TABLE 2.

Local and systemic reactogenicitya

Symptom and intensityNo. (%) of patients with reaction in dose group
2 mg (n = 5)4 mg (n = 8)8 mg (n = 8)Placebo (n = 6)
Local symptoms
    Pain or tenderness
        None0 (0.0)1 (12.5)2 (25.0)3 (50.0)
        Mild5 (100.0)5 (62.5)3 (37.5)3 (50.0)
        Moderate0 (0.0)2 (25.0)3 (37.5)0 (0.0)
        Severe0 (0.0)0 (0.0)0 (0.0)0 (0.0)
    Induration
        None3 (60.0)4 (50.0)2 (25.0)6 (100.0)
        Mild2 (40.0)4 (50.0)6 (75.0)0 (0.0)
        Moderate0 (0.0)0 (0.0)0 (0.0)0 (0.0)
        Severe0 (0.0)0 (0.0)0 (0.0)0 (0.0)
    Skin discoloration
        None2 (40.0)1 (12.5)2 (25.0)5 (83.3)
        Mild3 (60.0)7 (87.5)6 (75.0)1 (16.7)
        Moderate0 (0.0)0 (0.0)0 (0.0)0 (0.0)
        Severe0 (0.0)0 (0.0)0 (0.0)0 (0.0)
    Any local symptom
        None0 (0.0)1 (12.5)1 (12.5)3 (50.0)
        Mild5 (100.0)5 (62.5)4 (50.0)3 (50.0)
        Moderate0 (0.0)2 (25.0)3 (37.5)0 (0.0)
        Severe0 (0.0)0 (0.0)0 (0.0)0 (0.0)
Systemic symptoms
    Malaise
        None4 (80.0)6 (75.0)3 (37.5)4 (66.7)
        Mild1 (20.0)0 (0.0)4 (50.0)0 (0.0)
        Moderate0 (0.0)2 (25.0)0 (0.0)2 (33.3)
        Severeb0 (0.0)0 (0.0)1 (12.5)0 (0.0)
    Myalgia
        None5 (100.0)7 (87.5)5 (62.5)6 (100.0)
        Mild0 (0.0)1 (12.5)3 (37.5)0 (0.0)
        Moderate0 (0.0)0 (0.0)0 (0.0)0 (0.0)
        Severe0 (0.0)0 (0.0)0 (0.0)0 (0.0)
    Headache
        None4 (80.0)5 (62.5)6 (75.0)5 (83.3)
        Mild1 (20.0)3 (37.5)1 (12.5)1 (16.7)
        Moderate0 (0.0)0 (0.0)1 (12.5)0 (0.0)
        Severe0 (0.0)0 (0.0)0 (0.0)0 (0.0)
    Nausea
        None4 (80.0)6 (75.0)3 (37.5)5 (83.3)
        Mild1 (20.0)2 (25.0)4 (50.0)1 (16.7)
        Moderate0 (0.0)0 (0.0)1 (12.5)0 (0.0)
        Severe0 (0.0)0 (0.0)0 (0.0)0 (0.0)
    Fever
        None5 (100.0)7 (87.5)8 (100.0)6 (100.0)
        Mild0 (0.0)0 (0.0)0 (0.0)0 (0.0)
        Moderate0 (0.0)1 (12.5)0 (0.0)0 (0.0)
        Severe0 (0.0)0 (0.0)0 (0.0)0 (0.0)
    Any systemic symptom
        None4 (80.0)5 (62.5)3 (37.5)3 (50.0)
        Mild1 (20.0)1 (12.5)3 (37.5)1 (16.7)
        Moderate0 (0.0)2 (25.0)1 (12.5)2 (33.3)
        Severeb0 (0.0)0 (0.0)1 (12.5)0 (0.0)
  • a The local injection site reactions were recorded by clinicians at 30 to 45 min postinjection and were then recorded as self-assessments at home by subjects on a 7-day diary card. Systemic reactions were recorded as self-assessments at home by subjects on a 7-day diary card following each injection.

  • b A single severe systemic symptom (malaise) was related to a foot fracture which occurred 6 days following vaccination.