Safety and Immunogenicity of 3 Lots of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Volunteers ≥ 15y

June 11, 2008 updated by: GlaxoSmithKline

Safety and Immunogenicity of 3 Lots of GSK Biologicals' Novel Adjuvanted Hepatitis B Vaccine, Administered According to a 2 Dose Schedule, and Engerix™-B Administered According to a 3 Dose Schedule to Healthy Volunteers ≥ 15 Years of Age

This study was conducted to evaluate the lot-to-lot consistency of three lots of HBV-MPL vaccine and to compare their safety and immunogenicity with that of Engerix™-B.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Study Type

Interventional

Enrollment (Actual)

1303

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Parkville, Victoria, Australia, 3052
        • GSK Clinical Trials Call Center
  • Czech Republic
      • Hradec Kralové, Czech Republic
        • GSK Clinical Trials Call Center
  • Germany
      • München, Germany
        • GSK Clinical Trials Call Center
  • Italy
      • Bari, Italy
        • GSK Clinical Trials Call Center
  • Netherlands
      • Utrecht, Netherlands
        • GSK Clinical Trials Call Center
  • Switzerland
      • Lausanne, Switzerland
        • GSK Clinical Trials Call Center
  • United Kingdom
      • London, United Kingdom
        • GSK Clinical Trials Call Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A male or female aged ≥ 15 years at the time of the first vaccination. In Centre 103 (Germany) and Centre 1 (Netherlands), only subjects ≥ 18 years will be enrolled.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  • Written informed consent obtained from the subject and/or from the parent or guardian of the subject.
  • If the subject was a female, she was of non-childbearing potential, if of childbearing potential, she was abstinent or used adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination

Exclusion Criteria:

  • Use of any investigational or non-registered drug or vaccine other than the study vaccine (s) during the study period or within 30 days preceding the first dose of study vaccine.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after.
  • Previous vaccination against hepatitis B.
  • History of non-response to previous hepatitis B vaccination.
  • Known exposure to hepatitis B within the past 6 weeks.
  • History of hepatitis B infection.
  • Confirmed human immunodeficiency virus (HIV) infection.
  • A family history of congenital or hereditary immunodeficiency.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Acute disease at the time of enrollment.
  • Hepatomegaly, right upper quadrant abdominal pain or tenderness.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration/ administration during the study period.
  • Pregnant or lactating female

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
Three doses according to 0, 1, 6-month schedule
Biological: Engerix™-B
3-dose intramuscular injection
Experimental: Group B
Two doses according to 0, 6-month schedule, with a placebo injection at Month 1
Biological: HBV-MPL vaccine 208129
2-dose intramuscular injection 3 different vaccine lots
Experimental: Group C
Two doses according to 0, 6-month schedule, with a placebo injection at Month 1
Biological: HBV-MPL vaccine 208129
2-dose intramuscular injection 3 different vaccine lots
Experimental: Group D
Two doses according to 0, 6-month schedule, with a placebo injection at Month 1
Biological: HBV-MPL vaccine 208129
2-dose intramuscular injection 3 different vaccine lots

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anti-HBs antibody concentrations
Time Frame: At Month 7
At Month 7
Occurrence, intensity and causal relationship of any (solicited/unsolicited adverse event) general symptoms
Time Frame: Full course of vaccination
Full course of vaccination
Incidence of serious adverse events
Time Frame: Study period
Study period

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence and intensity of solicited local signs and symptoms
Time Frame: 4-day after vaccination
4-day after vaccination
Occurrence, intensity and relationship to vaccination of solicited general signs and symptoms
Time Frame: 4-day after vaccination
4-day after vaccination
Occurrence, intensity and relationship to vaccination of unsolicited signs and symptoms
Time Frame: 30 days after vaccination
30 days after vaccination
Occurrence and relationship to vaccination of SAEs
Time Frame: During the study period
During the study period
Anti-HBs antibody concentrations
Time Frame: At Months 1, 2, 6 and 7
At Months 1, 2, 6 and 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1999

Primary Completion (Actual)

February 1, 2000

Study Registration Dates

First Submitted

June 11, 2008

First Submitted That Met QC Criteria

June 11, 2008

First Posted (Estimate)

June 13, 2008

Study Record Updates

Last Update Posted (Estimate)

June 13, 2008

Last Update Submitted That Met QC Criteria

June 11, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 208129/031

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe