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| ID | Type | Description | Link |
|---|---|---|---|
| 63871860BAC1001 | Other Identifier | Janssen Pharmaceutical K.K., Japan |
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The purpose of this study is to assess the safety and tolerability of different doses of ExPEC4V (JNJ-63871860) in healthy Japanese participants greater than or equal to [> =] 20 years of age.
This is a Phase 1 double-blind (neither the Investigator nor the participant know the treatment), randomized (the study medication is assigned by chance), placebo-controlled (an inactive substance that is compared with a medication to test whether the medication has a real effect in a clinical study) parallel group, single center study in healthy Japanese participants aged greater than or equal to [> =] 20 years. A target of approximately 48 participants will be enrolled that are stratified according to their age in 2 groups: 24 participants > = 20 to less than [<] 50 years of age and 24 participants > = 50 years of age. Both groups will be randomized to a single vaccination with 1 of the 3 study dose levels of ExPEC4V or placebo (vaccine buffer). Participants will be enrolled in a dose ascending approach. Blood samples will be drawn on Days 1 (prevaccination), 15 and 30 for the assessment of immunogenicity. The study duration per participant will be approximately 38 days (Screening period and postvaccination follow-up included). Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Participants with age (greater than or equal to [>=] 20 to less than [<] 50 years) will receive single dose of 0.5 milliliter (mL) of ExPEC4V (4:4:4:4) or placebo on Day 1. |
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| Group 2 | Experimental | Participants with age >= 20 to < 50 will receive single dose of 0.5 mL of ExPEC4V (8:8:8:8) or placebo on Day 1. |
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| Group 3 | Experimental | Participants with age >= 20 to < 50 will receive single dose of 0.5 mL of ExPEC4V (16:16:16:16) or placebo on Day 1. |
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| Group 4 | Experimental | Participants with age greater than or equal to [>=] 50 will receive single dose of 0.5 mL of ExPEC4V (4:4:4:4) or placebo on Day 1. |
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| Group 5 | Experimental | Participants with age >= 50 will receive single dose of 0.5 mL of ExPEC4V (8:8:8:8) or placebo on Day 1. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ExPEC4V | Drug | Participant will receive single dose 0.5 ml of ExPEC4V as intramuscular injection on Day 1. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to follow-up (30 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody Levels Against the ExPEC4V Measured by an Enzyme-Linked Immunosorbent Assay (ELISA) | Up to Day 30 | |
| Antibody Levels Against the ExPEC4V Measured by Opsonophagocytic Killing (OPK) Assay | Up to Day 30 |
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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 |
|---|---|---|---|---|---|---|
| Fukuoka | Japan |
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| Group 6 | Experimental | Participants with age >= 50 will receive single dose of 0.5 mL of ExPEC4V (16:16:16:16) or placebo on Day 1. |
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| Placebo | Drug | Participant will receive single dose of Placebo on Day 1. |
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