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

NCT04648241

Last updated date
Study Location
Medical Co. LTA PS Clinic
Fukuoka,, Fukuoka, 812-0025, Japan
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Tick-Borne Encephalitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
1 + year
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

pfizer-logoClinical Trials
Interested in learning more about clinical trials?
Discover how clinical trials work and the impact your participation could have.

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Tick-Borne EncephalitisStudy to Evaluate the Immunogenicity, Safety, and Tolerability of a Tick-Borne Encephalitis (TBE) Vaccine in Healthy Japanese Participants 1 Year of Age and Older
NCT04648241
  1. Fukuoka,, Fukuoka
  2. Ebetsu Shi, Hokkaido
  3. Sapporo, Hokkaido
  4. Sapporo, Hokkaido
  5. Sapporo, Hokkaido
  6. Kofu-city, Yamanashi
ALL GENDERS
1 Year+
years
MULTIPLE SITES
Tick-borne EncephalitisFSME IMMUN NEW Follow-up to Study 205 in Children Aged 6 to 16 Years
NCT00161889
  1. Augsburg,
  2. Bad Saulgau,
  3. Bietigheim-Bissingen,
  4. Calw,
  5. Coburg,
  6. Elzach,
  7. Ettenheim,
  8. Gersfeld,
  9. Heilbronn,
  10. Kehl,
  11. Kirchzarten,
  12. Landsberg,
  13. Mannheim-Secken,
  14. Metzingen,
  15. Nuernberg,
  16. Offenburg,
  17. Schramberg,
  18. Tegernsee,
  19. Weingarten,
ALL GENDERS
6 Years+
years
MULTIPLE SITES
Tick-Borne EncephalitisImmunogenicity, Safety and Interchangeability of Two Tbe Vaccines Administered According to a Conventional Schedule in Children
NCT00840801
  1. Eferding, Upper Austria
  2. Wels, Upper Austria
  3. Havlickuv Brod,
  4. Hradec Králové,
  5. Pardubice-Polabiny,
  6. Pardubice,
  7. Pardubice,
  8. Pardubice,
ALL GENDERS
1 Year+
years
MULTIPLE SITES
Tick-borne EncephalitisSafety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 Years
NCT00161863
  1. Wels,
  2. Bad Saulgau,
  3. Heilbronn,
  4. Kehl,
  5. Kielce,
  6. Krakow,
  7. Lubartow,
  8. Olsztyn,
ALL GENDERS
1 Year+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Tick-Borne Encephalitis
Intervention  ICMJE
  • 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).
Study Arms  ICMJE
  • Experimental: ?16 Years Old
    TBE vaccine 0.5 mL (intramuscular injection).
    Intervention: Biological: TBE vaccine 0.5 mL
  • Experimental: 1 to <16 Years Old
    TBE vaccine 0.25?L (intramuscular injection).
    Intervention: Biological: TBE vaccine 0.25 mL
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 23, 2020)
165
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 14, 2022
Estimated Primary Completion Date February 14, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 1 Year and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04648241
Other Study ID Numbers  ICMJE B9371039
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP