Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT04223037 |
Other study ID # |
074201504 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
Phase 3
|
First received |
|
Last updated |
|
Start date |
September 1, 2015 |
Est. completion date |
December 31, 2022 |
Study information
Verified date |
March 2022 |
Source |
Chinese Academy of Medical Sciences |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This study evaluates the immunogenicity and safety of a purified inactivated JE vaccine
compared to a commercialized JE vaccine. In this phase III, randomized, blind trial, infants
at 6-23 months of age were randomly assigned to three groups to receive experimental vaccine
or control vaccine with two different vaccination schedule respectively.
Description:
The clinical study used randomized, blind method, commercialize inactivated Japanese
encephalitis vaccine as control. In Infants at 6-23 months of age were injected with
experimental vaccine with 0,7 days and 0,28 days vaccination schedule to evaluate
immunogenicity and safety of the experimental vaccine and the effectiveness of different
vaccination schedule. Participates were assigned to three groups (350 per group): group 1
with experimental vaccine using 0,7 days vaccination schedule; group 2 with control vaccine
using 0, 7 days vaccination schedule; group 3 with experimental vaccine using 0, 28
vaccination schedule.
Blood samples were collected before immunization and 30 days after immunization, and the
neutralization antibody of Japanese encephalitis was detected by plaque reduction
neutralization test. Medical observation was conducted 30 minutes after each injection. Body
temperature of participates was continuously measured for 7 days, and any adverse events were
observed and recorded from the first dose to 30 days after the whole vaccination. Serious
adverse events were collected within 6 months after the first dose.