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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
  Purpose

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


Condition Intervention Phase
Hepatitis B
Biological: Engerix™-B
Biological: HBV-MPL vaccine (208129)
Biological: Hepatitis B vaccine, experimental formulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence and intensity of solicited local and general symptoms [ Time Frame: 8 days follow-up after vaccination ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 60
Study Start Date: June 1993
Study Completion Date: July 1994
Primary Completion Date: July 1994 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A Biological: Engerix™-B
Intramuscular injection, 3 doses
Experimental: Group B Biological: Hepatitis B vaccine, experimental formulation
Intramuscular injection, 3 doses
Experimental: Group C Biological: HBV-MPL vaccine (208129)

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697125

Locations
Belgium
GSK Clinical Trials Call Center
Gent, Belgium
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Isabelle Harpigny, GSK
ClinicalTrials.gov Identifier: NCT00697125     History of Changes
Other Study ID Numbers: 208129/005
Study First Received: June 11, 2008
Last Updated: June 11, 2008
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by GlaxoSmithKline:
Hepatitis B
Engerix™-B
Recombinant hepatitis B vaccine

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 24, 2014