Status:
COMPLETED
Evaluation of Immunogenicity, Reactogenicity and Safety of Herpes Simplex (gD) Candidate Vaccine With/Without Adjuvant
Lead Sponsor:
GlaxoSmithKline
Conditions:
Prophylaxis Herpes Simplex
Eligibility:
All Genders
18-40 years
Phase:
PHASE2
Brief Summary
The purpose of the phase IIa study in healthy HSV seropositive and HSV seronegative adults is to evaluate the immunogenicity, reactogenicity and safety of herpes simplex (gD) candidate vaccine with or...
Detailed Description
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham
Eligibility Criteria
Inclusion
- Between 18 and 40 years of age
- 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
- History of persistent hepatic, renal, cardiac or respiratory diseases.
- 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
Key Trial Info
Start Date :
September 1 1992
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 1997
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00697567
Start Date
September 1 1992
End Date
December 1 1997
Last Update
June 16 2008
Active Locations (1)
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1
GSK Clinical Trials Call Center
Ghent, Belgium