A Study to Evaluate Safety and Immunogenicity of the ExPEC4V Clinical Trial Material After a Single Intramuscular Dose and a Second Dose 6 Months Later in Healthy Participants Aged 18 Years and Older



Status:Active, not recruiting
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:1/2/2019
Start Date:May 9, 2018
End Date:May 29, 2019

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A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety and Immunogenicity of the ExPEC4V (JNJ-63871860) Clinical Trial Material After a Single Intramuscular Dose and a Second Dose 6 Months Later in Healthy Subjects Aged 18 Years and Older

The purpose of this study is to evaluate the safety/reactogenicity of the ExPEC4V clinical
trial material (CTM) after the first vaccination and to evaluate the immunogenicity of the
ExPEC4V CTM, as measured by the enzyme-linked immunosorbent assay (ELISA), 14 days after the
first vaccination (on Day 15).


Inclusion Criteria:

- Participants who provides written informed consent and signs the informed consent form
(ICF) indicating that he or she understands the purpose, procedures and potential
risks and benefits of the study, and is willing to participate in the study

- Participant is medically stable as confirmed by documented medical history, physical
examination and vital signs. Participant may have underlying illnesses such as
hypertension, diabetes, or ischemic heart disease, as long as their symptoms/signs are
medically controlled. If he/she is on medication for a condition, the medication dose
must have been stable for at least 12 weeks preceding vaccination

- Participant must have a body mass index (BMI) of less than or equal to (<=)35.0
kilogram per square meter (kg/m^2)

- Contraceptive (birth control) use by woman should be consistent with local regulations
regarding the acceptable methods of contraception for participant participating in
clinical studies

- All females of childbearing potential must have a negative urine beta-human chorionic
gonadotropin (beta-hCG) at pregnancy test on Visit 1 (pre-vaccination) and Visit 4
(prior to the second vaccination)

Exclusion Criteria:

- Participant with contraindication to intramuscular (IM) injections and blood draws,
for example, bleeding disorders

- Participant with known allergies, hypersensitivity, or intolerance to ExPEC4V or its
excipients

- Participant with abnormal function of the immune system resulting from: a) clinical
conditions (for example, autoimmune disease or immunodeficiency); b) chronic or
recurrent use of systemic corticosteroids; c) administration of antineoplastic and
immunomodulating agents or radiotherapy

- Participant has a history of neoplastic disease (excluding non-melanoma skin cancer or
carcinoma in situ of the cervix that was successfully treated) within the past 1 year
or a history of any hematological malignancy

- Participant with history of acute polyneuropathy (for example, Guillain-Barre
syndrome)

- Participant who has a history of an underlying clinically significant acute or
(uncontrolled) chronic medical condition or physical examination findings for which,
in the opinion of the investigator, participation would not be in the best interest of
the participant (for example, compromise the well-being) or that could prevent, limit,
or confound the protocol-specified assessments
We found this trial at
2
sites
1928 Alcoa Highway
Knoxville, Tennessee 37920
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Knoxville, TN
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Wichita, Kansas 67207
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Wichita, KS
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