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An Efficacy Trial in Inactivated Enterovirus Type 71 (EV71) Vaccine

NCT01507857 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 10077

Last updated 2013-11-28

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy, immunogenicity and safety of EV71 Vaccines in preventing Hand, Foot and Mouth disease caused by EV71 in a total 10,000 healthy infants volunteers aged from 6 to 35months old.

Conditions

  • Hand, Foot and Mouth Disease

Interventions

BIOLOGICAL

400U /0.5ml EV71 vaccine

inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval

BIOLOGICAL

0/0.5ml placebo

0/0.5ml placebo, two doses, 28 days interval

Sponsors & Collaborators

  • Sinovac Biotech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Hua Wang, BS · Jiangsu Center for Diseases Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
35 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • China

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 NCT01507857 on ClinicalTrials.gov