Comparison of Safety, Immuno- and Reactogenicity of MPL-Adjuvanted Recombinant Hepatitis B Vaccine to That of Engerix™-B - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 12, 2008

Last Updated Date

June 13, 2008

Start Date ^†

January 1995

Current Primary Outcome Measures ^†

Anti-HBs antibody concentrations [ Time Frame: At M3 and M13 ]
Occurrence of local and general solicited symptoms [ Time Frame: 4-day follow-up after vaccination ]
Occurrence of unsolicited symptoms [ Time Frame: 30-day follow-up after vaccination ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00698087 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

SAEs [ Time Frame: Throughout the study up to 30 days after last vaccination ]
Anti-HBs antibody concentrations [ Time Frame: Months 2, 3, 6, 9, 12, 13 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Comparison of Safety, Immuno- and Reactogenicity of MPL-Adjuvanted Recombinant Hepatitis B Vaccine to That of Engerix™-B

Official Title ^†

Study to Compare the Safety, Immunogenicity and Reactogenicity of Different Formulations of GSK Biologicals' (Previously SmithKline Beecham Biologicals') MPL-Adjuvanted Recombinant Hepatitis B Vaccine to That of Engerix™-B

Brief Summary

The purpose of the study is to compare the safety, reactogenicity and immunogenicity of different formulations of adjuvanted recombinant hepatitis B vaccine to that of Engerix™-B when administered at 0, 2 months with a booster at month 12 if necessary

Detailed Description

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

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study

Condition ^†

Hepatitis B

Intervention ^†

Biological: MPL-Adjuvanted recombinant hepatitis B vaccine
Biological: Engerix™-B

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

February 1996

Primary Completion Date

February 1996 (final data collection date for primary outcome measure)

Eligibility 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 hepatitis B antibodies
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

Gender

Both

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Austria

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00698087

Responsible Party

Isabelle Harpigny, GSK

Secondary IDs ^††

Study Sponsor ^†

GlaxoSmithKline

Collaborators ^††

Investigators ^†

Study Director:

Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

June 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.