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

Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01349283
• Other study ID #: HVG-V-A002
• Status: Completed
• Phase: Phase 3
• First received: May 5, 2011
• Last updated: March 3, 2014
• Start date: May 2011
• Est. completion date: November 2013

Study information

• Verified date: January 2013
• Source: Crucell Holland BV
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1738
• Est. completion date: November 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 1 Day

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Biological:
• 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

Locations

Country	Name	City	State
China	Center for Disease Control and Prevention Jiangsu Province	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Crucell Holland BV

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Seroconversion rate for subjects in Stratum 1	Seroconversion rate is defined as HBsAb concentrations from ELISA =10 mIU/mL	Month 7	No
Secondary	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]	Days 1 to 4	Yes
Secondary	Seroconversion rate for subjects in Stratum 1	Seroconversion rate is defined as HBsAb concentrations from ELISA =10 mIU/mL	Month 12	No
Secondary	Positivity for HBsAg for subjects in Stratum 2		Months 2, 7 and 12	No