Working... Menu
Trial record 17 of 141 for:    MPL

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00697216
Recruitment Status : Completed
First Posted : June 13, 2008
Last Update Posted : June 13, 2008
Information provided by:

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatitis B Biological: HBV-MPL vaccine 208129 Biological: Engerix™-B Phase 3

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official 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)
Study Start Date : March 1997
Actual Primary Completion Date : March 1999

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Group A Biological: HBV-MPL vaccine 208129
2-dose intramuscular injection

Active Comparator: Group B Biological: Engerix™-B
3-dose intramuscular injection

Primary Outcome Measures :
  1. Anti-HBs antibody concentrations [ Time Frame: Month 7 ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00697216

Layout table for location information
GSK Clinical Trials Call Center
Brussels, Belgium
GSK Clinical Trials Call Center
Copenhagen, Denmark
Sponsors and Collaborators
Layout table for investigator information
Study Director: Clinical Trials GlaxoSmithKline

Layout table for additonal information
Responsible Party: Isabelle Harpigny, GSK Identifier: NCT00697216     History of Changes
Other Study ID Numbers: 208129/027
First Posted: June 13, 2008    Key Record Dates
Last Update Posted: June 13, 2008
Last Verified: June 2008

Keywords provided by GlaxoSmithKline:
Hepatitis B
Recombinant hepatitis B vaccine
Adjuvanted hepatitis B vaccine

Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Hepadnaviridae Infections
DNA Virus Infections
Immunologic Factors
Physiological Effects of Drugs