A PHASE III, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER CLINICAL TRIAL TO STUDY THE SAFETY, TOLERABILITY, EFFICACY, AND IMMUNOGENICITY OF V212 IN RECIPIENTS OF AUTOLOGOUS HEMATOPOIETIC CELL TRANSPLANTS (HCT)

MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 12 人开始时间: 2011年2月23日最近更新: 2023年9月4日

适应症

试验速览

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•The patient is> 18 years old on the day of signing the informed consent.
•The patient has a previous history of chickenpox, VZV antibodies (documented before receiving blood products), or resides in a country with VZV endemic infection for> 30 years or, if the patient is <30 years old, attended a Primary or secondary school in a country with VZV endemic infection.
•The patient is scheduled to undergo an autologous HCT for the treatment of lymphoma or other indication, including any other malignancy or an indication that is not a malignancy within 60 days of enrollment.
•The patient is highly unlikely to conceive for a period of time from 2 weeks prior to enrollment until 6 months after the last dose of vaccination,
•All potentially fertile female patients should have a serum or urine pregnancy test with a negative result.
•The patient understands the study procedures and agrees to participate in the study by providing written informed consent.
•The patient can understand and fill out the study questionnaires.

•The patient has a history of hypersensitivity reaction to any component of the vaccine, such as gelatin or neomycin (a history of neomycin contact dermatitis is not a criterion for exclusion from the study).
•The patient has a previous history of HZ within 1 year of enrollment.
•The patient has a previous history of receiving any vaccine against chickenpox or shingles.
•The patient has had more than 2 relapses of their underlying cancer. If the underlying cancer of the patient is Hodgkin lymphoma, more than 2 relapses are allowed.
•The patient is expected to undergo a tandem transplant procedure.
•The patient is expected to receive> 6 months (> I80 days) of prophylactic antiviral therapy after HCT.
•The patient is pregnant or breastfeeding or expects to conceive within the period of 2 weeks prior to enrollment until 6 months from the last dose of vaccination.
•The patient has received a live virus vaccine or is scheduled to receive a live virus vaccine in the period from 4 weeks prior to Dose 1 to 28 days Postdose 4.
•The patient has received an inactivated vaccine or is scheduled to receive an inactivated vaccine in the period between 7 days before and 28 days after Dose 1 to 4.
•The patient is unlikely to adhere to study procedures or keep appointments.
•Any other reason that, in the opinion of the researcher, could interfere with the evaluation required by the study.

发起方

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