Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CIC Vaccine Co-formulated tNIV2, SARSCoV-2 rS and Matrix-M Adjuvant · 1 trial · 1 indication
Numbers of participants with solicited local and systemic AEs over the 7 days post-vaccination.
Numbers of participants reporting unsolicited AEs and MAAEs over 21 days post-vaccination.
Numbers of participants with treatment-related MAAEs, AESIs (including PIMMC and myocarditis and/or pericarditis), and SAEs will be collected for 12 months (approximately 364 days) post-vaccination.
Hemagglutination Inhibition (HAI) antibody responses of the CIC vaccine compared to Fluzone High-Dose of homologous influenza strains (two influenza A strains and one influenza B-Victoria lineage strain) on Days 0 and 28
Hemagglutination Inhibition (HAI) antibody responses of the CIC vaccine compared to Fluzone High-Dose of homologous influenza strains (two influenza A strains and one influenza B-Victoria lineage strain) on Days 28
Percentage of Participants With a (HAI) antibody responses of the CIC vaccine compared to Fluzone High-Dose for 3 vaccine-homologous influenza strain on Days 28
Neutralizing Antibody (NAb) Responses Assessed against three homologous influenza strains (two influenza A strains and one influenza B-Victoria lineage strain) on Day 28
Neutralizing Antibody (NAb) Responses Assessed against three homologous influenza strains (two influenza A strains and one influenza B-Victoria lineage strain) on Day 28
Neutralizing Antibody (NAb) Responses Assessed against three homologous influenza strains (two influenza A strains and one influenza B-Victoria lineage strain) on Day 28
Hemagglutination Inhibition (HAI) antibody titers specific to HA receptor-binding domains of (tNIV) comparable to Fluzone High-Dose of 2 influenza A strains and an influenza B-Victoria lineage strain) on Day 28
Hemagglutination Inhibition (HAI) antibody titers specific to HA receptor-binding domains of (tNIV) comparable to Fluzone High-Dose of 2 influenza A strains and an influenza B-Victoria lineage strain) on Day 28
Hemagglutination Inhibition (HAI) antibody titers specific to HA receptor-binding domains of (tNIV) comparable to Fluzone High-Dose of 2 influenza A strains and an influenza B-Victoria lineage strain) on Day 28
| Arm | Type | Description |
|---|---|---|
| CIC Vaccine | EXPERIMENTAL | A single 0.5 mL IM injection on Day 0 |
| Novavax COVID-19 Vaccine | EXPERIMENTAL | A single 0.5 mL IM injection on Day 0 |
| tNIV Vaccine | EXPERIMENTAL | A single 0.5 mL IM injection on Day 0 |
| Fluzone High-Dose | EXPERIMENTAL | A single 0.5 mL IM injection on Day 0 |
| Name | Type | Description |
|---|---|---|
| CIC Vaccine Co-formulated tNIV2 , SARSCoV-2 rS and Matrix-M Adjuvant | BIOLOGICAL | CIC will contain SARs-CoV-2 antigen (35 μg), tNIV antigens (2 influenza A \[H1N1 and H3N2\] and 1 influenza B-Victoria lineage strains; 60 μg/strain |
| Novavax COVID-19 Vaccine | BIOLOGICAL | Each 0.5 mL dose comprises 5 µg SARS-CoV-2 S protein and 50 µg Matrix-M adjuvant |
| tNIV Vaccine | BIOLOGICAL | 2 influenza A \[H1N1 and H3N2\] and 1 influenza B-Victoria lineage strains (60 μg/strain), and Matrix-M adjuvant (75 μg) |
| Fluzone High Dose | BIOLOGICAL | Fluzone High-Dose is supplied as a suspension for IM injection 0.5 mL with 60 µg per strain |
Inclusion Criteria To be included in this study, each individual must satisfy all the following criteria: 1. Willing and able to give informed consent prior to study enrollment. 2. Medically stable adult male or female ≥ 65 years of age at Screening. 3. Participants may have 1 or more chronic medi...
Top 9 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | ibuzatrelvir, Nirmatrelvir/ ritonavir, BNT162b2/RIV |
| BioNTech SE Sponsored ADR | BNTX | 1 | PHASE3 | BNT162b2 |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Molnupiravir |
| Invivyd, Inc. | IVVD | 2 | PHASE3 | VYD2311 |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE3 | Tradipitant |
| BioVie Inc. Class A | BIVI | 1 | PHASE2 | NE3107 |
| ImmunityBio Inc | IBRX | 2 | PHASE2 | Nogapendekin alfa inbakicept |
| Traws Pharma, Inc. | TRAW | 1 | PHASE2 | Ratutrelvir |
| GeoVax Labs, Inc. | GOVX | 1 | PHASE2 | GEO-CM04S1 |
It is an investigational combination vaccine developed by Novavax, Inc. (NVAX) that combines an influenza vaccine component, tNIV2, with a SARS-CoV-2 recombinant spike protein (rS) component and the Matrix-M adjuvant in a single co-formulated product. It is designed to protect against both COVID-19 and influenza in one vaccination.
It is being developed for protection against COVID-19, with the combination format intended to address COVID-19 and influenza together in a single vaccine. The clinical program has studied it in adults aged 65 years and older, a population at higher risk from both respiratory infections.
Novavax, Inc., which trades on the Nasdaq under the ticker NVAX, is the developer of the CIC Vaccine Co-formulated tNIV2, SARSCoV-2 rS and Matrix-M Adjuvant. The company is responsible for the combination vaccine program and its clinical development.
The CIC Vaccine Co-formulated tNIV2, SARSCoV-2 rS and Matrix-M Adjuvant has been evaluated in a Phase 3 clinical trial. It is an investigational product and is not approved for commercial use. The Phase 3 study has been completed.
The combination vaccine was studied in trial NCT06291857, titled A Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine and Influenza Combination Vaccine. This completed Phase 3 trial enrolled 9,320 participants aged 65 years and older in Australia and New Zealand and used a controlled design.