Table 4.
Adverse events (AEs) after LAIV and placebo administration in placebo‐controlled studies
| AEs | Year 1, dose 1 | Year 1, dose 2 | Year 2 | ||||||
|---|---|---|---|---|---|---|---|---|---|
| LAIV, n (%) | Placebo, n (%) | Rate difference* | LAIV, n (%) | Placebo, n (%) | Rate difference* | LAIV, n (%) | Placebo, n (%) | Rate difference* | |
| Total number of events | 1380 | 841 | 893 | 657 | 955 | 482 | |||
| Subjects reporting ≥1 event | 975 (29·7) | 559 (27·6) | 2·2 | 616 (24·3) | 460 (26·5) | −2·2 | 624 (27·2) | 336 (26·8) | 0·4 |
| Events by organ class with absolute rate difference ≥0·10% | |||||||||
| General disorders and administration site conditions | 318 (9·7) | 152 (7·5) | 2·2† | 147 (5·8) | 119 (6·9) | −1·1 | 206 (9·0) | 97 (7·7) | 1·3 |
| Injury, poisoning and procedural complications | 25 (0·8) | 8 (0·4) | 0·4 | 13 (0·5) | 6 (0·3) | 0·2 | 4 (0·2) | 5 (0·4) | −0·2 |
| Psychiatric disorders | 30 (0·9) | 12 (0·6) | 0·3 | 15 (0·6) | 9 (0·5) | 0·1 | 21 (0·9) | 6 (0·5) | 0·4 |
| Nervous system disorders | 13 (0·4) | 4 (0·2) | 0·2 | 5 (0·2) | 2 (0·1) | 0·1 | 4 (0·2) | 0 (0·0) | 0·2 |
| Reproductive system and breast disorders | 5 (0·2) | 0 (0·0) | 0·2 | 2 (0·1) | 0 (0·0) | 0·1 | 1 (0·0) | 0 (0·0) | 0·04 |
| Metabolism and nutrition disorders | 11 (0·3) | 6 (0·3) | 0·04 | 13 (0·5) | 8 (0·5) | 0·1 | 15 (0·7) | 3 (0·2) | 0·4 |
| Immune system disorders | 3 (0·1) | 2 (0·1) | −0·01 | 0 (0·0) | 2 (0·1) | −0·1 | 0 (0·0) | 0 (0·0) | |
| Ear and labyrinth disorders | 7 (0·2) | 5 (0·2) | −0·03 | 1 (<0·1) | 6 (0·3) | −0·3† | 6 (0·3) | 6 (0·5) | −0·2 |
| Infections and infestations | 388 (11·8) | 243 (12·0) | −0·2 | 288 (11·4) | 228 (13·1) | −1·8 | 230 (10·0) | 124 (9·9) | 0·1 |
| Eye disorders | 14 (0·4) | 13 (0·6) | −0·2 | 18 (0·7) | 5 (0·3) | 0·4 | 8 (0·3) | 3 (0·2) | 0·1 |
| Skin and subcutaneous tissue disorders | 17 (0·5) | 16 (0·8) | −0·3 | 15 (0·6) | 11 (0·6) | −0·04 | 13 (0·6) | 2 (0·2) | 0·4 |
| Gastrointestinal disorders | 98 (3·0) | 67 (3·3) | −0·3 | 70 (2·8) | 34 (2·0) | 0·8 | 46 (2·0) | 30 (2·4) | −0·4 |
| Respiratory, thoracic and mediastinal disorders | 285 (8·7) | 188 (9·3) | −0·6 | 198 (7·8) | 137 (7·9) | −0·1 | 255 (11·1) | 135 (10·7) | 0·4 |
| Events of interest | |||||||||
| Lower respiratory illness | 58 (1·8) | 37 (1·8) | −0·1 | 48 (1·9) | 51 (2·9) | −1·0† | 40 (1·7) | 19 (1·5) | 0·2 |
| Wheezing illness | 22 (0·7) | 14 (0·7) | 0·0 | 16 (0·6) | 18 (1·0) | −0·4 | 17 (0·7) | 7 (0·6) | 0·2 |
LAIV, Ann Arbor strain live attenuated influenza vaccine.
*LAIV rate minus placebo rate.
† P < 0·05, unadjusted for multiplicity.