Active — Not RecruitingPhase 4

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

China60 participantsStarted 2025-10-12

Plain-language 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.

Who can participate

Age range

14 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Individuals aged 14-17 years.
. Volunteers and their guardians are able and willing to comply with the requirements of the clinical trial protocol and sign the informed consent form.

Exclusion criteria

. Allergy to any component of the vaccine product, including eggs, excipients, or gentamicin sulfate.
. Individuals with acute illnesses, severe chronic illnesses, acute exacerbations of chronic illnesses, or fever.
. Pregnant or lactating women.
. Individuals with Leigh syndrome who are receiving treatment with aspirin or aspirin-containing medications.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The level of IgG antibodies (ng/mL) against the vaccine strain in serum at 28 days post-vaccination.

Timeframe: Day 28 post-vaccination

The level of sIgA antibodies (AU/mL) against the vaccine strain in nasal secretions at 28 days post-vaccination.

Timeframe: Day 28 post-vaccination

Trial details

NCT IDNCT07232745

SponsorJiangsu Province Centers for Disease Control and Prevention

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2025-11-10

View on ClinicalTrials.gov More Influenza trials