Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05964582
Status:
COMPLETED
Last Update Posted:
2024-02-29
First Post:
2023-07-07
Brief Title:
Prospective Surveillance of Respiratory Syncytial Virus Disease in Infants and Toddlers
Sponsor:
Sanofi Pasteur a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Multi-center Multi-national Prospective Surveillance Study of Respiratory Syncytial Virus Disease in Infants and Toddlers 6 to 22 Months of Age
Status:
COMPLETED
Status Verified Date:
2024-09
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 study is a multi-center multi-national prospective surveillance study in which the study participants will not receive a study vaccine but will provide a baseline blood sample and be followed for acute respiratory disease during 6 months The 6-month follow-up will occur for the most part during the Respiratory Syncytial VirusRSV season based on enrollment timing and as per feasibility A maximum of 1000 children from 6 to 22 months of age are planned to be enrolled in 5 to 10 countries 1 to 2 sites per country targeting approximately 100 participants per country The purpose of the study is to assess the seroprevalence and incidence of RSV disease during the study period in the targeted countries and sites for a Phase III vaccine study
Detailed Description:
The duration of the study will be 6 months for each participant
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1281-0204 | REGISTRY | ICTRP | None |