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 @ 2:05 AM
Ignite Modification Date:
2025-12-25 @ 2:05 AM
NCT ID:
NCT02546960
Eligibility Criteria:
Inclusion Criteria:
* Participant must be in stable health. Participants may have underlying illnesses such as hypertension, diabetes, ischemic heart disease, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms/signs are medically controlled. If they are on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination and is expected to remain stable for the duration of the study
* Participant must meet the protocol defined laboratory criteria within 12 days before Day 1
* Participant must be able to attend all scheduled visits and to comply with all study procedures
* Participant must have a body mass index (BMI) of less than or equal to (\<=) 35 kilogram per square meter (kg/m\^2)
* A woman of childbearing potential must have a negative urine pregnancy test on Day 1 before vaccination
Exclusion Criteria:
* Participant is a woman who is pregnant, breast-feeding, or has a positive urine pregnancy test on Day 1 before vaccination, or is planning to become pregnant 3 months after study vaccine administration or within 3 months after study vaccine administration, or subject is a man who plans to father a child while enrolled in this study or within 3 months after study vaccine administration
* Participant has an acute illness, acute infection, or fever (body temperature greater than or equal to \[\>=\] 38 degree Celsius)
* Participant has a serious chronic disorder, including severe chronic obstructive pulmonary disease or clinically significant congestive heart failure, requirement for supplemental oxygen, end stage renal disease with or without dialysis, clinically unstable cardiac disease, or has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (example compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
* Participant has a history of neoplastic disease (excluding non-melanoma skin cancer that was successfully treated) within the past 5 years or a history of any hematological malignancy
* Participant has known or suspected congenital or acquired immunodeficiency (including leukemia, HIV seropositivity), has received immunosuppressive therapy (such as anti-cancer chemotherapy, radiation therapy or cytotoxic drugs), within the preceding 6 months; or long-term systemic corticosteroid therapy \[prednisone or equivalent for more than 2 consecutive weeks within the past 3 months\]), or has chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen and hepatitis C antibody, respectively
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02546960
Study Brief:
Protocol Section:
NCT02546960