Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ICC Vaccine · 1 trial · 2 indications
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...
Top 20 of 28 competitors
ICC Vaccine is an investigational combination vaccine being evaluated for the prevention of SARS-CoV infection and COVID-19. It is designed to target both influenza and COVID-19 in a single vaccine. The vaccine is currently in Phase 1 clinical development and is not yet approved for use.
ICC Vaccine is being developed by Novavax, Inc., a biotechnology company traded on the NASDAQ under the ticker symbol NVAX. The company is conducting clinical trials to evaluate the safety and immunogenicity of this combination vaccine candidate.
ICC Vaccine is currently in Phase 1 clinical development. A Phase 1 clinical trial has been completed to evaluate its safety and immunogenicity. The vaccine remains investigational and has not received regulatory approval for any use.
ICC Vaccine has been studied in one completed Phase 1 clinical trial registered as NCT04961541. This trial evaluated the safety and immunogenicity of an influenza and COVID-19 combination vaccine in 637 healthy volunteers aged 50 years and older in Australia.
Yes, ICC Vaccine is being developed as a combination vaccine targeting both influenza and COVID-19. The completed Phase 1 trial, NCT04961541, was designed to evaluate the safety and immunogenicity of this combined approach in adults aged 50 years and older.
ICC Vaccine is a combination vaccine designed to elicit an immune response against both influenza and SARS-CoV-2, the virus that causes COVID-19. By combining antigens from both viruses, the vaccine aims to provide protection against both respiratory infections with a single immunization.