Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Swine A/H1N1 influenza vaccine · 4 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Study Group 1 | EXPERIMENTAL | Swine-origin A/H1N1 Vaccine Low-dose |
| Study Group 2 | EXPERIMENTAL | Swine-origin A/H1N1 Vaccine High-dose |
| A/H1N1 Vaccine Group 1 | EXPERIMENTAL | All participants will receive A/H1N1 Influenza vaccine formulation 1 at Visits 1 and 2; and a subset will receive a trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset) |
| A/H1N1 Vaccine Group 2 | EXPERIMENTAL | All participants will receive A/H1N1 Influenza vaccine formulation 2 at Visits 1 and 2; and a subset will receive a trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset). |
| A/H1N1 Vaccine Group 3 | EXPERIMENTAL | Participants will receive A/H1N1 Influenza vaccine formulation 3 |
| Name | Type | Description |
|---|---|---|
| Swine A/H1N1 influenza vaccine (split virion, inactivated) | BIOLOGICAL | 0.3 mL, Intramuscular (IM) |
| Swine A/H1N1 influenza vaccine (split virion, inactivated + Adjuvant) | BIOLOGICAL | 0.5 mL, Intramuscular on Day 0 and Day 21 (all participants); and 0.5 mL of a trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset) |
Inclusion Criteria : * Aged 18 to 60 years on the day of inclusion * Informed consent form has been signed and dated * Able to attend all scheduled visits and to comply with all trial procedures * For a woman of childbearing potential, use of an effective method of contraception from at least 4 wee...