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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-09

Study Completion Date

2019-06-11

Brief Summary

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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).

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group 1: ExPEC4V (JNJ-63871860)

Participants will receive vaccination of ExPEC4V dose as an intramuscular (IM) injection into deltoid muscle on Days 1 and 181. The ExPEC4V doses contain polysaccharide antigen (4:4:4:8 microgram \[mcg\]) from the ExPEC4V serotypes O1A, O2, O6A, and O25B.

Group Type EXPERIMENTAL

ExPEC4V

Intervention Type BIOLOGICAL

Participants will receive ExPEC4V vaccine as an IM injection on Days 1 and 181.

Group 2: Placebo

Participants will receive placebo matching to ExPEC4V as an IM injection on Days 1 and 181.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Participants will receive placebo as an IM injection on Days 1 and 181.

Interventions

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ExPEC4V

Participants will receive ExPEC4V vaccine as an IM injection on Days 1 and 181.

Intervention Type BIOLOGICAL

Placebo

Participants will receive placebo as an IM injection on Days 1 and 181.

Intervention Type BIOLOGICAL

Other Intervention Names

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JNJ-63871860

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes