Clinical trial NCT04648241: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tick-Borne Encephalitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-12-01
Enrollment: 165
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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.

Primary outcomes:
measure: Percentage of Seropositive Participants at 4 Weeks After Dose 3
timeFrame: 4 weeks after Dose 3
measure: Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1
timeFrame: Within 7 days after Dose 1
measure: Percentage of Participants With Local Reactions Within 7 Days After Dose 2
timeFrame: Within 7 days after Dose 2
measure: Percentage of Participants With Local Reactions Within 7 Days After Dose 3
timeFrame: Within 7 days after Dose 3
measure: Percentage of Participants With Systemic Events (SE) Within 7 Days After Dose 1
timeFrame: Within 7 days after Dose 1
measure: Percentage of Participants With Systemic Events Within 7 Days After Dose 2
timeFrame: Within 7 days after Dose 2
measure: Percentage of Participants With Systemic Events Within 7 Days After Dose 3
timeFrame: Within 7 days after Dose 3
measure: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Dose 1
timeFrame: Within 1 month after Dose 1
measure: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Dose 2
timeFrame: Within 1 month after Dose 2
measure: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Dose 3
timeFrame: Within 1 month after Dose 3
measure: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Any Dose
timeFrame: Within 1 month after any Dose
measure: Percentage of Participants With Serious Adverse Events (SAEs) Throughout the Study
timeFrame: From Day 1 up to end of study (up to approximately 13 months)
Secondary outcomes:
measure: Percentage of Seropositive Participants at 4 Weeks After Dose 2
timeFrame: 4 weeks after Dose 2
measure: Geometric Mean Titers (GMTs) of TBEV Neutralizing Antibody Titers at 4 Weeks After Dose 2 and Dose 3
timeFrame: 4 weeks after Dose 2 and Dose 3
measure: Geometric Mean Fold Rise (GMFR) of TBEV Neutralizing Antibody Titers at 4 Weeks After Dose 2 as Compared to Baseline
timeFrame: From Baseline to 4 weeks after Dose 2
measure: Geometric Mean Fold Rise (GMFR) of TBEV Neutralizing Antibody Titers at 4 Weeks After Dose 3 as Compared to Baseline
timeFrame: From Baseline to 4 weeks after Dose 3
measure: Geometric Mean Fold Rise (GMFR) of TBEV Neutralizing Antibody Titers at 4 Weeks After Dose 3 as Compared to 4 Weeks After Dose 2
timeFrame: From 4 weeks after Dose 2 to 4 weeks after Dose 3
measure: Percentage of Participants With Neutralizing Antibody Titers >= Lower Limit of Quantification (LLOQ)
timeFrame: Before Dose 1, 4 weeks after Dose 2, Before Dose 3 and 4 weeks after Dose 3
Other outcomes:
Locations:
city: Fukuoka,
country: Japan
facility: Medical Co. LTA PS Clinic
state: Fukuoka
city: Ebetsu Shi
country: Japan
facility: Azuma kodomo katei clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: Watanabe Pediatric Allergy Clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: Ohigesenseino Kodomo Clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: SUZURAN Children's Clinic
state: Hokkaido
city: Kofu-city
country: Japan
facility: Childrens clinic of Kose
state: Yamanashi
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: