Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04537949 | A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults | PHASE1 | COMPLETED | 96 | — | — | Sep 9, 2020 | Feb 7, 2022 | Jan 5, 2024 | 2 | Germany |
Solicited local reactions at the injection site (pain, tenderness, erythema/redness, and induration/swelling) were monitored and graded using criteria based on the guidance given in US FDA Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials". The reporting of local reactions was based on the participant's assessments via daily solicited reports in the participant diaries.
Solicited systemic reactions (nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever) were monitored and graded using criteria based on the guidance given in US FDA Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials". The reporting of systemic reactions was based on the participant's assessments via daily solicited reports in the participant diaries.
Treatment emergent adverse events (TEAEs) were analyzed by age group, dose level, and for each IMP dose. The number and percentage of participants reporting at least one TEAE was summarized by adverse event types (any TEAE and any grade \>=3 TEAE) using the Safety Set.
Treatment emergent adverse events (TEAEs) were analyzed by age group, dose level, and for each IMP dose. The percentage of participants reporting at least one TEAE was summarized by adverse event types (any TEAE and any grade \>=3 TEAE) using the Safety Set.
| Arm | Type | Description |
|---|---|---|
| Part A participants aged 18 to 55 years | EXPERIMENTAL | Escalating dose levels |
| Part A participants aged 56 to 85 years (optional) | EXPERIMENTAL | Escalating dose levels |
| Name | Type | Description |
|---|---|---|
| BNT162b3 | BIOLOGICAL | Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost (P/B) regimen). |
Inclusion Criteria: * Have given informed consent by signing the informed consent form (ICF) before initiation of any trial-specific procedures. * They must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions (e.g., to practice social di...