Systems Biology Clinical Trial
Official title:
Systems Biology of Vaccination for EV71 Vaccine in Chinese Healthy Children Aged From 2 to 5 Years Old
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Unknown status |
NCT01123538 -
Progestagen Type in Postmenopausal Hormone Therapy and Blood Gene Expression Profile
|
Phase 4 |