Study Evaluating Persistence of Anti-HBs Antibodies in Uraemic Patients Receiving Henogen's HBV Vaccine, or Fendrix™

Henogen

Status and phase: Completed; Phase 3

Conditions: Hepatitis B

Treatments: Biological: Henogen HB vaccine; Biological: Fendrix vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00445185

HN015/HBV-EXT001

Details and patient eligibility

About

The current extension study will assess the persistence of anti-HBs antibodies at Months 12, 24 and 36 after primary vaccination with Henogen's HBV vaccine or Fendrix™. This protocol posting deals with the objectives & outcome measures of the extension phase at Months 12, 24 and 36. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00291941).

Full description

Subjects who received complete full vaccination with Henogen HBV adjuvanted vaccine or Fendrix™ will participate in this persistence study for three long-term time points (12, 24 and 36 months after the first dose of primary vaccination). Blood sampling will be done at each time point to measure immune persistence.

Enrollment: 102 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent obtained from the subject/ from the parent/ guardian of the subject.
• Subjects who completed the full course of primary vaccination.

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

1

Experimental group

Description:

Henogen Hepatitis B vaccine for uremic patients

Treatment:

Biological: Henogen HB vaccine

2

Active Comparator group

Description:

Fendrix hepatitis B vaccine for uremic patients

Treatment:

Biological: Fendrix vaccine