Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Monovalent Subvirion A/H1N1 Influenza vaccine · 3 trials · 2 indications
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Detectable anti HA antibody titer was defined as titers ≥ 10 (1/dilution) on Day 0 and Day 21 post-vaccination.
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (1/dil).
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay.
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Detectable anti-HA antibody titer was defined as titers ≥ 10 (1/dil).
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (1/dil).
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay.
Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering
Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.
Pre- and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Seroprotection: Antibody titer of ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Solicited Injection Site Reactions: Tenderness, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability.
Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering.
Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering.
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering (chills).
Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering (chills).
| Arm | Type | Description |
|---|---|---|
| A/H1N1 Vaccine Group 1 | EXPERIMENTAL | Participants will receive A/H1N1 vaccine formulation 1 (with adjuvant) |
| A/H1N1 Vaccine Group 2 | EXPERIMENTAL | Participants will receive A/H1N1 vaccine formulation 2 (with adjuvant) |
| A/H1N1 Vaccine Group 3 | ACTIVE_COMPARATOR | Participants will receive A/H1N1 vaccine formulation 3 |
| A/H1N1 Vaccine Group 4 | ACTIVE_COMPARATOR | Participants will receive A/H1N1 vaccine formulation 4 |
| Placebo Group 5 | PLACEBO_COMPARATOR | Participants will receive a placebo vaccine |
| Placebo Group | PLACEBO_COMPARATOR | Participants will receive a placebo vaccine |
| Name | Type | Description |
|---|---|---|
| Monovalent Subvirion A/H1N1 influenza vaccine with adjuvant | BIOLOGICAL | 0.5 mL, Intramuscular on Day 0 |
| Monovalent Subvirion A/H1N1 influenza vaccine | BIOLOGICAL | 0.5 mL, Intramuscular on Day 0 |
| Normal saline solution | BIOLOGICAL | 0.5 mL, Intramuscular on Day 0 |
| Normal saline solution (placebo) | BIOLOGICAL | 0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on day 0 and Day 21 (6 months to 35 Months) |
| Monovalent Subvirion A/H1N1 Influenza vaccine (7.5 µg of HA) | BIOLOGICAL | 0.5 mL, Intramuscular on Day 0 and on Day 21 |
| Monovalent Subvirion A/H1N1 Influenza vaccine (15 µg of HA) | BIOLOGICAL | 0.5 mL, Intramuscular on Day 0 and Day 21 |
| Monovalent Subvirion A/H1N1 Influenza vaccine (30 µg of HA) | BIOLOGICAL | 0.5 mL, Intramuscular on Day 0 and day 21 |
Inclusion Criteria : * Healthy adults aged 18 years or older on the day of inclusion * Informed consent has been signed and dated * Able to attend all scheduled visits and comply with all trial procedures * For a woman of child-bearing potential, use of an effective method of contraception or absti...
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 |
The Monovalent Subvirion A/H1N1 Influenza vaccine is an investigational vaccine developed by Sanofi for protection against swine-origin A/H1N1 pandemic influenza. It is a monovalent formulation, meaning it targets a single influenza strain, and it was studied in both adjuvanted and non-adjuvanted forms across healthy adult, elderly, and pediatric populations.
It is used for immunization against Influenza and swine-origin A/H1N1 Influenza. The vaccine is designed to prevent pandemic A/H1N1 influenza infection in healthy volunteers, including adults, the elderly, and children as young as 6 months of age, as evaluated in Phase 2 clinical studies conducted in the United States.
Sanofi develops the Monovalent Subvirion A/H1N1 Influenza vaccine. Sanofi trades on the New York Stock Exchange under the ticker SNY. The company sponsored the Phase 2 clinical program evaluating different formulations of the vaccine, including adjuvanted and non-adjuvanted versions, in healthy adult, elderly, and pediatric volunteers.
The Monovalent Subvirion A/H1N1 Influenza vaccine is in Phase 2 development. All three of its clinical trials have been completed, and no trials are currently active. The vaccine remains investigational and has not been established as an approved product based on the available development information.
Three completed Phase 2 trials studied the vaccine: NCT00953524 in 849 healthy adults and elderly participants, NCT00952419 in 474 healthy children aged 6 months to 9 years, and NCT00952276 in 548 healthy adults and elderly participants receiving adjuvanted formulations. All three were randomized, double-blind, placebo-controlled studies conducted in the United States, enrolling 1,871 participants total.