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Table 2 Incidence and nature of symptoms (solicited only) with causal relationship to vaccination, reported during the 7-day (Days 0–7 for dose 1, and Days 21–28 for dose 2) following each dose and overall (TVC)

From: Usability of daily SF36 questionnaires to capture the QALD variation experienced after vaccination with AS03A-adjuvanted monovalent influenza A (H5N1) vaccine in a safety and tolerability study

  Local symptoms General Symptoms Any Symptoms
   95% CI   95% CI   95% CI
  N n % LL UL N n % LL UL N n % LL UL
All causally related symptoms
Dose 1 50 43 86 73.3 94.2 50 28 56 41.3 70.0 50 45 90 78.2 96.7
Dose 2 50 40 80 66.3 90.0 50 28 56 41.3 70.0 50 46 92 80.8 97.8
Overall/dose 100 83 83 74.2 89.8 100 56 56 45.7 65.9 100 91 91 83.6 95.8
Overall/participant 50 46 92 80.8 97.8 50 33 66 51.2 78.8 50 48 96 86.3 99.5
Grade 3 causally related symptoms
Dose 1 50 3 6 1.3 16.5 50 2 4 0.5 13.7 50 4 8 2.2 19.2
Dose 2 50 2 4 0.5 13.7 50 1 2 0.1 10.6 50 2 4 0.5 13.7
Overall/dose 100 5 5 1.6 11.3 100 3 3 0.6 8.5 100 6 6 2.2 12.6
Overall/participant 50 4 8 2.2 19.2 50 2 4 0.5 13.7 50 5 10 3.3 21.8
  1. TVC total vaccinated cohort
  2. For each dose and overall/participant: N number of participants with at least one documented dose, n/% number/percentage of participants presenting at least one type of symptom whatever the study vaccine administered
  3. For overall/dose: N number of documented doses, n/% number/percentage of doses followed by at least one type of symptom whatever the study vaccine administered