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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035862
Receipt No. R000040852
Scientific Title Safety and efficacy of tick-borne encephalitis vaccine
Date of disclosure of the study information 2019/02/12
Last modified on 2019/02/12

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Basic information
Public title Safety and efficacy of tick-borne encephalitis vaccine
Acronym TBEV2018
Scientific Title Safety and efficacy of tick-borne encephalitis vaccine
Scientific Title:Acronym TBEV2018
Region
Japan

Condition
Condition Tick-borne encephalitis
Classification by specialty
Infectious disease Adult Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of safety and efficacy of tick-borne encephalitis vaccine
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes Frequency of local and systemic adverse reaction to first tick-borne encephalitis vaccination
Key secondary outcomes Seropositive rate after two tick-borne encephalitis vaccination

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Vaccine
Interventions/Control_1 Tick-borne encephalitis vaccine
For 16 years and older
FSME-IMMUN 0.5ml IM
3 vaccination(give 2nd 1 to 3 months after 1st, give 3rd 5 to 12 months after 2nd)

For 1 to 15 years old
FSME-IMMUN Junior 0.25ml IM
3 vaccination(give 2nd 1 to 3 months after 1st, give 3rd 5 to 12 months after 2nd)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
1 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key 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
Key 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
Target sample size 200

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Atsushi Nagasaka
Organization Sapporo City General Hospital
Division name Department of Infectious Diseases
Zip code
Address Kita-11, Nishi-13, Chuo-ku, Sapporo, Hokkaido, Japan
TEL 011-726-2211
Email atsushi.nagasaka@doc.city.sapporo.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Fumihiro Kodama
Organization Sapporo City General Hospital
Division name Department of Infectious Diseases
Zip code
Address Kita-11, Nishi-13, Chuo-ku, Sapporo, Hokkaido, Japan
TEL 011-726-2211
Homepage URL
Email fumihiro.kodama@doc.city.sapporo.jp

Sponsor
Institute Sapporo City General Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 12 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2016 Year 12 Month 21 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 02 Month 12 Day
Last modified on
2019 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040852

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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