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

MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 183 人开始时间: 2011年6月10日最近更新: 2023年9月4日

试验速览

暂无简介。

•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
•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.

•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.

发起方

MERCK SHARP & DOHME PERU S.R.L.,