Table 6

Subjects reporting local and systemic reactions within 14 days postvaccination in the safety population

Reactions by typeAge group (yr)aDifferenceb95% CIcP valuec
50–64 (n = 124–155)≥65 (n = 112–145)
No. reporting%No. reporting%
Local
    Any11777.08762.614.43.7, 24.90.008
    Rednessd
        Any1814.41915.8−1.4−10.7, 7.70.832
        Mild129.71613.3−3.7−12.1, 4.50.444
        Moderate118.887.01.8−5.4, 9.20.619
        Severe32.400.02.4−0.9, 6.90.117
    Swellingd
        Any2821.51613.38.2−1.4, 17.80.091
        Mild2318.11411.76.4−2.6, 15.70.167
        Moderate118.754.44.3−2.3, 11.20.242
        Severe32.410.91.5−2.6, 6.00.572
    Injection site paine
        Any11475.58360.614.93.8, 25.60.007
        Mild11274.28260.313.92.8, 24.70.014
        Moderate2821.5108.513.03.5, 22.20.005
        Severe43.243.5−0.3−6.0, 4.90.958
Systemic
    Any11976.88860.716.15.5, 26.40.003
    Fever
        ≥38°C32.41210.2−7.8−14.8, −1.50.012
        ≥38°C to <38.5°C21.643.5−2.0−7.3, 2.50.488
        ≥38.5°C to 39°C10.821.8−1.0−5.5, 2.80.625
        ≥39°C to ≤40°C10.821.8−1.0−5.5, 2.80.629
        >40°Cf00.054.3−4.3−9.8, −0.90.019
    Fatiguee
        Any6847.25138.68.6−3.3, 20.20.155
        Mild5639.44736.23.3−8.3, 14.90.583
        Moderate3626.92520.06.9−3.6, 17.20.199
        Severe86.365.31.0−5.5, 7.60.766
    Headachee
        Any6244.34232.611.70.0, 23.30.049
        Mild5539.33930.58.8−2.7, 20.30.134
        Moderate2418.61916.02.6−7.0, 12.30.594
        Severe54.065.2−1.2−7.4, 4.50.744
    Vomitingg
        Any54.021.82.2−2.7, 7.60.341
        Mild43.221.81.4−3.3, 6.50.576
        Moderate21.610.90.7−3.3, 4.90.739
        Severe00.000.00.0−3.3, 3.0>0.99
    Diarrheah
        Any3526.11815.011.11.1, 21.10.030
        Mild3023.31714.29.1−0.7, 19.00.068
        Moderate86.221.84.4−0.9, 10.40.100
        Severe10.810.9−0.1−4.1, 3.6>0.99
    Muscle paine
        Any8960.55843.916.64.8, 28.30.006
        Mild8759.65240.319.37.3, 30.80.001
        Moderate3123.52419.54.0−6.3, 14.30.448
        Severe75.676.0−0.4−7.1, 6.00.945
    Joint paine
        Any4935.34333.31.9−9.5, 13.50.750
        Mild4230.73829.90.7−10.5, 12.00.913
        Moderate1713.12117.1−4.0−13.1, 5.00.415
        Severe54.065.2−1.2−7.3, 4.60.760
  • a n values in each group are the numbers of subjects reporting “yes” for ≥1 day or “no” for all days. These values are used as the denominators for the percentages.

  • b Difference in proportions, calculated by 50 to 64 years value − ≥65 years value, expressed as a percentage.

  • c Exact 2-sided 95% confidence intervals (CIs) and corresponding P value for the difference in proportions, calculated by 50 to 64 years value − ≥65 years value, expressed as a percentage. The statistically significant differences are in bold type.

  • d Mild, 2.5 to 5.0 cm; moderate, 5.1 to 10.0 cm; severe, >10.0 cm.

  • e Mild, does not interfere with activity; moderate, some interference with activity; severe, prevents daily routine activity.

  • f Fever of >40°C reported in 5 subjects were data entry errors, as confirmed by the investigator.

  • g Mild, 1 to 2 times in 24 h; moderate, >2 times in 24 h; severe, requires intravenous hydration.

  • h Mild, 2 to 3 loose stools in 24 h; moderate, 4 to 5 loose stools in 24 h; severe ≥6 loose stools in 24 h.