臨床研究等提出・公開システム

Date of registration	Aug. 18, 2015
Last modified on	Dec. 20, 2019
Trial ID	jRCT2080222939

Scientific Title	Open study of quadrivalent VN-100 in healthy children
Public Title	Open study of quadrivalent VN-100 in healthy children

Completion Date or Terminated date	Nov. 23, 2015
Actual Enrolled Number	73
Baseline Characteristics	To confirm the immunogenicity and safety of quadrivalent VN-100 in Japanese healthy children 3 to 13 years of age
Participant flow	73 subjects who obtained informed consent from proxies were enrolled in this study. Two subjects were discontinued and 71 subjects were completed in this study.
Adverse events	- The incidence of injection site AEs was 98.6% (72/73), and the incidence of systemic AEs was 24.7% (18/73). - The main injection site AEs were injection site erythema 98.6% (72/73), injection site swelling 71.2% (52/73), injection site pruritus 61.6% (45/73), injection site hot feeling 57.5% (42/73), injection site pain 54.8% (40/73), and injection site induration 45.2% (33/73). - The main systemic AEs were fatigue 9.6% (7/73), nasopharyngitis 9.6% (7/73), and headache 5.5% (4/73).
Primary Outcome Measures	The seroprotection rate (95% CI) in HI antibody titer approximately 2 weeks after 2nd vaccination was A/H1N1 100.0% (94.94-100%), A/H3N2 100.0% (94.94-100%), B/Yamagata 78.87% (67.56-87.67%), B/Victoria 74.64% (62.92-84.23%).
Secondary Outcome Measures	- The seroconversion rate in HI antibody titer approximately 3 weeks after 2nd vaccination was A/H1N1 63.38%, A/H3N2 63.38%, B/Yamagata 47.89%, B/Victoria 56.34%. - The GMT ratio in HI antibody titer approximately 3 weeks after 2nd vaccination was A/H1N1 8.608, A/H3N2 5.854, B/Yamagata 4.272, B/Victoria 4.934. - The seroconversion rate in SRH antibody titer approximately 3 weeks after 2nd vaccination was A/H1N1 69.01%, A/H3N2 70.42%, B/Yamagata 70.42%, B/Victoria 81.69. - The GMT ratio in SRH antibody titer approximately 3 weeks after 2nd vaccination was A/H1N1 2.838, A/H3N2 2.404, B/Yamagata 2.961, B/Victoria 3.521.
Brief summary	As a result of quadrivalent VN-100 in healthy children 3 to 13 years of age, the HI antibody titer was confirmed to have good immunogenicity in any strain. There were no serious AEs, and there were no serious safety issues.
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description	-
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	DAIICHI SANKYO Co.,Ltd.
	Address
	Phone Number
	E-mail Address	dsclinicaltrial@daiichisankyo.co.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	DAIICHI SANKYO Co.,Ltd
	Address
	Phone Number
	E-mail Address	dsclinicaltrial@daiichisankyo.co.jp

Recruitment Status	completed

Date of First Enrolment		Sept. 26, 2015
Target Sample Size		70
Study Type		Interventional
Study Design	Study Design	Single-center, uncontrolled, open-label study
Study Design	Objective	prevention purpose
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	Japanese healthy children
	Exclusion Criteria	1) Subjects with history of seasonal influenza in the past 6 months 2) Subjects with history of seasonal influenza vaccination in the past 6 months
	Minimum Age	3age old over
	Maximum Age	12age old under
	Gender	Both
Health Condition or Problem Studied		Prophylaxis of influenza infection
Intervention(s)		investigational material(s) Generic name etc : VN-100 (intradermal vaccine for seasonal influenza) INN of investigational material : - Therapeutic category code : 631 Vaccines Dosage and Administration for Investigational material : Intradermal control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		efficacy Seroprotection rate of HI antibody titer
Secondary Outcome		safety efficacy 1)Seroconversion rate and GMT ratio of HI antibody titer 2)Seroconversion rate, GMT ratio and Seroprotection rate of SRH antibody titer

Primary Sponsor	DAIICHISANKYO Co.,Ltd.
Secondary Sponsor	TERUMO CORPORATION
Secondary Sponsor	KITASATO DAIICHI SANKYO VACCINE COMPANY, LIMITED
Secondary Sponsor	JAPAN VACCINE COMPANY, LIMITED

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	Institutional review board of Shinanosaka clinic
Address of IRB	Yotsuya Medical Building 3F, 20 Samon-cho, Shinjuku-ku, Tokyo
Phone Number of IRB	+81-3-5366-3006
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	Sept. 01, 2015

Secondary ID No.	JapicCTI-152991
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
8	Dec. 20, 2019	(this page)	Changes
7	Dec. 17, 2018	Detail	Changes
6	Mar. 09, 2016	Detail	Changes
5	Mar. 09, 2016	Detail	Changes
4	Oct. 01, 2015	Detail	Changes
3	Oct. 01, 2015	Detail	Changes
2	Aug. 18, 2015	Detail	Changes
1	Aug. 18, 2015	Detail

List of change history