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Completed Phase 3 Interventional Accepts healthy volunteers Results available

HerpeVac Trial for Young Women

NCT00057330
Conditions
Herpes Simplex Infection
Interventions
HSV vaccine or SB208141, GSK Biologicals' glycoprotein D (gD)-Alum/3-deacylated form of Monophosphoryl Lipid A (MPL) candidate genital herpes vaccine, Havrix™, GlaxoSmithKline (GSK) Biologicals' licensed Hepatitis A vaccine
Biological
Lead sponsor
GlaxoSmithKline
Industry
Eligibility
18 Years to 30 Years · Female only
Enrollment
8,323 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2003 – 2009
U.S. locations
67
States / cities
Birmingham, Alabama • Chandler, Arizona • Mesa, Arizona + 56 more
Conditions
Herpes Simplex
Interventions
Valaciclovir
Drug
Lead sponsor
GlaxoSmithKline
Industry
Eligibility
1 Month to 6 Years
Enrollment
36 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2003 – 2007
U.S. locations
10
States / cities
Birmingham, Alabama • Little Rock, Arkansas • San Diego, California + 7 more
Conditions
Genital Herpes
Interventions
HSV 2 Formulation 1, HSV 2 Formulation 2, HSV 2 Formulation 3, HSV 2 Formulation 4, HSV 2 Formulation 5, HSV 2 Formulation 6, Sodium Chloride 0.9%
Biological
Lead sponsor
Sanofi Pasteur, a Sanofi Company
Industry
Eligibility
18 Years to 55 Years
Enrollment
24 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020 – 2021
U.S. locations
4
States / cities
Hollywood, Florida • Boston, Massachusetts • Raleigh, North Carolina + 1 more
Conditions
Pneumococcal Immunisation, Diphtheria Immunisation, Tetanus Immunisation, Pertussis Immunisation, Hepatitis B Immunisation, Haemophilus Influenzae Type b Immunisation, Polio Immunisation, Measles Immunisation, Rubella Immunisation, Varicella Immunisation, Mumps Immunisation
Interventions
Pneumococcal Conjugate Vaccine formulation 1, Pneumococcal Conjugate Vaccine formulation 2, Pneumococcal Conjugate Vaccine formulation 3, Varicella Virus Vaccine Live, Measles, Mumps, and Rubella Virus Vaccine Live, Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein], Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate), Rotavirus Vaccine, Live, Oral, Pentavalent, Hepatitis B Vaccine* [Recombinant] *as applicable
Biological
Lead sponsor
Sanofi Pasteur, a Sanofi Company
Industry
Eligibility
42 Days to 15 Months
Enrollment
852 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020 – 2023
U.S. locations
49
States / cities
Jonesboro, Arkansas • Bellflower, California • Huntington Park, California + 41 more
Conditions
AML (Acute Myelogenous Leukemia), Acute Lymphoid Leukemia (ALL), Acute Leukemia (Category), MDS (Myelodysplastic Syndrome), CML (Chronic Myelogenous Leukemia), CLL (Chronic Lymphocytic Leukemia), Prolymphocyctic Leukemia, Chronic Myelomonocytic Leukemia (CMML), Myeloproliferative Neoplasm (MPN), Lymphoma, Myelofibrosis
Interventions
Conditioning Regimen A, Conditioning Regimen B, Conditioning Regimen C, Conditioning Regimen D, Conditioning Regimen E, Hematopoietic Cell Transplantation, PTCy (50 mg/kg D3, D4), PTCy (25 mg/kg D3, D4), Post-transplant Tacrolimus, Post-transplant Mycophenolate mofetil, Post-transplant Abatacept, Post-transplant Ruxolitinib, Supportive Care: Growth Factors, Supportive Care: Blood Products, Supportive Care: Infection Prophylaxis, Supportive Care: Intravenous immune globulin (IVIG), Supportive Care: Seizure prophylaxis, Supportive Care: Monitoring and management of CRS, Supportive Care: Prophylaxis against infections, Supportive Care: Prophylaxis against infections, Supportive Care: Lipid elevations, Study treatment compliance, Prohibited Concomitant Therapy, Permitted Concomitant Therapy
Drug · Procedure · Other
Lead sponsor
Center for International Blood and Marrow Transplant Research
Network
Eligibility
18 Years to 66 Years
Enrollment
358 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2028
U.S. locations
13
States / cities
Birmingham, Alabama • Duarte, California • Palo Alto, California + 10 more