Skip to main content
OpenTrials
Completed

NCT Number: NCT03281174

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hand, Foot and Mouth Disease Coxsackievirus Infections Enterovirus Infections Infections Picornaviridae Infections RNA Virus Infections Virus Diseases

Age range

6 month–35 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Sheyang Center for Disease Control and Prevention

Yancheng, Jiangsu, 210009, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The seropositive rate of EV71 neutralizing antibody-1

    Time frame: 5 years (64 months)

    Calculated based on the cutoff value of 1:8

Secondary outcomes

  1. The seropositive rate of EV71 neutralizing antibody-2

    Time frame: 5 years (64 months)

    Calculated based on the cutoff value of 1:16

  2. The seropositive rate of EV71 neutralizing antibody-3

    Time frame: 5 years (64 months)

    Calculated based on the cutoff value of 1:32

  3. The GMT of EV71 neutralizing antibody

    Time frame: 5 years (64 months)

    The GMT of EV71 neutralizing antibody 64 months after the first dose injection

Sponsors and collaborators

Lead sponsor

Sinovac Biotech Co., Ltd

Industry

Registry information

Official study title

Phase IV, Open-labelled, Five-year Immune Persistence Study of Inactivated Enterovirus Type 71 (EV71) Vaccine

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 13, 2017
Registry last updated
Sep 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.