID: 27753794DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhu Fencai, MD
Jiangsu Provincial Center for Disease Prevention and Control, China
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2011
First Posted
May 6, 2011
Study Start
May 1, 2011
Primary Completion
November 1, 2012
Study Completion
November 1, 2013
Last Updated
March 4, 2014
Record last verified: 2013-01