Table 5. Summary of solicited events observed during days 0 to 6 after dose for LAIV and either placebo or TIV control recipients; Adults 18 to 59 years of age (1).
| Solicited Event | Placebo Controlled Studies | TIV Controlled Studies | ||
|---|---|---|---|---|
|
LAIV N=64 – 3,265a % |
Placebo N=65 – 1,711a % |
LAIV N=10 - 80a % |
Injectable Influenza Vaccine N=11 - 77a % |
|
| Any solicited event | 69.1 | 58.9 | 62.5 | 58.4 |
| Runny/stuffy nose | 43.6 | 26.2 | 40.0 | 33.8 |
| Headache | 37.5 | 34.5 | 25.0 | 36.4 |
| Sore throat | 24.7 | 15.2 | 15.0 | 11.7 |
| Malaiseb | 23.8 | 19.3 | 11.4 | 20.5 |
| Muscle ache | 15.4 | 13.7 | 16.3 | 18.2 |
| Cough | 13.1 | 10.2 | 18.8 | 14.3 |
| Chills | 7.7 | 5.6 | 6.3 | 6.5 |
| Decreased appetite | 5.8 | 8.9 | 2.3 | 9.1 |
| Abdominal pain/stomach ache | 4.7 | 6.2 | 0.0 | 9.1 |
| Vomiting | 3.5 | 3.8 | 2.3 | 2.3 |
| Fever | ||||
| ≥38.0ºC | 0.9 | 1.2 | 2.5 | 0.0 |
| ≥38.5ºC | 0.2 | 0.4 | 1.3 | 0.0 |
| ≥39.0ºC | 0.1 | 0.0 | 1.3 | 0.0 |
a Number of subjects evaluated for the specific solicited event. Range reflects differences in data collection between the pooled studies, which have different sample sizes.
b Collected as decreased activity/tiredness/weakness/malaise