Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
GlaxoSmithKline |
---|---|
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00698568 |
This study will evaluate, versus a placebo, the safety of Herpes simplex candidate vaccine with adjuvant in initially HSV seropositive or seronegative subjects who have no genital herpes disease.
Condition | Intervention | Phase |
---|---|---|
Prophylaxis for Herpes Simplex |
Biological: Herpes simplex candidate vaccine- adjuvanted GSK 208141 Biological: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Study to Evaluate the Safety of GSK Biologicals' Herpes Simplex Candidate Vaccine (gD2t) With MPL in HSV Seropositive or Seronegative Subjects Without Genital Herpes Disease |
Enrollment: | 7460 |
Study Start Date: | October 1996 |
Study Completion Date: | April 1999 |
Primary Completion Date: | April 1999 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Group A: Experimental |
Biological: Herpes simplex candidate vaccine- adjuvanted GSK 208141
Intramuscular injection, 3 doses
|
Group B: Placebo Comparator |
Biological: Placebo
Intramuscular injection, 3 doses
|
This study was monitored by a Data Safety Monitoring Board. At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Isabelle Harpigny ) |
Study ID Numbers: | 208141/016 |
Study First Received: | June 16, 2008 |
Last Updated: | June 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00698568 History of Changes |
Health Authority: | Australia: Human Research Ethics Committee; Austria: Ethikkommission; Belgium: Institutional Review Board; Canada: Health Canada; France: Ministry of Health; Germany: Ministry of Health; South Africa: Department of Health; Spain: Ministry of Health; Switzerland: Ethikkommission; United States: Food and Drug Administration; Denmark: National Board of Health |
Herpes simplex, Herpes simplex candidate vaccine |
Virus Diseases Herpes Simplex Skin Diseases, Infectious Skin Diseases |
Herpes Genitalis Adjuvants, Immunologic DNA Virus Infections Herpesviridae Infections |
Skin Diseases, Viral Virus Diseases Herpes Simplex Skin Diseases, Infectious |
Skin Diseases DNA Virus Infections Herpesviridae Infections |