- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00697125
Immunogenicity & Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine With Different Adjuvants
June 11, 2008 updated by: GlaxoSmithKline
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
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
Study Overview
Status
Completed
Conditions
Detailed Description
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Gent, Belgium
- GSK Clinical Trials Call Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group B
|
Intramuscular injection, 3 doses
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Experimental: Group C
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Active Comparator: Group A
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Intramuscular injection, 3 doses
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Occurrence and intensity of solicited local and general symptoms
Time Frame: 8 days follow-up after vaccination
|
8 days follow-up after vaccination
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Anti-HBs antibody concentrations
Time Frame: Months 0, 1, 3, 6, 7, 8 and 12
|
Months 0, 1, 3, 6, 7, 8 and 12
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Occurrence, intensity of unsolicited adverse events
Time Frame: 30-day follow-up after vaccination
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30-day follow-up after vaccination
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Occurrence of serious adverse events
Time Frame: During the study period up to 30 days after last vaccination
|
During the study period up to 30 days after last vaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 1993
Primary Completion (Actual)
July 1, 1994
Study Completion (Actual)
July 1, 1994
Study Registration Dates
First Submitted
June 11, 2008
First Submitted That Met QC Criteria
June 11, 2008
First Posted (Estimate)
June 13, 2008
Study Record Updates
Last Update Posted (Estimate)
June 13, 2008
Last Update Submitted That Met QC Criteria
June 11, 2008
Last Verified
June 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis B
- Hepatitis
- Hepatitis A
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
Other Study ID Numbers
- 208129/005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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