Phase 3
N=165
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
Tick-Borne Encephalitis
Bottom Line
View on ClinicalTrials.gov: NCT04648241 ↗Enrolled (actual)
165
Serious AEs
1.8%
Results posted
Nov 2023
Primary outcome: Primary: Percentage of Seropositive Participants at 4 Weeks After Dose 3 — 98.0; 100 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- TBE vaccine 0.5 mL (Biological); TBE vaccine 0.25 mL (Biological)
- Age
- Pediatric, Adult, Older Adult · 1+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Seropositive Participants at 4 Weeks After Dose 3 |
98.0; 100 | — |
| PRIMARY Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 |
2.0; 3.1; 0; 1.5; 0; 0 | — |
| PRIMARY Percentage of Participants With Local Reactions Within 7 Days After Dose 2 |
0.0; 3.1; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants With Local Reactions Within 7 Days After Dose 3 |
2.0; 7.7; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants With Systemic Events (SE) Within 7 Days After Dose 1 |
2.0; 5.3; 25.0; 2.0; 3.5; 25.0 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Dose 2 |
1.0; 7.0; 0; 1.0; 3.5; 0 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Dose 3 |
1.0; 10.5; 12.5; 0; 8.8; 12.5 | — |
| PRIMARY Percentage of Participants With Adverse Events (AEs) Within 1 Month After Dose 1 |
6.0; 21.5 | — |
| PRIMARY Percentage of Participants With Adverse Events (AEs) Within 1 Month After Dose 2 |
2.0; 10.8 | — |
| PRIMARY Percentage of Participants With Adverse Events (AEs) Within 1 Month After Dose 3 |
6.1; 29.2 | — |
| PRIMARY Percentage of Participants With Adverse Events (AEs) Within 1 Month After Any Dose |
14.0; 41.5 | — |
| PRIMARY Percentage of Participants With Serious Adverse Events (SAEs) Throughout the Study |
2.0; 1.5 | — |
| SECONDARY Percentage of Seropositive Participants at 4 Weeks After Dose 2 |
93; 92.3 | — |
| SECONDARY Geometric Mean Titers (GMTs) of TBEV Neutralizing Antibody Titers at 4 Weeks After Dose 2 and Dose 3 |
28.2; 29.4; 80.1; 233.1 | — |
| SECONDARY Geometric Mean Fold Rise (GMFR) of TBEV Neutralizing Antibody Titers at 4 Weeks After Dose 2 as Compared to Baseline |
11.2; 11.8 | — |
| SECONDARY Geometric Mean Fold Rise (GMFR) of TBEV Neutralizing Antibody Titers at 4 Weeks After Dose 3 as Compared to Baseline |
32.0; 93.2 | — |
| SECONDARY Geometric Mean Fold Rise (GMFR) of TBEV Neutralizing Antibody Titers at 4 Weeks After Dose 3 as Compared to 4 Weeks After Dose 2 |
2.8; 7.9 | — |
| SECONDARY Percentage of Participants With Neutralizing Antibody Titers >= Lower Limit of Quantification (LLOQ) |
0; 0; 96.0; 98.5; 63.6; 86.2 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04648241). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.