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Enrolling by invitationNCT07545564Updated Apr 22, 2026

A Study on Mucosal Specific IgA Immunokinetics After Administration of Nasal Spray Live Attenuated Influenza Vaccine

A Phase 4 interventional study of LAIV and Placebo in Influenza, sponsored by Changchun BCHT Biotechnology Co.. Enrolling by invitation at 1 site in China. Open to participants aged 3 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-22.

Sponsored by Changchun BCHT Biotechnology Co. · Phase 4, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Apr 2026, 5 months ago, but the record still lists the study as enrolling by invitation.
Phase
Phase 4
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
3 Years to 17 Years
Sex
All
01

Study 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

02

Conditions studied

  • Influenza

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03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's planned enrollment of 200 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Changchun BCHT Biotechnology Co. is the lead sponsor of 20 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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;

Exclusion criteria

Exclusion Criteria:

  • 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;
  • 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.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Vaccine

    LAIV

    Biological: LAIV

  • Placebo comparator
    Placebo

    sterile water

    Biological: Placebo

Interventions

  • BiologicalLAIV

    Nasal spray live attenuated influenza vaccine

  • BiologicalPlacebo

    sterile water

06

What researchers measure

Primary outcomes

  1. Membrane-specific sIgA antibody

    Time frame: 14days after vaccination

07

Study locations

1 site
  • Neimenggu CDC
    Hohhot, Inner Mongolia, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07545564
Lead sponsor
Changchun BCHT Biotechnology Co.
Responsible party
Sponsor
First posted
Apr 22, 2026
Start date
Apr 9, 2026
Primary completion
Apr 23, 2026 (estimated)
Completion
May 9, 2026 (estimated)
Last update
Apr 22, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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