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 19 of 30 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | VLA15, Prevenar 20, 13vPnC, ATM-AVI, PG4 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE3 | PCV21 |
| GSK plc Sponsored ADR | GSK | 4 | PHASE2 | Penmenvy, iNTS-TCV, Strep A vaccine, Pan-Salmonella vaccine |
| Grifols, S.A. Sponsored ADR Class B | GRFS | 1 | PHASE3 | Xembify |
| CorMedix Inc. | CRMD | 1 | PHASE3 | DefenCath |
| Sinovac Biotech Ltd. | SVA | 4 | PHASE3 | Sinovac PCV24, Group ACYW135X Meningococcal Conjugate Vaccine, Group ACYW135 Meningococcal Conjugate Vaccine |
| Novartis AG Sponsored ADR | NVS | 2 | PHASE2 | EDI048 |
| Innoviva, Inc. | INVA | 3 | PHASE2 | Eravacycline, Sulbactam-durlobactam |
| BiomX Inc. | PHGE | 1 | PHASE2 | BX004 |
| Hoffmann-La Roche | RHHBY | 1 | PHASE3 | Baloxavir Marboxil |
| Merck & Co., Inc. | MRK | 2 | PHASE1 | V118C |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD7760 |
| BioNTech SE Sponsored ADR | BNTX | 1 | PHASE1 | BNT163 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |
| Tarsus Pharmaceuticals, Inc. | TARS | 1 | PHASE2 | TP-05 |
| Moderna, Inc. | MRNA | 1 | PHASE2 | mRNA-1982 |
| AN2 Therapeutics, Inc. | ANTX | 1 | PHASE2 | Epetraborole |
| Emergent BioSolutions Inc. | EBS | 4 | - | AIGIV/kg |
| Phathom Pharmaceuticals, Inc. | PHAT | 1 | - | Vonoprazan |
The ICC Vaccine is an investigational combination vaccine developed by Novavax, Inc. that pairs influenza and COVID-19 immunization in a single product. It is being studied for protection against SARS-CoV infection and COVID-19. The candidate has completed a Phase 1 clinical trial and is not an approved product.
The ICC Vaccine is being developed to protect against SARS-CoV infection and COVID-19 alongside influenza in one combination regimen. Its Phase 1 study enrolled healthy volunteers aged 50 years and older in Australia. Because it remains investigational, it is not currently available for use outside clinical research.
Novavax, Inc., which trades on Nasdaq under the ticker NVAX, is the developer of the ICC Vaccine. The company sponsored the Phase 1 trial evaluating the combination of influenza and COVID-19 vaccine components. Novavax is a vaccine-focused biotechnology company.
The ICC Vaccine is in Phase 1 development. Its single registered trial, NCT04961541, has completed, and no active trials are currently listed. The candidate is investigational and has not been approved by the FDA or any other regulatory agency based on the available information.
The ICC Vaccine has been evaluated in one clinical trial, NCT04961541, titled Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine. The Phase 1 study was randomized, double-blind, and controlled, enrolling 637 healthy volunteers aged 50 and older in Australia. It is now completed.