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:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-24 @ 11:52 PM
NCT ID:
NCT01245751
Eligibility Criteria:
Inclusion Criteria:
* All Groups:
* Must not have a fever of ≥100.4° F on the day of vaccination
* Any underlying chronic illness must be in stable condition
* History of varicella or residence in a VZV-endemic area for ≥30 years
* Group 1:
* 70 years of age or older
* Took part in the Shingles Prevention Study (SPS) (V211-004, NCT00007501) and received a single dose of Zoster Vaccine, Live ≥10 years prior to enrollment in this study
* Group 2:
* 70 years of age or older
* Group 3:
* 60 to 69 years of age
* Group 4:
* 50 to 59 years of age
Exclusion Criteria:
* All Groups:
* History of hypersensitivity reaction to any vaccine component or an anaphylactic/anaphylactoid reaction to neomycin
* Prior history of herpes zoster
* Pregnant or breast-feeding, or expecting to conceive within the duration of the study
* Has been treated with immunoglobulin or any blood products, other than autologous (self-donated) blood transfusion, in the 5 months prior to vaccination
* Received any other vaccine within 4 weeks prevaccination
* On immunosuppressive therapy
* Has known or suspected immune dysfunction
* Is taking any non-topical antiviral therapy with activity against herpesviruses, including, but not limited to acyclovir, famciclovir, valacyclovir, and ganciclovir.
* Groups 2, 3, and 4:
* Has previously received any varicella or zoster vaccine
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT01245751
Study Brief:
Protocol Section:
NCT01245751