Hand, Foot and Mouth Disease
Conditions
Keywords
Inactivated Enterovirus Type 71 (EV71) Vaccine, 5-year Immune Persistence
Brief 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.
Detailed 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.
Interventions
None listed
Sponsors
Sinovac Biotech Co., Ltd
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Months to 35 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The seropositive rate of EV71 neutralizing antibody-1 | 5 years (64 months) | Calculated based on the cutoff value of 1:8 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The seropositive rate of EV71 neutralizing antibody-2 | 5 years (64 months) | Calculated based on the cutoff value of 1:16 |
| The seropositive rate of EV71 neutralizing antibody-3 | 5 years (64 months) | Calculated based on the cutoff value of 1:32 |
| The GMT of EV71 neutralizing antibody | 5 years (64 months) | The GMT of EV71 neutralizing antibody 64 months after the first dose injection |
Countries
China
Outcome results
None listed