None listed
Conditions
Interventions
THE STUDY WILL ENROLL PATIENTS WHO ARE 18 YEARS OF AGE AND OIDER WHO HAVE EITHER STM OR HM AND ARE RECEIVING CHEMOTHERAPY, V212 EXCLUDING ANTI-CD20 MONOCLONAL, ANTIBODY THERAPY. PATIENTS WHO HAVE RECE
OF ANTI-CD20 MONODONAL ANTIBODY THERAPY. IN ADDITION, PATIENTS 50 YEARS OF AGE AND OIDER WHO HAVE HM, NOT IN REMISSION, WILL BE ENROLLED REGARDLESS OF WHETHER THEY ARE RECEIVING CHEMOTHERAPY.
APPRO
2632 IN THE PLACEBO GROUP), 18 YEARS OF AGE OR OIDER WILL BE RANDOMIZED TO RECEIVE EITHER V212 OR PLACEBO GIVEN AS A 4-DOSE REGIMEN ADMINISTERED 30 DAYS APART. RANDOMIZATION WILL BE STRATIFIED BY BASE
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. PATIENT HAS BEEN DIAGNOSED WITH A SOLID TUMOR OR HEMATOLOGIC MALIGNANCY AND IS NOT LIKELY TO UNDERGO HEMATOPOIETIC CELL TRANSPLANT (HCT) AND MEETS ONE OF THE CRITERIA SPECIFIED BELOW. • LS 18 YEARS OF AGE OR OIDER AND IS RECEIVING A CYTOTOXIC OR IMMUNOSUPPRESSIVE CHEMOTHERAPY REGIMEN THAT DOES NOT INCLUDE AN ANTI-CD20 MONOCLONAL ANTIBODV • LS 50 YEARS OF AGE AR OIDER WITH A HEMATOLOGIC MALIGNANCY, NOT! IN REMISSION, REGARDLESS OF WHETHER THE PATIENT IS OR IS NOT RECEIVING CHEMOTHERAPY AND • LS NOT RECEIVING AND NOT EXPECTED TO REQUIRE ANTI-CD20 MONOCLONAL ANTIBODY THERAPY BEGINNING 3 MONTHS PRIOR TO ENROLLMENT THROUGH 28 DAYS POSTVACCINATION DOSE 4. 2. LIFE EXPECTANCY ≥ 12 MONTHS. 3. SIGNED AN INFORMED CONSENT PRIOR TO ANY STUDY PROCEDURES. 4. PATIENT HAS PRIOR HISTORY OF VARICELLA, ANTIBODIES TO VZV (DOCUMENTED PRIOR TO RECEIPT OF BLOOD PRODUCTS), OR RESIDENCE (FOR ≥ 30 YEARS) IN A COUNTRY WITH ENDEMIC VZV INFECTION, OR IF PARTICIPANT IS <30 YEARS OLD, ATTENDED PRIMARY OR SECONDARY SCHOOL IN A COUNTRY WITH ENDEMIC VZV INFECTION (SEE SECTION 3.2.8 FOR MORE DETAILS). 5. ALL FEMALE PATIENTS OF CHILDBEARING POTENTIAL (AS DEFINED BELOW UNDER #7) MUST HAVE A NEGATIVE SERUM OR URINE PREGNANCY TEST (SENSITIVE TO 25IU Β-HCG). 6. ABLE TO UNDERSTAND AND COMPLETE STUDY QUESTIONNAIRES.
Exclusion criteria
Exclusion criteria: 1. A HISTORY OF ALLERGIC REACTION TO ANY VACCINE COMPONENT (INCLUDING GELATIN) OR AN ANAPHYLACTIC/ANAPHYLACTOID REACTION TO NEOMYCIN (A HISTORY OF CONTACT DERMATITIS TO NEOMYCIN IS NOT A CRITERION FOR STUDY EXCLUSION). 2. PRIOR HISTORY OF HZ WITHIN 1 YEAR OF ENROLLMENT. 3. PRIOR OR EXPECTED RECEIPT OF ANY VARICELLA OR NON-STUDY ZOSTER VACCINE. 4. PATIENT IS CURRENTLY RECEIVING OR EXPECTED TO RECEIVE LONG-TERM ANTIVIRAL PROPHYLAXIS (GREATER THAN 4 WEEKS DURATION) WITH ACTIVITY AGAINST HERPES SIMPLEX VIRUS (HSV), VZV OR CYTOMEGALOVIRUS (CMV). 5. PATIENT IS RECEIVING OR EXPECTED TO RECEIVE A CHEMOTHERAPY REGIMEN CONTAINING AN ANTI-CD20 MONOCIONAL ANTIBODY AT ANY TIME DURING THE TIME PERIOD BEGINNING 3 MONTHS PRIOR TO ENROLLMENT THROUGH 28 DAYS POSTVACCINATION DOSE 4. 6. PATIENT IS PREGNANT OR BREASTFEEDING OR EXPECTING TO CONCEIVE WITHIN THE PERIOD OF 2 WEEKS PRIOR TO ENROLLMENT THROUGHOUT 6 MONTHS AFTER LAST VACCINATION CLOSE. 7. ANY LIVE VIRUS VACCINE ADMINISTERED OR SCHEDULED IN THE PERIOD FROM 4 WEEKS PRIOR TO DOSE 1 THROUGH 28 DAYS POSTVACCINATION DOSE 4. 8. ANY INACTIVATED VACCINE ADMINISTERED OR SCHEDULED WITHIN THE PERIOD FROM 7 DAYS PRIOR TO, THROUGH 7 DAYS FOLLOWING, ANY DOSE OF STUDY VACCINE.
Countries
Arabia Saudi, Argentina, Australia, Austria, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Ecuador, Estonia, France, Germany, Greece, Honduras, Italy, Jordan, Korea South, Lebano, Lithuania, Mexico, New Zealand, Panama, Philippines, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Taiwan, Thailand, Turkey, United Kindgdom, United States
Contacts
Public ContactJorge Timoteo
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed