Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...