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 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)

	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

TVC total vaccinated cohort
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
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

ISSN: 1477-7525