NCT03500679

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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).

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	ExPEC4V	Participants will receive ExPEC4V vaccine as an IM injection on Days 1 and 181.
BIOLOGICAL	Placebo	Participants will receive placebo as an IM injection on Days 1 and 181.

Timeline

• Start date: 2018-05-09
• Primary completion: 2018-11-05
• Completion: 2019-06-11
• First posted: 2018-04-18
• Last updated: 2019-11-26
• Results posted: 2019-11-26

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study