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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Tick-Borne Encephalitis

Treatments: Biological: TBE vaccine 0.5 mL; Biological: TBE vaccine 0.25 mL

Study type: Interventional

Funder types: Industry

Identifiers

NCT04648241

B9371039

Details and patient eligibility

About

The main purpose of this study is to provide safety and immunogenicity data in Japanese participants.

Enrollment: 165 patients

Sex: All

Ages: 1+ year old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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165 participants in 2 patient groups

≥16 Years Old

Experimental group

Description:

TBE vaccine 0.5 mL (intramuscular injection).

Treatment:

Biological: TBE vaccine 0.5 mL

1 to <16 Years Old

Experimental group

Description:

TBE vaccine 0.25ｍL (intramuscular injection).

Treatment:

Biological: TBE vaccine 0.25 mL