Phase
Condition
N/ATreatment
N/AClinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant must be in stable health. Participants may have underlying illnesses suchas hypertension, diabetes, ischemic heart disease, hyperlipoproteinemia, orhypothyroidism, as long as their symptoms/signs are medically controlled. If they areon 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 ofthe study
Participant must meet the protocol defined laboratory criteria within 12 days beforeDay 1
Participant must be able to attend all scheduled visits and to comply with all studyprocedures
Participant must have a body mass index (BMI) of less than or equal to (<=) 35kilogram per square meter (kg/m^2)
A woman of childbearing potential must have a negative urine pregnancy test on Day 1before vaccination
Exclusion
Exclusion Criteria:
Participant is a woman who is pregnant, breast-feeding, or has a positive urinepregnancy test on Day 1 before vaccination, or is planning to become pregnant 3 monthsafter study vaccine administration or within 3 months after study vaccineadministration, or subject is a man who plans to father a child while enrolled in thisstudy or within 3 months after study vaccine administration
Participant has an acute illness, acute infection, or fever (body temperature greaterthan or equal to [>=] 38 degree Celsius)
Participant has a serious chronic disorder, including severe chronic obstructivepulmonary disease or clinically significant congestive heart failure, requirement forsupplemental oxygen, end stage renal disease with or without dialysis, clinicallyunstable cardiac disease, or has any condition for which, in the opinion of theinvestigator, participation would not be in the best interest of the subject (examplecompromise the well-being) or that could prevent, limit, or confound theprotocol-specified assessments
Participant has a history of neoplastic disease (excluding non-melanoma skin cancerthat was successfully treated) within the past 5 years or a history of anyhematological malignancy
Participant has known or suspected congenital or acquired immunodeficiency (includingleukemia, HIV seropositivity), has received immunosuppressive therapy (such asanti-cancer chemotherapy, radiation therapy or cytotoxic drugs), within the preceding 6 months; or long-term systemic corticosteroid therapy [prednisone or equivalent formore than 2 consecutive weeks within the past 3 months]), or has chronic activehepatitis B or hepatitis C infection, documented by hepatitis B surface antigen andhepatitis C antibody, respectively
Study Design
Study Description
Connect with a study center
Mesa, Arizona
United StatesSite Not Available
Hollywood, Florida
United StatesSite Not Available
Leesburg, Florida
United StatesSite Not Available
Miami, Florida
United StatesSite Not Available
Boise, Idaho
United StatesSite Not Available
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Meridian, Idaho
United StatesSite Not Available
Wichita, Kansas
United StatesSite Not Available
Bardstown, Kentucky
United StatesSite Not Available
Baltimore, Maryland
United StatesSite Not Available
Saint Paul, Minnesota
United StatesSite Not Available
Kansas City, Missouri
United StatesSite Not Available
Las Vegas, Nevada
United StatesSite Not Available
Cary, North Carolina
United StatesSite Not Available
Raleigh, North Carolina
United StatesSite Not Available
Cincinnati, Ohio
United StatesSite Not Available
Knoxville, Tennessee
United StatesSite Not Available
Austin, Texas
United StatesSite Not Available
Houston, Texas
United StatesSite Not Available
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