NCT02748967

A Study to Evaluate the Safety and Immunogenicity of Different Doses of ExPEC4V (JNJ-63871860) in Healthy Japanese Adult Participants

Randomized, Double-Blind, Placebo-controlled Phase 1 Study in Healthy Japanese Adult Subjects to Evaluate the Safety and Immunogenicity of Different Doses of JNJ-63871860

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Janssen Pharmaceutical K.K. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ExPEC4V	Participant will receive single dose 0.5 ml of ExPEC4V as intramuscular injection on Day 1.
DRUG	Placebo	Participant will receive single dose of Placebo on Day 1.

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2016-04-22
• Last updated: 2016-10-04

Locations

1 site across 1 country: Japan