| 1 |
NCT02704572 |
Completed |
Optimal Timing of Zoster Vaccine After Zoster Illness |
|
|
Interventional |
Not Applicable |
- Seoul National University Hospital
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Varicella-zoster virus-specific interferon-gamma ELISPOT response
- Antibody titer against glycoprotein of varicella-zoster virus
|
60 |
All |
50 Years and older (Adult, Senior) |
NCT02704572 |
H1511046718 |
|
March 2016 |
August 2017 |
August 2017 |
March 10, 2016 |
October 13, 2017 |
|
- Seoul National University Hospital
Seoul, Korea, Republic of
|
| 2 |
NCT01331161 |
Completed
Has Results |
Systems Biology of Zoster Vaccine (ZOSTAVAX®) in Young and Elderly |
|
|
Interventional |
Not Applicable |
- Emory University
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Number of Participants With Innate Immunity Signatures That Correlate With the T Cell Adaptive Immunity Responses After ZOSTAVAX
- The Number of Participants With Innate Immune Signatures That Correlate With the B and T Cells Adaptive Immunity Responses After ZOSTAVAX
|
77 |
All |
25 Years to 79 Years (Adult, Senior) |
NCT01331161 |
IRB00050285
U19AI090023
HIPCVAX005 |
|
July 2011 |
April 2012 |
October 2012 |
April 7, 2011 |
February 17, 2016 |
February 17, 2016 |
- University of Colorado
Aurora, Colorado, United States - Emory University
Atlanta, Georgia, United States
|
| 3 |
NCT02624375 |
Recruiting |
Immune Response to Shingles Vaccination |
|
- Drug: Zoster Vaccine Live
|
Interventional |
Phase 4 |
- University of Washington
- Merck Sharp & Dohme Corp.
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- VZV-specific T-cells
- Levels of VZV-specific CD4 or CD8 T cells in skin
- Adverse Events due to Zostavax
|
50 |
All |
70 Years and older (Senior) |
NCT02624375 |
STUDY00001399
53354 |
|
February 2016 |
December 2018 |
December 2018 |
December 8, 2015 |
April 3, 2018 |
|
- University of Washington Virology Research Clinic
Seattle, Washington, United States
|
| 4 |
NCT01519570 |
Completed |
Use of an Electronic Medical Record in the Primary Care Setting to Improve Herpes Zoster Vaccination Rates |
|
- Other: An informational packet regarding shingles and the HZV was sent to patients identified by the EMR
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
- Number of participants who received the herpes zoster vaccine
- Difference in vaccination rates between patients who recieved a mailed letter versus a secure email
- Amount of time required by a clinical pharmacist to manage this workflow
|
2589 |
All |
60 Years and older (Adult, Senior) |
NCT01519570 |
2010H0290 |
|
March 2011 |
December 2011 |
December 2011 |
January 27, 2012 |
January 27, 2012 |
|
- The Ohio State University Martha Morehouse General Internal Medicine Clinic
Columbus, Ohio, United States
|
| 5 |
NCT03314103 |
Recruiting |
Efficacy Trial of a Vaccine to Prevent Herpes Zoster in Adults Over 40 Years of Age |
|
- Biological: One shot of the varicella-zoster virus vaccine
- Biological: one shot of placebo
|
Interventional |
Phase 3 |
- Jiangsu Province Centers for Disease Control and Prevention
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Prevention
|
- The incidence of herpes zoster 30 days after vaccination.
- The incidence of herpes zoster after vaccination.
- The incidence of laboratory-confirmed herpes zoster 30 days after vaccination.
- (and 10 more...)
|
30000 |
All |
40 Years and older (Adult, Senior) |
NCT03314103 |
CS-HZ-2017 |
|
October 6, 2017 |
October 30, 2019 |
December 30, 2019 |
October 19, 2017 |
October 19, 2017 |
|
- Hunan Provincial Center for Disease Control and Prevention
Loudi, Hunan, China - Jiangsu Province Centers for Disease Control and Prevention
Nanjing, Jiangsu, China - Zhejiang Provincial Center for Disease Control and Prevention
Hanzhou, Zhejiang, China
|
| 6 |
NCT03016884 |
Recruiting |
Safety and Tolerability of Herpes Zoster Vaccine Rheumatologic Patients |
|
- Biological: Zostavax vaccine
|
Interventional |
Phase 4 |
- HaEmek Medical Center, Israel
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Number of patients with Injection site adverse reactions
- Number of patients with Hypersensitivity
- number of patients with Post vaccination non-injection-site zoster-like and varicella-like rashes
- (and 7 more...)
|
250 |
All |
50 Years and older (Adult, Senior) |
NCT03016884 |
142-016-EMC |
|
January 2017 |
January 2019 |
May 2019 |
January 11, 2017 |
January 30, 2018 |
|
- Ha'Emek Medical center, Unit of Rheumatology
Afula, Israel - Carmel Medical Center
Haifa, Israel - Tel Aviv Medical Center, Unit pf Rheumatology
Tel Aviv, Israel
|
| 7 |
NCT02735915 |
Active, not recruiting |
Study to Evaluate Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine at 9 and 10 Years After Vaccine Administration and Assessment of Re-vaccination With 2 Additional Doses at 10 Years After Initial Vaccination, in Healthy Subjects Aged 60 Years of Age(YOA) and Older |
|
- Biological: Herpes Zoster Vaccine GSK1437173A
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Antigen-specific antibody (Ab) concentrations.
- Frequencies of antigen-specific CD4 T-cells.
- Number of subjects with any serious adverse events (SAEs) related to study participation or to a concurrent GSK medication/vaccine (including HZ/su administered during the Zoster-003 (NCT00434577) study).
- (and 7 more...)
|
70 |
All |
68 Years and older (Senior) |
NCT02735915 |
204926
2015-004400-30 |
|
April 11, 2016 |
August 28, 2017 |
November 28, 2018 |
April 13, 2016 |
April 17, 2018 |
|
- GSK Investigational Site
Hradec Kralove, Czechia - GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany - GSK Investigational Site
Wuerzburg, Bayern, Germany - (and 4 more...)
|
| 8 |
NCT02690207 |
Active, not recruiting |
Cross-vaccination Study of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine (GSK 1437173A) in Subjects Who Previously Received Placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) Studies. |
|
- Biological: Herpes Zoster Vaccine GSK1437173A
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Occurrence, intensity and relationship to vaccination of unsolicited AEs according to the Medical Dictionary for Regulatory Activities (MedDRA) classification in all subjects
- Occurrence and relationship to vaccination of all SAEs
- Occurrence and relationship to vaccination of any potential Immune Mediated Diseases (pIMDs)
- Occurrence of suspected Herpes Zoster (HZ) cases
|
14535 |
All |
50 Years and older (Adult, Senior) |
NCT02690207 |
204486
2015-000965-30 |
|
March 16, 2016 |
May 24, 2019 |
May 24, 2019 |
February 24, 2016 |
April 24, 2018 |
|
- GSK Investigational Site
Mesa, Arizona, United States - GSK Investigational Site
Phoenix, Arizona, United States - GSK Investigational Site
Phoenix, Arizona, United States - (and 192 more...)
|
| 9 |
NCT02723773 |
Active, not recruiting |
A Long-term Follow-up Study (ZOE-LTFU) of Two Studies 110390 (ZOSTER-006) and 113077 (ZOSTER-022) to Assess the Efficacy, Safety, and Immunogenicity Persistence of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine and Assessment of 1 or 2 Additional Doses in Two Subgroups of Older Adults |
|
- Biological: Herpes Zoster Vaccine GSK1437173A
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Factorial Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Number of subjects with confirmed herpes zoster (HZ).
- Number of subjects with confirmed post herpetic neuralgia (PHN).
- Antigen-glicoprotein E (gE) humoral immunogenicity.
- (and 6 more...)
|
7732 |
All |
50 Years and older (Adult, Senior) |
NCT02723773 |
201190
2015-001778-17 |
|
April 16, 2016 |
July 28, 2023 |
July 28, 2023 |
March 30, 2016 |
March 13, 2018 |
|
- GSK Investigational Site
Mesa, Arizona, United States - GSK Investigational Site
Phoenix, Arizona, United States - GSK Investigational Site
Phoenix, Arizona, United States - (and 160 more...)
|
| 10 |
NCT01911065 |
Completed
Has Results |
T Cell Responses to Varicella Zoster Virus (VZV) Vaccine SLVP020 |
|
|
Interventional |
Phase 4 |
- Stanford University
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Number of Participants Who Received Zostavax Immunization or Had Natural Exposure to VZV
- Number of Participants With Related Adverse Events
|
54 |
All |
40 Years and older (Adult, Senior) |
NCT01911065 |
SU-19385
1U19AI090019-01 |
|
September 2010 |
December 2011 |
December 2011 |
July 30, 2013 |
April 21, 2017 |
March 3, 2017 |
- Stanford University School of Medicine
Stanford, California, United States
|
| 11 |
NCT01165177 |
Completed
Has Results |
Study to Evaluate Efficacy, Safety and Immunogenicity of GSK Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 50 Years and Older |
|
- Biological: Herpes Zoster Vaccine GSK1437173A
- Biological: Placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Number of Subjects With Confirmed Herpes Zoster (HZ) Cases
- Number of Subjects With Any Episodes of Post-Herpetic Neuralgia (PHN)
- Number of Subjects With a Reduction of Duration of Severe 'Worst' HZ-associated Pain
- (and 17 more...)
|
16165 |
All |
50 Years and older (Adult, Senior) |
NCT01165177 |
110390
2008-000367-42 |
|
August 1, 2010 |
May 9, 2014 |
July 27, 2015 |
July 19, 2010 |
March 14, 2018 |
May 1, 2017 |
- GSK Investigational Site
Mesa, Arizona, United States - GSK Investigational Site
Phoenix, Arizona, United States - GSK Investigational Site
Phoenix, Arizona, United States - (and 211 more...)
|
| 12 |
NCT01245751 |
Completed
Has Results |
Safety, Tolerability, and Immunogenicity of a Booster Dose of Zoster Vaccine, Live (V211-029) |
- Herpes Zoster
- Varicella-zoster Vaccine
|
- Biological: Zoster Vaccine, Live
|
Interventional |
Phase 3 |
- Merck Sharp & Dohme Corp.
- University of Colorado, Denver
- Duke University
|
Industry / Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Geometric Mean Titer (GMT) of the Antibody Responses to Varicella-Zoster Virus (VZV)
- Geometric Mean Fold Rise (GMFR) From Day 1 (Baseline) to Week 6 Postvaccination in VZV Antibody Titers
- Number of Participants Reporting One or More Adverse Experiences
|
600 |
All |
50 Years and older (Adult, Senior) |
NCT01245751 |
V211-029 |
|
April 2011 |
July 2012 |
May 2015 |
November 22, 2010 |
April 12, 2017 |
May 29, 2013 |
|
| 13 |
NCT01165229 |
Completed
Has Results |
Study to Evaluate Efficacy, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 70 Years and Older |
|
- Biological: Herpes Zoster Vaccine GSK1437173A
- Biological: Placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Number of Subjects With Any Episodes of Herpes Zoster (HZ)
- Outcome Measure for the Pooled Analysis of Combined Data From Studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229): Number of Subjects With Post-herpetic Neuralgia (PHN)
- Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Confirmed HZ
- (and 24 more...)
|
14819 |
All |
70 Years and older (Senior) |
NCT01165229 |
113077
2009-015791-94 |
|
August 2, 2010 |
July 24, 2015 |
July 24, 2015 |
July 19, 2010 |
February 1, 2018 |
November 20, 2017 |
- GSK Investigational Site
Mesa, Arizona, United States - GSK Investigational Site
Phoenix, Arizona, United States - GSK Investigational Site
Phoenix, Arizona, United States - (and 212 more...)
|
| 14 |
NCT02514018 |
Active, not recruiting |
Pilot Study to Describe Immune Responses of Healthy Women Following Immunization With Varicella Zoster Virus Vaccine |
|
- Biological: Live-attenuated varicella-zoster virus vaccine
|
Interventional |
Phase 4 |
- University of Toronto
- Kenyan AIDS Vaccine Initiative - Institute of Clinical Research (KAVI-ICR)
- University of Nairobi
- Canadian Institutes of Health Research (CIHR)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
|
- Change in the median frequency of cervical CD38+HLA-DR+CD4+T cells after VZV-vaccination as a measure of immune activation
- Composite measures of immune activation observed in mucosal tissues
- Composite measures of mucosal homing marker and HIV co-receptors observed in mucosal tissues
- (and 8 more...)
|
45 |
Female |
18 Years to 50 Years (Adult) |
NCT02514018 |
KAVI-VZV-001 |
KAVI-VZV-001 |
September 2015 |
January 2017 |
July 2017 |
August 3, 2015 |
October 17, 2016 |
|
- KAVI-ICR, University of Nairobi
Nairobi, Kenya
|
| 15 |
NCT01600079 |
Active, not recruiting |
ZOSTAVAX™ (Zoster Vaccine Live) Long-term Effectiveness Study (V211-024) |
|
|
Observational |
|
- Merck Sharp & Dohme Corp.
- Kaiser Permanente
|
Industry / Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Incidence of Herpes Zoster in Vaccinated and Unvaccinated Cohorts, Overall, and by Age (50-59, 60-69, 70-79 ≥80) at Vaccination
- Incidence of Herpes Zoster in Vaccinated and Unvaccinated Cohorts by Time since Vaccination
- Incidence of Postherpetic Neuralgia in Vaccinated and Unvaccinated Cohorts, Overall, and by Age (50-59, 60-69, 70-79, ≥80) at Vaccination
- Incidence of Postherpetic Neuralgia in Vaccinated and Unvaccinated Cohorts by Time since Vaccination
|
30000 |
All |
50 Years and older (Adult, Senior) |
NCT01600079 |
V211-024
8003.016 |
|
May 15, 2012 |
October 30, 2023 |
October 30, 2023 |
May 16, 2012 |
October 20, 2017 |
|
|
| 16 |
NCT00007501 |
Completed |
Shingles Prevention Study |
- Herpes Zoster
- Postherpetic Neuralgia
|
- Biological: Varicella-zoster vaccine
- Biological: Placebo
|
Interventional |
Phase 3 |
- VA Office of Research and Development
- Merck Sharp & Dohme Corp.
- National Institute of Allergy and Infectious Diseases (NIAID)
|
U.S. Fed / Industry / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Reduce burden of illness due to herpes zoster (HZ)
|
38456 |
All |
60 Years and older (Adult, Senior) |
NCT00007501 |
403 |
SPS |
November 1998 |
April 2004 |
February 2011 |
January 1, 2001 |
July 4, 2013 |
|
- VA Medical Center, Birmingham
Birmingham, Alabama, United States - VA Palo Alto Health Care System
Palo Alto, California, United States - VA San Diego Healthcare System, San Diego
San Diego, California, United States - (and 19 more...)
|
| 17 |
NCT02114333 |
Active, not recruiting |
Comparison of a Live Herpes Zoster Vaccine and a Recombinant Vaccine in 50-59 and 70-85 Year Olds |
|
- Biological: Zostavax
- Biological: HZ/su vaccine
- Biological: Placebo
|
Interventional |
Phase 1 |
- University of Colorado, Denver
- GlaxoSmithKline
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Basic Science
|
- Changes in Interferon gamma/ Interleukin 2 (IFNg/IL2) dual color fluorospot number
- Changes in glycoprotein-based enzyme-linked immunosorbent assay (gpELISA)
|
160 |
All |
50 Years to 85 Years (Adult, Senior) |
NCT02114333 |
13-3192 |
|
May 2014 |
March 2016 |
December 2019 |
April 15, 2014 |
March 3, 2017 |
|
- Pediatric Infectious Diseases and Clinical Trials, Universtiy of Colorado School of Medicine
Aurora, Colorado, United States
|
| 18 |
NCT02408159 |
Terminated |
Varicella Zoster Vaccine in Patients With Plaque Psoriasis Treated With Biologic Therapy |
|
- Drug: Varicella Zoster Vaccine
- Drug: Placebo
|
Interventional |
Phase 4 |
- Innovaderm Research Inc.
- Merck Sharp & Dohme Corp.
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Varicella Zoster Virus (VZV) antibody
- Geometric mean titer of VZV antibody
- Serious Adverse Events
- Presenting with Varicella or Herpes Zoster
|
3 |
All |
50 Years and older (Adult, Senior) |
NCT02408159 |
Inno-6041 |
|
June 2016 |
January 2017 |
March 2017 |
April 3, 2015 |
July 2, 2017 |
|
- Inno-6041 study site
London, Ontario, Canada - Inno-6041 study site
Markham, Ontario, Canada - Innovaderm Research Inc.
Montreal, Quebec, Canada
|
| 19 |
NCT03192319 |
Recruiting |
Optimal Timing of Zoster Vaccine After Hematopoietic Stem Cell Transplantation |
|
|
Interventional |
Not Applicable |
- Seoul National University Hospital
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Varicella-zoster virus-specific interferon-gamma ELISPOT response
- Antibody titer against varicella-zoster virus
|
120 |
All |
50 Years and older (Adult, Senior) |
NCT03192319 |
H1705030852 |
|
July 1, 2017 |
May 31, 2018 |
May 31, 2018 |
June 20, 2017 |
November 14, 2017 |
|
- Seoul National University Hospital
Seoul, Korea, Republic of
|
| 20 |
NCT01262300 |
Active, not recruiting |
Vitamin D Supplementation And Varicella Zoster Virus Vaccine Responsiveness In Older Long-Term Care Residents |
|
- Biological: Varicella Zoster Virus Vaccine (Zostavax)
|
Interventional |
Phase 1 |
- University of Colorado, Denver
- National Institute on Aging (NIA)
- Merck Sharp & Dohme Corp.
|
Other / NIH / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- VZV-specific cell mediated immunity, as measured by the interferon-γ ELISPOT assay
- VZV-gpELISA to measure the VZV-specific antibody concentration
- VZV-specific effector and memory T cells
- -specific cell mediated immunity, as measured by the responder cell frequency assay
|
33 |
All |
60 Years and older (Adult, Senior) |
NCT01262300 |
10-0189
K23AG040708 |
|
November 2010 |
November 2014 |
December 2018 |
December 17, 2010 |
December 2, 2017 |
|
- University of Colorado Denver
Aurora, Colorado, United States
|
| 21 |
NCT00900783 |
Completed |
A Study of FV-100 Versus Valacyclovir in Patients With Herpes Zoster |
|
- Drug: valacyclovir
- Drug: FV-100
- Drug: Valacyclovir placebo
- Drug: FV-100 placebo
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Herpes zoster associated pain, as measured by the Zoster Brief Pain INventory (ZBPI)
- Herpes zoster associated pain
- Herpes zoster lesion healing
- Routine clinical labs
|
350 |
All |
50 Years and older (Adult, Senior) |
NCT00900783 |
INH-FV1-005
INH-FV1-005-PK
INH-FV1-005-VR
INH-FV1-AGE |
|
May 2009 |
November 2010 |
December 2010 |
May 13, 2009 |
October 12, 2015 |
|
|
| 22 |
NCT00109122 |
Completed |
Safety, Tolerability, and the Body's Ability to Develop Resistance to an Investigational Vaccine for Shingles (V211-007) |
|
- Biological: zoster vaccine live (Oka/Merck)
- Biological: Comparator: placebo (unspecified)
|
Interventional |
Phase 2 |
- Merck Sharp & Dohme Corp.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Prevention
|
- VZV ELISPOT response ~6 weeks after 1 and 2 doses
- To assess the safety and tolerability of the zoster vaccine. To evaluate the long-term persistence of the VZV-specific cell mediate immunity and the VZV-specific antibody response at 1 through 3 years after 2 doses of vaccine or placebo
|
180 |
All |
60 Years and older (Adult, Senior) |
NCT00109122 |
V211-007
2005_017 |
|
November 2001 |
February 2003 |
July 2006 |
April 25, 2005 |
March 15, 2017 |
|
|
| 23 |
NCT02832986 |
Completed |
Herpes Zoster Prevalence in Frailty Consultations |
|
- Other: Medical Questionary
|
Observational |
|
- University Hospital, Toulouse
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Frequence of zoster antecedent as assessed by percentage of subject with zoster antecedent
- Frequence of ophthalmic zoster antecedent as assessed by percentage of subject with ophthalmic zoster antecedent
- Frequence of postherpetic pain antecedent as assessed by percentage of subject with postherpetic pain antecedent
- (and 3 more...)
|
1245 |
All |
65 Years and older (Adult, Senior) |
NCT02832986 |
RC31-15-7581 |
|
January 2015 |
December 2015 |
June 2016 |
July 14, 2016 |
July 14, 2016 |
|
- University Hospital of Toulouse - geriatric pole
Toulouse, France
|
| 24 |
NCT00322231 |
Completed
Has Results |
A Study of an Investigational Zoster Vaccine, in Subjects With a History of Herpes Zoster (V211-014) |
|
- Biological: zoster vaccine live (ZOSTAVAX™)
- Biological: Comparator: Placebo
|
Interventional |
Phase 3 |
- Merck Sharp & Dohme Corp.
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Prevention
|
- Vaccine-related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination
- Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination
- Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination
|
101 |
All |
50 Years and older (Adult, Senior) |
NCT00322231 |
V211-014
2006_010 |
|
May 2006 |
July 2007 |
July 2007 |
May 5, 2006 |
January 26, 2015 |
December 15, 2010 |
|
| 25 |
NCT00130793 |
Completed
Has Results |
A Study to Evaluate Safety, Tolerability, and Immunogenicity of an Investigational Zoster Vaccine In Subjects With a History of Varicella (Chickenpox)(V211-010)(COMPLETED) |
|
- Biological: Comparator: zoster vaccine live (Oka/Merck) refrigerated formulation
- Biological: Comparator: zoster vaccine live (Oka/Merck) frozen formulation
|
Interventional |
Phase 3 |
- Merck Sharp & Dohme Corp.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Prevention
|
- Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination
- Vaccine-Related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination
|
368 |
All |
50 Years and older (Adult, Senior) |
NCT00130793 |
V211-010
2005_035 |
|
August 2005 |
November 2005 |
November 2005 |
August 16, 2005 |
January 26, 2015 |
July 3, 2009 |
|
| 26 |
NCT01610414 |
Completed
Has Results |
Study to Evaluate Efficacy, Safety, and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A |
|
- Biological: Herpes Zoster vaccine GSK1437173A
- Biological: Placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Number of Subjects With Confirmed Herpes Zoster (HZ) Episode
- Duration of 'Worst' HZ-associated Pain
- Number of Subjects With Confirmed HZ-associated Complications
- (and 9 more...)
|
1877 |
All |
18 Years and older (Adult, Senior) |
NCT01610414 |
115523
2012-000138-20 |
|
July 13, 2012 |
November 4, 2016 |
February 1, 2017 |
June 4, 2012 |
January 23, 2018 |
January 23, 2018 |
- GSK Investigational Site
Duarte, California, United States - GSK Investigational Site
San Francisco, California, United States - GSK Investigational Site
Aurora, Colorado, United States - (and 175 more...)
|
| 27 |
NCT00434577 |
Completed |
Safety and Immunogenicity of the Zoster Vaccine GSK1437173A in Elderly Subjects |
- Herpes Zoster (Shingles)
- Shingles
|
- Biological: Herpes Zoster vaccine GSK1437173A
- Biological: Placebo
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Prevention
|
- Cell mediated immune response (CMI) in terms of frequencies of CD4 T cells specific for VZV antigens
- CMI in terms of frequencies of CD4/CD8 T cells specific for VZV antigens
- VZV-specific Ab concentrations
- (and 7 more...)
|
715 |
All |
60 Years and older (Adult, Senior) |
NCT00434577 |
108494
108516
108518
108520 |
|
February 2007 |
October 2007 |
July 2010 |
February 13, 2007 |
March 28, 2012 |
|
- GSK Investigational Site
Hradec Kralove, Czech Republic - GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany - GSK Investigational Site
Wuerzburg, Bayern, Germany - (and 7 more...)
|
| 28 |
NCT03493776 |
Recruiting
New |
Safety and Immunogenicity of Non-live, Recombinant Subunit Herpes Zoster Vaccine Before and After Lung Transplantation |
|
- Biological: VZV subunit vaccine
|
Interventional |
Phase 4 |
- Deepali Kumar
- University Health Network, Toronto
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Prevention
|
- Cellular immunity to varicella zoster induced by varicella zoster subunit vaccine.
- Humoral immunogenicity to varicella zoster induced by varicella zoster subunit vaccine in lung transplant recipients.
- Humoral immunogenicity to varicella zoster induced by varicella zoster subunit vaccine in post-transplant group vs. pre-transplant group
|
75 |
All |
50 Years and older (Adult, Senior) |
NCT03493776 |
UHN-Shingrix-001 |
|
April 15, 2018 |
September 5, 2019 |
March 5, 2020 |
April 10, 2018 |
April 10, 2018 |
|
- University Health Network, Toronto General Hospital, Multi-Organ Transplant
Toronto, Ontario, Canada
|
| 29 |
NCT01827839 |
Completed
Has Results |
Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine GSK1437173A in Adults With a Prior Episode of Herpes Zoster |
|
- Biological: Herpes Zoster vaccine (GSK1437173A)
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Number of Vaccine Responders for Anti-gE Antibodies as Determined by ELISA
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms
- Number of Days With Solicited Local Symptoms
- (and 8 more...)
|
96 |
All |
50 Years and older (Adult, Senior) |
NCT01827839 |
116796
2012-003643-30 |
|
June 10, 2013 |
February 10, 2014 |
November 25, 2014 |
April 10, 2013 |
November 27, 2017 |
March 7, 2017 |
- GSK Investigational Site
Coquitlam, British Columbia, Canada - GSK Investigational Site
Pointe-Claire, Quebec, Canada - GSK Investigational Site
Barnaul, Russian Federation - GSK Investigational Site
Ekaterinburg, Russian Federation
|
| 30 |
NCT02075515 |
Completed
Has Results |
Consistency, Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults ≥ 50 Years of Age |
|
- Biological: Herpes Zoster vaccine (GSK 1437173A)
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Prevention
|
- Number of Subjects With Anti-gE Antibody Concentrations Equal to or Above the Cut-off Value
- Anti-gE Humoral Immunogenicity
- Number of Vaccine Responders for Anti-gE Concentrations as Determined by ELISA
- (and 7 more...)
|
651 |
All |
50 Years and older (Adult, Senior) |
NCT02075515 |
117177
2013-000373-76 |
|
August 13, 2014 |
April 29, 2015 |
April 25, 2016 |
March 3, 2014 |
May 24, 2017 |
May 24, 2017 |
- GSK Investigational Site
Mesa, Arizona, United States - GSK Investigational Site
Wichita, Kansas, United States - GSK Investigational Site
Milford, Massachusetts, United States - (and 5 more...)
|
| 31 |
NCT00118885 |
Completed |
Shingles: Immune Effects of Tai Chi |
|
|
Interventional |
Phase 2 |
- National Institute on Aging (NIA)
- National Center for Complementary and Integrative Health (NCCIH)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
|
- varicella zoster specific immunity
- measures of health status including SF-36 scores, depressive symptoms, and health behaviors
|
140 |
All |
60 Years to 90 Years (Adult, Senior) |
NCT00118885 |
AG0029
R01AG018367 |
|
July 2001 |
December 2004 |
December 2004 |
July 12, 2005 |
December 11, 2009 |
|
- Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute
Los Angeles, California, United States
|
| 32 |
NCT01573182 |
Recruiting |
Herpes Zoster Vaccine for Bone Marrow Transplant Donors |
|
|
Interventional |
Phase 2 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Percentage of transplant recipients with VZV specific T cell proliferation within the first 12 moths post-transplant.
- Donor VZV positivity by PCR and genotype and donor VZV specific T cell response to vaccination
|
10 |
All |
50 Years and older (Adult, Senior) |
NCT01573182 |
VADOVAR |
VZV-Zostavax |
April 2012 |
December 2017 |
December 2018 |
April 6, 2012 |
May 4, 2017 |
|
- Westmead Hospital
Sydney, New South Wales, Australia
|
| 33 |
NCT00561080 |
Completed
Has Results |
Immunogenicity and Safety of a 1-dose Regimen of a Zoster Vaccine Versus Different 2-dose Regimens in Participants ≥ 70 Years of Age. (V211-043) |
- Prevention of : Herpes-Zoster
|
|
Interventional |
Phase 3 |
- Merck Sharp & Dohme Corp.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Geometric Mean Titer (GMT) of Varicella Zoster Virus (VZV) Antibodies 4 Weeks After Each Vaccination: Groups 2 and 3
- Geometric Mean Titer (GMT) of VZV Antibodies 4 Weeks After Vaccination: Group 1
- Geometric Mean Fold Rise (GMFR) in VZV Antibody Titres From Pre-vaccination to 4 Weeks Post-dose 1 in Groups 1, 2 and 3 and 4 Weeks Post-dose 2 in Groups 2 and 3
- (and 20 more...)
|
759 |
All |
70 Years and older (Senior) |
NCT00561080 |
V211-043
X06-Z-305
2007-000744-28 |
|
October 26, 2007 |
June 3, 2009 |
June 3, 2009 |
November 20, 2007 |
February 16, 2018 |
December 22, 2017 |
|
| 34 |
NCT02590068 |
Terminated |
Effects of Chronic Viral Infection on Immune Response to Zoster Vaccination |
|
- Drug: Zoster vaccine live
|
Interventional |
Not Applicable |
- Rockefeller University
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Serum zoster antibody level
- Interferon stimulated gene (ISG) expression
- Serum biomarkers of immune activation (expressed in %)
- (and 2 more...)
|
14 |
All |
50 Years to 60 Years (Adult) |
NCT02590068 |
OJE-0890
5U19AI111825-02 |
|
December 2015 |
September 8, 2017 |
September 8, 2017 |
October 28, 2015 |
November 24, 2017 |
|
- Rockefeller University Hospital
New York, New York, United States
|
| 35 |
NCT01777321 |
Completed
Has Results |
Safety and Immunogenicity Study of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine GSK1437173A When Administered Subcutaneously Intramuscularly in Adults Aged ≥50 Years |
|
- Biological: Herpes zoster vaccine GSK1437173A
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Number of Subjects With Anti-Glycoprotein E (Anti-gE) Antibody Concentrations ≥ 18 mIU/mL
- Anti-gE Antibody Concentrations
- Number of Subjects With Vaccine Response for Anti-gE Antibody Concentrations
- (and 10 more...)
|
60 |
All |
50 Years and older (Adult, Senior) |
NCT01777321 |
116760
2012-005671-14 |
|
June 17, 2013 |
October 10, 2013 |
November 11, 2014 |
January 28, 2013 |
December 21, 2017 |
January 6, 2017 |
- GSK Investigational Site
Fukuoka, Japan
|
| 36 |
NCT01086449 |
Completed |
Safety and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine 1437173A in Healthy Ethnic Japanese Adults |
|
- Biological: Herpes Zoster Vaccine GSK 1437173A
|
Interventional |
Phase 1 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Solicited local and general symptoms
- Unsolicited adverse events
- Serious adverse events
- (and 3 more...)
|
20 |
All |
18 Years to 69 Years (Adult, Senior) |
NCT01086449 |
113819 |
|
March 4, 2010 |
June 25, 2010 |
November 25, 2010 |
March 15, 2010 |
March 9, 2018 |
|
- GSK Investigational Site
Randwick, New South Wales, Australia
|
| 37 |
NCT00920218 |
Completed
Has Results |
Safety & Immunogenicity of GlaxoSmithKline Biologicals' Herpes Zoster Vaccine 1437173A |
|
- Biological: Herpes Zoster Vaccine 1437173A
- Biological: Placebo vaccine (saline)
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
- Number of Subjects With Any and Grade 3 Unsolicited Adverse Events (AEs)
- (and 11 more...)
|
121 |
All |
18 Years and older (Adult, Senior) |
NCT00920218 |
110258 |
|
July 14, 2009 |
April 26, 2011 |
March 21, 2012 |
June 15, 2009 |
December 12, 2017 |
December 12, 2017 |
- GSK Investigational Site
Little Rock, Arkansas, United States - GSK Investigational Site
Duarte, California, United States - GSK Investigational Site
Frisco, California, United States - (and 8 more...)
|
| 38 |
NCT02979639 |
Active, not recruiting |
Study to Evaluate the Impact of Reactogenicity on Quality of Life (QoL), After Administration of GlaxoSmithKline (GSK) Biologicals' Candidate Herpes Zoster Subunit (HZ/su) Vaccine (GSK1437173A) in Adults ≥ 50 Years of Age |
|
- Biological: GSK Biologicals Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A)
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Change in mean Short Form 36-item-health survey (SF 36) Physical Form (PF) scale score.
- Change in mean SF-36 PF single item scores.
- Change in SF-36 Role Physical scores.
- (and 17 more...)
|
404 |
All |
50 Years and older (Adult, Senior) |
NCT02979639 |
204928 |
|
January 16, 2017 |
April 12, 2017 |
August 14, 2018 |
December 1, 2016 |
March 19, 2018 |
|
- GSK Investigational Site
Oakland, California, United States - GSK Investigational Site
Aurora, Colorado, United States - GSK Investigational Site
Colorado Springs, Colorado, United States - (and 8 more...)
|
| 39 |
NCT00534248 |
Completed
Has Results |
Study to Evaluate the Safety and Effectiveness of Zostavax™ in Subjects 50 - 59 Years of Age (V211-022) |
|
- Biological: Zoster Vaccine, Live (Zostavax™)
- Biological: Comparator: Placebo
|
Interventional |
Phase 3 |
- Merck Sharp & Dohme Corp.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Prevention
|
- Incidence of Confirmed Herpes Zoster (HZ) Cases by Vaccination Group
- Varicella-zoster Virus (VZV) Antibody Response at 6 Weeks Post Vaccination by Vaccination Group
- Number of Participants Reporting One or More Serious Adverse Experiences by Vaccination Group During the 42-day Postvaccination Follow-up Period
|
22439 |
All |
50 Years to 59 Years (Adult) |
NCT00534248 |
V211-022
2007_551 |
|
October 2007 |
January 2010 |
January 2010 |
September 24, 2007 |
April 12, 2017 |
May 2, 2011 |
|
| 40 |
NCT02679339 |
Terminated |
Study to Evaluate the Safety and Pharmacokinetics of Topically Applied 40% Lidocaine Gel Compared With Placebo in Subjects With Acute Herpes Zoster (Shingles) Pain |
- Acute-onset Herpes Zoster Pain
|
- Drug: CNTX-2022 (lidocaine gel, 40%)
- Drug: Placebo
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- To evaluate the safety of topically applied 40% lidocaine gel measuring incidence, intensity, relationship, and seriousness of treatment-emergent AEs
- To evaluate the pharmacokinetics of topically applied 40% lidocaine gel measuring Tmax
- To assess the effect of 40% lidocaine gel on 0-10 numeric pain rating scale (NPRS) scores related to acute herpes zoster
|
1 |
All |
18 Years to 85 Years (Adult, Senior) |
NCT02679339 |
2022-HZ-011 |
|
January 2015 |
August 2015 |
August 2015 |
February 10, 2016 |
February 10, 2016 |
|
- Nucleus Network
Melbourne, Victoria, Australia
|
| 41 |
NCT01527370 |
Completed
Has Results |
Safety, Tolerability, and Immunogenicity of Zoster Vaccine Live (ZOSTAVAX™) in Healthy Adults in India (V211-025) |
|
- Biological: Zoster Vaccine Live
|
Interventional |
Phase 3 |
- Merck Sharp & Dohme Corp.
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- The Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody at 6 Weeks Postvaccination
- Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers at 6 Weeks Postvaccination
- Number of Participants With Serious Adverse Events
|
250 |
All |
50 Years and older (Adult, Senior) |
NCT01527370 |
V211-025
CTRI/2012/08/002922 |
|
October 2012 |
April 2013 |
April 2013 |
February 7, 2012 |
April 12, 2017 |
December 30, 2013 |
|
| 42 |
NCT03120962 |
Not yet recruiting |
Effect of Early Use of Oxycodone During the Acute Phase of Herpes Zoster on Preventing Postherpetic Neuralgia |
- Herpes Zoster
- Post-herpetic Neuralgia
|
- Drug: Oxycodone
- Drug: Gabapentin
- Drug: Famciclovir
|
Interventional |
Not Applicable |
- Second Affiliated Hospital, School of Medicine, Zhejiang University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of patients with zoster pain.
- Proportion of patients with zoster pain
- Pain intensity
- (and 2 more...)
|
140 |
All |
50 Years and older (Adult, Senior) |
NCT03120962 |
2017-012 |
|
May 2017 |
May 2020 |
November 2020 |
April 19, 2017 |
April 19, 2017 |
|
|
| 43 |
NCT01556451 |
Completed
Has Results |
ZOSTAVAX™ Safety and Immunogenicity in Korean Adults (V211-034) |
|
- Biological: Zoster Vaccine Live
|
Interventional |
Phase 4 |
- Merck Sharp & Dohme Corp.
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Geometric Mean Fold Rise (GMFR) From Day 1 in Varicella Zoster Virus (VZV) Antibody
- Geometric Mean Titer (GMT) of VZV Antibody
- Percentage of Participants With Clinical Adverse Experiences
- Percentage of Participants Discontinued Due to Clinical Adverse Experiences
|
180 |
All |
50 Years and older (Adult, Senior) |
NCT01556451 |
V211-034 |
|
April 2012 |
October 2012 |
October 2012 |
March 16, 2012 |
April 12, 2017 |
September 23, 2013 |
|
| 44 |
NCT01254630 |
Completed
Has Results |
A Study to Evaluate the Safety and Efficacy of Inactivated Varicella-zoster Vaccine (VZV) as a Preventative Treatment for Herpes Zoster (HZ) and HZ-related Complications in Adult Participants With Solid Tumor or Hematologic Malignancy (V212-011) |
|
- Biological: V212
- Biological: Placebo
|
Interventional |
Phase 3 |
- Merck Sharp & Dohme Corp.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Prevention
|
- Incidence of Confirmed Herpes-Zoster
- Percentage of Participants With One or More Serious Adverse Events
- Incidence of Moderate to Severe Herpes-Zoster-Associated Pain
- (and 2 more...)
|
5305 |
All |
18 Years and older (Adult, Senior) |
NCT01254630 |
V212-011
CTRI/2012/05/002673
2010-023156-89 |
|
June 24, 2011 |
April 11, 2017 |
April 11, 2017 |
December 6, 2010 |
April 13, 2018 |
April 13, 2018 |
|
| 45 |
NCT00487682 |
Completed |
Dose-finding Study of ASP2151 in Subjects With Herpes Zoster |
|
- Drug: ASP2151
- Drug: Valacyclovir hydrochloride
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- To compare the efficacy and safety of ASP2151 with valacyclovir in subjects with Herpes Zoster
- Improvement of cutaneous symptoms and pain
|
403 |
All |
20 Years to 79 Years (Adult, Senior) |
NCT00487682 |
15L-CL-221 |
|
August 2007 |
September 2008 |
September 2008 |
June 18, 2007 |
December 21, 2011 |
|
- Chubu, Japan
- Hokkaido, Japan
- Kanto, Japan
- (and 2 more...)
|
| 46 |
NCT01165203 |
Completed
Has Results |
Study to Evaluate GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Human Immunodeficiency Virus (HIV)-Infected Subjects |
|
- Biological: Herpes Zoster Vaccine GSK1437173A
- Biological: Placebo
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Number of Subjects With Serious Adverse Events (SAEs)
- Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication/Vaccine
- Number of Subjects With Any Fatal SAEs
- (and 20 more...)
|
123 |
All |
18 Years and older (Adult, Senior) |
NCT01165203 |
112673 |
|
September 30, 2010 |
July 6, 2012 |
May 14, 2013 |
July 19, 2010 |
November 27, 2017 |
June 7, 2017 |
- GSK Investigational Site
Long Beach, California, United States - GSK Investigational Site
San Francisco, California, United States - GSK Investigational Site
Orlando, Florida, United States - (and 12 more...)
|
| 47 |
NCT01229267 |
Completed |
A Study to Evaluate the Safety and Efficacy of Inactivated Varicella-zoster Vaccine (VZV) as a Preventative Treatment for Herpes Zoster (HZ) and HZ-related Complications in Participants Undergoing Hematopoietic Cell Transplants (HCTs) (Study No. V212-001 AM4) |
|
- Biological: V212
- Biological: Matching placebo
|
Interventional |
Phase 3 |
- Merck Sharp & Dohme Corp.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Incidence of herpes zoster (HZ)
- Incidence of moderate to severe HZ-associated pain
- Incidence of HZ complications
- Incidence of postherpetic neuralgia (PHN)
|
1257 |
All |
18 Years and older (Adult, Senior) |
NCT01229267 |
V212-001 |
|
November 2010 |
December 2015 |
December 2015 |
October 27, 2010 |
July 28, 2016 |
|
|
| 48 |
NCT01798056 |
Completed |
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ/su) Vaccine in Adults With Solid Tumours Receiving Chemotherapy |
|
- Biological: GSK 1437173A
- Drug: Placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Adjusted geometric means (GMC) of GSK1437173A over placebo for anti-glycoprotein E (gE) antibody enzyme-linked immunosorbent assay (ELISA) concentrations in PreChemo Groups only
- GMCs for anti-Varicella Zoster Virus (VZV) gE antibodies
- Number of subjects with anti-gE antibody concentrations as determined by ELISA above the cut-off value (97 mIU/mL)
- (and 6 more...)
|
237 |
All |
18 Years and older (Adult, Senior) |
NCT01798056 |
116427
2012-002966-11 |
|
March 2013 |
June 2015 |
May 2016 |
February 25, 2013 |
October 6, 2016 |
|
- GSK Investigational Site
Kelowna, British Columbia, Canada - GSK Investigational Site
Halifax, Nova Scotia, Canada - GSK Investigational Site
Toronto, Ontario, Canada - (and 27 more...)
|
| 49 |
NCT00886613 |
Completed
Has Results |
A Study to Evaluate Immunity to Varicella Zoster Virus After Immunization With V212 Vaccine or Zostavax (V212-003) |
|
- Biological: V212
- Biological: Comparator: Zostavax™
- Biological: Comparator: Placebo
- (and 2 more...)
|
Interventional |
Phase 1 |
- Merck Sharp & Dohme Corp.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Prevention
|
- Number of Participants With a Negative VZV Skin Test at Baseline (Part A)
- Number of Healthy, Elderly, Immunocompetent Participants With a Positive VZV Skin Test After Administration of 2 Doses of V212 Vaccine (Part B)
- VZV Skin Test Reactions at 48 and 72 Hours (Part A)
- (and 2 more...)
|
120 |
All |
60 Years and older (Adult, Senior) |
NCT00886613 |
V212-003
2009_579 |
|
March 2009 |
December 2009 |
December 2009 |
April 23, 2009 |
October 6, 2015 |
April 13, 2011 |
|
| 50 |
NCT01483378 |
Completed
Has Results |
Increasing Use of the Vaccine Against Herpes Zoster/Shingles at NYULMC and Bellevue Hospital |
|
- Other: Choosing to receive the vaccine
|
Interventional |
Not Applicable |
- New York University School of Medicine
- Merck Sharp & Dohme Corp.
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
- Answers to Survey Questions
|
170 |
All |
60 Years and older (Adult, Senior) |
NCT01483378 |
11-02029 |
|
January 2012 |
February 2012 |
February 2012 |
December 1, 2011 |
August 9, 2013 |
August 9, 2013 |
- Bellevue Hospital
New York, New York, United States - NYU Langone Medical Center
New York, New York, United States
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