Table 1.
Number of subjects in safety populations from TIV‐ and placebo‐controlled clinical studies
| AE and reactogenicity event populations (refrigerated LAIV) | Year 1 | Year 2 | ||
|---|---|---|---|---|
| Dose 1 | Dose 2 | |||
| TIV‐controlled studies | ||||
| Reactogenicity event population: LAIV | 4108 | 2187 | NA | |
| Reactogenicity event population: TIV | 4118 | 2223 | NA | |
| AE population: LAIV | 4147 | 2230 | NA | |
| AE population: TIV | 4182 | 2270 | NA | |
| Placebo‐controlled studies | ||||
| Reactogenicity event population: LAIV | 3245 | 2503 | 2287 | |
| Reactogenicity event population: Placebo | 1994 | 1702 | 1248 | |
| AE population: LAIV | 3278 | 2533 | 2295 | |
| AE population: Placebo | 2026 | 1734 | 1256 | |
| SAE populations (Frozen & Refrigerated LAIV) | Year 1 | Year 2 | ||
|---|---|---|---|---|
| Days 0–42 PLD | Days 0–180 PLD | Days 0–42 PLD | Days 0–180 PLD | |
| TIV‐controlled studies | ||||
| LAIV | 4245 | 4130 | NA | NA |
| TIV | 4278 | 4163 | NA | NA |
| Placebo‐controlled studies | ||||
| LAIV | 10 693 | 2408 | 3212 | 2295 |
| Placebo | 5667 | 1546 | 1697 | 1256 |
AE, adverse event; LAIV, Ann Arbor live attenuated influenza vaccine; NA, data not available; PLD, post‐last dose (dose 1 or, if administered, dose 2); SAE, serious AE; TIV, trivalent inactivated influenza vaccine.