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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03281174
Other study ID # PRO-EV71-4007
Secondary ID
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
Health authority
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

Study Design


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)
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