An observational study in Hand, Foot and Mouth Disease, sponsored by Sinovac Biotech Co., Ltd. Completed at 1 site in China. Open to participants aged 6 Months to 35 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-13.
Sponsored by Sinovac Biotech Co., Ltd · Observational
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.
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.
The studied subjects are infants aged 6-35 months old infants when enrolled into the phase III clinical trial, and they are children aged 6-8 years old five years after the EV71 vaccine /placebo injection.
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:
Exclusion Criteria:
The group which received two doses EV71 vaccine (400U/0.5ml) on day 0,28 in phase III clinical trial.
The group which received two doses placebo (0U/0.5ml) on day 0,28 in phase III clinical trial.
The seropositive rate of EV71 neutralizing antibody-1
Calculated based on the cutoff value of 1:8
Time frame: 5 years (64 months)
The seropositive rate of EV71 neutralizing antibody-2
Calculated based on the cutoff value of 1:16
Time frame: 5 years (64 months)
The seropositive rate of EV71 neutralizing antibody-3
Calculated based on the cutoff value of 1:32
Time frame: 5 years (64 months)
The GMT of EV71 neutralizing antibody
The GMT of EV71 neutralizing antibody 64 months after the first dose injection
Time frame: 5 years (64 months)
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Sinovac Biotech Co., Ltd