A Follow-up Study for a Phase III, Efficacy Trial in Inactivated Enterovirus Type 71 (EV71) Vaccine

Completed

• Conditions: Hand, Foot and Mouth Disease
• Interventions: Biological: EV71 vaccine

• Registration Number: NCT02001233
• Lead Sponsor: Sinovac Biotech Co., Ltd

Brief Summary

The purpose of this follow-up study is to evaluate the two-year efficacy, immunogenicity and safety of EV71 Vaccines in preventing Hand, Foot and Mouth disease caused by EV71 in a total 10,000 healthy infants volunteers aged from 6 to 35months old.

Detailed Description

The phase III, efficacy trial of inactivated vaccine (vero cell) against EV71 has completed on March 2013 in China. The data from the phase III study suggested that the inactivated EV71 vaccine had protection effects on healthy Chinese infants against Hand, Foot and Mouth disease caused by EV71 within one-year surveillance period, and had clinically acceptable safety and good one-year immune persistence.

This study is the phase III, open-labelled, follow-up research, in order to evaluate the two-year efficacy, safety and immune persistence.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-11-27
• Study First Submitted QC: 2013-11-27
• Study First Posted: 2013-12-04
• Primary Completion: 2014-03
• Study Completion: 2014-10
• Status Verified: 2015-05
• Last Update Submitted: 2022-05-25
• Last Update Posted: 2022-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10077

Inclusion Criteria

• All subjects vaccinated at least one injection of EV71 vaccine or the placebo in the phase III efficacy trial.

Exclusion Criteria

• subjects who refuse to continue in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EV71 Vaccine	EV71 vaccine	Inactivated vaccine (vero cell) against EV71 of 400U /0.5ml in 5000 infants aged 6-35 months old on day0,28

Primary Outcome Measures

Name	Time	Method
The incidence rate of Hand, Foot and Mouth disease caused by EV71 within the second year observation period after the second vaccination	Within the second year after the second vaccination	to evaluate the efficacy of EV71 vacccine against HFMD caused by EV71

Secondary Outcome Measures

Name	Time	Method
The GMT of anti-EV71 antibodies in serum two years after second vaccination	26 months after second vaccination	to evaluate the immune persistence of anti-EV71 antibodies in serum
Frequency of serious adverse events (SAEs) with the second year after the second vaccination	within the second year after the second vaccination	Frequency of serious adverse events in healthy infants during the oney-year follow-up period

Trial Locations

Locations (3)

Ganyu; 🇨🇳 Lianyungang, Jiangsu, China

Taixing; 🇨🇳 Taizhou, Jiangsu, China

Sheyang; 🇨🇳 Yancheng, Jiangsu, China