臨床研究等提出・公開システム

Japanese

Date of registration	Mar. 08, 2019
Last modified on	Jan. 22, 2026
Trial ID	jRCTs011180010

Scientific Title	Safety and efficacy of tick-borne encephalitis vaccine (TBEV2018)
Public Title	Safety and efficacy of tick-borne encephalitis vaccine (TBEV2018)

Contact for Scientific Queries	Name	Nagasaka Atsushi
	Affiliation	Sapporo City General Hospital
	Address	Kita 11 Nishi 13 Chuo-ku Sapporo-shi Hokkaido Japan
	Telephone	+81-11-726-2211
	E-mail	atsushi.nagasaka@doc.city.sapporo.jp
Contact for Public Queries	Name	Kodama Fumihiro
	Affiliation	Sapporo City General Hospital
	Address	Kita 11 Nishi 13 Chuo-ku Sapporo-shi Hokkaido Japan
	Telephone	+81-11-726-2211
	E-mail	fumihirokodama@hotmail.com

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Dec. 01, 2016
Actual date of first enrollment		April. 24, 2017
Target sample size		300
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Age above 1 at study consent 2. Anyone who has risk of tick bite 3. Subjects who understand and agree with participation of their free will
	Exclusion Criteria	1. Patients suspected with acute illness such as fever 2. Patients currently under treatment for any acute illness or patients who have not recovered from acute illness for more than 1 week 3. Severe immunodeficiency 4. History of severe adverse reaction or allergy after tick-borne encephalitis vaccine 5. Hypersensitivity to formaldehyde, neomycin, gentamycin, protamine sulfate) 6. Severe hypersensitivity to egg and chick proteins (anaphylactic reaction after oral ingestion of egg protein) 7. Severe hypersensitivity to latex (anaphylactic reaction to latex) 8. Pregnancy or breastfeeding 9. Participants who deemed inappropriate by principal investigator 10. For first time vaccination: tick bite within 4 weeks
	Age Minimum	1age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Tick-Borne Encephalitis
Intervention(s)		FSME-IMMUN, FSME-IMMUN Junior vaccination
Health Condition(s) Keyword		Tick-Borne Encephalitis, Vaccine
Intervention(s) Keyword		Vaccination
Health Condition(s) Code		Encephalitis, Tick-Borne
Primary Outcome(s)		Frequency of local and systemic adverse reaction of 1st tick-borne encephalitis vaccination
Secondary Outcome(s)		Seroconversion rate of tick-borne encephalitis antibody after 2nd tick-borne encephalitis vaccination

Name of Certified Review Board	Hokkaido University Clinical Research Review Board
Address	Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido, Hokkaido
Telephone	+81-11-706-7934
E-Mail	recjimu@huhp.hokudai.ac.jp
Approval Status	Approval
Date of approval	Feb. 21, 2019

Secondary ID(s)	UMIN000035862
Issuing Authority	University Hospital Medical Information Network

Countries of Recruitment（Except Japan）	None

History of Changes

No	Publication date
9	Jan. 22, 2026	(this page)	Changes
8	June. 22, 2022	Detail	Changes
7	April. 23, 2021	Detail	Changes
6	April. 15, 2021	Detail	Changes
5	Nov. 06, 2020	Detail	Changes
4	Jan. 16, 2020	Detail	Changes
3	April. 23, 2019	Detail	Changes
2	April. 18, 2019	Detail	Changes
1	Mar. 08, 2019	Detail

List of change history