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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

Primary Purpose

Tick-Borne Encephalitis

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
TBE vaccine 0.5 mL
TBE vaccine 0.25 mL
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tick-Borne Encephalitis

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Medical Co. LTA PS Clinic
  • Azuma kodomo katei clinic
  • Watanabe Pediatric Allergy Clinic
  • Ohigesenseino Kodomo Clinic
  • SUZURAN Children's Clinic
  • Childrens clinic of Kose

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

≥16 Years Old

1 to <16 Years Old

Arm Description

TBE vaccine 0.5 mL (intramuscular injection).

TBE vaccine 0.25ｍL (intramuscular injection).

Outcomes

Primary Outcome Measures

The proportion who are seropositive (achieving neutralization test [NT] titer ≥1:10) in 16 years of age and older.
TBEV-neutralizing antibody titers.
The proportion who are seropositive (achieving NT titer ≥1:10) in 1 to <16 years old.
TBEV-neutralizing antibody titers.
The percentage of participants reporting local reactions.
Prompted local reactions after each dose.
The percentage of participants reporting systemic events.
Prompted systemic events after each dose.
The percentage of participants reporting AEs.
AEs within 1months after vaccination.
The percentage of participants reporting SAEs.
SAEs throughout the study.

Secondary Outcome Measures

The proportion who are seropositive (achieving NT titer ≥1:10) in 16 years of age and older.
TBEV-neutralizing antibody titers.
NT GMTs in 16 years of age and older.
TBEV-neutralizing antibody titers.
NT GMFRs as compared to baseline in 16 years of age and older.
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.
TBEV-neutralizing antibody titers.
The proportion who are seropositive (achieving NT titer ≥1:10) in 1 to <16 years old.
TBEV-neutralizing antibody titers.
NT GMTs in 1 to <16 years old.
TBEV-neutralizing antibody titers.
NT GMFRs as compared to baseline in 1 to <16 years old.
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.
TBEV-neutralizing antibody titers.

Full Information

First Posted
November 9, 2020
Last Updated
March 17, 2022
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT04648241
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 18, 2021 (Actual)
Primary Completion Date
February 21, 2022 (Actual)
Study Completion Date
February 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tick-Borne Encephalitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
≥16 Years Old
Arm Type
Experimental
Arm Description
TBE vaccine 0.5 mL (intramuscular injection).
Arm Title
1 to <16 Years Old
Arm Type
Experimental
Arm Description
TBE vaccine 0.25ｍL (intramuscular injection).
Intervention Type
Biological
Intervention Name(s)
TBE vaccine 0.5 mL
Intervention Description
TBE vaccine 0.5 mL (intramuscular injection).
Intervention Type
Biological
Intervention Name(s)
TBE vaccine 0.25 mL
Intervention Description
TBE vaccine 0.25 mL (intramuscular injection).
Primary Outcome Measure Information:
Title
The proportion who are seropositive (achieving neutralization test [NT] titer ≥1:10) in 16 years of age and older.
Description
TBEV-neutralizing antibody titers.
Time Frame
4 weeks after third dose.
Title
The proportion who are seropositive (achieving NT titer ≥1:10) in 1 to <16 years old.
Description
TBEV-neutralizing antibody titers.
Time Frame
4 weeks after third dose.
Title
The percentage of participants reporting local reactions.
Description
Prompted local reactions after each dose.
Time Frame
7 days after each vaccination.
Title
The percentage of participants reporting systemic events.
Description
Prompted systemic events after each dose.
Time Frame
7 days after each vaccination.
Title
The percentage of participants reporting AEs.
Description
AEs within 1months after vaccination.
Time Frame
1 month after each vaccination.
Title
The percentage of participants reporting SAEs.
Description
SAEs throughout the study.
Time Frame
Up to approximately 15 months.
Secondary Outcome Measure Information:
Title
The proportion who are seropositive (achieving NT titer ≥1:10) in 16 years of age and older.
Description
TBEV-neutralizing antibody titers.
Time Frame
4 weeks after the second dose.
Title
NT GMTs in 16 years of age and older.
Description
TBEV-neutralizing antibody titers.
Time Frame
4 weeks after the second and 4 weeks after the third dose.
Title
NT GMFRs as compared to baseline in 16 years of age and older.
Description
TBEV-neutralizing antibody titers.
Time Frame
4 weeks after the second and 4 weeks after the third dose.
Title
NT GMFR 4 weeks after the third dose as compared to 4 weeks after the second dose in 16 years of age and older.
Description
TBEV-neutralizing antibody titers.
Time Frame
4 weeks after the second dose to 4 weeks after the third dose.
Title
The proportion who are seropositive (achieving NT titer ≥1:10) in 1 to <16 years old.
Description
TBEV-neutralizing antibody titers.
Time Frame
4 weeks after the second dose.
Title
NT GMTs in 1 to <16 years old.
Description
TBEV-neutralizing antibody titers.
Time Frame
4 weeks after the second and 4 weeks after the third dose.
Title
NT GMFRs as compared to baseline in 1 to <16 years old.
Description
TBEV-neutralizing antibody titers.
Time Frame
4 weeks after the second and 4 weeks after the third dose.
Title
NT GMFR 4 weeks after the third dose as compared to 4 weeks after the second dose in 1 to <16 years old.
Description
TBEV-neutralizing antibody titers.
Time Frame
4 weeks after the second dose to 4 weeks after the third dose.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Medical Co. LTA PS Clinic
City
Fukuoka,
State/Province
Fukuoka
ZIP/Postal Code
812-0025
Country
Japan
Facility Name
Azuma kodomo katei clinic
City
Ebetsu Shi
State/Province
Hokkaido
ZIP/Postal Code
069-0816
Country
Japan
Facility Name
Watanabe Pediatric Allergy Clinic
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
006-0831
Country
Japan
Facility Name
Ohigesenseino Kodomo Clinic
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
062-0907
Country
Japan
Facility Name
SUZURAN Children's Clinic
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
063-0841
Country
Japan
Facility Name
Childrens clinic of Kose
City
Kofu-city
State/Province
Yamanashi
ZIP/Postal Code
400-0853
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=B9371039
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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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