Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06609811
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-13
Brief Title:
The Interaction Between Mucosal Microbiota Colonization and the Immune Response to an Intranasal Influenza Live Attenuated Vaccine
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Interaction Between Mucosal Microbiota Colonization in the Nasal Cavity and Gut and the Immune Response to an Intranasal Influenza Live Attenuated Vaccine in Children and Adolescents Aged 6 to 17 Years A Single-Center Randomized Open-Label Trial
Status:
NOT_YET_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 is a single-center randomized open-label trial designed to explore the interaction between mucosal microbiota colonization in the nasal cavity and gut and the immune response to an intranasal live attenuated influenza vaccine LAIV The study plans to enroll 200 children and adolescents aged 6-17 years with approximately 50 in the 6-11 years age group and 50 in the 12-17 years age group Participants and their guardians must be able and willing to comply with the clinical trial protocol and provide informed consent Eligible participants will be randomly assigned in a 11 ratio stratified by age groups to either the immediate vaccination group or the delayed vaccination group Nasal swabs will be collected for all participants of both the immediate vaccination group or the delayed vaccination group after randomization for the detection of nasal and gut microbiota Then the immediate vaccination group will receive one dose of 02 mL of LAIV 28 days after randomization while the delayed vaccination group will receive one dose of 02 mL of LAIV 56 days after randomization Blood and mucosal samples nasal stool will be collected on the day before vaccination and on 28 days after vaccination for humoral and mucosal immunogenicity analysis Moreover the occurrence of adverse events within 28 days after vaccination will be collected
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