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Safety and efficacy of tick-borne encephalitis vaccine

Safety and efficacy of tick-borne encephalitis vaccine - TBEV2018

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000035862
Enrollment
300
Registered
2019-02-12
Start date
2017-04-24
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tick-borne encephalitis

Interventions

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

Sponsors

Sapporo City General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
Frequency of local and systemic adverse reaction to first tick-borne encephalitis vaccination

Secondary

MeasureTime frame
Seropositive rate after two tick-borne encephalitis vaccination

Countries

Japan

Contacts

Public ContactFumihiro Kodama

Sapporo City General Hospital Department of Infectious Diseases

fumihirokodama@hotmail.com011-726-2211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026