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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06291857 | A Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine and Influenza Combination Vaccine | PHASE3 | COMPLETED | 9,320 | — | — | Dec 9, 2024 | Feb 9, 2026 | Jun 5, 2026 | 58 | Australia, New Zealand |
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...