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

NCT07545564 | Enrolling By Invitation Phase 4

• 1 other identifier: PFLG20260224
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

• Membrane-specific sIgA antibody

  14days after vaccination

Study Arms (2)

Vaccine

EXPERIMENTAL

LAIV

Biological: LAIV

Placebo

PLACEBO COMPARATOR

sterile water

Biological: Placebo

Interventions

LAIV BIOLOGICAL

Nasal spray live attenuated influenza vaccine

Vaccine

Placebo BIOLOGICAL

sterile water

Placebo

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changchun BCHT Biotechnology Co.: lead

Study Sites (1)

Neimenggu CDC

Hohhot, Inner Mongolia, China

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 22, 2026
• Study Start: April 9, 2026
• Primary Completion: April 23, 2026
• Study Completion (Estimated): May 9, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)