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 @ 2:00 PM
Ignite Modification Date:
2025-12-24 @ 2:00 PM
NCT ID:
NCT02180295
Eligibility Criteria:
Inclusion Criteria:
* Afebrile (\<=100.4 °F \[\<=38.0 °C\]) oral or equivalent on Day 1 before the first vaccination
* Any underlying chronic illness that is not in stable condition
* History of varicella, antibodies to VZV, or residence (for \>=30 years) in a country with endemic VZV infection
* Female participants of childbearing potential must have a negative pregnancy test. A female not of reproductive potential has reached natural menopause, or is 6-weeks postsurgical bilateral oophorectomy and/or hysterectomy or bilateral tubal ligation
* Male, or female of childbearing potential who agrees to remain abstinent or use 2 acceptable methods of birth control from 2 weeks before enrollment to 6 months after the last study vaccination
Exclusion Criteria:
* History of allergic reaction to any vaccine component, or an anaphylactic/anaphylactoid reaction to neomycin (not including contact dermatitis to neomycin)
* Prior history of herpes zoster
* History of receipt or expects to receive any varicella or zoster vaccine during the study period
* Is pregnant or breastfeeding, or expects to conceive from 2 weeks before enrollment to 6 months after the last study vaccination
* Has received a live virus vaccine or is scheduled to receive any live virus vaccine from 4 weeks before the first dose of study vaccination and throughout the study
* Has received any inactivated vaccine or is scheduled to receive any inactivated vaccine from 7 days before to 7 days after any study vaccination
* Received immunoglobulin or any blood products or is scheduled to receive them from 5 months before the first dose of study vaccination and throughout the study
* Has participated in an investigational drug or vaccine study within 30 days before enrollment
* Has any acute illness or significant underlying illness that may interfere with interpretation of the study
* Receiving immunosuppressive therapy (including systemic corticosteroid doses exceeding physiological replacement doses within 14 days prior to the first vaccination), except topical, ophthalmic, or inhaled corticosteroids or intra-articular or soft-tissue injections of steroids
* Has known or suspected immune dysfunction
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
59 Years
Study:
NCT02180295
Study Brief:
Protocol Section:
NCT02180295