NCT01679665

Systems Biology of Vaccination for EV71 Vaccine in Humans

Systems Biology of Vaccination for EV71 Vaccine in Chinese Healthy Children Aged From 2 to 5 Years Old

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Jiangsu Province Centers for Disease Control and Prevention · Network
• Sex: All
• Age: 2 Years – 5 Years
• Healthy volunteers: Not accepted

Summary

Recently, an inactivated vaccine (vero cell) against EV71 has been investigated in Phase 1 and Phase 2 clinical trials. Data from these trials showed that the EV71 vaccine has good safety profile and was immunogenic. 320 U alum-adjuvant vaccine has been chosen as the candidate vaccine for the phase 3 clinical trial. This clinical trial is a supplementary phase 2 trial, which is designed to study the gene expression patterns induced by EV71 vaccine in Chinese healthy children aged from 2 to 5 years old use a systems biology approach combined with microarray analysis，RT-PCR and neutralizing antibody testing for PBMC and serum collected form the studied children population, to predict immunogenicity, and explore mechanistic insights about the EV71 vaccine.

Conditions

• Systems Biology
• Early Gene
• EV71 Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	320U /0.5ml	inactivated vaccine(vero cell) against EV71 of 320U /0.5ml, two doses, 4 weeks interval
BIOLOGICAL	0/0.5ml placebo	0/0.5ml placebo, two doses, 4 weeks interval

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2012-09-06
• Last updated: 2013-05-08

Locations

1 site across 1 country: China