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InfluenzaPhase 4NCT07232745

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

A Phase 4 study testing LAIV in people with Influenza, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 14 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
LAIV
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
12 Oct 2025to 10 May 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.
  • Individuals with immunodeficiency, immunosuppression, or those undergoing immunosuppressive therapy.
  • Individuals with uncontrolled epilepsy, other progressive neurological disorders, or a history of Guillain-Barré syndrome.
Show all 16Show fewer
  • Individuals with rhinitis or asthma.
  • Individuals with a personal or family history of seizures, chronic diseases, epilepsy, or allergic tendencies.
  • Individuals who have received immunoglobulin injections within the last 3 months prior to vaccination.
  • Individuals who have used other live attenuated vaccines within 1 month prior to vaccination.
  • Individuals planning to use antiviral drugs for influenza within 48 hours before or 2 weeks after vaccination.
  • Individuals planning to use any other intranasal medication within 2 days after vaccination.
  • Subjects with underlying gastrointestinal diseases, including but not limited to inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), chronic diarrhea, peptic ulcer, and intestinal polyps.
  • Subjects with metabolic diseases, such as diabetes mellitus, obesity (BMI ≥ 25.9 kg/m²), hyperlipidemia, or metabolic syndrome.
  • Subjects who have used antibiotics, probiotics, or other drugs that may affect the intestinal microbiota within the past 3 months.
  • Other circumstances in which the subject is deemed unsuitable for participation in the study by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Haizhou District Center for Disease Control and Prevention

    Lianyungang, Jiangsu

Other trials in China

About this study

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

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.

Conditions
Influenza
Being tested
LAIV
Keywords
Systemic Immunity, Mucosal Immunity, Intranasal Influenza Live Attenuated Vaccine
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LAIVBiological

    This vaccine is produced by Changchun BCHT Biotechnology Co.

Study groups in NCT07232745
Study groupRoleWhat they receive
The vaccination group (Self-Controlled)ExperimentalNot described
Receives: Biological: LAIV

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured by Enzyme-Linked Immunosorbent Assay (ELISA)

    Measured: Day 28 post-vaccination

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

    Measured by Enzyme-Linked Immunosorbent Assay (ELISA)

    Measured: Day 28 post-vaccination

Secondary outcomes (11)

  1. The levels of cytokines in serum at 7 days post-vaccination.

    Measured by Meso Scale Discovery

    Measured: Day 7 post-vaccination

  2. The levels of cytokines in nasal mucosal secretions at 7 days post-vaccination.

    Measured by Meso Scale Discovery

    Measured: Day 7 post-vaccination

  3. The levels of cytokines in serum at 28 days post-vaccination.

    Measured by Meso Scale Discovery

    Measured: Day 28 post-vaccination

  4. The levels of cytokines in nasal mucosal secretions at 28 days post-vaccination.

    Measured by Meso Scale Discovery

    Measured: Day 28 post-vaccination

  5. The level of IgG antibodies (ng/mL) against the vaccine strain in serum at 7 days post-vaccination.

    Measured by Enzyme-Linked Immunosorbent Assay (ELISA)

    Measured: Day 7 post-vaccination

  6. The level of neutralizing antibodies (NT50 and IC50, ng/mL) against the vaccine strain in serum at 28 days post-vaccination.

    Measured by Neutralization Assay

    Measured: Day 28 post-vaccination

  7. The gene expression levels in PBMCs (Peripheral Blood Mononuclear Cells) at 7 days post-vaccination.

    Measured by Bulk Ribonucleic Acid Sequencing.

    Measured: from baseline (pre-vaccination) to 7 days post-vaccination

  8. The gene expression levels in nasal mucosal cells at 7 days post-vaccination.

    Measured by Bulk Ribonucleic Acid Sequencing.

    Measured: from baseline (pre-vaccination) to 7 days post-vaccination

  9. The gene expression levels in PBMCs (Peripheral Blood Mononuclear Cells) at 28 days post-vaccination.

    Measured by Bulk Ribonucleic Acid Sequencing.

    Measured: Day 28 post-vaccination

  10. The gene expression levels in nasal mucosal cells at 28 days post-vaccination.

    Measured by Bulk Ribonucleic Acid Sequencing.

    Measured: Day 28 post-vaccination

  11. The level of sIgA antibodies (AU/mL) against the vaccine strain in nasal secretions at 7 days post-vaccination.

    Measured by Enzyme-Linked Immunosorbent Assay (ELISA)

    Measured: Day 7 post-vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2025
  2. Study start12 Oct 2025
  3. Primary completion10 Nov 2025 (estimated)
  4. Study completion10 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07232745
Sponsor's protocol ID
JSJKYMS002
Status last verified
Oct 2025
First submitted
14 Nov 2025
Last updated
18 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing LAIV in people with Influenza, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The level of IgG antibodies (ng/mL) against the vaccine strain in serum at 28 days post-vaccination. (time frame: Day 28 post-vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07232745.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.

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