Comparing Immunogenicity and Safety of Different Formulations of HBV-MPL Vaccine With Engerix™-B in Adults Aged 18-40 y

This study has been completed.

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00698555

First received: June 13, 2008

Last updated: June 16, 2008

Last verified: June 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

June 13, 2008

Last Updated Date

June 16, 2008

Start Date ^ICMJE

March 1997

Primary Completion Date

May 1998 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Anti-HBs antibody concentrations [ Time Frame: Month 7 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00698555 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Anti-HBs antibody concentrations [ Time Frame: Month 1, 2, 6 and 12 ]
Cell mediated immunity [ Time Frame: Month 1, 2, 6, 7 and 12 ]
Occurrence and intensity and relationship to vaccination of solicited local and general symptoms [ Time Frame: 4-day follow-up after vaccination ]
Occurrence and intensity and relationship to vaccination of unsolicited symptoms [ Time Frame: 31-day follow-up after vaccination ]
Incidence of SAE [ Time Frame: Throughout the study period ]

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

Comparing Immunogenicity and Safety of Different Formulations of HBV-MPL Vaccine With Engerix™-B in Adults Aged 18-40 y

Official Title ^ICMJE

Study Comparing the Immunogenicity and Reactogenicity of Different Formulations of GSK Bio's HBV-MPL Vaccine Injected as a 0, 6 Months Schedule With That of Engerix™-B Injected as a 0, 1, 6 Months Schedule in Healthy Adults Aged 18-40 Years

Brief Summary

This study will evaluate the immunogenicity and safety of different formulations of the candidate HBV-MPL vaccine administered according to a 2-dose schedule and compare it to that of Engerix™-B administered according to a 3-dose schedule in order to determine the optimal dose of each component of the candidate HBV-MPL vaccine when administered at 0 and 6 months

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: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Hepatitis B

Intervention ^ICMJE

Biological: HBV-MPL vaccine
5 different formulations, 2-dose intramuscular injection
Biological: Engerix™-B
3-dose intramuscular injection

Study Arm (s)

Experimental: Group A
Intervention: Biological: HBV-MPL vaccine
Experimental: Group B
Intervention: Biological: HBV-MPL vaccine
Experimental: Group C
Intervention: Biological: HBV-MPL vaccine
Experimental: Group D
Intervention: Biological: HBV-MPL vaccine
Experimental: Group E
Intervention: Biological: HBV-MPL vaccine
Active Comparator: Group F
Intervention: Biological: Engerix™-B

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

163

Completion Date

Not Provided

Primary Completion Date

May 1998 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Age: between 18 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

Exclusion Criteria:

Positive titres at screening for anti-hepatitis 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
Vaccination one month before and one month after each dose of the study vaccine

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

NCT00698555

Other Study ID Numbers ^ICMJE

208129/025

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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