A phase III, multicentric, multinational, long-term follow-up study to evaluate the persistence of anti-HBs antibodies at Months 12, 24 and 36 in pre-dialysis / peritoneal dialysis or haemodialysis patients who had previously received a primary vaccination course of either Henogen’s new adjuvanted hepatitis B vaccine, HB-AS02V or GlaxoSmithKline Biologicals’ Fendrix - HN015/HBVEXT001

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-004056-13-CZ

Enrollment

300

Registered

2007-01-02

Start date

2007-01-24

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hepatitis B pre-dialysis, peritoneal dialysis and haemodialysis patient from 15 year of age

Interventions

Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ·Subjects for whom the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol (e.g., return for follow-up visits) should be enrolled in the study. ·Written informed consent obtained from the subject/ from the parent/ guardian of the subject at the first long-term time point that the subject comes back to participate in this study. ·Subjects who completed the full course of primary vaccination (three doses of HBV-AS02V vaccine or four doses of Fendrix vaccine) in the study 105757 (HN014/HBV-001) and return at any of the long-term time points (i.e. 12, 24 or 36 months) after the first dose of the primary vaccination. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: ·Immunosuppression caused by the administration of parenteral steroids or chemotherapy. ·Any confirmed or suspected human immunodeficiency virus (HIV) infection.

Design outcomes

Primary

Measure	Time frame
Main Objective: ·To evaluate persistence of anti-HBs antibodies at Months 12, 24 and 36, elicited by primary vaccination with HB-AS02V vaccine in comparison to that elicited by primary vaccination with Fendrix vaccine.;Secondary Objective: ·To evaluate the quality of the immune response elicited at Months 12, 24 and 36 in a subset of subjects using a competitive RF1 ELISA. ·To describe serious adverse events (SAE) reported retrospectively at each of the long-term time points (i.e Months 12, 24 and 36).;Primary end point(s): Observed variable · Anti-HBs antibody concentrations at Months 12, 24 and 36. Derived variable · Anti-HBs seroprotection rate (percentage of subjects with anti-HBs antibody concentrations ³ 10 mIU/ml) at Months 12, 24 and 36.	—

Measure

Time frame

Main Objective: ·To evaluate persistence of anti-HBs antibodies at Months 12, 24 and 36, elicited by primary vaccination with HB-AS02V vaccine in comparison to that elicited by primary vaccination with Fendrix vaccine.;Secondary Objective: ·To evaluate the quality of the immune response elicited at Months 12, 24 and 36 in a subset of subjects using a competitive RF1 ELISA. ·To describe serious adverse events (SAE) reported retrospectively at each of the long-term time points (i.e Months 12, 24 and 36).;Primary end point(s): Observed variable · Anti-HBs antibody concentrations at Months 12, 24 and 36. Derived variable · Anti-HBs seroprotection rate (percentage of subjects with anti-HBs antibody concentrations ³ 10 mIU/ml) at Months 12, 24 and 36.

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Countries

Czech Republic, Hungary

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026