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

Sponsor
Changchun BCHT Biotechnology Co.
Study ID
NCT07545564
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

  • Influenza

Eligibility Criteria

Sex
ALL
Age
3 Years - 17 Years
Healthy Volunteers
Accepted

Interventions

  • LAIV — BIOLOGICAL
    Nasal spray live attenuated influenza vaccine
  • Placebo — BIOLOGICAL
    sterile water

Study Details

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

Key Dates

First listed
Apr 22, 2026
Start date
Apr 9, 2026
Status verified
Apr 2026
Primary completion
Apr 23, 2026
Completion
May 9, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Vaccine
    LAIV
  • Placebo Comparator: Placebo
    sterile water

Primary Outcome Measure

Membrane-specific sIgA antibody [ Time Frame: 14days after vaccination ]

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