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

April 16, 2026 updated by: Changchun BCHT Biotechnology Co.

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Inner Mongolia
      • Hohhot, Inner Mongolia, China
        • Neimenggu CDC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vaccine
LAIV
Biological: LAIV
Nasal spray live attenuated influenza vaccine
Placebo Comparator: Placebo
sterile water
Biological: Placebo
sterile water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Membrane-specific sIgA antibody
Time Frame: 14days after vaccination
14days after vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changchun BCHT Biotechnology Co.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2026

Primary Completion (Estimated)

April 23, 2026

Study Completion (Estimated)

May 9, 2026

Study Registration Dates

First Submitted

April 16, 2026

First Submitted That Met QC Criteria

April 16, 2026

First Posted (Actual)

April 22, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PFLG20260224

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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