Table 5

Incidence of TIV reactogenicity events from Day 0to Day 3 in the Safety Set

Symptom

TIV

N = 3783 n (%)

Placebo

N = 3828 n (%)

P-value


At least 1 vaccine reactogenicity event

2487 (66)

1675 (44)

<0.0001

Fever

96 (3)

55 (1)

0.0005

Injection site pain/soreness

1933 (51)

530 (14)

<0.0001

Injection site redness

475 (13)

234 (6)

<0.0001

Injection site swelling

418 (11)

109 (3)

<0.0001

Myalgia and/or arthralgia

692 (18)

389 (10)

<0.0001

Headache

683 (18)

716 (19)

0.5491

Tiredness

761 (20)

678 (18)

0.0049

Chills

158 (4)

136 (4)

0.1526

Malaise

338 (9)

236 (6)

<0.0001

Red eyes

250 (7)

231 (6)

0.2772

Swelling of the face

51 (1)

37 (<1)

0.1327

Cough

286 (8)

250 (7)

0.0719

Chest tightness or difficulty in breathing

128 (3)

107 (3)

0.1274

Sore throat, hoarseness or pain on swallowing

324 (9)

344 (9)

0.5689


>30 minutes post-vaccination

Fisher's Exact test (p < 0.05 considered significant)

Temperature ≥37.5°C/99.5°F

Jackson et al. BMC Infectious Diseases 2010 10:71   doi:10.1186/1471-2334-10-71

Open Data