Skip to main content
OpenTrials
Completed

NCT Number: NCT00697229

Immunogenicity & Reactogenicity of HBV-MPL Vaccine and Engerix™-B in Healthy Adults Following 2 Different Schedules

The purpose of this study is to evaluate the safety, immunogenicity and reactogenicity of MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in healthy adult volunteers following two different schedules: 0, 2 months and 0, 6 months

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Clinical Trials Call Center

Wilrijk, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • Positive titres for anti hepatitis B antibodies.
  • Any vaccination against hepatitis B in the past.
  • Elevated serum liver enzymes.
  • History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
  • Axillary temperature > 37°C at the time of injection.
  • Any acute disease at the moment of entry.
  • Chronic alcohol consumption.
  • Any chronic drug treatment, including any treatment with immunosuppressive drugs, 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.

Treatment and study plan

Engerix™-B

Biological

Intramuscular injection, 1 or 3 doses

HBV-MPL vaccine

Biological

Intramuscular injection, 1 or 3 doses

Primary outcomes

  1. Anti-hepatitis B surface antigen (HBs) antibody concentrations

    Time frame: One month after the full primary vaccination course and one month after the booster vaccination at 70 months

Secondary outcomes

  1. Anti-HBs antibody concentrations

    Time frame: Months 1, 2, 3, 6, 12, 13, 42

  2. Serious adverse experiences (SAE).

    Time frame: Throughout the study period

  3. Occurrence and intensity of solicited local symptoms

    Time frame: 8-day follow-up after vaccination

  4. Occurrence, intensity and relationship of solicited general symptoms

    Time frame: 8-day follow-up after vaccination

  5. Incidence of unsolicited symptoms

    Time frame: During the 30-day follow-up after vaccination

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Study to Evaluate the Immunogenicity and Reactogenicity of GSK Biologicals' MPL-Adjuvanted Recombinant Hepatitis B Vaccine in Comparison With Those of Engerix™-B in Healthy Adult Volunteers Following 2 Different Schedules

Important dates

Study start
1992
Primary completion
1996
Study completion
1998
First posted
Jun 13, 2008
Registry last updated
Jun 13, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.