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

JRCT ID: jRCT2031200302

Registered date:15/01/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Tick-Borne Encephalitis
• Date of first enrollment: 18/01/2021
• Target sample size: 165
• Study type: Interventional

Intervention(s)

Biological: TBE vaccine 0.5 mL
TBE vaccine 0.5 mL (intramuscular injection).
Biological: TBE vaccine 0.25 mL
TBE vaccine 0.25 mL (intramuscular injection).

Outcome(s)

Primary Outcome

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

Secondary Outcome

Secondary Outcome Measures:
1.The proportion who are seropositive (achieving NT titer >=1:10) in 16 years of age and older. [ Time Frame: 4 weeks after the second dose. ]
TBEV-neutralizing antibody titers.
2.NT GMTs in 16 years of age and older. [ Time Frame: 4 weeks after the second and 4 weeks after the third dose. ]
TBEV-neutralizing antibody titers.
3.NT GMFRs as compared to baseline in 16 years of age and older. [ Time Frame: 4 weeks after the second and 4 weeks after the third dose. ]
TBEV-neutralizing antibody titers.
4.NT GMFR 4 weeks after the third dose as compared to 4 weeks after the second dose in 16 years of age and older. [ Time Frame: 4 weeks after the second dose to 4 weeks after the third dose. ]
TBEV-neutralizing antibody titers.
5.The proportion who are seropositive (achieving NT titer >=1:10) in 1 to <16 years old. [ Time Frame: 4 weeks after the second dose. ]
TBEV-neutralizing antibody titers.
6.NT GMTs in 1 to <16 years old. [ Time Frame: 4 weeks after the second and 4 weeks after the third dose. ]
TBEV-neutralizing antibody titers.
7.NT GMFRs as compared to baseline in 1 to <16 years old. [ Time Frame: 4 weeks after the second and 4 weeks after the third dose. ]
TBEV-neutralizing antibody titers.
8.NT GMFR 4 weeks after the third dose as compared to 4 weeks after the second dose in 1 to <16 years old. [ Time Frame: 4 weeks after the second dose to 4 weeks after the third dose. ]
TBEV-neutralizing antibody titers.

Key inclusion & exclusion criteria

• Age minimum: >= 1age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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 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.

Related Information

• Primary Sponsor: Kawai Norisuke
• Secondary ID(s): NCT04648241