Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Quadrivalent RIV with H3 strain 1 · 2 trials · 3 indications
Immediate adverse events are unsolicited systemic adverse events reported in the 30 minutes after vaccination
Solicited injection site reactions: injection site pain, erythema, swelling, induration and bruising; solicited systemic reactions: fever, headache, malaise, and myalgia
Unsolicited (spontaneously reported) adverse events not not fulfilling criteria for solicited reactions
Serious adverse events are collected throughout the study
Adverse events of special interest are collected throughout the study
Laboratory tests include complete blood count (CBC), platelet count, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, serum creatinine, serum lipase, and serum amylase)
Influenza antibody titers are measured by HAI and SN assays
Titers ratio is calculated for the following time points: Day 7/Day 0, Day 28/Day 0, and Day 90/Day 0
Seroconversion is defined as HAI antibody titer \< 10 \[1/dil\] at Day 0 and post-injection titer ≥ 40 \[1/dil\] at Day 28, or titer ≥ 10 \[1/dil\] at Day 0 and a ≥ 4-fold increase in titer \[1/dil\] at Day 28)
Influenza vaccine antibody titers are measured by HAI assay
Influenza vaccine antibody titers are measured by SN assay
Influenza vaccine antigens are measured by HAI assay
Titers ratio are calculated for Day 8/Day 0 and Day 28/Day 0, Day 56/Day 28 and Day 90/Day 28
Seroconversion is defined as HAI antibody titer \< 10 \[1/dil\] at Day 0 and post-injection titer ≥ 40 \[1/dil\] at Day 28, or titer ≥ 10 \[1/dil\] at Day 0 and a ≥ 4-fold increase in titer \[1/dil\] at Day 28
Influenza vaccine antigens are measured by HAI assay
| Arm | Type | Description |
|---|---|---|
| Group 1: Quadrivalent RIV with H3 strain 1, without adjuvant | EXPERIMENTAL | 1 injection of quadrivalent RIV containing H3 strain 1, without adjuvant, in participants ≥ 50 years old |
| Group 2: Quadrivalent RIV with H3 strain 1, with adjuvant | EXPERIMENTAL | 1 injection of quadrivalent RIV containing H3 strain 1, with adjuvant, in participants ≥ 50 years old |
| Group 3: Quadrivalent RIV with H3 strain 2, without adjuvant | EXPERIMENTAL | 1 injection of quadrivalent RIV containing H3 strain 2, without adjuvant, in participants ≥ 50 years old |
| Group 4: Quadrivalent RIV with H3 strain 2, with adjuvant | EXPERIMENTAL | 1 injection of quadrivalent RIV containing H3 strain 2, with adjuvant, in participants ≥ 50 years old |
| Group 5: Quadrivalent RIV Control, without adjuvant | ACTIVE_COMPARATOR | 1 injection of quadrivalent RIV containing 2018-19 Northern Hemisphere (NH) recommended H3 strain, without adjuvant, in participants ≥ 50 years old |
| Group 6: Quadrivalent RIV Control, with adjuvant | ACTIVE_COMPARATOR | 1 injection of quadrivalent RIV containing 2018-19 NH recommended H3 strain, with adjuvant, in participants ≥ 50 years old |
| Group 7: Quadrivalent RIV Control, without adjuvant | ACTIVE_COMPARATOR | 1 injection of quadrivalent RIV containing 2018-19 NH recommended H3 strain, without adjuvant, in participants 18-30 years old |
| Quadrivalent RIV with H3 strain 1 | EXPERIMENTAL | 1 injection of Quadrivalent RIV containing H3 strain 1 |
| Quadrivalent RIV with H3 strain 2 | EXPERIMENTAL | 1 injection of Quadrivalent RIV containing H3 strain 2 |
| Quadrivalent RIV with H3 strain 3 | EXPERIMENTAL | 1 injection of Quadrivalent RIV containing H3 strain 3 |
| Quadrivalent RIV with H3 strain 4 | EXPERIMENTAL | 1 injection of Quadrivalent RIV containing H3 strain 4 |
| Quadrivalent RIV Control | ACTIVE_COMPARATOR | 1 injection of Quadrivalent RIV containing 2018-19 NH recommended H3 strain |
| Name | Type | Description |
|---|---|---|
| Quadrivalent RIV with H3 strain 1 | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: Intramuscular |
| Quadrivalent RIV with H3 strain 1 and adjuvant | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: Intramuscular |
| Quadrivalent RIV with H3 strain 2 | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: Intramuscular |
| Quadrivalent RIV with H3 strain 2 and adjuvant | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: Intramuscular |
| Quadrivalent RIV with 2018-2019 NH H3 strain | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: Intramuscular |
| Quadrivalent RIV with 2018-2019 NH H3 strain and adjuvant | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: Intramuscular |
| Quadrivalent RIV with H3 strain 3 | BIOLOGICAL | Pharmaceutical form: Pre-filled single-dose vial Route of administration: Intramuscular |
| Quadrivalent RIV with H3 strain 4 | BIOLOGICAL | Pharmaceutical form: Pre-filled single-dose vial Route of administration: Intramuscular |
Inclusion criteria : * Older adults: Aged 50 years and older on the day of inclusion Young adults: Aged 18 to 30 years on the day of inclusion * Informed consent form has been signed and dated * Able to attend all scheduled visits and to comply with all trial procedures Exclusion criteria: * Part...
Top 8 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 3 | PHASE3 | mRNA Seasonal Flu vaccine, Flu/COVID-19 mRNA combination vaccine |
| Sinovac Biotech Ltd. | SVA | 1 | PHASE3 | Quadrivalent influenza vaccine (split virion), inactivated |
| Moderna, Inc. | MRNA | 2 | PHASE3 | mRNA-1018-H5, mRNA-1010, Fluarix Trivalent |
| Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | CDTX | 1 | PHASE3 | CD388 |
| Traws Pharma, Inc. | TRAW | 2 | PHASE2 | TRX-100 |
| Sanofi SA Sponsored ADR | SNY | 4 | PHASE1 | H5N8 pandemic influenza vaccine (adjuvanted) |
| Hoffmann-La Roche | RHHBY | 2 | PHASE3 | Baloxavir Marboxil |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD4117, AZD5315 |
Quadrivalent RIV with H3 strain 1 is an investigational quadrivalent recombinant influenza vaccine being studied for the immunisation against influenza. It is designed to prevent influenza by including four hemagglutinin antigens, with a focus on different H3 strains. The vaccine is currently in Phase 1 clinical development for healthy adults.
Quadrivalent RIV with H3 strain 1 is being developed by Sanofi, a biopharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the safety and immunogenicity of this recombinant influenza vaccine candidate in healthy adult subjects.
Quadrivalent RIV with H3 strain 1 is in Phase 1 clinical development. It is an investigational vaccine, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and immunogenicity. Two Phase 1 studies have been completed, with a total enrollment of 210 participants.
Quadrivalent RIV with H3 strain 1 has been studied in two completed Phase 1 clinical trials. NCT04144179 evaluated the safety and immunogenicity of quadrivalent recombinant influenza vaccine formulations containing different H3 hemagglutinin antigens in healthy adults aged 18 to 30 years. NCT04451954 studied recombinant influenza vaccine containing different H3 antigens without or with adjuvant in healthy adults.
Quadrivalent RIV with H3 strain 1 is a recombinant influenza vaccine that works by presenting hemagglutinin antigens, including a specific H3 strain, to the immune system. This exposure triggers an immune response that prepares the body to recognise and fight influenza viruses. The vaccine is designed to provide protection against four influenza strains.
Quadrivalent RIV with H3 strain 1 is a recombinant influenza vaccine, which differs from standard egg-based flu vaccines in how it is manufactured. It is quadrivalent, meaning it targets four influenza strains, and includes a specific H3 antigen. It is currently investigational and not yet approved for public use.