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

Table 3 Incidence of solicited local and general symptoms reported during the 7-day period after each dose (Days 0–7 for dose 1, and Days 21–28 for dose 2), overall by participant (TVC)

N Number of participants with at least one documented dose, TVC Total vaccinated cohort
Symptom intensity was graded on a scale of 1 (mild) to 3 (severe) for all symptoms except for body temperature which was graded on a scale of 1 to 4. Grade 3 symptoms were defined as follows: for redness or swelling, a diameter > 100 mm; for fever, body temperature ≥ 39.0–40.0 °C (grade 4: > 40.0 °C); and for all other events, preventing normal activities

ISSN: 1477-7525