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About
Since its discovery in 1969, enterovirus 71 (EV71) has been recognised as a frequent cause of epidemics of hand-foot-mouth disease (HFMD) associated with severe neurological sequelae in a small proportion of cases. There has been a significant increase in EV71 epidemic activity throughout the Asia-Pacific region since 1997. Recent HFMD epidemics in this region have heen associated with a severe from of brainstem encephalitis associated with pulmonary oedema and high case-fatality rates.
The data from the phase 1 and 2 trials suggested that the inactivated EV71 vaccine had a clinically acceptable safety and good immunogenicity for healthy Chinese children and infants. According to the immunogenicity and safety results, the 320U with adjuvant with immunizing schedule of two doses (per 28 day) will be applied in phase 3 clinical trial.
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Inclusion criteria
Only subjects fulfilling all of the following criteria will be eligible for the study:
Exclusion criteria
Subjects will not be eligible for the study if any of the following criteria is met:
Exclusion Criteria for the second dose:
Subjects will not be eligible for the second dose if any of following adverse events happened after the first dose. They can continue other process of the study without the second dose vaccination according to the opinion of the investigator.
Primary purpose
Allocation
Interventional model
Masking
10,245 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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