Clinical trial NCT01349283: Immunogenicity and Safety of the Hepatitis B Vaccine Hepavax-Gene TF and a Comparator Hepatitis B Vaccine in Newborns
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Keywords: Hepatitis B Vaccine
Hepatitis B Virus
Antigen
Antibody
Vaccination
Lead sponsor: Crucell Holland BV
Sponsor class: INDUSTRY
First posted: 2011-05-06
Enrollment: 1738
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Seroconversion rate for subjects in Stratum 2
timeFrame: Month 7
measure: Positivity for HBsAg for subjects in Stratum 1
timeFrame: Month 2, Month 7 and Month 12
Secondary outcomes:
measure: Seroconversion rate for subjects in Stratum 1
timeFrame: Month 7
measure: Solicited adverse events
timeFrame: Days 1 to 4
measure: Seroconversion rate for subjects in Stratum 1
timeFrame: Month 12
measure: Positivity for HBsAg for subjects in Stratum 2
timeFrame: Months 2, 7 and 12
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Center for Disease Control and Prevention Jiangsu Province
state: Jiangsu
Study officials:
affiliation: Jiangsu Provincial Center for Disease Prevention and Control, China
name: Zhu Fencai, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.