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Safety and Immunogenicity of CJ-40010 in Healthy Subjects

NCT04182932 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-12-03

No results posted yet for this study

Summary

This study aims to evaluate the safety and immunogenicity of CJ-40010 after administration in healthy subjects

Conditions

  • Hand, Foot and Mouth Disease

Interventions

BIOLOGICAL

CJ-40010 EV71 vaccine A dose

Inactivated vaccine against EV71, three doses, 28 days interval

BIOLOGICAL

CJ-40010 EV71 vaccine B dose

Inactivated vaccine against EV71, three doses, 28 days interval

BIOLOGICAL

CJ-40010 CVA16 vaccine C dose

Inactivated vaccine against CVA16, three doses, 28 days interval

BIOLOGICAL

CJ-40010 CVA16 vaccine D dose

Inactivated vaccine against CVA16, three doses, 28 days interval

BIOLOGICAL

CJ-40010 Bivalent vaccine E dose

Inactivated vaccine against EV71/CVA16, three doses, 28 days interval

BIOLOGICAL

CJ-40010 Bivalent vaccine high dose

Inactivated vaccine against EV71/CVA16, three doses, 28 days interval

BIOLOGICAL

Placebo

Placebo, three doses, 28 days interval

Sponsors & Collaborators

  • HK inno.N Corporation

    lead INDUSTRY

Principal Investigators

  • In-Jin Jang · Seoul National University Hospital, Dept. of Clinical Pharmacology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
19 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-02
Primary Completion
2021-11-30
Completion
2021-12-31

Countries

  • South Korea

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 NCT04182932 on ClinicalTrials.gov