Safety, Immunogenicity and Reactogenicity of Recombinant Hepatitis B Vaccine (Adjuvanted & New Formulation) and Engerix™-B

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00697840
First received: June 12, 2008
Last updated: June 13, 2008
Last verified: June 2008
  Purpose

The purpose of the present trial is to assess the safety, reactogenicity and immunogenicity of adjuvanted hepatitis B vaccine, Engerix™-B and hepatitis B vaccine new formulation when administered at 0, 6 months


Condition Intervention Phase
Hepatitis B
Biological: Engerix™-B
Biological: HBV-MPL 208129
Biological: Vaccine containing HBsAg absorbed on aluminium salts - experimental formulation
Phase 3

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 Assess the Safety, Immunogenicity and Reactogenicity of GSK Biologicals' (Previously SmithKline Beecham Biologicals') Adjuvanted Recombinant Hepatitis B Vaccine, Recombinant Hepatitis B Vaccine New Formulation and Engerix™-B

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Anti-HBs antibody concentrations [ Time Frame: At month 7 ]
  • Occurrence and intensity of solicited local and general symptoms [ Time Frame: 4-day follow-up after vaccination ]
  • Occurrence of unsolicited adverse events [ Time Frame: 30-days after vaccination ]
  • Incidence of serious adverse events [ Time Frame: Throughout the study period ]
  • Anti-Hbs antibody concentrations [ Time Frame: Months 1, 6 and 24 ]

Enrollment: 150
Study Start Date: June 1995
Study Completion Date: January 1996
Primary Completion Date: January 1996 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Biological: HBV-MPL 208129
Intramuscular injection, 2 doses
Active Comparator: Group B Biological: Engerix™-B
Intramuscular injection, 2 doses
Experimental: Group C Biological: Vaccine containing HBsAg absorbed on aluminium salts - experimental formulation
Intramuscular injection, 2 doses; experimental formulation

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.
  • Positive titres for anti HBs antibody.
  • Any vaccination against hepatitis B in the past.
  • Any previous administration of MPL.
  • Elevated serum liver enzymes.
  • 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.
  • Simultaneous administration of any other vaccine(s).
  • Administration of any immunoglobulin during the study period.
  • Simultaneous participation in any other clinical trial.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00697840

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

No publications provided

Responsible Party: Isabelle Harpigny, GSK
ClinicalTrials.gov Identifier: NCT00697840     History of Changes
Other Study ID Numbers: 208129/019
Study First Received: June 12, 2008
Last Updated: June 13, 2008
Health Authority: Austria: Ethikkommission

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

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

ClinicalTrials.gov processed this record on April 22, 2014