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
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Among 20 studies in Hand, Foot and Mouth Disease by Sinovac Biotech Co., Ltd — 4 open to participants now, 4 under way, 2 of them phase 3. Hand, Foot and Mouth Disease · Sinovac Biotech Co., Ltd.
Among the 20 studies in Hand, Foot and Mouth Disease by Sinovac Biotech Co., Ltd, this one is one of 3 that started in 2017, is one of 5 observational ones, and was the 7th registered.
59 studies on the registry are indexed under Hand, Foot and Mouth Disease; 10 are open to participants now.
Browse Hand, Foot and Mouth Disease studies →4 of the 20 studies in Hand, Foot and Mouth Disease by Sinovac Biotech Co., Ltd are open now, in 2 countries. Recruiting first, the newest first:
Sinovac Biotech Co., Ltd · Sites in China
Ages 6 mo–71 mo · Healthy volunteers
Sinovac Biotech Co., Ltd · Sites in Vietnam
Ages 6 mo–71 mo · Healthy volunteers
Sinovac Biotech Co., Ltd · Sites in China
Ages 6 mo–71 mo · Healthy volunteers
Sinovac Biotech Co., Ltd
Ages 6 mo–18 yrs
By country, each count listing its studies:
Of the 4 Hand, Foot and Mouth Disease studies recruiting now, 1 sets no upper age limit and 3 stop at 75 or younger; 4 take children under 18; 3 take healthy volunteers.
This study: 6 Months to 35 Months · all sexes · healthy volunteers too.
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20 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 2 · Phase 3 5 · Phase 4 6
First in 2011; this study’s year is marked. 3 started in 2017.
Median enrollment 744 across the 15 interventional studies, 600 across the 5 observational. Of the 14 that completed or were terminated, 0 (0%) have results posted.
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Sinovac Biotech Co., Ltd is the lead sponsor of 93 studies on the registry; 19 are open to participants now.
1 of the studies in Hand, Foot and Mouth Disease by Sinovac Biotech Co., Ltd that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07793175Sinovac Biotech Co., LtdBridging Clinical Trial of EV71 Vaccine in Vietnamese Children | 2027-01-09 |
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Among the 20 studies in Hand, Foot and Mouth Disease by Sinovac Biotech Co., Ltd, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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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)
Ran from May 2017 to primary completion in May 2017, 0 months.
How these figures are worked out, and which studies are left out of them.
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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Hand, Foot and Mouth Disease →