Evaluation of Immunogenicity, Reactogenicity and Safety of Herpes Simplex (gD) Candidate Vaccine With/Without Adjuvant
NCT ID: NCT00697567
Last Updated: 2008-06-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
80 participants
INTERVENTIONAL
1992-09-30
1997-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Group A
HSV seropositive subjects
Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvant
Intramuscular injection, 3 doses
Group B
HSV seronegative subjects
Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvant
Intramuscular injection, 3 doses
Group C
HSV seropositive subjects
Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvant
Intramuscular injection, 3 doses
Group D
HSV seronegative subjects
Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvant
Intramuscular injection, 3 doses
Interventions
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Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvant
Intramuscular injection, 3 doses
Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvant
Intramuscular injection, 3 doses
Eligibility Criteria
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Inclusion Criteria
* Written informed consent
* Female volunteers must be using contraceptive and should avoid becoming pregnant for the duration of this study.
* Good clinical condition as evidenced by history taking and physical examination
Exclusion Criteria
* Clinical signs of acute illness at the time of entry into the study.
* Seropositive for antibodies against the human immunodeficiency virus (HIV).
* Pregnancy, lactation.
* Treatment with corticosteroids or immunomodulating drugs.
* Simultaneous participation in another clinical trial.
* Any previous history of allergy.
* Any concomitant vaccination or administration of immunoglobulin during the study period.
* Any abnormal laboratory value among the tests performed at screening
18 Years
40 Years
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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GSK
Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Clinical Trials Call Center
Ghent, , Belgium
Countries
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Other Identifiers
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208141/002
Identifier Type: -
Identifier Source: org_study_id