drugset
drugset / Trial / 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

NCT03500679 ↗

Phase 2 Completed 100 enrolled Janssen Research & Development, LLC
RandomizedParallel-groupDouble-blindPrevention

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).

Timeline

Start
2018-05-09
Primary completion
2018-11-05
Completion
2019-06-11

Drugs

EvaluationDrugModalityDoseRoute
Subject ExPEC4V Vaccine — Intramuscular

Indications

No indication recorded.