A Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine

NCT01268787 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-04-16

No results posted yet for this study

Summary

This study is aims to evaluate the safety, reactogenicity and immunogenicity of EV71 vaccine at a 0.25ml or 0.5ml dose in health volunteers

Conditions

  • Enterovirus Infection

Interventions

BIOLOGICAL

EV71 vaccine

Two-vaccination 0.25ml or 0.5ml dose assigned to two groups.

Sponsors & Collaborators

  • National Health Research Institutes, Taiwan

    lead OTHER

Principal Investigators

  • Pele Chong, Ph.D. · National Health Research Institutes, Taiwan

  • Chia-Chyi Liu, Ph.D. · National Health Research Institutes, Taiwan

  • C P Fung, M.D. · Taipei Veterans General Hospital, Taiwan

  • S M Hsieh, M.D · Taipei Meidcal College

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2012-03-31
Completion
2012-09-30

Countries

  • Taiwan

Study Locations

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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 NCT01268787 on ClinicalTrials.gov