Immuno & Safety Study of GSK Biologicals' Thio or Preservative Free Hepatitis B Vaccine in Subjects Aged 11-15 Yrs

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Hepatitis B

Treatments: Biological: placebo; Biological: Engerix™-B (thiomersal-free) 20µg; Biological: 10 μg Engerix™-B (preservative-free)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00343915

101698 (Other Identifier)

101695 Ext. Mth30

2015-001531-20 (EudraCT Number)

101697 (Other Identifier)

101696 (Other Identifier)

Details and patient eligibility

About

To evaluate the persistence of antibodies against hepatitis B at 30, 42, 54 and 66 months after the first dose of the hepatitis B primary vaccination course.

Subjects were aged 11 to 15 years at the time of the primary vaccination course.

At the time of enrollment in the present long-term follow-up study subjects were aged 13 to 18 years.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Full description

All subjects who participated in the primary study, in which they received either 2 or 3 doses of GSK Biologicals hepatitis B vaccine, and who consented to participate in the long-term follow-up at Month 42 were contacted by the investigators.

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

Enrollment: 267 patients

Sex: All

Ages: 13 to 20 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Subjects have participated in primary study HBV-280
• Written informed consent will be obtained from each subject and/ or parent or guardian of the subject before the blood-sampling visit of each year

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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267 participants in 2 patient groups

2-Dose Engerix

Experimental group

Description:

subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.

Treatment:

Biological: placebo

Biological: Engerix™-B (thiomersal-free) 20µg

3-Dose Engerix

Active Comparator group

Description:

subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.

Treatment:

Biological: 10 μg Engerix™-B (preservative-free)