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

NCT00343915 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 267

Last updated 2019-06-10

Study results available
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Summary

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.

Conditions

Interventions

BIOLOGICAL

Engerix™-B (thiomersal-free) 20µg

In the primary study: 2 deep intramuscular injections (Months 0, \& 6)

BIOLOGICAL

10 μg Engerix™-B (preservative-free)

In the primary study: 3 deep intramuscular injections (months 0, 1 \& 6)

BIOLOGICAL

placebo

In the primary study: 1 deep intramuscular injection (month 1)

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-04-21
Primary Completion
2008-01-10
Completion
2008-01-10

Countries

  • Australia
  • Belgium
  • Ukraine

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00343915 on ClinicalTrials.gov