NCT06609811

The Interaction Between Mucosal Microbiota Colonization and the Immune Response to an Intranasal Influenza Live Attenuated Vaccine

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: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: Jiangsu Province Centers for Disease Control and Prevention · Network
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Accepted

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 1:1 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 0.2 mL of LAIV 28 days after randomization, while the delayed vaccination group will receive one dose of 0.2 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.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Intranasal Influenza Live Attenuated Vaccine	This vaccine is produced by Changchun BCHT Biotechnology Co.
BIOLOGICAL	Intranasal Influenza Live Attenuated Vaccine	This vaccine is produced by Changchun BCHT Biotechnology Co.

Timeline

• Start date: 2024-09-21
• Primary completion: 2024-12-31
• Completion: 2025-01-17
• First posted: 2024-09-24
• Last updated: 2026-04-15

Locations

1 site across 1 country: China