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

Not Applicable

• Registration Number: PER-014-11
• Lead Sponsor: MERCK SHARP & DOHME PERU S.R.L.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-10
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 183

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified