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 @ 4:21 PM
Ignite Modification Date:
2025-12-24 @ 4:21 PM
NCT ID:
NCT02594566
Eligibility Criteria:
Inclusion Criteria:
* Healthy female adults, 18 to 35 years of age
* Able and willing to be followed for approximately 15 months
* Lack serum antibodies specific for CMV
* Able to provide informed consent
Exclusion Criteria:
* History of receiving any previous CMV vaccine
* Pregnant, trying to become pregnant, or breastfeeding
* Receipt or donation of blood, blood products, or plasma within 30 days of the initial injection
* Clinically significant findings from clinical evaluation or laboratory tests, evidence of medical disease(s) or medical/psychiatric condition(s), or unable to participate due to occupation or other social reasons
* Use of immunomodulatory therapy (drugs that suppress the immune system) within the past 6 months or other medications or nutritional supplements as determined by the study investigators that may interfere with the vaccine response, or increase safety risks to the participant, that have been taken within 30 days prior to the initial injection on Day 0
* Antinuclear antibody (ANA) titer \>1:80
* Body mass index (BMI) \>30
* Less than 18 years of age or older than 35 years of age
* No access to a telephone
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT02594566
Study Brief:
Protocol Section:
NCT02594566