Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IIV-HD · 1 trial · 2 indications
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...
IIV-HD is an investigational high-dose inactivated influenza vaccine being studied for immunization against influenza. It is being evaluated in combination with a recombinant COVID-19 vaccine for adult participants 50 years of age and older, as part of a Phase 1 clinical trial.
IIV-HD is being developed by Sanofi, a biopharmaceutical company listed on the stock exchange under the ticker symbol SNY. The company is conducting clinical research on this vaccine candidate for influenza immunization.
IIV-HD is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The Phase 1 trial has been completed, with results not yet publicly reported.
IIV-HD was studied in a Phase 1 clinical trial with the identifier NCT06695117. This completed trial enrolled 980 participants aged 50 years and older in the United States and evaluated a combination vaccine comprising different recombinant spike antigen levels of a Matrix-M adjuvanted recombinant COVID-19 vaccine and high-dose inactivated influenza vaccine.
IIV-HD is a high-dose inactivated influenza vaccine, not a COVID-19 vaccine. It is being studied in combination with a recombinant COVID-19 vaccine to assess the safety and immune response of the combined formulation in older adults.