Table 3.
Frequency of solicited local injection site reactions and systemic adverse reactions within 7 days of administration of Flublok or comparator in adults at least 65 years of age, studies PSC03 and PSC11, total vaccinated cohort*.
| Flublok N = 1078 |
IIV31
N = 1081 |
|||||
|---|---|---|---|---|---|---|
| Any | Mod$ | Sev$ | Any | Mod$ | Sev$ | |
| Local | % | |||||
| Pain | 19 | <1 | <1 | 20 | <1 | <1 |
| Redness | 7 | 1 | <1 | 7 | 1 | 1 |
| Firmness/swelling | 7 | 2 | <1 | 7 | <1 | <1 |
| Systemic | % | |||||
| Fatigue | 13 | 3 | <1 | 15 | 2 | <1 |
| Headache | 10 | <1 | <1 | 9 | 1 | <1 |
| Muscle pain | 8 | 2 | <1 | 8 | 1 | <1 |
| Joint pain | 6 | 1 | <1 | 6 | 1 | <1 |
| Shivers/chills | 5 | <1 | <1 | 5 | <1 | <1 |
| Nausea | 4 | <1 | <1 | 3 | <1 | <1 |
| Fever‡ | 3 | <1 | <1 | 2 | 0 | 0 |
Data based on the most severe response reported by subjects. Results of at least 1% are reported to nearest whole percent; results greater than 0 but less than 1% reported as less than 1%.
Data were pooled from studies PSC03 and PSC11. For studies PSC03 and PSC011, the US-licensed IIV3 comparators were Fluzone and Afluria, respectively.
Moderate (Mod) = had it, and it was bad enough to prevent a significant part of usual activities; severe (Sev) = had it, and it prevented most or all of normal activities, or had to see a doctor for prescription medicine.
Fever defined as at least 100.4°F (38°C): mild (⩾100.4° to <101.1°F); moderate (⩾101.2°F to <102.2°F); severe (⩾102.2°F).