Ignite Creation Date:
2024-05-06 @ 3:01 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04491877
Status:
COMPLETED
Last Update Posted:
2024-06-13
First Post:
2020-07-27
Brief Title:
Study of an Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers
Sponsor:
Sanofi Pasteur a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
Safety Immunogenicity Infectivity and Dose-Finding Study of an Investigational Live-Attenuated Respiratory Syncytial Virus RSV Vaccine in Infants and Toddlers
Status:
COMPLETED
Status Verified Date:
2024-05
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:
VAD00001
Brief Summary:
The primary objectives of the study were
To assess the safety profile of each dose of the study product after each and any administration in all infants and toddlers regardless of baseline serostatus
To characterize the Respiratory Syncytial Virus RSV A serum neutralizing antibody responses to the study product in each vaccine group after vaccination in RSV-naïve participants
The secondary objectives of the study were
To quantify the amount of vaccine virus shed by each participant by baseline serostatus
To determine the proportion of vaccinated infants and toddlers in each vaccine group infected with the vaccine virus at D56 56 days after vaccination 1 for Cohorts 1 2 3 and 4 and at Day 84 28 days after vaccination 2 for Cohorts 2 and 4 by baseline serostatus
To characterize the RSV A serum neutralizing antibody responses to the study product in each vaccine group after vaccination in RSV-experienced participants
To characterize serum RSV anti-F immunoglobulin G IgG antibody responses to the study product in each vaccine group after vaccination by baseline serostatus
To characterize serum RSV antibody responses RSV A-neutralizing and anti-RSV F IgG to the study product in each vaccine group after the RSV surveillance season or at least 5 months after the last vaccine administration by baseline serostatus
To assess the safety profile of each dose of the study product after each and any administration in all infants and toddlers regardless of baseline serostatus
To characterize the Respiratory Syncytial Virus RSV A serum neutralizing antibody responses to the study product in each vaccine group after vaccination in RSV-naïve participants
The secondary objectives of the study were
To quantify the amount of vaccine virus shed by each participant by baseline serostatus
To determine the proportion of vaccinated infants and toddlers in each vaccine group infected with the vaccine virus at D56 56 days after vaccination 1 for Cohorts 1 2 3 and 4 and at Day 84 28 days after vaccination 2 for Cohorts 2 and 4 by baseline serostatus
To characterize the RSV A serum neutralizing antibody responses to the study product in each vaccine group after vaccination in RSV-experienced participants
To characterize serum RSV anti-F immunoglobulin G IgG antibody responses to the study product in each vaccine group after vaccination by baseline serostatus
To characterize serum RSV antibody responses RSV A-neutralizing and anti-RSV F IgG to the study product in each vaccine group after the RSV surveillance season or at least 5 months after the last vaccine administration by baseline serostatus
Detailed Description:
Study duration per participant was maximum 12 months
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1238-1869 | REGISTRY | ICTRP | None |