Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06503900
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Simultaneous mRNA COVID-19 and IIV Vaccination in Pregnancy Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Safety of Simultaneous Versus Sequential Administration of mRNA COVID-19 Vaccine and Inactivated Influenza Vaccine IIV in Pregnant People
Status:
RECRUITING
Status Verified Date:
2024-09
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 study is a prospective randomized clinical trial During this studypregnant participants will be randomly assigned to receive IIV and mRNA COVID-19 vaccine either simultaneously or sequentially 7-14 days apart All participants will receive an mRNA COVID-19 vaccine at Visit 1 Day 1
Solicited local and systemic symptoms of reactogenicity will be assessed on day of visit for Visits 1 and 2 and daily during the 6 days following each visit using either electronic or paper symptoms diaries depending on study participant preference Serious adverse events SAE and adverse events of special interest AESI will be collected throughout the duration of the study
Pregnant people will be followed through delivery with comprehensive obstetric and infant outcomes obtained from medical record review for 90 days post-delivery
Maternal serum samples will be collected for antibody titers relevant to Influenza and COVID-19 prior to vaccination at Day 29 both groups as well as Days 36-43 if in sequential group When feasible maternal blood at delivery and cord blood serum will be analyzed for serological analyses of placental influenza and COVID-19 antibody transfer cord blood maternal antibody ratio will be determined
Solicited local and systemic symptoms of reactogenicity will be assessed on day of visit for Visits 1 and 2 and daily during the 6 days following each visit using either electronic or paper symptoms diaries depending on study participant preference Serious adverse events SAE and adverse events of special interest AESI will be collected throughout the duration of the study
Pregnant people will be followed through delivery with comprehensive obstetric and infant outcomes obtained from medical record review for 90 days post-delivery
Maternal serum samples will be collected for antibody titers relevant to Influenza and COVID-19 prior to vaccination at Day 29 both groups as well as Days 36-43 if in sequential group When feasible maternal blood at delivery and cord blood serum will be analyzed for serological analyses of placental influenza and COVID-19 antibody transfer cord blood maternal antibody ratio will be determined
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