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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04380701 | A Trial Investigating the Safety and Effects of Four BNT162 Vaccines Against COVID-19 in Healthy and Immunocompromised Adults | PHASE1 | COMPLETED | 512 | — | — | Apr 23, 2020 | Apr 13, 2022 | Jul 12, 2024 | 5 | 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.
TEAEs without AEs based on solicited reporting via diaries, were analyzed by vaccine, 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.
TEAEs, without AEs based on solicited reporting via diaries, were analyzed by vaccine, 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 |
|---|---|---|
| BNT162a1 (P/B) - Part A 18-55 years of age | EXPERIMENTAL | Escalating dose levels |
| BNT162b1 (P/B) - Part A 18-55 years of age | EXPERIMENTAL | Escalating dose levels |
| BNT162b2 (P/B) - Part A 18-55 years of age | EXPERIMENTAL | Escalating dose levels |
| BNT162c2 (P/B) - Part A 18-55 years of age | EXPERIMENTAL | Escalating dose levels |
| BNT162c2 (prime only) - Part A 18-55 years of age | EXPERIMENTAL | Single dose |
| BNT162b1 (P/B) - Part A 56-85 years of age | EXPERIMENTAL | Escalating dose levels |
| BNT162b2 (P/B) - Part A 56-85 years of age | EXPERIMENTAL | Escalating dose levels |
| BNT162b2 (P/B) - Part A 18-85 years of age (Expansion cohorts 11 to 13) | EXPERIMENTAL | Fixed doses used; cohort 11: alternative posology dose group expansion cohort; cohort 12: adaptive immune response dose group expansion cohort; cohort 13: immunocompromised (IC) participants expansion cohort |
| BNT162b2 (P/B) - Part A 18-85 years of age (Expansion cohort 14) | EXPERIMENTAL | fixed doses used; B-cell immune response dose group expansion cohort |
| Name | Type | Description |
|---|---|---|
| BNT162a1 | BIOLOGICAL | Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection. |
| BNT162b1 | BIOLOGICAL | Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection. |
| BNT162b2 | BIOLOGICAL | Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection. |
| BNT162c2 | BIOLOGICAL | Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection. |
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...