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Phase 4 mucosal sIgA response after LAIV nasal spray

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Summary

A Phase 4 clinical trial (NCT07545564) registered April 22, 2026, will evaluate mucosal-specific sIgA antibody geometric mean titer (GMT) responses and the achievement of 2-fold and 4-fold increases in nasal mucosal sIgA antibodies following administration of a nasal spray Live Attenuated Influenza Vaccine (LAIV). The study includes LAIV and placebo intervention arms and is categorised under the condition of Influenza.

“Evaluate the achievement of 2-fold and 4-fold increases in the geometric mean titer (GMT) of specific nasal mucosal sIgA antibodies after vaccination”

NIH , verbatim from source
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About this source

GovPing monitors ClinicalTrials.gov Studies for new healthcare & life sciences regulatory changes. Every update since tracking began is archived, classified, and available as free RSS or email alerts — 686 changes logged to date.

What changed

A new Phase 4 clinical trial registration (NCT07545564) has been posted to ClinicalTrials.gov by the NIH. The study will assess mucosal-specific sIgA antibody geometric mean titer (GMT) as the primary outcome, measuring both absolute GMT and the proportion of participants achieving 2-fold and 4-fold increases from baseline following LAIV nasal spray vaccination, compared to placebo.

For pharmaceutical sponsors, contract research organisations, and clinical investigators involved in influenza vaccine development, this post-marketing study registration signals an active LAIV programme entering the immunogenicity evaluation phase. Sites currently recruiting or considering participation should review eligibility criteria and investigator requirements upon availability of the full ClinicalTrials.gov record.

Archived snapshot

Apr 23, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

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

Phase 4 NCT07545564 Kind: PHASE4 Apr 22, 2026

Abstract

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

Interventions: LAIV, Placebo

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Last updated

Classification

Agency
NIH
Published
April 22nd, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Pharmaceutical companies Clinical investigators
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Clinical trial registration Vaccine immunogenicity study
Geographic scope
United States US

Taxonomy

Primary area
Public Health
Operational domain
Clinical Operations
Topics
Pharmaceuticals

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