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Your journey
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More info
You can access this
clinical trial
if you have
Hand, Foot, and Mouth Disease or Enterovirus Infections
and you are
between 6 and 60
years old
1
This is an early phase trial to determine
the dosage and safety of the new treatment.
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The purpose

Hand, foot, and mouth disease (HFMD) is a common viral illness in infants and children caused by viruses that belong to the enterovirus genus of the picornavirus family. Although most HFMD cases do not result in serious complications, outbreaks of HFMD caused by enterovirus 71 (EV71) can present with a high rate of neurological complications, including meningoencephalitis, pulmonary complications, and can even cause infant death. HFMD caused by EV71 has become a major emerging infectious disease in Asia and the highly pathogenic potential of EV71 clearly requires the attention of world medical community. Recently, an inactivated vaccine(vero cell) against EV71 has been licensed by SFDA in China, this clinical trial phase Ib is armed to evaluate safety in Chinese healthy children (from 13 to 60 months old) and infants (from 6 to 12 months old) and also provide the evidences for the EV71 vaccine immunogenicity and the probable immunizing dose.

Provided treatments

  • Biological: 160U /0.5ml
  • Biological: 320U /0.5ml
  • Biological: 640U /0.5ml
  • Biological: 0/0.5ml placebo

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01313715. The sponsor of the trial is Jiangsu Province Centers for Disease Control and Prevention and it is looking for 360 volunteers for the current phase.
Official trial title:
A Phase Ib Clinical Trial for Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children and Infants