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Clinical Trial of Enterovirus 71（EV71） Inactivated Vaccine in Children Aged 36-71 Months

NCT03909074 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2022-05-26

No results posted yet for this study

Summary

The purpose of this study is to evaluate the non-inferiority of experimental EV71 vaccine compared to the control EV71 vaccine in children aged 36-71 months, to evaluate the non-inferiority of EV71 vaccine used in children aged 36-71 months compared to 6-35 months. The experimental vaccine was manufactured by Sinovac Biotech Co., Ltd, and the control vaccine was manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.

Conditions

  • Hand, Foot and Mouth Disease

Interventions

BIOLOGICAL

36-71 months old children-experimental EV71 vaccine.

Two doses experimental EV71 vaccine at the 0, 30 days vaccination schedule.

BIOLOGICAL

36-71 months old children-control EV71 vaccine.

Two doses control EV71 vaccine at the 0, 30 days vaccination schedule.

BIOLOGICAL

6-35 months old children-experimental EV71 vaccine.

Two doses experimental EV71 vaccine at the 0, 30 days vaccination schedule.

Sponsors & Collaborators

  • Sinovac Biotech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Lifen Zhang, Master · Yunnan Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-03-10
Primary Completion
2019-06-17
Completion
2019-11-13

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 NCT03909074 on ClinicalTrials.gov