Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
H5N8 pandemic influenza vaccine (adjuvanted) · 1 trial · 2 indications
Immediate adverse events are medically relevant unsolicited systemic adverse events reported in the 30 minutes after vaccination
A solicited reaction is an adverse reaction (sign or symptom) observed and reported under the conditions pre-listed (for example: injection site pain or headache). Solicited administration site reactions are reactions at and around the injection/administration site
All solicited reactions that are not solicited injection or administration site reactions
Unsolicited AE: an observed AE that does not fulfill the conditions of solicited reactions
MAAEs are collected throughout the study
AESIs are collected throughout the study
SAEs are collected throughout the study
Safety laboratory assessments will include clinical chemistry and hematology
AEs leading to discontinuation are collected throughout the study
Influenza vaccine antibody titers are measured by HAI assay
Influenza vaccine antibody titers are measured by HAI assay
Seroconversion is defined as HAI Ab titer \< 10 (1/dil) on Day 01 and post-injection titer ≥ 40 (1/dil) on Day 43; or defined as HAI Ab titer ≥ 10 (1/dil) on Day 01 and a ≥ 4-fold increase in titer (1/dil) on Day 43
Influenza vaccine antibody titers are measured by HAI assay
| Arm | Type | Description |
|---|---|---|
| Group 1: Flu H5 egg pandemic low dose vaccine, with adjuvant | EXPERIMENTAL | Participants receive 2 intramuscular injections of flu H5 egg pandemic low dose vaccine, with adjuvant |
| Group 2: Flu H5 Egg Pandemic medium dose vaccine, with adjuvant | EXPERIMENTAL | Participants receive 2 intramuscular injections of flu H5 egg pandemic medium dose vaccine, with adjuvant |
| Group 3: Flu H5 Egg Pandemic high dose vaccine, with adjuvant | EXPERIMENTAL | Participants receive 2 intramuscular injections of flu H5 egg pandemic high dose vaccine, with adjuvant |
| Group 4: Flu H5 Egg Pandemic high dose vaccine, without adjuvant | EXPERIMENTAL | Participants receive 2 intramuscular injections of flu H5 egg pandemic high dose vaccine, without adjuvant |
| Name | Type | Description |
|---|---|---|
| Flu H5 egg pandemic low dose vaccine, with adjuvant | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM) |
| Flu H5 Egg Pandemic medium dose vaccine, with adjuvant | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM) |
| Flu H5 Egg Pandemic high dose vaccine, with adjuvant | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM) |
| Flu H5 Egg Pandemic high dose vaccine, without adjuvant | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM) |
Inclusion Criteria: * Aged 18 years or above on the day of inclusion * Participants who are healthy as determined by medical evaluation including medical history * Not pregnant/breastfeeding; non-childbearing potential or uses effective contraception/abstinence from ≥4 weeks before the first study ...
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 |
| 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 |
| Sinovac Biotech Ltd. | SVA | 1 | PHASE1 | Cell-based Trivalent Split Influenza Virus Vaccine, Egg-based Trivalent Split Influenza Virus Vaccine |
The H5N8 pandemic influenza vaccine (adjuvanted) is an investigational egg-based vaccine designed to protect against H5N8 avian influenza. It combines a low dose of H5 antigen with an adjuvant and is being studied in healthy adults 18 years of age and older. It is a pandemic preparedness vaccine candidate, not a seasonal flu shot.
It is intended for prevention of influenza caused by the H5N8 virus, a pandemic influenza strain. The Phase 1 study enrolls healthy volunteers 18 years of age and above to assess safety and immune response. The vaccine is adjuvanted, meaning an immune-boosting component is added to a low dose of egg-based H5 antigen.
Sanofi (ticker SNY) is the developer of the H5N8 pandemic influenza vaccine (adjuvanted). The candidate is an egg-based, low-dose H5 pandemic influenza vaccine formulated with an adjuvant.
The H5N8 pandemic influenza vaccine (adjuvanted) is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The single Phase 1 trial is currently recruiting participants in the United States.
The H5N8 pandemic influenza vaccine (adjuvanted) is being studied in trial NCT07779408, a Phase 1 study assessing safety and immunogenicity of an egg-based H5N8 influenza vaccine at multiple dose levels adjuvanted with Matrix-M in healthy participants 18 years of age and above. The trial is recruiting, is randomized, double-blind, and controlled, and plans to enroll 640 participants in the United States.