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A Study to Evaluate the Different Doses of VAC52416 (ExPEC10V) in Japanese Adults

NCT04306302 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-01-20

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and reactogenicity of different doses of extraintestinal pathogenic Escherichia coli 10 valent (ExPEC10V) in Japanese participants greater than or equal to (\>=) 60 to less than or equal to (\<=) 85 years of age.

Conditions

  • Healthy

Interventions

BIOLOGICAL

ExPEC10V

Participants will receive a single IM injection of ExPEC10V.

BIOLOGICAL

Placebo

Participants will receive single IM injection of matching placebo.

Sponsors & Collaborators

  • Janssen Pharmaceutical K.K.

    lead INDUSTRY

Principal Investigators

  • Janssen Pharmaceutical K.K., Japan Clinical Trial · Janssen Pharmaceutical K.K.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-13
Primary Completion
2020-12-24
Completion
2020-12-24

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04306302 on ClinicalTrials.gov