Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06577298
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
A Study to Evaluate the Safety and Immunogenicity of VLP-Polio in Infants and Toddlers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase III Randomized Double-blind Positive-controlled Dose-exploration Study to Evaluate the Safety and Immunogenicity of a Virus-like Particle VLP Based Vaccine Against Poliomyelitis VLP-Polio in Infants From 6 Weeks of Age and Toddlers 12-18 Months of Age
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase III randomized double-blind and positive-controlled study Participants in the phase I toddler group will receive 1 dose of either high dose VLP-Polio Dose H or control vaccine in a ratio of 31 The phase I infant cohort will have 4 arms randomly assigned to receive either investigational vaccine Low-adjuvant dose VLP-Polio Medium dose VLP-Polio or High dose VLP-Polio or control vaccine in a ratio of 31 Phase II infant cohort will have 4 arms randomly assigned to receive either investigational vaccine Low-adjuvant dose VLP-Polio Medium dose VLP-Polio or High dose VLP-Polio or control vaccine in a ratio of 31 Each infant participant will be administrated 3 doses of the assigned vaccine with 28 days apart and the booster dose will be given when the infant is 12-18 months old Enrollment of Phase I and Phase II will be staggered in descending order of age group but ascending order of dosing levels Blood and mucosal samples will be collected for immunogenicity evaluation over the time course of the study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None