Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 an investigational monoclonal antibody being developed for COVID-19 immunization. It is intended for use in adults 50 years of age and older. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
RIV is being developed by Sanofi, a multinational pharmaceutical company traded on the stock exchange under the ticker symbol SNY. Sanofi is conducting clinical research to evaluate the safety and efficacy of RIV for COVID-19 immunization.
RIV is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved for use outside of clinical trials. The Phase 1 trial for RIV has been completed, and the drug remains under evaluation.
RIV has been studied in one clinical trial with the identifier NCT06695130. This was a Phase 1, randomized, double-blind, controlled study that evaluated a combination vaccine in adult participants aged 50 years and older. The trial enrolled 980 participants and was conducted in the United States.
RIV is a monoclonal antibody being developed for COVID-19 immunization, not a traditional vaccine. It is designed to provide immunity against COVID-19, but it works differently from vaccines. RIV is currently in Phase 1 clinical trials and is not yet approved.