Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as RIV (recombinant influenza vaccine)
RIV · 1 trial · 2 indications
Within 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 Day 30/Day 01
SARS-CoV-2 neutralizing titers
Individual SARS-CoV-2 neutralizingtiters ratio Day 30/Day 01
| Arm | Type | Description |
|---|---|---|
| Group 1: RIV (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: RIV (in right or left deltoid) and rC19 (dose 1) (in opposite deltoid) | EXPERIMENTAL | two IM injections on D01 |
| Group 4: RIV + rC19 (dose 1) (in right or left deltoid) and placebo (in opposite deltoid) | EXPERIMENTAL | two IM injections on D01 |
| Group 5: RIV + rC19 (dose 2) (in right or left deltoid) and placebo | EXPERIMENTAL | two IM injections on D01 |
| Group 6: RIV + rC19 (dose 3) (in right or left deltoid) and placebo | EXPERIMENTAL | two IM injections on D01 |
| Group 7: RIV + rC19 (dose 4) (in right or left deltoid) and placebo (in opposite deltoid) | EXPERIMENTAL | two IM injections on D01 |
| Name | Type | Description |
|---|---|---|
| RIV (recombinant influenza vaccine) | BIOLOGICAL | Influenza, inactivated, split virus or surface antigen |
| rC19 (dose 1) | BIOLOGICAL | Protein subunit |
| RIV + rC19 (dose 1) | BIOLOGICAL | RIV component: Influenza, inactivated, split virus or surface antigen NVXC19 component: Protein subunit |
| RIV + rC19 (dose 2) | BIOLOGICAL | RIV component: Influenza, inactivated, split virus or surface antigen NVXC19 component: Protein subunit |
| RIV + rC19 (dose 3) | BIOLOGICAL | RIV component: Influenza, inactivated, split virus or surface antigen NVXC19 component: Protein subunit |
| RIV + rC19 (dose 4) | BIOLOGICAL | RIV component: Influenza, inactivated, split virus or surface antigen NVXC19 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 * 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...
RIV is a recombinant influenza vaccine developed by Sanofi. It is being studied in a Phase 1 clinical trial as part of a combination vaccine approach that pairs recombinant influenza vaccine with a Matrix-M adjuvanted recombinant COVID-19 vaccine in adults 50 years of age and older.
RIV is being evaluated for influenza immunization and, in its current clinical program, for COVID-19 immunization as part of a combination vaccine. The Phase 1 study enrolled adults 50 years of age and older in the United States to assess the combination of recombinant influenza vaccine with a Matrix-M adjuvanted recombinant COVID-19 vaccine.
RIV is developed by Sanofi, which trades on the New York Stock Exchange under the ticker SNY. Sanofi is the sponsor of the clinical program evaluating the recombinant influenza vaccine, including its use in a combination vaccine with a Matrix-M adjuvanted recombinant COVID-19 vaccine.
RIV is in Phase 1 clinical development. The single Phase 1 trial of the combination vaccine containing recombinant influenza vaccine has been completed, and no active trials are currently listed. RIV is investigational and has not been approved by the FDA for any indication.
RIV has been studied in one Phase 1 trial, NCT06695130, titled a study of a combination vaccine comprised of different recombinant spike antigen levels of a Matrix-M adjuvanted recombinant COVID-19 vaccine and recombinant influenza vaccine in adult participants 50 years of age and older. The trial enrolled 980 participants in the United States and is completed.
Yes, RIV stands for recombinant influenza vaccine. RIV is the shorthand name used for the recombinant influenza vaccine developed by Sanofi, and the two terms refer to the same vaccine asset being evaluated in the Phase 1 combination vaccine study.