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 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT01229267
Eligibility Criteria:
Inclusion Criteria:
* Has prior history of varicella, antibodies to VZV (documented prior to receipt of blood products), or residence in a country with endemic VZV infection for ≥30 years or if participant is \<30 years old, attended primary or secondary school in a country with endemic VZV infection.
* Scheduled to undergo an autologous hematopoietic cell transplant within 60 days of enrollment
* Is highly unlikely to conceive during the time period starting 2 weeks prior to enrollment through 6 months from last vaccination dose
* Female participants of childbearing potential must have a negative serum or urine
pregnancy test.
Exclusion Criteria:
* History of hypersensitivity reaction to any vaccine component
* Prior history of herpes zoster within 1 year of enrollment
* Prior receipt of any varicella or zoster vaccine
* More than 2 relapses of the underlying cancer (participants with Hodgkin's lymphoma may have had more than 2 relapses)
* Expectation of tandem transplant procedure
* Is expected to receive \>6 months (\>180 days) of prophylactic antiviral therapy post-HCT.
* Is pregnant or breastfeeding or expecting to conceive within the period of 2 weeks prior to enrollment through 6 months from last vaccination dose.
* 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 through 28 days Postdose 4.
* Has received an inactivated vaccine or is scheduled to receive an inactivated vaccine in the period between 7 days prior to and 28 days following Doses 1 through 4.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01229267
Study Brief:
Protocol Section:
NCT01229267