An observational study in Hand, Foot and Mouth Disease, sponsored by Sinovac Biotech Co., Ltd. Completed at 3 sites in China. Open to participants aged 6 Months to 35 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-26.
Sponsored by Sinovac Biotech Co., Ltd · Observational
The purpose of this follow-up study is to evaluate the two-year efficacy, immunogenicity and safety of EV71 Vaccines in preventing Hand, Foot and Mouth disease caused by EV71 in a total 10,000 healthy infants volunteers aged from 6 to 35months old.
The phase III, efficacy trial of inactivated vaccine (vero cell) against EV71 has completed on March 2013 in China. The data from the phase III study suggested that the inactivated EV71 vaccine had protection effects on healthy Chinese infants against Hand, Foot and Mouth disease caused by EV71 within one-year surveillance period, and had clinically acceptable safety and good one-year immune persistence.
This study is the phase III, open-labelled, follow-up research, in order to evaluate the two-year efficacy, safety and immune persistence.
59 studies on the registry are indexed under Hand, Foot and Mouth Disease; 11 are open to participants now.
Browse Hand, Foot and Mouth Disease studies →Sinovac Biotech Co., Ltd is the lead sponsor of 93 studies on the registry; 19 are open to participants now.
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Healthy Chinese infants aged 6 to 35 months old
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Exclusion Criteria:
Inactivated vaccine (vero cell) against EV71 of 400U /0.5ml in 5000 infants aged 6-35 months old on day0,28
Biological: EV71 vaccine
placebo in 5000 infants aged 6-35 months old on day0,28
inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval
The incidence rate of Hand, Foot and Mouth disease caused by EV71 within the second year observation period after the second vaccination
to evaluate the efficacy of EV71 vacccine against HFMD caused by EV71
Time frame: Within the second year after the second vaccination
The GMT of anti-EV71 antibodies in serum two years after second vaccination
to evaluate the immune persistence of anti-EV71 antibodies in serum
Time frame: 26 months after second vaccination
Frequency of serious adverse events (SAEs) with the second year after the second vaccination
Frequency of serious adverse events in healthy infants during the oney-year follow-up period
Time frame: within the second year after the second vaccination
This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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Hand, Foot and Mouth Disease →