Table 5.
Adverse Events (AEs) and SAEs because of lower respiratory illness and wheezing in children 24–35 months of age
| AEs, days 0–10 | Year 1 | Year 2 | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Dose 1 | Dose 2 | ||||||||
| LAIV, n (%) | Comparator, n (%) | Rate difference* | LAIV, n (%) | Comparator, n (%) | Rate difference* | LAIV, n (%) | Comparator, n (%) | Rate difference* | |
| TIV‐controlled studies | |||||||||
| Lower respiratory illness | 33 (2·0) | 45 (2·7) | −0·7 | 27 (2·5) | 28 (2·6) | −0·1 | NA | NA | NA |
| Wheezing illness | 23 (1·4) | 27 (1·6) | −0·2 | 9 (0·8) | 13 (1·2) | −0·4 | NA | NA | NA |
| Placebo‐controlled studies | |||||||||
| Lower respiratory illness | 58 (1·8) | 37 (1·9) | −0·1 | 48 (1·9) | 51 (2·9) | −1·0† | 23 (2·2) | 9 (1·6) | 0·6 |
| Wheezing illness | 22 (0·7) | 14 (0·7) | 0·0 | 16 (0·6) | 18 (1·0) | −0·4 | 9 (0·8) | 5 (0·9) | 0·0 |
| SAEs | Year 1 | Year 2 | ||||
|---|---|---|---|---|---|---|
| LAIV, n (%) | Comparator, n (%) | Rate difference* | LAIV, n (%) | Comparator, n (%) | Rate difference* | |
| TIV‐controlled studies, days 0–42 | ||||||
| Lower respiratory illness | 9 (0·55) | 9 (0·55) | 0·00 | NA | NA | NA |
| Wheezing illness | 3 (0·18) | 2 (0·12) | 0·06 | NA | NA | NA |
| TIV‐controlled studies, days 0–180 | ||||||
| Lower respiratory illness | 29 (1·29) | 19 (1·17) | 0·12 | NA | NA | NA |
| Wheezing illness | 6 (0·37) | 3 (0·18) | 0·18 | NA | NA | NA |
| Placebo‐controlled studies, day 0–42 | ||||||
| Lower respiratory illness | 13 (0·41) | 8 (0·42) | −0·01 | 4 (0·38) | 3 (0·52) | −0·15 |
| Wheezing illness | 7 (0·22) | 4 (0·21) | 0·01 | 1 (0·09) | 0 (0·00) | 0·09 |
| Placebo‐controlled studies, day 0–180 | ||||||
| Lower respiratory illness | 28 (1·17) | 15 (0·97) | 0·20 | 7 (0·66) | 4 (0·70) | −0·04 |
| Wheezing illness | 9 (0·38) | 5 (0·32) | 0·05 | 2 (0·19) | 0 (0·00) | 0·19 |
LAIV, Ann Arbor live attenuated influenza vaccine; AE, adverse event; SAE, serious AE; TIV, trivalent inactivated influenza vaccine.
*LAIV rate minus comparator rate.
† P < 0·05, unadjusted for multiplicity.