Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-27 @ 12:31 PM
Study NCT ID:
NCT06716567
Status:
COMPLETED
Last Update Posted:
2025-03-24
First Post:
2024-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maternal Determinants of Immunity to Influenza
Sponsor:
Centre Hospitalier Universitaire Saint Pierre
Organization:
Study Overview
Official Title:
Maternal Determinants of Immunity to Influenza (MADI-01)
Status:
COMPLETED
Status Verified Date:
2025-03
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:
MADI-01
Brief Summary:
The overall objective of the project is to determine the impact of pregnancy on the response to influenza immunization.
Detailed Description:
The study compares immune responses to influenza vaccination between a group of pregnant women and a group of non-pregnant controls women. Specifically, the study has three aims:
1. To compare the quality of antibodies induced by influenza immunization in pregnant and non-pregnant women;
2. To identify immune predictors of vaccine responses in pregnant women and compare them to the determinants of vaccine responses in non-pregnant women;
3. To identify immune predictors of the transfer of maternal antibodies to the newborn following influenza immunization during pregnancy;
1. To compare the quality of antibodies induced by influenza immunization in pregnant and non-pregnant women;
2. To identify immune predictors of vaccine responses in pregnant women and compare them to the determinants of vaccine responses in non-pregnant women;
3. To identify immune predictors of the transfer of maternal antibodies to the newborn following influenza immunization during pregnancy;
Study Oversight
Has Oversight DMC:
False
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?: