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

Phase 3

Completed

• Conditions: Hepatitis B
• Interventions: Biological: Engerix B; Biological: HepavaxGene (thiomersal free)

• Registration Number: NCT01349283
• Lead Sponsor: Crucell Holland BV

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-05
• Study First Submitted QC: 2011-05-05
• Study First Posted: 2011-05-06
• Primary Completion: 2012-11
• Status Verified: 2013-01
• Study Completion: 2013-11
• Last Update Submitted: 2014-03-03
• Last Update Posted: 2014-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1738

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comparator vaccine Stratum 2	Engerix B	Subjects of mothers without chronic hepatitis B (negative for both HBsAg and HBeAg)
HepavaxGene Stratum 1b	HepavaxGene (thiomersal free)	Subjects of mothers with chronic hepatitis B (positive for HBsAg only)
Comparator vaccine Stratum 1b	Engerix B	Subjects of mothers with chronic hepatitis B (positive for HBsAg only)
HepavaxGene Stratum 1a	HepavaxGene (thiomersal free)	Subjects of mothers with chronic hepatitis B (positive for both HBsAg and hepatitis B envelope antigen - HBeAg)
Comparator vaccine Stratum 1a	Engerix B	Subjects of mothers with chronic hepatitis B (positive for both HBsAg and HBeAg)
HepavaxGene Stratum 2	HepavaxGene (thiomersal free)	Subjects of mothers without chronic hepatitis B (negative for both HBsAg and HBeAg)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Seroconversion rate for subjects in Stratum 1	Month 12	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

Trial Locations

Locations (1)

Center for Disease Control and Prevention Jiangsu Province; 🇨🇳 Nanjing, Jiangsu, China