UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035862 |
|---|---|
| Receipt number | R000040852 |
| Scientific Title | Safety and efficacy of tick-borne encephalitis vaccine |
| Date of disclosure of the study information | 2019/02/12 |
| Last modified on | 2021/02/15 08:38:08 |
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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 less than 16 years
FSME-IMMUN Junior 0.25ml 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
300
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Nagasaka |
Organization
Sapporo City General Hospital
Division name
Department of Infectious Diseases
Zip code
060-8604
Address
Kita-11, Nishi-13, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-726-2211
atsushi.nagasaka@doc.city.sapporo.jp
Public contact
Name of contact person
| 1st name | Fumihiro |
| Middle name | |
| Last name | Kodama |
Organization
Sapporo City General Hospital
Division name
Department of Infectious Diseases
Zip code
060-8604
Address
Kita-11, Nishi-13, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-726-2211
Homepage URL
fumihirokodama@hotmail.com
Sponsor or person
Institute
Sapporo City General Hospital
Institute
Department
Personal name
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
Sapporo City General Hospital
Address
Kita-11, Nishi-13, Chuo-ku, Sapporo, Hokkaido, Japan
Tel
011-726-2211
fumihiro.kodama@doc.city.sapporo.jp
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
| 2019 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 30 | Day |
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
| 2021 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040852
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
