NCT01399853

A Phase II Clinical Trial for Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children and Infants

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,200 (actual)
• Sponsor: Jiangsu Province Centers for Disease Control and Prevention · Network
• Sex: All
• Age: 6 Months – 36 Months
• Healthy volunteers: Not accepted

Summary

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. The phase I study of inactivated vaccine (vero cell) against EV71 has completed last month in Jiangsu Province in China. The data from the phase I study suggested that the inactivated EV71 vaccine had a clinically acceptable safety and good immunogenicity for healthy Chinese children and infants. In order to provide more evidence for the immunogenicity of the vaccine, to further explore the probable immunizing dose and the safety profile of this vaccine, a phase II clinical trial is planed to conduct.

Conditions

• Immunogenicity
• Safety

Interventions

Type	Name	Description
BIOLOGICAL	160U /0.5ml EV71 Vaccine	inactivated vaccine (vero cell) against EV71 of 160U /0.5ml, two doses, 28 days interval
BIOLOGICAL	320U /0.5ml EV71 vaccine	inactivated vaccine(vero cell) against EV71 of 320U /0.5ml, two doses, 28 days interval
BIOLOGICAL	640U /0.5ml EV71 vaccine	inactivated vaccine (vero cell) against EV71 of 640U /0.5ml, two doses, 28 days interval
BIOLOGICAL	(without adjuvant) 640U /0.5ml	inactivated vaccine (vero cell) against EV71 of (without adjuvant) 640U /0.5ml, two doses, 28 days interval
BIOLOGICAL	0/0.5ml placebo	0/0.5ml placebo, two doses, 28 days interval

Timeline

• Start date: 2011-07-01
• Primary completion: 2011-11-01
• Completion: 2012-05-01
• First posted: 2011-07-22
• Last updated: 2012-05-31

Locations

1 site across 1 country: China