Overview

This trial is active, not recruiting.

Condition herpes zoster
Treatments v212, placebo
Phase phase 3
Sponsor Merck Sharp & Dohme Corp.
Start date June 2011
End date February 2017
Trial size 5264 participants
Trial identifier NCT01254630, CTRI/2012/05/002673, V212-011

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
0.5 mL subcutaneous (SC) injection per dose, in a four dose regimen.
v212 Inactivated Varicella-Zoster (VZV) vaccine
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.
(Placebo Comparator)
0.5 mL SC injection per dose, in a four dose regimen.
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.

Primary Outcomes

Measure
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 Outcomes

Measure
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
Incidence of HZ complications in the STM Population
time frame: Approximately 5 years
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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..