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An Immunity Persistence Study of Enterovirus 71 Inactivated Vaccine (Vero Cell)

NCT05397587 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 474

Last updated 2022-06-10

No results posted yet for this study

Summary

This is an open，observational and follow-up clinical trial based on the clinical trial of EV71 vaccine extended age group.The purpose of this study is to evaluate the immunity persistence of EV71 vaccine developed by Sinovac Biotech Co., Ltd in subjects aged 6 \~71 months after full immunization of two doses of vaccine.

Conditions

  • Hand, Foot and Mouth Disease

Interventions

BIOLOGICAL

Experimental Vaccine

The EV71 vaccine was manufactured by Sinovac Biotech Co., Ltd and inactivated EV71 virus antigen was no less than 3.0EU in 0.5 mL of aluminium hydroxide solution per injection.

BIOLOGICAL

Control Vaccine

The EV71 vaccine was manufactured by Institute of Medical Biology,Chinese Academy of Medical Sciences ,and inactivated EV71 virus antigen was no less than 3.0EU in 0.5 mL of aluminium hydroxide solution per injection.

Sponsors & Collaborators

  • Sinovac Biotech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Yan Zheng, Master · Yunnan 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
2022-07-30
Primary Completion
2025-07-30
Completion
2025-10-30

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 NCT05397587 on ClinicalTrials.gov