InfluenzaPhase 4NCT07545564
A Study on Mucosal Specific IgA Immunokinetics After Administration of Nasal Spray Live Attenuated Influenza Vaccine
A Phase 4 study testing LAIV in people with Influenza, run by Changchun BCHT Biotechnology Co. at 1 site in China.
Trial summary
Mucosal-specific sIgA antibody GMT;Evaluate the achievement of 2-fold and 4-fold increases in the geometric mean titer (GMT) of specific nasal mucosal sIgA antibodies after vaccination Read more about this study
- Who is it for?
- Ages 3 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?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 9 Apr 2026to 9 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 3 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- People aged 3 to 17 years old who voluntarily receive the live attenuated influenza nasal spray vaccine;
- The participant themselves can comply with the protocol requirements and complete sample collection;
- Obtain the consent of the participants' guardians and sign the informed consent form;
Who cannot join
- Axillary temperature > 37.0°C on the day of enrollment;
- Received any influenza vaccine within the past 2 years and plans to receive other influenza vaccines during the trial period;
- Clinically diagnosed with influenza in a medical institution within the past year (with confirmed etiological diagnosis);
- Individuals with known hypersensitivity to any ingredient contained in this product, including eggs, excipients, and gentamicin sulfate;
- Individuals suffering from acute diseases, severe chronic diseases, acute exacerbations of chronic diseases, and fever;
- Pregnant women;
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- Patients with Leigh syndrome who are being treated with aspirin or aspirin-containing medications;
- Individuals with immunodeficiency or those undergoing immunosuppressive therapy;
- Individuals with uncontrolled epilepsy and other progressive neurological diseases, or those with a history of Guillain-Barré syndrome;
- Nasal abnormalities that, in the judgment of a clinician, may affect vaccination, individuals in the medication period for allergic rhinitis, or those currently receiving nasal spray administration;
- Having received a live attenuated vaccine within 14 days prior to enrollment, or a subunit or inactivated vaccine within 7 days prior to enrollment;
- Presence of other factors deemed unsuitable for participation in this study by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Study on Nasal Mucosal Specific IgA Antibody Levels and Immunokinetics After Administration of Nasal Spray Live Attenuated Influenza Vaccine
Mucosal-specific sIgA antibody GMT;Evaluate the achievement of 2-fold and 4-fold increases in the geometric mean titer (GMT) of specific nasal mucosal sIgA antibodies after vaccination
- Conditions
- Influenza
- Being tested
- LAIV, Placebo
- 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
Nasal spray live attenuated influenza vaccine
PlaceboBiological
sterile water
| Study group | Role | What they receive |
|---|---|---|
| Vaccine | Experimental | LAIV Receives: Biological: LAIV |
| Placebo | Placebo comparator | sterile water Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Membrane-specific sIgA antibody
Measured: 14days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start9 Apr 2026
- Primary completion23 Apr 2026 (estimated)
- Study completion9 May 2026 (estimated)
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun BCHT Biotechnology Co.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545564
- Sponsor's protocol ID
- PFLG20260224
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 22 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 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Nasal Mucosal Specific IgA Antibody Levels and Immunokinetics After Administration of Nasal Spray Live Attenuated Influenza Vaccine
- ClinicalTrials.gov ID
- NCT07545564
- Acronym / sponsor ID
- PFLG20260224
- Conditions
- Influenza
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Changchun BCHT Biotechnology Co.Industry (pharma, biotech, devices)
- Study start
- 9 Apr 2026 (actual)
- Primary completion
- 23 Apr 2026 (estimated)
- Study completion
- 9 May 2026 (estimated)
- First posted
- 22 Apr 2026 (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.
Mucosal-specific sIgA antibody GMT;Evaluate the achievement of 2-fold and 4-fold increases in the geometric mean titer (GMT) of specific nasal mucosal sIgA antibodies after vaccination
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccine | Experimental | Biological: LAIVLAIV |
| Placebo | Placebo comparator | Biological: Placebosterile water |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- People aged 3 to 17 years old who voluntarily receive the live attenuated influenza nasal spray vaccine;
- The participant themselves can comply with the protocol requirements and complete sample collection;
- Obtain the consent of the participants' guardians and sign the informed consent form;
Key exclusion criteria (12 listed)
- Axillary temperature > 37.0°C on the day of enrollment;
- Received any influenza vaccine within the past 2 years and plans to receive other influenza vaccines during the trial period;
- Clinically diagnosed with influenza in a medical institution within the past year (with confirmed etiological diagnosis);
- Individuals with known hypersensitivity to any ingredient contained in this product, including eggs, excipients, and gentamicin sulfate;
- Individuals suffering from acute diseases, severe chronic diseases, acute exacerbations of chronic diseases, and fever;
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 |
|---|---|---|
| LAIVNasal spray live attenuated influenza vaccine | Biological | Vaccine |
| Placebosterile water | Biological | Placebo |
Primary outcome
Membrane-specific sIgA antibody
Time frame: 14days after vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 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.
The record lists no contact. Use the official record to reach the sponsor.
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 LAIV in people with Influenza, run by Changchun BCHT Biotechnology Co. 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 3 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: enrolling by invitation, as of the sponsor's last update on 22 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. Some participants in this study may receive a placebo. 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?
Membrane-specific sIgA antibody (time frame: 14days after vaccination). 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 22 Apr 2026.