臨床研究等提出・公開システム

Japanese

Date of registration	Oct. 30, 2024
Last modified on	Jan. 24, 2025
Trial ID	jRCTs031240442

Scientific Title	A Multicenter Study to Evaluate the Safety and Efficacy of Intranasal Live Influenza Vaccine in Pediatric Patients with Atopic Dermatitis Treated with Dupilumab
Public Title	Safety/Efficacy Evaluation of Live Influenza Vaccine in Patients Receiving Dupilumab

Contact for Scientific Queries	Name	Nagasawa Koo
	Affiliation	Chiba University Hospital
	Address	1-8-1 Inohana, Chuo-ku, Chiba-city, Chiba
	Telephone	+81-432227171
	E-mail	k-nagasawa@chiba-u.jp
Contact for Public Queries	Name	Nagasawa Koo
	Affiliation	Chiba University Hospital
	Address	1-8-1 Inohana, Chuo-ku, Chiba-city, Chiba
	Telephone	+81-43-222-7171
	E-mail	k-nagasawa@chiba-u.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Oct. 30, 2024
Actual date of first enrollment
Target sample size		50
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	historical control
	assignment	single assignment
	purpose	prevention purpose
Key inclusion & exclusion 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	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
	Age Minimum	2age old over
	Age Maximum	19age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Pediatric patient with atopic dermatitis on Dupilumab treatment
Intervention(s)		Intranasal live influenza vaccine is administered to eligible patients.
Health Condition(s) Keyword		atopic dermatitis
Intervention(s) Keyword		live vaccine, Influenza
Health Condition(s) Code		D003876
Intervention(s) Code
Primary Outcome(s)		Percentage of fourfold or greater increase in antibodies to all three types of vaccine-containing influenza viruses before and after vaccination
Secondary Outcome(s)		Influenza incidence in the 25 weeks after vaccination Systemic and local adverse events (including influenza-like symptoms) 4 weeks after vaccination

Primary Sponsor

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Chiba University Hospital
Secondary Sponsor	Not applicable

Name of Certified Review Board	Chiba University Hospital Certified Clinical Research Review Board
Address	1-8-1 Inohana Chuo-ku Chiba, Chiba
Telephone	+81-43-226-2616
E-Mail	prc-jim@chiba-u.jp
Approval Status	Approval
Date of approval	Oct. 21, 2024

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Jan. 24, 2025	(this page)	Changes
1	Oct. 30, 2024	Detail

List of change history