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Completed

NCT Number: NCT00697216

Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Adults (15-40 Yrs).

This study evaluates the safety and immunogenicity of the candidate HBV-MPL vaccine administered to healthy adults aged from 15 to 40 years, according to a 0, 6- month vaccination schedule, with Engerix™-B as control administered at 0, 1, 6 months.

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Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

15 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Clinical Trials Call Center, Brussels, Belgium

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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

  • Age: between 15 and 40 years old.
  • Good physical condition as established by clinical examination and history taking at the time of entry.
  • Female participants who are at risk to become pregnant will be on a contraceptive programme if necessary during the study period.
  • Written informed consent obtained from the subjects aged between 18 and 40 and from the parents/tutor when the subjects are aged between 15 and 17 years.

Exclusion criteria

  • Positive titres at screening for anti-HBs antibodies.
  • Elevated serum liver enzymes.
  • History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
  • Any acute disease at the moment of entry.
  • Chronic alcohol consumption.
  • Hepatomegaly, right upper quadrant abdominal pain or tenderness.
  • 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.
  • Simultaneous participation in any other clinical trial.
  • Previous vaccination with a hepatitis B vaccine.
  • Previous vaccination with an MPL containing vaccine.
  • Administration of immunoglobulins in the past 6 months and during the whole study period
  • Simultaneous vaccination one week before and one week after each dose of the study vaccine

Treatment and study plan

HBV-MPL vaccine 208129

Biological

2-dose intramuscular injection

Engerix™-B

Biological

3-dose intramuscular injection

Primary outcomes

  1. Anti-HBs antibody concentrations

    Time frame: Month 7

Secondary outcomes

  1. Anti-HBs antibody concentrations

    Time frame: At months 1, 2, 6, 7 and 12

  2. Occurrence, intensity and relationship to vaccination of solicited local and general symptoms

    Time frame: 4-day follow-up period after vaccination

  3. Occurrence, intensity and relationship to vaccination of unsolicited symptoms

    Time frame: 31-day follow-up after vaccination

  4. Occurrence and relationship to vaccination of Serious Adverse Events (SAEs)

    Time frame: During the study period

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Study Comparing the Immunogenicity and Reactogenicity of GSK Biologicals' HBV-MPL Vaccine Injected According to a 0, 6 Months Schedule With That of Engerix™-B Injected as a 0, 1, 6 Months Schedule in a Healthy Adult Population (15-40 Years)

Important dates

Study start
1997
Primary completion
1999
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.

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