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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EV71 Vaccine | Inactivated vaccine (vero cell) against EV71 of 400U /0.5ml in 5000 infants aged 6-35 months old on day0,28 |
| |
| Placebo | placebo in 5000 infants aged 6-35 months old on day0,28 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EV71 vaccine | Biological | inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Within the second year after the second vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| The GMT of anti-EV71 antibodies in serum two years after second vaccination | to evaluate the immune persistence of anti-EV71 antibodies in serum | 26 months after second vaccination |
| Frequency of serious adverse events (SAEs) with the second year after the second vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy Chinese infants aged 6 to 35 months old
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| Name | Affiliation | Role |
|---|---|---|
| Feng-Cai Zhu, BS | Jiangsu Center for Diseases Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ganyu | Lianyungang | Jiangsu | 222100 | China | ||
| Taixing |
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| ID | Term |
|---|---|
| D006232 | Hand, Foot and Mouth Disease |
| ID | Term |
|---|---|
| D003384 | Coxsackievirus Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
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Serum samples will be taken from 1200 subjects in the immunogenicity subgroup 26 months after the first vaccination.
Throat and anal swab samples will be taken from the cases with Hand, Foot and mouth disease for the detection of PCR assays and the isolation of EV71.
Frequency of serious adverse events in healthy infants during the oney-year follow-up period |
| within the second year after the second vaccination |
| Taizhou |
| Jiangsu |
| 225400 |
| China |
| Sheyang | Yancheng | Jiangsu | 224300 | China |
| D014777 | Virus Diseases |
| D007239 | Infections |