Hepatitis B
Conditions
Keywords
Hepatitis B Vaccine, Hepatitis B Virus, Antigen, Antibody, Vaccination
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.
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
Sponsors
Crucell Holland BV
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Days
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroconversion rate for subjects in Stratum 2 | Month 7 | 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 | Month 2, Month 7 and Month 12 | The presence of hepatitis B surface antigen (HBsAg), as determined by ELISA, for subjects whose mothers are positive for chronic hepatitis B |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seroconversion rate for subjects in Stratum 1 | Month 7 | Seroconversion rate is defined as HBsAb concentrations from ELISA ≥10 mIU/mL |
| Solicited adverse events | Days 1 to 4 | Local adverse events: pain, erythema, swelling at the injection site Systemic adverse events: irritability, sleepiness, change in eating/breast feeding habits, crying, fever \[body temperature ≥38°C\] |
| Positivity for HBsAg for subjects in Stratum 2 | Months 2, 7 and 12 | — |
Countries
China
Outcome results
None listed