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

Hand, Foot and Mouth Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03281174
• Other study ID #: PRO-EV71-4007
• Status: Completed
• Phase: N/A
• First received: September 8, 2017
• Last updated: September 8, 2017
• Start date: May 20, 2017
• Est. completion date: May 21, 2017

Study information

• Verified date: September 2017
• Source: Sinovac Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 343
• Est. completion date: May 21, 2017
• Est. primary completion date: May 21, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 35 Months

Eligibility

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

Related Conditions & MeSH terms

• Enterovirus Infections
• Hand, Foot and Mouth Disease
• Mouth Diseases

Locations

Country	Name	City	State
China	Sheyang Center for Disease Control and Prevention	Yancheng	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Sinovac Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The seropositive rate of EV71 neutralizing antibody-1	Calculated based on the cutoff value of 1:8	5 years (64 months)
Secondary	The seropositive rate of EV71 neutralizing antibody-2	Calculated based on the cutoff value of 1:16	5 years (64 months)
Secondary	The seropositive rate of EV71 neutralizing antibody-3	Calculated based on the cutoff value of 1:32	5 years (64 months)
Secondary	The GMT of EV71 neutralizing antibody	The GMT of EV71 neutralizing antibody 64 months after the first dose injection	5 years (64 months)