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)
|ClinicalTrials.gov Identifier: NCT01254630|
Recruitment Status : Completed
First Posted : December 6, 2010
Last Update Posted : July 28, 2017
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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 or disease||Intervention/treatment||Phase|
|Herpes Zoster||Biological: V212 Biological: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5307 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||June 24, 2011|
|Primary Completion Date :||April 11, 2017|
|Study Completion Date :||April 11, 2017|
Experimental: V212 Arm
0.5 mL subcutaneous (SC) injection per dose, in a four dose regimen.
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.
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.
Primary 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 ]
- The number of participants experiencing serious adverse events in the STM Population [ Time Frame: From vaccination day 1 through 28 days post vaccination dose 4 ]
Secondary Outcome Measures :
- Incidence of moderate to severe HZ-associated pain in the STM Population [ Time Frame: From HZ onset through the end of the 6 month HZ-follow-up period ]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 in the STM Population [ Time Frame: Approximately 5 years ]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) in the STM Population [ Time Frame: From HZ onset through the end of the 6 month HZ-follow-up period ]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.
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