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Immunogenicity and Safety of Two Different Commercial EV71 Vaccines

NCT03873740 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2021-07-29

No results posted yet for this study

Summary

The purpose of this study is to evaluate the immunogenicity and safety of sequential vaccination of two EV71 inactived vaccines in healthy infants aged 6-35 months.

Conditions

  • Hand, Foot and Mouth Disease

Interventions

BIOLOGICAL

EV71 inactived vaccine（Vero cells）

The EV71 inactived vaccine（Vero cells） was manufactured by Sinovac Biotech Co., Ltd.

BIOLOGICAL

EV71 inactived vaccine（Human diploid cells）

The EV71 inactived vaccine（Human diploid cells） was manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.

Sponsors & Collaborators

  • Shandong Province Centers for Disease Control and Prevention

    collaborator OTHER

  • Sinovac Biotech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • AIqiang Xu · Shandong Provincal Center for Disease Control and Preventione

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-11-06
Primary Completion
2019-01-21
Completion
2019-01-23

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 NCT03873740 on ClinicalTrials.gov