Approval Probability
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Augment-Tasmania influenza vaccine · 1 trial · 2 indications
Includes unsolicited systemic adverse events (or) medically relevant unsolicited systemic adverse events, including those related to the product administered
Adverse reactions prelisted in the participant diary
Adverse reactions prelisted in the participant diary
Adverse events other than solicited reactions
SAEs occurring throughout the study
AESIs occurring throughout the study
| Arm | Type | Description |
|---|---|---|
| Group 1 (Stage 1) | ACTIVE_COMPARATOR | Trivalent-Darwin standard dose (SD) formulation will be administered in a single injection to participants aged 18 to 49 years old |
| Group 2 (Stage 1) | EXPERIMENTAL | Augment-Tasmania SD formulation will be administered in a single injection to participants aged 18 to 49 years old |
| Group 3 (Stage 1) | EXPERIMENTAL | TIV-2X Darwin SD formulation will be administered in a single injection to participants aged 18 to 49 years old |
| Group 4 (Stage 1) | EXPERIMENTAL | Trivalent-Tasmania SD formulation will be administered in a single injection to participants aged 18 to 49 years old |
| Group 5 (Stage 2) | ACTIVE_COMPARATOR | Trivalent-Darwin high dose (HD) formulation will be administered in a single injection to participants of 60 years and older |
| Group 6 (Stage 2) | EXPERIMENTAL | Augment-Tasmania HD formulation will be administered in a single injection to participants of 60 years and older |
| Group 7 (Stage 2) | EXPERIMENTAL | TIV-2X Darwin HD formulation will be administered in a single injection to participants of 60 years and older |
| Group 8 (Stage 2) | EXPERIMENTAL | Trivalent-Tasmania HD formulation will be administered in a single injection to participants of 60 years and older |
| Name | Type | Description |
|---|---|---|
| Trivalent-Darwin influenza vaccine | BIOLOGICAL | Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular |
| Augment-Tasmania influenza vaccine | BIOLOGICAL | Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular |
| TIV-2X Darwin influenza vaccine | BIOLOGICAL | Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular |
| Trivalent-Tasmania influenza vaccine | BIOLOGICAL | Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular |
Inclusion Criteria: * Aged 18 to 49 years (Stage 1) or 60 years of age and older (Stage 2) on the day of inclusion * Participants who are healthy as determined by medical evaluation including medical history and physical examination, if deemed necessary * A female participant is eligible to partici...
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 Augment-Tasmania influenza vaccine is an investigational vaccine developed by Sanofi for influenza. It is a Phase 1 candidate studied in healthy adult volunteers. The clinical program evaluated influenza vaccines containing an additional H3 antigen, given to participants 18 to 49 years of age and to those 60 years of age and older.
Sanofi makes the Augment-Tasmania influenza vaccine. Sanofi trades under the ticker SNY. The company is the developer of this investigational influenza vaccine candidate, which has been studied in a completed Phase 1 trial conducted in Australia.
The Augment-Tasmania influenza vaccine is in Phase 1. Its single recorded clinical trial, NCT06507553, is a completed Phase 1 study. The candidate is investigational and is not an approved product; it remains in clinical development for influenza.
The Augment-Tasmania influenza vaccine was studied in trial NCT06507553, titled Study of Influenza Vaccines Containing an Additional H3 Antigen in Healthy Adult Participants 18 to 49 Years of Age and 60 Years of Age and Older. The Phase 1 trial enrolled 400 participants in Australia, was randomized, double-blind, and active-controlled, and is completed.
Trial NCT06507553 was a randomized, double-blind, active-controlled Phase 1 study of the Augment-Tasmania influenza vaccine in healthy volunteers. It enrolled 400 participants aged 18 years and older, including cohorts 18 to 49 years of age and 60 years of age and older, and was conducted in Australia. The study is completed.