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Safety/Efficacy Evaluation of Live Influenza Vaccine in Patients Receiving Dupilumab

A Multicenter Study to Evaluate the Safety and Efficacy of Intranasal Live Influenza Vaccine in Pediatric Patients with Atopic Dermatitis Treated with Dupilumab

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031240442
Enrollment
50
Registered
2024-10-30
Start date
2024-11-20
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric patient with atopic dermatitis on Dupilumab treatment atopic dermatitis

Interventions

Intranasal live influenza vaccine is administered to eligible patients.
live vaccine, Influenza

Sponsors

Nagasawa Koo
Lead Sponsor
Ishiwada Naruhiko
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who meet all of the following requirements are eligible 1) 2 years of age and older but less than 19 years of age 2) Atopic dermatitis being treated with dupilumab 3) Patients who wish to receive the live influenza vaccine.

Exclusion criteria

Exclusion criteria: Patients with any of the following conditions are not eligible 1) Patients in poor general health 2) Patients with gelatin allergy 3) Pregnant patients 4) Patients who have previously received Flumist 5) Patients on Flumist contraindicated drugs 6) Other than the above, patients deemed by the physician to be inappropriate to participate in the program

Design outcomes

Primary

MeasureTime frame
Percentage of fourfold or greater increase in antibodies to all three types of vaccine-containing influenza viruses before and after vaccination

Secondary

MeasureTime frame
Influenza incidence in the 25 weeks after vaccination Systemic and local adverse events (including influenza-like symptoms) 4 weeks after vaccination

Contacts

Public ContactKoo Nagasawa

Chiba University Hospital

k-nagasawa@chiba-u.jp+81-43-222-7171

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026