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| ID | Type | Description | Link |
|---|---|---|---|
| VAC52416BAC1002 | Other Identifier | Janssen Pharmaceutical K.K. |
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The purpose of this study is to evaluate the safety and reactogenicity of different doses of extraintestinal pathogenic Escherichia coli 10 valent (ExPEC10V) in Japanese participants greater than or equal to (>=) 60 to less than or equal to (<=) 85 years of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medium-dose ExPEC10V or Placebo: Group 1 | Experimental | Participants will be randomized to receive a single intramuscular (IM) injection of medium dose of ExPEC10V or Placebo on Day 1. |
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| High-dose ExPEC10V or Placebo: Group 2 | Experimental | Participants will be randomized to receive a single IM injection of high dose (based on safety assessment through Day 15 postvaccination of medium dose) of ExPEC10V or Placebo on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ExPEC10V | Biological | Participants will receive a single IM injection of ExPEC10V. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Solicited Local Adverse Events (AEs) Collected for 14 days post-Vaccination | Number of participants with solicited local AEs will be reported. Solicited local AEs (pain/tenderness, erythema, and swelling at the injection site) and will be noted in the participant diary for 14 days post-vaccination. | 14 days post-Vaccination (Up to Day 15) |
| Number of Participants with Solicited Systemic AEs Collected for 14 days post-Vaccination | Number of participants with solicited systemic AEs will be reported. Solicited systemic AEs (oral body temperature, headache, fatigue, nausea, and myalgia) will be noted in the participant diary for 14 days post-vaccination. | 14 days post-Vaccination (Up to Day 15) |
| Number of Participants with Unsolicited AEs From the Administration of Study Vaccine until 29 Days post-Vaccination | Number of participants with unsolicited AEs will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participants diary. | From the administration of study vaccine until 29 days post-Vaccination (Up to Day 30) |
| Number of Participants with Serious AEs from the Administration of the Study Vaccine until Day 181 | Number of participants with SAEs will be reported. A SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life threatening experience, is a congenital anomaly/birth defect, is suspected transmission of any infectious agent via a medicinal product, is medically important, and may jeopardize participant or may require medical or surgical intervention to prevent one of the outcomes listed above. | From the administration of study vaccine until 180 days post-Vaccination (Up to Day 181) |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody Titers for ExPEC10V as Determined by Multiplex ECL-based Immunoassay | Antibody titers for ExPEC10V will be determined by multiplex ECL-based immunoassay. | Days 15 and 30 |
| Antibody Titers for ExPEC10V as Determined by Multiplex Opsonophagocytic Assay (MOPA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K., Japan Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SOUSEIKAI PS Clinic | Fukuoka | 8120025 | Japan |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu
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| Placebo | Biological | Participants will receive single IM injection of matching placebo. |
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Antibody titers for ExPEC10V will be determined by MOPA. |
| Day 15 and 30 |