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A Clinical Study for Inactivated Vaccine Against EV71

NCT02200237 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 366

Last updated 2017-08-18

No results posted yet for this study

Summary

This study aims to evaluate the safety, reactogenicity and immunogenicity of EV71 vaccine in health children and infants aged from 2 months to \<12yrs.

Conditions

  • Enterovirus 71 Human

Interventions

BIOLOGICAL

EV71 with adjuvant aluminium phosphate

Two arms, EV71 with aluminium phosphate

BIOLOGICAL

Placebo

Phosphate Buffer Saline with adjuvant aluminium phosphate

Sponsors & Collaborators

  • Medigen Vaccine Biologics Corp.

    lead INDUSTRY

Principal Investigators

  • Li-Min Huang, M.D., PhD. · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2017-05-31
Completion
2017-08-31

Countries

  • Taiwan

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 NCT02200237 on ClinicalTrials.gov