Evaluation of Immunogenicity and Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine

June 13, 2008 updated by: GlaxoSmithKline

Study to Evaluate the Immunogenicity and Reactogenicity of Various Formulations of GSK Biologicals' (Previously SmithKline Beecham Biologicals') Recombinant Hepatitis B Vaccine in Healthy Adult Volunteers

The purpose of the present trial is to evaluate 6 vaccine formulations of recombinant hepatitis B vaccine for their reactogenicity and immunogenicity when administered at 0-2 months with a booster at month 12

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)

321

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

  • Austria
      • Vienna, Austria
        • 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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Between 18 and 40 years old.
  • Written informed consent will have been obtained from the subjects.
  • Good physical condition as established by physical examination and history taking at the time of entry.
  • Female participants will avoid becoming pregnant during the study period and they will have been on a contraceptive program for at least 2 months before entry.

Exclusion Criteria:

  • Pregnancy or lactation.
  • Positivity for anti hepatitis antibodies.
  • Any vaccination against hepatitis B in the past.
  • Any previous administration of MPL.
  • Elevated serum liver enzymes.
  • History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
  • Axillary temperature > 37.5°C at the time of injection.
  • Any acute disease at the moment of entry.
  • Chronic alcohol consumption.
  • Any treatment with immunosuppressive or immunostimulant therapy.
  • Any chronic drug treatment, which in the investigator's opinion, precludes inclusion into the study.
  • History of allergic disease likely to be stimulated by any component of the vaccine.
  • Administration of any other vaccine(s) or any immunoglobulin during the study period.
  • Simultaneous participation in any other clinical trial

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Biological: HBsAg formulated with different concentrations of MPL and Aluminium Salts
Intramuscular injection, 3 doses
Experimental: Group B
Biological: HBsAg formulated with different concentrations of MPL and Aluminium Salts
Intramuscular injection, 3 doses
Experimental: Group C
Biological: HBsAg formulated with different concentrations of MPL and Aluminium Salts
Intramuscular injection, 3 doses
Experimental: Group D
Biological: HBsAg formulated with different concentrations of MPL and Aluminium Salts
Intramuscular injection, 3 doses
Experimental: Group E
Biological: HBsAg formulated with different concentrations of MPL and Aluminium Salts
Intramuscular injection, 3 doses
Active Comparator: Group F
Biological: Engerix™-B
Intramuscular injection, 3 doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anti-HBs antibody concentrations
Time Frame: After two doses and after the booster dose
After two doses and after the booster dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence and intensity of local and general solicited symptoms
Time Frame: 8 days after vaccination
8 days after vaccination
Anti-HBs antibody concentrations
Time Frame: Screening, M1, 2, 3, 4, 6, 12, 13
Screening, M1, 2, 3, 4, 6, 12, 13
Occurrence of unsolicited adverse events
Time Frame: 30-day after vaccination
30-day after vaccination
Occurrence of serious adverse events
Time Frame: During the study period and 30 days after the last vaccination
During the study period and 30 days after the last vaccination

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

November 1, 1993

Primary Completion (Actual)

April 1, 1995

Study Completion (Actual)

April 1, 1995

Study Registration Dates

First Submitted

June 12, 2008

First Submitted That Met QC Criteria

June 13, 2008

First Posted (Estimate)

June 16, 2008

Study Record Updates

Last Update Posted (Estimate)

June 16, 2008

Last Update Submitted That Met QC Criteria

June 13, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 208129/006

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.

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