Immunogenicity and Safety of the Hepatitis B Vaccine Hepavax-Gene TF and a Comparator Hepatitis B Vaccine in Newborns
NCT ID: NCT01349283
Last Updated: 2014-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1738 participants
INTERVENTIONAL
2011-05-31
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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HepavaxGene Stratum 1a
Subjects of mothers with chronic hepatitis B (positive for both HBsAg and hepatitis B envelope antigen - HBeAg)
HepavaxGene (thiomersal free)
10 µg/0.5 mL, intramuscular injection on Day 1, Month 1, Month 6
Comparator vaccine Stratum 1a
Subjects of mothers with chronic hepatitis B (positive for both HBsAg and HBeAg)
Engerix B
10 µg/0.5 mL, intramuscular injection on Day 1, Month 1, Month 6
HepavaxGene Stratum 1b
Subjects of mothers with chronic hepatitis B (positive for HBsAg only)
HepavaxGene (thiomersal free)
10 µg/0.5 mL, intramuscular injection on Day 1, Month 1, Month 6
Comparator vaccine Stratum 1b
Subjects of mothers with chronic hepatitis B (positive for HBsAg only)
Engerix B
10 µg/0.5 mL, intramuscular injection on Day 1, Month 1, Month 6
HepavaxGene Stratum 2
Subjects of mothers without chronic hepatitis B (negative for both HBsAg and HBeAg)
HepavaxGene (thiomersal free)
10 µg/0.5 mL, intramuscular injection on Day 1, Month 1, Month 6
Comparator vaccine Stratum 2
Subjects of mothers without chronic hepatitis B (negative for both HBsAg and HBeAg)
Engerix B
10 µg/0.5 mL, intramuscular injection on Day 1, Month 1, Month 6
Interventions
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HepavaxGene (thiomersal free)
10 µg/0.5 mL, intramuscular injection on Day 1, Month 1, Month 6
Engerix B
10 µg/0.5 mL, intramuscular injection on Day 1, Month 1, Month 6
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
1 Day
ALL
Yes
Sponsors
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Crucell Holland BV
INDUSTRY
Responsible Party
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Principal Investigators
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Zhu Fencai, MD
Role: PRINCIPAL_INVESTIGATOR
Jiangsu Provincial Center for Disease Prevention and Control, China
Locations
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Center for Disease Control and Prevention Jiangsu Province
Nanjing, Jiangsu, China
Countries
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References
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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.
Other Identifiers
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HVG-V-A002
Identifier Type: -
Identifier Source: org_study_id
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