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ACTIVE NOT RECRUITING
NCT07232745
PHASE4

Mucosal and Systemic Immune Responses Induced by an Intranasal Influenza Live Attenuated Vaccine

Sponsor: Jiangsu Province Centers for Disease Control and Prevention

View on ClinicalTrials.gov

Summary

This is a single-center, open-label, single-arm clinical trial designed to evaluate the mucosal and systemic immune responses induced by an intranasal influenza live attenuated vaccine, and to explore the correlation between the two. The study plans to recruit 60 healthy volunteers aged 14-17 years, with a male-to-female ratio of 1:1. Participants and their guardians must be able and willing to comply with the clinical trial protocol and provide informed consent. Eligible participants will receive a single 0.2 mL dose of LAIV prior to the influenza season. Information on participants' historical vaccination records, baseline demographic data, and past health status will be collected. Nasal specimens (nasal secretions and nasal mucosal cells) and blood samples (serum and PBMCs) will be collected on Day 0 (before vaccination), Day 7, and Day 28 after vaccination for transcriptome sequencing and immunogenicity analysis. In addition, fecal samples will be collected on Day 0 (before vaccination), Day 7, and Day 28 after vaccination for intestinal microbiota detection.

Official title: Mucosal and Systemic Immune Responses Induced by an Intranasal Influenza Live Attenuated Vaccine: A Single-Center, Open-Label, Single-Arm Clinical Study

Key Details

Gender

All

Age Range

14 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-10-12

Completion Date

2026-05-10

Last Updated

2025-11-18

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

LAIV

This vaccine is produced by Changchun BCHT Biotechnology Co.

Locations (1)

Haizhou District Center for Disease Control and Prevention

Lianyungang, Jiangsu, China