Study to Evaluate the Immunogenicity, Safety, and Tolerability of a Tick-Borne Encephalitis (TBE)… (NCT04648241) | Clinical Trial Compass
CompletedPhase 3
Study to Evaluate the Immunogenicity, Safety, and Tolerability of a Tick-Borne Encephalitis (TBE) Vaccine in Healthy Japanese Participants 1 Year of Age and Older
Japan165 participantsStarted 2021-01-18
Plain-language summary
The main purpose of this study is to provide safety and immunogenicity data in Japanese participants.
Who can participate
Age range1 Year
SexALL
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Inclusion Criteria:
* Japanese male or female participants ≥1 years old at Visit 1.
* Participants and/or a legally acceptable representative/parent/legal guardian are willing and able to comply with all scheduled visits, vaccination plan, and other study procedures including completion of the e-diary for 7 days for participants after each of 3 vaccinations.
* Participants and/or a legally acceptable representative/parent/legal guardian must be able to be contacted by telephone during study participation.
* Participants and/or a legally acceptable representative/parent/legal guardian are capable of giving signed informed consent.
Exclusion Criteria:
* Major known congenital malformation or serious chronic disorder.
* Known history of TBEV infection.
* Known history of other flavivirus infection (eg, dengue fever, yellow fever, JEV, West Nile virus).
* Known history of infection with HIV, HCV, or HBV.
* Immunocompromised participants with known or suspected immunodeficiency.
* History of autoimmune disease or an active autoimmune disease requiring therapeutic intervention.
* Previous vaccination with any licensed or investigational TBE vaccine, or planned receipt of other flavivirus vaccines apart from JEV vaccine (eg, yellow fever, dengue fever) during the study. Administration of JEV vaccine is prohibited during participation.
What they're measuring
1
Percentage of Seropositive Participants at 4 Weeks After Dose 3
Timeframe: 4 weeks after Dose 3
2
Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1
Timeframe: Within 7 days after Dose 1
3
Percentage of Participants With Local Reactions Within 7 Days After Dose 2
Timeframe: Within 7 days after Dose 2
4
Percentage of Participants With Local Reactions Within 7 Days After Dose 3
Timeframe: Within 7 days after Dose 3
5
Percentage of Participants With Systemic Events (SE) Within 7 Days After Dose 1
Timeframe: Within 7 days after Dose 1
6
Percentage of Participants With Systemic Events Within 7 Days After Dose 2
Timeframe: Within 7 days after Dose 2
7
Percentage of Participants With Systemic Events Within 7 Days After Dose 3
Timeframe: Within 7 days after Dose 3
8
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Dose 1