Five-year Immune Persistence Study of Inactivated Enterovirus Type 71 (EV71) Vaccine

Completed

• Conditions: Hand, Foot and Mouth Disease

• Registration Number: NCT03281174
• Lead Sponsor: Sinovac Biotech Co., Ltd

Brief Summary

The purpose of this study is to evaluate the 5-year Immune Persistence of Inactivated Enterovirus Type 71 (EV71) Vaccine manufactured by Sinovac (Beijing) Biotech Co., Ltd.

Detailed Description

The phase III, efficacy trial of inactivated vaccine (vero cell) against EV71 has completed on March 2013 in China,and a follow up study for phase III clinical trial has completed on March 2014.

On the basis of phase III, this study is the Phase IV, open-labelled research, in order to evaluate the 5-year immune persistence of EV71 vaccine.

Study Timeline

• Study Start: 2017-05-20
• Primary Completion: 2017-05-21
• Study Completion: 2017-05-21
• Status Verified: 2017-09
• Study First Submitted: 2017-09-08
• Study First Submitted QC: 2017-09-08
• Last Update Submitted: 2017-09-08
• Study First Posted: 2017-09-13
• Last Update Posted: 2017-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 343

Inclusion Criteria

In the prior phase III clinical trial, 10077 subjects in three counties (Ganyu, Sheyang and Taixing ) were enrolled ( Experimental group: 5044; Control group: 5043 ), with 1293 of them in immunogenicity subgroup (Experimental group: 648; Control group: 645). In Sheyang county, 3351 subjects were enrolled (Experimental group: 1676 ; Control group :1675) , with 435 of them in immunogenicity subgroup (Experimental group: 418 ; Control group :418).

The subjects in Sheyang immunogenicity subgroup with the following conditions were included in this study:

• Guardian(s) of the volunteer should be capable of understanding the written consent form, and such form should be signed before the infant being included into this study
• Received at least one injection of EV71 vaccine or the placebo in the phase III clinical trial
• Finished the blood sampling 64 months after the vaccination

Exclusion Criteria

• Received extra EV71 vaccination after the phase III clinical trial
• Refused to join the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The seropositive rate of EV71 neutralizing antibody-1	5 years (64 months)	Calculated based on the cutoff value of 1:8

Secondary Outcome Measures

Name	Time	Method
The seropositive rate of EV71 neutralizing antibody-3	5 years (64 months)	Calculated based on the cutoff value of 1:32
The seropositive rate of EV71 neutralizing antibody-2	5 years (64 months)	Calculated based on the cutoff value of 1:16
The GMT of EV71 neutralizing antibody	5 years (64 months)	The GMT of EV71 neutralizing antibody 64 months after the first dose injection

Trial Locations

Locations (1)

Sheyang Center for Disease Control and Prevention; 🇨🇳 Yancheng, Jiangsu, China