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

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Brief Title

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

Official Title

A PHASE 3, SINGLE-ARM, OPEN-LABEL STUDY TO EVALUATE THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF A TICK-BORNE ENCEPHALITIS VACCINE IN HEALTHY JAPANESE PARTICIPANTS 1 YEAR OF AGE AND OLDER

Brief Summary

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


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

The proportion who are seropositive (achieving neutralization test [NT] titer ≥1:10) in 16 years of age and older.

Secondary Outcome

 The proportion who are seropositive (achieving NT titer ≥1:10) in 16 years of age and older.

Condition

Tick-Borne Encephalitis

Intervention

TBE vaccine 0.5 mL

Study Arms / Comparison Groups

 ≥16 Years Old
Description:  TBE vaccine 0.5 mL (intramuscular injection).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

165

Start Date

January 18, 2021

Completion Date

January 25, 2022

Primary Completion Date

January 25, 2022

Eligibility 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:

          -  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.
      

Gender

All

Ages

1 Year - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Pfizer CT.gov Call Center, , 

Location Countries

Japan

Location Countries

Japan

Administrative Informations


NCT ID

NCT04648241

Organization ID

B9371039


Responsible Party

Sponsor

Study Sponsor

Pfizer


Study Sponsor

Pfizer CT.gov Call Center, Study Director, Pfizer


Verification Date

June 2021