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OpenTrials
Enrolling by Invitation

NCT Number: NCT07545564

A Study on Mucosal Specific IgA 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

Enrolling by Invitation

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Key information

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Neimenggu CDC

Hohhot, Inner Mongolia, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LAIV

Biological

Nasal spray live attenuated influenza vaccine

Placebo

Biological

sterile water

Primary outcomes

  1. Membrane-specific sIgA antibody

    Time frame: 14days after vaccination

Sponsors and collaborators

Lead sponsor

Changchun BCHT Biotechnology Co.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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