NCT01508247

A Clinical Trial to Assess the Efficacy and Safety of an Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children Aged 6-35 Months

A Multiple-center Randomized Double-blind Placebo-controlled Phase 3 Clinical Trial to Assess the Efficacy and Safety of an Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children Aged 6-35 Months

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 10,245 (actual)
• Sponsor: Jiangsu Province Centers for Disease Control and Prevention · Network
• Sex: All
• Age: 6 Months – 35 Months
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hand, Foot and Mouth Disease
• Herpangina
• Other EV71-associated Diseases

Interventions

Type	Name	Description
BIOLOGICAL	inactivated vaccine (Vero Cell) against EV71	inactivated vaccine (vero cell) against EV71, 320U /0.5ml, two doses, on day0, 28
BIOLOGICAL	0/0.5ml placebo	0/0.5ml placebo, two doses, on day0, 28

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2012-01-11
• Last updated: 2013-03-29

Locations

4 sites across 1 country: China