Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06361875
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-04-04
Brief Title:
A Study to Investigate the Safety and Immunogenicity of the Quadrivalent Influenza mRNA Vaccines in Adults Aged 18 Years and Above
Sponsor:
Sanofi Pasteur a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Phase III Study to Investigate the Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccines MRT5421 MRT5424 and MRT5429 in Healthy Participants Aged 18 Years and Above
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular IM injection of different formulations of Quadrivalent Influenza Vaccine QIV messenger ribonucleic acid mRNA MRT5421 MRT5424 and MRT5429 compared to an active control QIV- standard dose SD QIV- high dose HD adults 65 years of age only or quadrivalent recombinant influenza vaccine RIV4 in adults 18 years of age and older
Detailed Description:
Study duration per participant is approximately 12 months
Treatment duration 1 injection of one of the 7 QIV mRNA or one of the controls
Dose escalation with sequential enrollment
Treatment duration 1 injection of one of the 7 QIV mRNA or one of the controls
Dose escalation with sequential enrollment
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1295-2852 | REGISTRY | ICTRP | None |