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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06695117 | Study of a Combination Vaccine Comprised of Different Recombinant Spike Antigen Levels of a Matrix-M Adjuvanted Recombinant COVID-19 Vaccine and High-Dose Inactivated Influenza Vaccine in Adult Participants 50 Years of Age and Older | PHASE1 | COMPLETED | 980 | — | — | Nov 19, 2024 | Apr 16, 2026 | May 5, 2026 | 12 | United States |
Immediate adverse events are any unsolicited systemic adverse events reported in the 30 minutes after vaccination
Solicited injection site reactions include injection site pain, erythema and swelling
Solicited systemic reactions include fever, headache, fatigue, myalgia and chills
Unsolicited (spontaneously reported) AEs, not fulfilling criteria for solicited adverse reactions
AESIs
MAAEs
MAAEs relating to predefined PIMDs
SAEs
Related SAEs
MAAEs relating to predefined PIMDs that meet the criteria for SAEs
HAI titers
Individual HAI titers ratio D30/D01
SARS-CoV-2 neutralizing titers
Individual SARS-CoV-2 neutralizing titers ratio D30/D01
| Arm | Type | Description |
|---|---|---|
| Group 1: IIV-HD (in right or left deltoid) and placebo (in opposite deltoid) | EXPERIMENTAL | two IM injections on D01 |
| Group 2: rC19 (dose 1) (in right or left deltoid) and placebo (in opposite deltoid) | EXPERIMENTAL | two IM injections on D01 |
| Group 3: IIV-HD (in right or left deltoid) and rC19 (dose1) (in opposite deltoid) | EXPERIMENTAL | two IM injections on D01 |
| Group 4: IIV-HD + rC19 (dose 1) (in right or left deltoid) and placebo (in opposite deltoid) | EXPERIMENTAL | two IM injections on D01 |
| Group 5: IIV-HD + rC19 (dose 2) (in right or left deltoid) and placebo (in opposite deltoid) | EXPERIMENTAL | two IM injections on D01 |
| Group 6: IIV-HD + rC19 (dose 3) (in right or left deltoid) and placebo (in opposite deltoid) | EXPERIMENTAL | two IM injections on D01 |
| Group 7: IIV-HD + rC19 (dose 4) (in right or left deltoid) and placebo (in opposite deltoid) | EXPERIMENTAL | two IM injections on D01 |
| Name | Type | Description |
|---|---|---|
| IIV-HD | BIOLOGICAL | Inactivated, split-virion |
| rC19 (dose 1) | BIOLOGICAL | Protein subunit |
| IIV-HD + rC19 (dose 1) | BIOLOGICAL | IIV-HD component: Inactivated, split-virion rC19 component: Protein subunit |
| IIV-HD + rC19 (dose 2) | BIOLOGICAL | IIV-HD component: Inactivated, split-virion rC19 component: Protein subunit |
| IIV-HD + rC19 (dose 3) | BIOLOGICAL | IIV-HD component: Inactivated, split-virion rC19 component: Protein subunit |
| IIV-HD + rC19 (dose 4) | BIOLOGICAL | IIV-HD component: Inactivated, split-virion rC19 component: Protein subunit |
| Placebo (0.9% NaCl) | OTHER | Normal saline |
Inclusion Criteria: Inclusion criteria to be checked at Screening Visit * Aged 50 years or older on the day of inclusion * Informed consent form has been signed and dated. * Able to attend all scheduled visits and to comply with all study procedures. * Participant must be able to receive an inject...