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

Phase 3

• Conditions: Tick-Borne Encephalitis

• Registration Number: JPRN-jRCT2031200302
• Lead Sponsor: Kawai Norisuke

Brief Summary

The 3-dose series of TBE vaccine was observed to elicit a robust immune response by TBEV neutralization in Japanese adult and pediatric participants. There was a >=98% TBEV neutralization seropositivity rate demonstrated in both adult and pediatric populations 4 weeks after Dose 3. The safety and tolerability of TBE vaccine in Japanese adult and pediatric participants was acceptable and consistent with the known profile of TBE vaccine.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-15
• Study Completion: 2022-06-03
• Results First Posted: 2023-03-03
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

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

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 e 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome Measures:<br>1.The proportion who are seropositive (achieving neutralization test [NT] titer >=1:10) in 16 years of age and older. [ Time Frame: 4 weeks after third dose. ]<br>TBEV-neutralizing antibody titers.<br>2.The proportion who are seropositive (achieving NT titer >=1:10) in 1 to <16 years old. [ Time Frame: 4 weeks after third dose. ]<br>TBEV-neutralizing antibody titers.<br>3.The percentage of participants reporting local reactions. [ Time Frame: 7 days after each vaccination. ]<br>Prompted local reactions after each dose.<br>4.The percentage of participants reporting systemic events. [ Time Frame: 7 days after each vaccination. ]<br>Prompted systemic events after each dose.<br>5.The percentage of participants reporting AEs. [ Time Frame: 1 month after each vaccination. ]<br>AEs within 1months after vaccination.<br>6.The percentage of participants reporting SAEs. [ Time Frame: Up to approximately 15 months. ]<br>SAEs throughout the study.