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 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT03843632
Eligibility Criteria:
Inclusion Criteria:
* has a negative clinical history for varicella and herpes zoster
* females of reproductive potential have a negative pregnancy test prior to each study vaccination
* females of reproductive potential remain abstinent or use 2 acceptable methods of birth control during study until 3 months following last study vaccination
* females not of reproductive potential do not require a pregnancy test or use of contraceptives
* legal representative of adult or parent of children understands risks involved with, consent to participate in, and comply with the study procedures
Exclusion Criteria:
* has a history of allergy or anaphylactic reaction to neomycin, gelatin, or any component of VARIVAX\^TM
* has received any form of varicella or herpes zoster vaccine at any time prior to study, or anticipates receiving any during study
* has received immune globulin, a blood transfusion or blood derived products within prior 5 months or plans to do so during study
* has received aspirin or any aspirin-containing products within prior 14 days
* has been exposed to varicella or herpes zoster in the prior 4 weeks involving playmate, hospital or continuous household contact, or had contact with a newborn whose mother had chickenpox 5 days before or 2 days after delivery
* has, or lives with a person who has, any congenital or acquired immune deficiency, neoplastic disease, or depressed immunity including those resulting from corticosteroid use or other immunosuppressive therapy
* has received glucocorticosteroids for more than 5 consecutive days within prior 3 months, or any dose of glucocorticoids within prior 7 days, or expects to use glucocorticosteroids during the study
* was vaccinated with licensed non-live or live vaccine within prior 30 days or expects vaccination during 42 day follow-up postvaccination period
* had a fever within 72 hours prior to study vaccination
* has participated in another trial within prior 30 days, is currently participating in another trial, or plans to participate in another trial during the planned study period for this trial
* is pregnant or nursing
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
75 Years
Study:
NCT03843632
Study Brief:
Protocol Section:
NCT03843632