LT F-up Study 16-20 Yrs After Vaccine Dose of Hepatitis B With/Without HBIg in Newborns to HBeAg+ Mothers

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Hepatitis B

Treatments: Biological: Engerix™ -B; Biological: Hepatitis B immunoglobulin (HBIg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00240526

100450

Details and patient eligibility

About

To evaluate the persistence of anti-HBs antibodies up to 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

No additional subjects will be recruited during this long-term follow-up study and no vaccine will be administered.

Full description

The primary study was to evaluate the reactogenicity, immunogenicity and protective efficacy of a hepatitis B vaccine in healthy neonates of HBeAg positive mothers if administered with or without a dose of HBIg at birth. The current study describes the long term follow up of these subjects between Y16 and 20 after primary vaccination.

Enrollment: 79 patients

Sex: All

Ages: 16 to 20 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects who had received at least one dose of the study vaccine in the primary study
• Written informed consent obtained from each subject before each blood sampling visit

Exclusion criteria

• None

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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79 participants in 4 patient groups

Engerix 4D + HBIg Group

Experimental group

Description:

Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.

Treatment:

Biological: Hepatitis B immunoglobulin (HBIg)

Biological: Engerix™ -B

Engerix 3D + HBIg Group

Experimental group

Description:

Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.

Treatment:

Biological: Hepatitis B immunoglobulin (HBIg)

Biological: Engerix™ -B

Engerix 4D

Experimental group

Description:

Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, 6 and 60.

Treatment:

Biological: Engerix™ -B

Engerix 3D Group

Experimental group

Description:

Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, and 6.

Treatment:

Biological: Engerix™ -B