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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04961541 | Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine | PHASE1 | COMPLETED | 637 | — | — | Sep 8, 2021 | Apr 22, 2022 | Apr 10, 2025 | 10 | Australia |
Numbers of participants with solicited local and systemic AEs over the 7 days post-injection after first and second doses.
Number of participants reporting all AEs, (solicited and unsolicited), over 70 days after the first dose.
Number of participants with Medical Attended Adverse Events (MAAE's), Adverse events (AESI's), Including potential immune-mediated medical conditions (PIMMCs), Serious Adverse Events SAEs.
| Arm | Type | Description |
|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | EXPERIMENTAL | 2 doses of Formulation 1. 1 dose each on Days 0 and Day 56. |
| Group B -ICC Vaccine Formulation | EXPERIMENTAL | 2 doses of Formulation 2. 1 dose each on Days 0 and Day 56. |
| Group D - ICC Vaccine Formulation | EXPERIMENTAL | 2 doses of Formulation 3. 1 dose each on Days 0 and Day 56. |
| Group E - ICC Vaccine Formulation | EXPERIMENTAL | 2 doses of Formulation 4. 1 dose each on Days 0 and Day 56. |
| Group F- ICC Vaccine Formulation | EXPERIMENTAL | 2 doses of Formulation 5. 1 dose each on Days 0 and Day 56. |
| Group G- ICC Vaccine Formulation | EXPERIMENTAL | 2 doses of Formulation 6. 1 dose each on Days 0 and Day 56. |
| Group H and Group N- ICC Vaccine Formulation | EXPERIMENTAL | 2 doses of Formulation 7. 1 dose each on Day 0 and Day 56. |
| Group I- ICC Vaccine Formulation | EXPERIMENTAL | 2 doses of Formulation 8. 1 dose each on Days 0 and Day 56. |
| Group J -ICC Vaccine Formulation | EXPERIMENTAL | 2 doses of Formulation 9. 1 dose each on Days 0 and Day 56. |
| Group K - ICC Vaccine Formulation | EXPERIMENTAL | 2 doses of Formulation 10. 1 dose each on Days 0 and Day 56. |
| Group L - ICC Vaccine Formulation | EXPERIMENTAL | 2 doses of Formulation 11. 1 dose each on Days 0 and Day 56. |
| Group M -ICC Vaccine Formulation | EXPERIMENTAL | 2 doses of Formulation 12. 1 dose each on Days 0 and Day 56. |
| Group O - qNIV with Matrix-M1 adjuvant | EXPERIMENTAL | 2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70. |
| Group P- SARS-CoV-2 rS with Matrix-M1 adjuvant | EXPERIMENTAL | 2 doses of Formulation 14. 1 dose each on Days 0 and Day 56. |
| Name | Type | Description |
|---|---|---|
| ICC Vaccine | BIOLOGICAL | Intramuscular (deltoid) injections of in-clinic mix of various doses of quadrivalent hemagglutinin nanoparticle influenza vaccine(qNIV2), SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56. |
| qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant | BIOLOGICAL | Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70. |
| SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant | BIOLOGICAL | Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56. |
Inclusion Criteria: 1. Healthy, medically stable adult males or females ≥ 50 to ≤ 70 years of age at screening. 2. Willing and able to give informed consent prior to study enrollment. 3. Able to attend study visits, comply with study requirements, and provide reliable and complete reports of AEs. 4...