Safety and efficacy of tick-borne encephalitis vaccine

Phase 2

Recruiting

• Conditions: Tick-Borne Encephalitis; Tick-Borne Encephalitis, Vaccine; Encephalitis, Tick-Borne

• Registration Number: JPRN-jRCTs011180010
• Lead Sponsor: agasaka Atsushi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-08
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of local and systemic adverse reaction of 1st tick-borne encephalitis vaccination

Secondary Outcome Measures

Name	Time	Method
Seroconversion rate of tick-borne encephalitis antibody after 2nd tick-borne encephalitis vaccination