InfluenzaPhase 4NCT06609811
The Interaction Between Mucosal Microbiota Colonization and the Immune Response to an Intranasal Influenza Live Attenuated Vaccine
A Phase 4 study testing Intranasal Influenza Live Attenuated Vaccine in people with Influenza, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Intranasal Influenza Live Attenuated Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteChina
- Study dates
- 21 Sep 2024to 17 Jan 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Individuals aged 6-17 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Haizhou District Center for Disease Control and Prevention
Lianyungang, Jiangsu
About this study
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
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
- Being tested
- Intranasal Influenza Live Attenuated Vaccine
- Keywords
- Intranasal Influenza Live Attenuated Vaccine, Nasal Microbiota, Gut Microbiota, Colonization, Mucosal Immunity
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal Influenza Live Attenuated VaccineBiological
This vaccine is produced by Changchun BCHT Biotechnology Co.
Intranasal Influenza Live Attenuated VaccineBiological
This vaccine is produced by Changchun BCHT Biotechnology Co.
| Study group | Role | What they receive |
|---|---|---|
| The immediate vaccination group. | Experimental | Participants are assigned to receive one dose of 0.2 mL of intranasal live attenuated influenza vaccine immediately (Day 0) Receives: Biological: Intranasal Influenza Live Attenuated Vaccine |
| The delayed vaccination group | Experimental | Participants are assigned to receive one dose of 0.2 mL of intranasal live attenuated influenza vaccine after a delay (Day 28). Receives: Biological: Intranasal Influenza Live Attenuated Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The responses of sIgA antibodies against the vaccine strain in the nasal mucosal secretions 28 days post-vaccination.
Measured by Meso Scale Discovery
Measured: Day 28 post-vaccination
Changes in the density of nasal mucosal bacterial colonization (CFU/mL) compared to baseline
Measured by 16s RNA or metagenomic analysis
Measured: Day 28 post-vaccination
Changes in the abundance (α Diversity and β Diversity) of nasal mucosal bacterial colonization compared to baseline
Measured by 16s RNA or metagenomic analysis
Measured: Day 28 post-vaccination
Secondary outcomes (6)
The level of HI antibodies against the vaccine strain in serum at 28 days post-vaccination
Measured by HI
Measured: Day 28 post-vaccination
Changes in the density of gut bacterial colonization (CFU/mL) compared to baseline
Measured by 16s RNA or metagenomic analysis
Measured: Day 28 post-vaccination
Changes in the abundance (α Diversity and β Diversity) of gut bacterial colonization compared to baseline
Measured by 16s RNA or metagenomic analysis
Measured: Day 28 post-vaccination
The incidence of adverse reactions within 28 days post-vaccination
Measured: within 28 days post-vaccination
Number of IFN-γ secreting cells in nasal mucosal epithelial cells in response to influenza virus-based synthetic peptide pools at Day 28 post-vaccination (Exploratory)
The number of IFN-γ secreting cells will be quantified using an ELISpot assay.
Measured: Day 28 post-vaccination
Frequency of activated T-cell subsets in nasal mucosal epithelial cells at Day 28 post-vaccination (Exploratory)
The phenotype and activation status of local mucosal T-cell subsets were measured by flow cytometry.
Measured: Day 28 post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start21 Sep 2024
- Primary completion31 Dec 2024
- Study completion17 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jing-Xin Li, PhD, Principal investigator, Jiangsu Provincial Center for Diseases Control and PreventionJiangsu Provincial Center for Diseases Control and Prevention, Study director, Jiangsu Provincial Center for Diseases Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609811
- Sponsor's protocol ID
- JSJKYMS001
- Status last verified
- Apr 2026
- First submitted
- 13 Sep 2024
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06609811
- Acronym / sponsor ID
- JSJKYMS001
- Conditions
- Influenza
- Keywords
- Intranasal Influenza Live Attenuated Vaccine, Nasal Microbiota, Gut Microbiota, Colonization, Mucosal Immunity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Study start
- 21 Sep 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 17 Jan 2025 (actual)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The immediate vaccination group. | Experimental | Biological: Intranasal Influenza Live Attenuated VaccineParticipants are assigned to receive one dose of 0.2 mL of intranasal live attenuated influenza vaccine immediately (Day 0) |
| The delayed vaccination group | Experimental | Biological: Intranasal Influenza Live Attenuated VaccineParticipants are assigned to receive one dose of 0.2 mL of intranasal live attenuated influenza vaccine after a delay (Day 28). |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Individuals aged 6-17 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intranasal Influenza Live Attenuated VaccineThis vaccine is produced by Changchun BCHT Biotechnology Co. | Biological | The delayed vaccination group |
| Intranasal Influenza Live Attenuated VaccineThis vaccine is produced by Changchun BCHT Biotechnology Co. | Biological | The immediate vaccination group. |
Primary outcome
The responses of sIgA antibodies against the vaccine strain in the nasal mucosal secretions 28 days post-vaccination.
Time frame: Day 28 post-vaccination
Measured by Meso Scale Discovery
Changes in the density of nasal mucosal bacterial colonization (CFU/mL) compared to baseline
Time frame: Day 28 post-vaccination
Measured by 16s RNA or metagenomic analysis
Changes in the abundance (α Diversity and β Diversity) of nasal mucosal bacterial colonization compared to baseline
Time frame: Day 28 post-vaccination
Measured by 16s RNA or metagenomic analysis
6 secondary outcomes
The level of HI antibodies against the vaccine strain in serum at 28 days post-vaccination
Time frame: Day 28 post-vaccination
Changes in the density of gut bacterial colonization (CFU/mL) compared to baseline
Time frame: Day 28 post-vaccination
Changes in the abundance (α Diversity and β Diversity) of gut bacterial colonization compared to baseline
Time frame: Day 28 post-vaccination
The incidence of adverse reactions within 28 days post-vaccination
Time frame: within 28 days post-vaccination
Number of IFN-γ secreting cells in nasal mucosal epithelial cells in response to influenza virus-based synthetic peptide pools at Day 28 post-vaccination (Exploratory)
Time frame: Day 28 post-vaccination
Frequency of activated T-cell subsets in nasal mucosal epithelial cells at Day 28 post-vaccination (Exploratory)
Time frame: Day 28 post-vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing-Xin Li, PhD principal investigator
Jiangsu Provincial Center for Diseases Control and Prevention
Jiangsu Provincial Center for Diseases Control and Prevention study director
Jiangsu Provincial Center for Diseases Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intranasal Influenza Live Attenuated Vaccine 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 12 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: finished, as of the sponsor's last update on 15 Apr 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 responses of sIgA antibodies against the vaccine strain in the nasal mucosal secretions 28 days post-vaccination. (time frame: Day 28 post-vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2026.