Trial record 2 of 9 for:
merck v212
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)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified February 2015 by Merck Sharp & Dohme Corp.
Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01254630
First received: December 3, 2010
Last updated: February 24, 2015
Last verified: February 2015
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Purpose
This is a randomized, double-blind, placebo-controlled study to assess the safety and tolerability of V212 when administered to adults with solid tumor malignancy (STM) or hematologic malignancy (HM) and to determine whether V212 reduces the incidence of herpes zoster (HZ) in adults with STM or HM, as compared to placebo.
| Condition | Intervention | Phase |
|---|---|---|
|
Herpes Zoster |
Biological: V212 Biological: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase III Randomized, Placebo-Controlled, Clinical Trial to Study the Safety and Efficacy of V212 in Adult Patients With Solid Tumor or Hematologic Malignancy |
Resource links provided by NLM:
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- The number of HZ cases per 1000 person-years of follow-up [ Time Frame: From study enrollment up to approximately 5 years ] [ Designated as safety issue: No ]
- The number of participants experiencing serious adverse events [ Time Frame: From vaccination day 1 through 28 days post vaccination dose 4 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- The number of HZ cases per 1000 person-years of follow-up in the STM population [ Time Frame: From study enrollment up to approximately 5 years ] [ Designated as safety issue: No ]
- The number of HZ cases per 1000 person-years of follow-up in the HM population [ Time Frame: From study enrollment up to approximately 5 years ] [ Designated as safety issue: No ]
- Incidence of moderate to severe HZ-associated pain [ Time Frame: From HZ onset through the end of the 6 month HZ-follow-up period ] [ Designated as safety issue: No ]Moderate to severe HZ-associated pain is defined as 2 or more occurrences of a score of 3 or greater (0 to 10 scale) on the Zoster Brief Pain Inventory (ZBPI)
- Incidence of HZ complications [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]HZ complications defined as the occurrence of any of the following during the study: hospitalization or prolongation of hospitalization due to HZ, disseminated HZ (including disseminated HZ rash or VZV viremia), visceral HZ, ophthalmic HZ, neurological impairment due to HZ, or administration of intravenous acyclovir therapy for treatment of HZ.
- Incidence of postherpetic neuralgia (PHN) [ Time Frame: From HZ onset through the end of the 6 month HZ-follow-up period ] [ Designated as safety issue: No ]Postherpetic neuralgia (PHN) is defined as a worst pain score (in the last 24 hours) of 3 or greater (0 to 10 scale) on the Zoster Brief Pain Inventory (ZBPI) that persists or appears >= 90 days after the onset of the HZ rash.
| Estimated Enrollment: | 5264 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | June 2016 |
| Estimated Primary Completion Date: | June 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: V212 Arm
0.5 mL subcutaneous (SC) injection per dose, in a four dose regimen.
|
Biological: V212
V212 viral antigen for HZ, 0.5 mL SC injection per dose, in a four dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
Other Name: Inactivated Varicella-Zoster (VZV) vaccine
|
|
Placebo Comparator: Placebo Arm
0.5 mL SC injection per dose, in a four dose regimen.
|
Biological: Placebo
Vaccine stabilizer for V212 with no virus antigen, 0.5 mL SC injection per dose, in a four dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria;
- Participant has been diagnosed with an STM or HM and is not likely to undergo hematopoietic cell transplant (HCT) and:
- Participant is ≥18 years of age and receiving a cytotoxic or immunosuppressive chemotherapy regimen
- Participant is ≥ 50 years of age with a hematologic malignancy that is not in remission,
whether on therapy or not
- Participant has a life expectancy ≥ 12 months.
- Participant has prior history of varicella or antibodies to VZV due to exposure to the disease in a
country where the disease is common.
Exclusion criteria:
- Participant has a history of allergic reaction to any vaccine component (including gelatin) or an
anaphylactic/anaphylactoid reaction to neomycin.
- Participant has a prior history of HZ within 1 year of enrollment.
- Participant has received or is expected to receive any varicella or non-study zoster vaccine.
- Participant is currently receiving or expected to receive long-term antiviral prophylaxis (>4 weeks
duration) with activity against herpes simplex virus (HSV), VZV or cytomegalovirus (CMV)
- Participant is pregnant or breastfeeding or expecting to conceive within the period of 2
weeks prior to enrollment throughout 6 months after last vaccination dose.
- Participant has had any live virus vaccine administered or scheduled in the period from 4 weeks
prior to Dose 1 through 28 days post vaccination dose 4
- Participant has had inactivated vaccine administered or scheduled within the period from 7 days
prior to, through 7 days following, any dose of study vaccine.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
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: NCT01254630
Hide Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01254630
Contacts
| Contact: Toll Free Number | 1-888-577-8839 |
Hide Study Locations
Locations
| United States, California | |
| Call for Information (Investigational Site 0324) | Recruiting |
| Burbank, California, United States, 91505 | |
| Call for Information (Investigational Site 0425) | Recruiting |
| Corona, California, United States, 92879 | |
| Call for Information (Investigational Site 0380) | Recruiting |
| Fair Oaks, California, United States, 95628 | |
| Call for Information (Investigational Site 0431) | Recruiting |
| Fountain Valley, California, United States, 92708 | |
| Call for Information (Investigational Site 0430) | Recruiting |
| Highland, California, United States, 92346 | |
| Call for Information (Investigational Site 0251) | Recruiting |
| La Jolla, California, United States, 92093 | |
| Call for Information (Investigational Site 0121) | Recruiting |
| Mission Hills, California, United States, 91345 | |
| Call for Information (Investigational Site 0252) | Recruiting |
| Mission Hills, California, United States, 91345 | |
| Call for Information (Investigational Site 0433) | Recruiting |
| Orange, California, United States, 92868 | |
| Call for Information (Investigational Site 0350) | Recruiting |
| Rancho Mirage, California, United States, 92270 | |
| Call for Information (Investigational Site 0418) | Recruiting |
| Riverside, California, United States, 92501 | |
| Call for Information (Investigational Site 0354) | Recruiting |
| San Diego, California, United States, 92123 | |
| United States, Colorado | |
| Call for Information (Investigational Site 0444) | Recruiting |
| Aurora, Colorado, United States, 80012 | |
| Call for Information (Investigational Site 0304) | Recruiting |
| Englewood, Colorado, United States, 80113 | |
| United States, District of Columbia | |
| Call for Information (Investigational Site 0309) | Recruiting |
| Washington, District of Columbia, United States, 20422 | |
| United States, Florida | |
| Call for Information (Investigational Site 0028) | Recruiting |
| Miami, Florida, United States, 33135 | |
| Call for Information (Investigational Site 0243) | Recruiting |
| Miami, Florida, United States, 33175 | |
| Call for Information (Investigational Site 0284) | Recruiting |
| Miami, Florida, United States, 33169 | |
| Call for Information (Investigational Site 0340) | Recruiting |
| Miami, Florida, United States, 33142 | |
| Call for Information (Investigational Site 0419) | Recruiting |
| Orlando, Florida, United States, 32806 | |
| United States, Illinois | |
| Call for Information (Investigational Site 0024) | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Call for Information (Investigational Site 0023) | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Call for Information (Investigational Site 0454) | Recruiting |
| Chicago, Illinois, United States, 60608 | |
| Call for Information (Investigational Site 0407) | Recruiting |
| Joliet, Illinois, United States, 60436 | |
| Call for Information (Investigational Site 0443) | Recruiting |
| Rockford, Illinois, United States, 61108 | |
| Call for Information (Investigational Site 0303) | Recruiting |
| Skokie, Illinois, United States, 60076 | |
| Call for Information (Investigational Site 0386) | Recruiting |
| Skokie, Illinois, United States, 60077 | |
| United States, Indiana | |
| Call for Information (Investigational Site 0025) | Recruiting |
| Anderson, Indiana, United States, 46011 | |
| Call for Information (Investigational Site 0257) | Recruiting |
| Avon, Indiana, United States, 46123 | |
| Call for Information (Investigational Site 0427) | Recruiting |
| Indianapolis, Indiana, United States, 46237 | |
| Call for Information (Investigational Site 0442) | Recruiting |
| Kokomo, Indiana, United States, 46902 | |
| United States, Iowa | |
| Call for Information (Investigational Site 0249) | Recruiting |
| Ames, Iowa, United States, 50010 | |
| Call for Information (Investigational Site 0286) | Recruiting |
| Cedar Rapids, Iowa, United States, 52403 | |
| Call for Information (Investigational Site 0360) | Recruiting |
| Cedar Rapids, Iowa, United States, 52403 | |
| Call for Information (Investigational Site 0197) | Recruiting |
| Des Moines, Iowa, United States, 50309 | |
| Call for Information (Investigational Site 0382) | Recruiting |
| Waterloo, Iowa, United States, 50701 | |
| United States, Kansas | |
| Call for Information (Investigational Site 0199) | Recruiting |
| Wichita, Kansas, United States, 67214 | |
| United States, Louisiana | |
| Call for Information (Investigational Site 0200) | Recruiting |
| New Orleans, Louisiana, United States, 70121 | |
| United States, Maryland | |
| Call for Information (Investigational Site 0012) | Recruiting |
| Bethesda, Maryland, United States, 20817 | |
| United States, Minnesota | |
| Call for Information (Investigational Site 0282) | Recruiting |
| Duluth, Minnesota, United States, 55802 | |
| Call for Information (Investigational Site 0022) | Recruiting |
| Minneapolis, Minnesota, United States, 55417 | |
| Call for Information (Investigational Site 0202) | Recruiting |
| St. Cloud, Minnesota, United States, 56303 | |
| United States, Nebraska | |
| Call for Information (Investigational Site 0240) | Recruiting |
| Lincoln, Nebraska, United States, 68506 | |
| United States, New Jersey | |
| Call for Information (Investigational Site 0327) | Recruiting |
| Somerville, New Jersey, United States, 08876 | |
| United States, New York | |
| Call for Information (Investigational Site 0451) | Recruiting |
| Armonk, New York, United States, 10504 | |
| Call for Information (Investigational Site 0201) | Recruiting |
| Bronx, New York, United States, 10461 | |
| Call for Information (Investigational Site 0258) | Recruiting |
| Great Neck, New York, United States, 11021 | |
| Call for Information (Investigational Site 0230) | Recruiting |
| Lake Success, New York, United States, 11042 | |
| Call for Information (Investigational Site 0233) | Recruiting |
| Manhasset, New York, United States, 11030 | |
| United States, North Carolina | |
| Call for Information (Investigational Site 0342) | Recruiting |
| Asheville, North Carolina, United States, 28801 | |
| Call for Information (Investigational Site 0315) | Recruiting |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, North Dakota | |
| Call for Information (Investigational Site 0153) | Recruiting |
| Fargo, North Dakota, United States, 58122 | |
| Call for Information (Investigational Site 0301) | Recruiting |
| Fargo, North Dakota, United States, 58103 | |
| United States, Ohio | |
| Call for Information (Investigational Site 0250) | Recruiting |
| Akron, Ohio, United States, 44302 | |
| Call for Information (Investigational Site 0323) | Recruiting |
| Akron, Ohio, United States, 44304 | |
| Call for Information (Investigational Site 0422) | Recruiting |
| Canton, Ohio, United States, 44710 | |
| United States, Pennsylvania | |
| Call for Information (Investigational Site 0417) | Recruiting |
| Bethlehem, Pennsylvania, United States, 18015 | |
| Call for Information (Investigational Site 0026) | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Call for Information (Investigational Site 0016) | Recruiting |
| West Reading, Pennsylvania, United States, 19611 | |
| United States, South Carolina | |
| Call for Information (Investigational Site 0316) | Recruiting |
| Charleston, South Carolina, United States, 29406 | |
| United States, South Dakota | |
| Call for Information (Investigational Site 0241) | Recruiting |
| Rapid City, South Dakota, United States, 57701 | |
| Call for Information (Investigational Site 0151) | Recruiting |
| Sioux Falls, South Dakota, United States, 57104 | |
| Call for Information (Investigational Site 0225) | Recruiting |
| Watertown, South Dakota, United States, 57201 | |
| United States, Texas | |
| Call for Information (Investigational Site 0404) | Recruiting |
| Austin, Texas, United States, 78701 | |
| Call for Information (Investigational Site 0372) | Recruiting |
| Corpus Christi, Texas, United States, 78404 | |
| Call for Information (Investigational Site 0366) | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Call for Information (Investigational Site 0027) | Recruiting |
| Galveston, Texas, United States, 77555 | |
| Call for Information (Investigational Site 0255) | Recruiting |
| Houston, Texas, United States, 77055 | |
| Call for Information (Investigational Site 0314) | Recruiting |
| Killeen, Texas, United States, 76549 | |
| Call for Information (Investigational Site 0441) | Recruiting |
| New Braunfels, Texas, United States, 78130 | |
| Call for Information (Investigational Site 0245) | Recruiting |
| Round Rock, Texas, United States, 78665 | |
| Call for Information (Investigational Site 0317) | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Call for Information (Investigational Site 0034) | Recruiting |
| Temple, Texas, United States, 76508 | |
| Call for Information (Investigational Site 0343) | Recruiting |
| Temple, Texas, United States, 76504 | |
| United States, Utah | |
| Call for Information (Investigational Site 0313) | Recruiting |
| Salt Lake City, Utah, United States, 84106 | |
| United States, Wisconsin | |
| Call for Information (Investigational Site 0236) | Recruiting |
| La Crosse, Wisconsin, United States, 54601 | |
| Call for Information (Investigational Site 0311) | Recruiting |
| Madison, Wisconsin, United States, 53705 | |
| Argentina | |
| Merck Sharp & Dohme (Argentina) Inc. | Recruiting |
| Buenos Aires, Argentina | |
| Contact: Alfredo Wilkinson 54 11 4796 8200 | |
| Belgium | |
| MSD Belgium BVBA/SPRL | Recruiting |
| Brussels, Belgium | |
| Contact: Marc Denayer 32 2 776 60 28 | |
| Bulgaria | |
| Merck Sharp & Dohme Bulgaria EOOD | Recruiting |
| Sofia, Bulgaria | |
| Contact: Eran Gefen 38 (044) 393 74 80 | |
| Colombia | |
| MDS Colombia SAS | Recruiting |
| Bogota, Colombia | |
| Contact: Francesca Carvajal 57 1219109011090 | |
| Ecuador | |
| MSD Ecuador | Recruiting |
| Quito, Ecuador | |
| Contact: Jaime Burbano 593 2 2941-700 | |
| Estonia | |
| Merck Sharp & Dohme OU | Recruiting |
| Tallinn, Estonia | |
| Contact: Andrius Bacevicius 370 52780243 | |
| Peru | |
| Merck Sharp & Dohme, Peru S.R.L. | Recruiting |
| Lima, Peru | |
| Contact: Oscar Espinoza (51-1) 411-5100 | |
| Puerto Rico | |
| Call for Information (Investigational Site 0226) | Recruiting |
| Ponce, Puerto Rico, 00716 | |
| Call for Information (Investigational Site 0098) | Recruiting |
| San Juan, Puerto Rico, 00927 | |
| Call for Information (Investigational Site 0228) | Recruiting |
| San Juan, Puerto Rico, 00919 | |
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
More Information
No publications provided
| Responsible Party: | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT01254630 History of Changes |
| Other Study ID Numbers: | V212-011, CTRI/2012/05/002673 |
| Study First Received: | December 3, 2010 |
| Last Updated: | February 24, 2015 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Merck Sharp & Dohme Corp.:
|
Herpes zoster vaccine solid tumor malignancy |
hematologic malignancy immunocompromised herpes-zoster-related complications |
Additional relevant MeSH terms:
|
Herpes Zoster DNA Virus Infections Herpesviridae Infections Virus Diseases |
ClinicalTrials.gov processed this record on March 02, 2015