Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Trivalent-Darwin 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...
Trivalent-Darwin influenza vaccine is an investigational vaccine being studied for the prevention of influenza. It is designed for use in healthy adults, including those aged 18 to 49 years and those 60 years and older. The vaccine is currently in Phase 1 clinical development.
Sanofi (ticker: SNY) is developing Trivalent-Darwin influenza vaccine. The vaccine is currently in Phase 1 clinical development for influenza prevention.
Trivalent-Darwin influenza vaccine is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 1 clinical trial has been completed.
Trivalent-Darwin influenza vaccine has been studied in one completed Phase 1 clinical trial, identified as NCT06507553. This trial enrolled 400 healthy adult participants aged 18 years and older in Australia and evaluated influenza vaccines containing an additional H3 antigen.
Trivalent-Darwin influenza vaccine is a trivalent vaccine, meaning it contains three influenza virus components. The clinical trial NCT06507553 studied influenza vaccines containing an additional H3 antigen, but the vaccine itself is trivalent, not quadrivalent.