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Efficacy Trial of a Commercial EV71 Vaccine

NCT03903926 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15500

Last updated 2021-07-27

No results posted yet for this study

Summary

The purpose of this post-marketing study is to evaluate the efficacy, immunogenicity, and safety of the EV71 vaccine post marketing, and explore the protective levels of various enterovirus neutralizing antibodies

Conditions

  • Hand, Foot and Mouth Disease

Interventions

BIOLOGICAL

5000 volunteers (6-35 months)-EV71 vaccine

two doses EV71 vaccines will be administrated on day 0, 30 respectively

Sponsors & Collaborators

  • Sinovac Biotech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Xuhua Guan, Doctor · Hubei Provincial Center for Disease Control and Prevention

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-03-26
Primary Completion
2020-06-30
Completion
2020-10-30

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 NCT03903926 on ClinicalTrials.gov