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A Study of an Investigational V212/Heat-Treated VZV Vaccine in Immunocompromised Adults (V212-002)(COMPLETED)
This study has been completed.
Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00535236
First received: September 25, 2007
Last updated: October 5, 2015
Last verified: October 2015
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Purpose
The proposed indication for the investigational heat-treated varicella-zoster virus (VZV) vaccine is the prevention of herpes zoster (HZ) and HZ-related complications in immunocompromised individuals.
| Condition | Intervention | Phase |
|---|---|---|
| Herpes Zoster Herpes Zoster-related Complications | Biological: Comparator: V212 Biological: Comparator: Placebo | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Prevention |
| Official Title: | A Phase I, Double-Blind, Randomized, Placebo-Controlled, Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of V212/Heat-Treated Varicella-Zoster Virus (VZV) Vaccine in Immunocompromised Adults |
Resource links provided by NLM:
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- Immunogenicity of V212 when administered to immunocompromised patients [ Time Frame: 28 days postdose 4 ]
- Safety and tolerability of V212 when administered to immunocompromised patients [ Time Frame: through 28 days postdose 4 ]
Secondary Outcome Measures:
- Safety and tolerability of V212 in immunocompromised patients [ Time Frame: 28 days post dose 4 ]
| Enrollment: | 341 |
| Study Start Date: | November 2007 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Arm 1: Vaccine
|
Biological: Comparator: V212
0.65 ml V212 in 4 dose regimen. Treatment period of 125 days
|
|
Placebo Comparator: 2
Arm 2: Pbo Comparator
|
Biological: Comparator: Placebo
0.65 ml V212 Pbo in 4 dose regimen. Treatment period of 125 days
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Men and women > or = to 18 years of age who are scheduled to receive an autologous or allogeneic hematopoietic cell transplant within 60 days of enrollment
- HIV-infected patients with a baseline CD4 cell count < or = to 200 cells/mm^3
- Patients with hematologic malignancies; or patients who are receiving chemotherapy for breast, colorectal, lung, or ovarian malignancies
Exclusion Criteria:
- History of allergy to any vaccine component
- Prior history of HZ
- Prior history of receipt of any varicella or zoster vaccine
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00535236
Please refer to this study by its ClinicalTrials.gov identifier: NCT00535236
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
| Study Director: | Medical Monitor | Merck Sharp & Dohme Corp. |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT00535236 History of Changes |
| Other Study ID Numbers: |
V212-002 2007_608 |
| Study First Received: | September 25, 2007 |
| Last Updated: | October 5, 2015 |
Keywords provided by Merck Sharp & Dohme Corp.:
|
Prevention of herpes zoster and HZ-related complications |
Additional relevant MeSH terms:
|
Herpes Zoster Herpesviridae Infections DNA Virus Infections Virus Diseases |
Vaccines Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 21, 2017