Table 2.
Demographics of subjects by study type and vaccine received
| SAE population | Reactogenicity event/AE population | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| TIV‐controlled | Placebo‐controlled | TIV‐controlled | Placebo‐controlled | |||||||||
| Year 1 | Year 1 | Year 2 | Year 1 | Year 1 | Year 2 | |||||||
| LAIV | TIV | LAIV | Placebo | LAIV | Placebo | LAIV | TIV | LAIV | Placebo | LAIV | Placebo | |
| Number of subjects | 4245 | 4278 | 10 693 | 5677 | 3212 | 1697 | 4147 | 4182 | 3278 | 2026 | 2295 | 1256 |
| Age, year Mean (SD) | 4·9 (3·9) | 4·8 (3·8) | 5·8 (4·3) | 5·7 (4·4) | 3·0 (1·1) | 2·9 (1·0) | 4·9 (3·9) | 4·8 (3·8) | 2·4 (2·0) | 2·7 (2·7) | 2·6 (0·6) | 2·6 (0·6) |
| Range | 2–17 | 2–17 | 2–17 | 2–17 | 2–7 | 2–7 | 2–17 | 2–17 | 2–17 | 2–17 | 2–4 | 2–4 |
| Age, 24–35 month, n | 1650 | 1647 | 4117 | 2383 | 1223 | 660 | 1650 | 1647 | 3149 | 1900 | 1063 | 574 |
| Age, 36–59 month, n | 1219 | 1247 | 1636 | 790 | 1615 | 866 | 1219 | 1247 | 11 | 4 | 1232 | 682 |
| Age, 5–17 year, n | 1376 | 1384 | 4940 | 2504 | 374* | 171* | 1278 | 1288 | 118 | 122 | 0 | 0 |
| Gender, % Male | 53·8 | 55·5 | 50·0 | 50·0 | 51·1 | 49·4 | 53·9 | 55·7 | 52·3 | 51·2 | 53·0 | 49·5 |
| Region, % | ||||||||||||
| USA | 22·1 | 22·4 | 68·7 | 63·4 | 28·5 | 26·0 | 20·3 | 20·6 | 0·5 | 0·8 | 0·0 | 0·0 |
| Asia/Oceania† | 3·1 | 3·1 | 14 | 17·5 | 25·4 | 31·2 | 3·2 | 3·2 | 45·7 | 48·9 | 35·5 | 42·1 |
| Latin America | 0·0 | 0·0 | 7·8 | 6·5 | 15·7 | 9·8 | 0·0 | 0·0 | 25·0 | 17·8 | 22·0 | 13·2 |
| Africa‡ | 0·0 | 0·0 | 2·7 | 2·7 | 11·6 | 8·0 | 0·0 | 0·0 | 8·8 | 7·7 | 16·2 | 10·8 |
| Europe§ | 74·8 | 74·5 | 6·7 | 9·9 | 18·8 | 25·0 | 76·5 | 76·2 | 19·9 | 24·8 | 26·4 | 33·8 |
AE, adverse event; LAIV, live attenuated influenza vaccine; SAE, serious AE; TIV, trivalent inactivated influenza vaccine; USA, United States of America.
*Age 5–7 year.
†East Asia, Southeast Asia, South Asia, and Australia.
‡South Africa only.
§Western Europe, Eastern Europe including Scandinavia, Lebanon, and Israel.