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Immunogenicity & Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine With Different Adjuvants

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00697125
First received: June 11, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted

June 11, 2008
June 11, 2008
June 1993
July 1994   (final data collection date for primary outcome measure)
Occurrence and intensity of solicited local and general symptoms [ Time Frame: 8 days follow-up after vaccination ]
Same as current
No Changes Posted
  • Anti-HBs antibody concentrations [ Time Frame: Months 0, 1, 3, 6, 7, 8 and 12 ]
  • Occurrence, intensity of unsolicited adverse events [ Time Frame: 30-day follow-up after vaccination ]
  • Occurrence of serious adverse events [ Time Frame: During the study period up to 30 days after last vaccination ]
Same as current
Not Provided
Not Provided
 
Immunogenicity & Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine With Different Adjuvants
Study to Evaluate the Immunogenicity and Reactogenicity of Various Formulations of GSK Biologicals' (Previously SmithKline Beecham Biologicals') Recombinant Hepatitis B Vaccine With Different Adjuvants in Healthy Adult Volunteers

The purpose of this study is to evaluate the immunogenicity and reactogenicity of various formulations of recombinant hepatitis B vaccine with different adjuvants in healthy adult volunteers following the 0, 1, 6 months schedule

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Hepatitis B
  • Biological: Engerix™-B
    Intramuscular injection, 3 doses
  • Biological: HBV-MPL vaccine (208129)
  • Biological: Hepatitis B vaccine, experimental formulation
    Intramuscular injection, 3 doses
  • Active Comparator: Group A
    Intervention: Biological: Engerix™-B
  • Experimental: Group B
    Intervention: Biological: Hepatitis B vaccine, experimental formulation
  • Experimental: Group C
    Intervention: Biological: HBV-MPL vaccine (208129)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
July 1994
July 1994   (final data collection date for primary outcome measure)

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.
  • Serological signs of HBV infection
  • Elevated serum liver enzymes
  • Any vaccination against hepatitis B in the past.
  • Any previous administration of MPL.
  • 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.
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00697125
208129/005
Not Provided
Isabelle Harpigny, GSK
GlaxoSmithKline
Not Provided
Study Director: Clinical Trials GlaxoSmithKline
GlaxoSmithKline
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP