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Clinical Trials/NCT00698087
NCT00698087CompletedPhase 3

Study to Compare the Safety, Immunogenicity and Reactogenicity of Different Formulations of GSK Biologicals' (Previously SmithKline Beecham Biologicals') MPL-Adjuvanted Recombinant Hepatitis B Vaccine to That of Engerix™-B

GlaxoSmithKline1 site in 1 country60 target enrollmentStarted: January 1995Last updated:
Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
Anti-HBs antibody concentrations

Study Overview

Brief Summary

The purpose of the study is to compare the safety, reactogenicity and immunogenicity of different formulations of adjuvanted recombinant hepatitis B vaccine to that of Engerix™-B when administered at 0, 2 months with a booster at month 12 if necessary

Detailed Description

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.
  • Positive titres for anti hepatitis B 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.
  • Simultaneous administration of any other vaccine(s).
  • Administration of any immunoglobulin during the study period.
  • Simultaneous participation in any other clinical trial

Outcomes

Primary Outcomes

Anti-HBs antibody concentrations

Time Frame: At M3 and M13

Occurrence of local and general solicited symptoms

Time Frame: 4-day follow-up after vaccination

Occurrence of unsolicited symptoms

Time Frame: 30-day follow-up after vaccination

Secondary Outcomes

  • Anti-HBs antibody concentrations(Months 2, 3, 6, 9, 12, 13)
  • SAEs(Throughout the study up to 30 days after last vaccination)

Investigators

Sponsor Class
Industry

Study Sites (1)

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