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
NCT ID: NCT04648241
Last Updated: 2023-11-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
165 participants
INTERVENTIONAL
2021-01-18
2022-02-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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≥16 Years Old
TBE vaccine 0.5 mL (intramuscular injection).
TBE vaccine 0.5 mL
TBE vaccine 0.5 mL (intramuscular injection).
1 to <16 Years Old
TBE vaccine 0.25ｍL (intramuscular injection).
TBE vaccine 0.25 mL
TBE vaccine 0.25 mL (intramuscular injection).
Interventions
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TBE vaccine 0.5 mL
TBE vaccine 0.5 mL (intramuscular injection).
TBE vaccine 0.25 mL
TBE vaccine 0.25 mL (intramuscular injection).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
1 Year
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Medical Co. LTA PS Clinic
Fukuoka, Fukuoka, Japan
Azuma kodomo katei clinic
Ebetsu Shi, Hokkaido, Japan
Watanabe Pediatric Allergy Clinic
Sapporo, Hokkaido, Japan
Ohigesenseino Kodomo Clinic
Sapporo, Hokkaido, Japan
SUZURAN Children's Clinic
Sapporo, Hokkaido, Japan
Childrens clinic of Kose
Kofu, Yamanashi, Japan
Countries
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References
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Yonekawa M, Watanabe T, Kogawara O, Yoshii C, Yamaji M, Aizawa M, Erber W, Ito S, Jug B, Koelch D, de Solom R, Lockhart SP. Phase 3 immunogenicity and safety study of a tick-borne encephalitis vaccine in healthy Japanese participants 1 year of age and older. Vaccine. 2024 May 10;42(13):3180-3189. doi: 10.1016/j.vaccine.2024.03.071. Epub 2024 Apr 12.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B9371039
Identifier Type: -
Identifier Source: org_study_id