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Immunogenicity and Safety of Three Consecutive Lots of a New Inactivated Enterovirus Type 71 (EV71) Vaccine

NCT01636245 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1400

Last updated 2013-03-15

No results posted yet for this study

Summary

The purpose of this study is to evaluate the immunogenicity and safety of three consecutive lots of EV71 Vaccines in healthy infants volunteers aged from 6 months to 5 years old.

Conditions

  • Hand, Foot and Mouth Disease

Interventions

BIOLOGICAL

three consecutive lots of EV71 vaccine

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

BIOLOGICAL

placebo

placebo, two doses, 28 days interval

Sponsors & Collaborators

  • Sinovac Biotech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Yue-Mei Hu, 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
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2012-09-30
Completion
2013-02-28

Countries

  • China

Study Locations

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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 NCT01636245 on ClinicalTrials.gov