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Safety and Immunogenicity of Concomitant Administration of EV71 Vaccine With Expanded Programme on Immunization Vaccines

NCT04111432 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 372

Last updated 2021-07-29

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and immunogenicity of concomitant administration of EV71 vaccine with measles mumps, and rubella combined live attenuated vaccine/ encephalitis live attenuated vaccine.

Conditions

  • Hand, Foot and Mouth Disease

Interventions

BIOLOGICAL

Concomitant administration of EV71vaccine with EPI vaccines

The investigated EV17 vaccine was manufactured by Sinovac Biotech Co., Ltd.# the MMR vaccine was manufactured by Shanghai Institute of Biological Products Co.,Ltd.; the Live attenuated Japanese encephalitis vaccine was manufactured by Chengdu Institute of Biological Products Co.,Ltd.

BIOLOGICAL

Single injection of EPI vaccine

The MMR vaccine was manufactured by Shanghai Institute of Biological Products Co.,Ltd.; the Live attenuated Japanese encephalitis vaccine was manufactured by Chengdu Institute of Biological Products Co.,Ltd.

BIOLOGICAL

EV71 Vaccine only

The investigated EV17 vaccine was manufactured by Sinovac Biotech Co., Ltd.

Sponsors & Collaborators

  • Shaanxi Provincial Center for Disease Control and Prevention

    collaborator OTHER

  • Sinovac Biotech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Shaobai Zhang · Shaanxi Provincal Center for Disease Control and Preventione

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-26
Primary Completion
2019-11-25
Completion
2020-03-25

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 NCT04111432 on ClinicalTrials.gov