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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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ClinicalTrials.gov Identifier: NCT04648241
Recruitment Status : Recruiting
First Posted : December 1, 2020
Last Update Posted : April 6, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE November 9, 2020
First Posted Date  ICMJE December 1, 2020
Last Update Posted Date April 6, 2021
Actual Study Start Date  ICMJE January 18, 2021
Estimated Primary Completion Date February 14, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2020)
  • 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.
  • 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.
  • The percentage of participants reporting local reactions. [ Time Frame: 7 days after each vaccination. ]
    Prompted local reactions after each dose.
  • The percentage of participants reporting systemic events. [ Time Frame: 7 days after each vaccination. ]
    Prompted systemic events after each dose.
  • The percentage of participants reporting AEs. [ Time Frame: 1 month after each vaccination. ]
    AEs within 1months after vaccination.
  • The percentage of participants reporting SAEs. [ Time Frame: Up to approximately 15 months. ]
    SAEs throughout the study.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 0.25mL (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 Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
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/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2021

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