Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04760236
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
2021-01-13
Brief Title:
Immune Non-Inferiority Safety and Lot-to-Lot Consistency of Oral Cholera Vaccine-Simplified Compared to Shanchol
Sponsor:
International Vaccine Institute
Organization:
International Vaccine Institute
Study Overview
Official Title:
Phase III Multicenter Observer-Blinded Randomized Active Controlled Trial to Evaluate Immune Non-Inferiority Safety and Lot-to-Lot Consistency of OCV-S Compared to Shanchol in 1 to 40 Years Old Healthy Nepalese Participants
Status:
COMPLETED
Status Verified Date:
2023-06
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 study is to evaluate immune non-inferiority safety and lot-to-lot consistency of OCV-S compared to Shanchol in 1 to 40 years old healthy Nepalese participants The investigators hypothesize that the simplified formulation is able to induce non-inferior immunogenicity compared to licensed OCV Shanchol
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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