A Study in Healthy Adults to Evaluate the Safety and Immunogenicity of Different Doses of JNJ-63871860

Phase 2 Completed 848 enrolled Janssen Research & Development, LLC

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of this study is to evaluate the safety, tolerability of different doses of JNJ-63871860 (ExPEC4V) in participants greater than or equal to (\>=)18 years of age and to evaluate the dose-dependent immunogenicity of ExPEC as measured by enzyme-linked immunosorbent assay (ELISA).

Timeline

Start: 2015-11-12
Primary completion: 2016-09-12
Completion: 2019-06-21

Publications

Frenck RW Jr, Ervin J, Chu L, Abbanat D, Spiessens B, Go O, Haazen W, van den Dobbelsteen G, Poolman J, Thoelen S, Ibarra de Palacios P. Safety and immunogenicity of a vaccine for extra-intestinal pathogenic Escherichia coli (ESTELLA): a phase 2 randomised controlled trial. Lancet Infect Dis. 2019 Jun;19(6):631-640. doi: 10.1016/S1473-3099(18)30803-X. Epub 2019 May 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ExPEC4V	Vaccine	4 ug	Intramuscular
Subject	ExPEC4V	Vaccine	8 ug	Intramuscular
Subject	ExPEC4V	Vaccine	16 ug	Intramuscular

Indications

No indication recorded.