Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-25 @ 5:02 AM
NCT ID:
NCT00920218
Eligibility Criteria:
Inclusion Criteria:
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol;
* Male and female subjects at least 18 years old at the time of vaccination;
* Serological evidence of prior VZV infection for all subjects born in 1980 or later and for subjects born outside the US before 1980 in a tropical or sub-tropical region. No testing for serological evidence of prior VZV infection is required for US subjects born before 1980;
* Has undergone autologous HCT within the past 50-70 days for treatment of Hodgkin lymphoma, non-Hodgkin lymphoma (T or B cell), myeloma or acute myeloid leukemia, and there are no plans for additional HCTs
* Written informed consent obtained from the subject;
* If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
Exclusion Criteria:
* Use of any investigational non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period;
* Administration or planned administration of a vaccine that is not part of the study protocol since transplantation. However licensed non-replicating vaccines (i.e. inactivated and subunit vaccines, including inactivated and subunit influenza vaccines, with or without adjuvant) may be administered up to 8 days prior to dose 1;
* Administration of immunoglobulins since transplantation;
* Previous vaccination against varicella or HZ;
* History of HZ within the previous 12 months;
* Known exposure to VZV since transplantation;
* Evidence of active infection at the time of enrollment including a temperature of ≥ 37.5° C or any serious HCT-related complication;
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine;
* Hypersensitivity or intolerance to acyclovir or valacyclovir;
* Pregnant or lactating female.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00920218
Study Brief:
Protocol Section:
NCT00920218