Ignite Creation Date:
2024-05-06 @ 3:31 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04650399
Status:
COMPLETED
Last Update Posted:
2024-05-03
First Post:
2020-11-25
Brief Title:
A Multicenter Study to Evaluate Safety and Immunogenicity of a Live-attenuated Chikungunya Vaccine in Adolescents
Sponsor:
Butantan Institute
Organization:
Butantan Institute
Study Overview
Official Title:
A Multicenter Randomized Controlled Double Blinded Pivotal Study to Evaluate Safety and Immunogenicity of a Live-attenuated Chikungunya Virus Vaccine Candidate VLA1553 in Adolescents Aged 12 Years to 18 Years
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective randomized double-blinded multicenter pivotal study evaluating the final dose of VLA1553 1 x10E4 TCID50 per dose in comparison to a placebo control The final dose of VLA1553 or control will be administered as single immunization on Day 1 Overall approximately 750 male and female subjects aged 12 years to 18 years will be enrolled into the study
Detailed Description:
This is a prospective double-blinded multicenter randomized pivotal Phase 3 study comprising approximately 750 subjects aged 12 years to 18 years randomized in a 21 ratio to the live-attenuated CHIKV vaccine candidate VLA1553 or placebo The final dose of lyophilized VLA1553 or placebo will be administered as a single intramuscular immunization Subjects in this study will be stratified by baseline serostatus The primary objective of the study is to evaluate the immunogenicity and safety of the adult dose of VLA1553 28 days following the single immunization Immunogenicity evaluations in the immunogenicity subset will include the proportion of subjects with seroprotective neutralizing CHIKV antibody titers above a surrogate threshold indicative of protection The surrogate of protection reasonably likely to predict clinical benefit has been established in non-human primate passive transfer studies using human sera from the Phase 1 study Safety data collection and immunogenicity will continue to be assessed until Month 12
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None