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

Tracking Information

First Received Date ^ICMJE

June 11, 2008

Last Updated Date

June 11, 2008

Start Date ^ICMJE

June 1993

Primary Completion Date

July 1994 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Hepatitis B

Intervention ^ICMJE

Biological: Engerix™-B
Intramuscular injection, 3 doses
Biological: HBV-MPL vaccine (208129)
Biological: Hepatitis B vaccine, experimental formulation
Intramuscular injection, 3 doses

Study Arm (s)

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)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 1994

Primary Completion Date

July 1994 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium

Administrative Information

NCT Number ^ICMJE

NCT00697125

Other Study ID Numbers ^ICMJE

208129/005

Has Data Monitoring Committee

Not Provided

Responsible Party

Isabelle Harpigny, GSK

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

June 2008

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

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