Table 2.

Cumulative participants (%) reporting AEs post-dose 1 by week and age group (safety set)

ISO weeks	Belgium N = 306		Germany N = 288		Spain N = 460		Total N = 1054
	N	n (%) 95% CI, LL–UL	N	n (%) 95% CI, LL–UL	N	n (%) 95% CI, LL–UL	N	n (%) 95% CI, LL–UL
Age 6 months–17 years at dose 1 of GSK’s IIV4
40–43	0	–	0	–	1	1 (100.0) 2.5–100.0	1	1 (100.0) 2.5–100.0
40–44	0	–	0	–	194	80 (41.2) 34.2–48.5	194	80 (41.2) 34.2–48.5
40–45	0	–	0	–	289	101 (35.0) 25.0–46.0	289	101 (35.0) 25.0–46.0
40–46	0	–	0	–	310	112 (36.1) 27.8–45.1	310	112 (36.1) 27.8–45.1
40–47	0	–	0	–	319	112 (35.1) 26.2–44.9	319	112 (35.1) 26.2–44.9
40–48	0	–	0	–	319	112 (35.1) 26.2–44.9	319	112 (35.1) 26.2–44.9
40–49	0	–	0	–	321	113 (35.2) 26.4–44.8	321	113 (35.2) 26.4–44.8
40–50	0	–	0	–	321	113 (35.2) 26.4–44.8	321	113 (35.2) 26.4–44.8
40–51	0	–	0	–	321	113 (35.2) 26.4–44.8	321	113 (35.2) 26.4–44.8
40–52	0	–	0	–	321	113 (35.2) 26.4–44.8	321	113 (35.2) 26.4–44.8
Age 18–65 years at dose 1 of GSK’s IIV4
40–40	0	–	56	26 (46.4) 0.0–100.0	0	–	56	26 (46.4) 0.0–100.0
40–41	0	–	93	38 (40.9) 0.3–98.2	0	–	93	38 (40.9) 0.3–98.2
40–42	0	–	116	52 (44.8) 1.2–97.3	0	–	116	52 (44.8) 1.2–97.3
40–43	2	1 (50.0) 1.3–98.7	120	55 (45.8) 1.3–97.5	44	26 (59.1) 43.3–73.7	166	82 (49.4) 20.2–78.9
40–44	2	1 (50.0) 1.3–98.7	121	55 (45.5) 1.4–97.1	113	60 (53.1) 43.5–62.6	236	116 (49.2) 28.3–70.3
40–45	2	1 (50.0) 1.3–98.7	121	55 (45.5) 1.4–97.1	139	75 (54.0) 45.3–62.4	262	131 (50.0) 30.6–69.4
40–46	6	2 (33.3) 4.3–77.7	121	55 (45.5) 1.4–97.1	139	75 (54.0) 45.3–62.4	266	132 (49.6) 30.3–69.0
40–47	11	4 (36.4) 10.9–69.2	121	55 (45.5) 1.4–97.1	139	75 (54.0) 45.3–62.4	271	134 (49.5) 30.4–68.7
40–48	12	4 (33.3) 9.9–65.1	121	55 (45.5) 1.4–97.1	139	75 (54.0) 45.3–62.4	272	134 (49.3) 30.1–68.6
40–49	14	4 (28.6) 8.4–58.1	121	55 (45.5) 1.4–97.1	139	75 (54.0) 45.3–62.4	274	134 (48.9) 29.5–68.5
40–50	14	4 (28.6) 8.4–58.1	121	55 (45.5) 1.4–97.1	139	75 (54.0) 45.3–62.4	274	134 (48.9) 29.5–68.5
40–51	98	40 (40.8) 5.3–86.3	121	55 (45.5) 1.4–97.1	139	75 (54.0) 45.3–62.4	358	170 (47.5) 33.0–62.3
40–52	114	52 (45.6) 4.0–93.3	121	55 (45.5) 1.4–97.1	139	75 (54.0) 45.3–62.4	374	182 (48.7) 35.7–61.8
Age > 65 years at dose 1 of GSK’s IIV4
40–40	0	–	58	18 (31.0) 0.0–99.9	0	–	58	18 (31.0) 0.0–99.9
40–41	0	–	103	27 (26.2) 3.0–68.6	0	–	103	27 (26.2) 3.0–68.6
40–42	3	2 (66.7) 9.4–99.2	125	29 (23.2) 1.7–68.2	0	–	128	31 (24.2) 6.1–53.5
40–43	26	10 (38.5) 0.0–100.0	133	32 (24.1) 3.2–63.0	0	–	159	42 (26.4) 11.9–45.9
40–44	47	19 (40.4) 7.4–82.1	159	37 (23.3) 4.0–58.0	0	–	206	56 (27.2) 13.5–44.9
40–45	59	24 (40.7) 8.9–79.9	167	42 (25.2) 7.3–52.6	0	–	226	66 (29.2) 17.2–43.9
40–46	94	37 (39.4) 3.1–89.1	167	42 (25.2) 7.3–52.6	0	–	261	79 (30.3) 18.3–44.6
40–47	156	52 (33.3) 0.2–95.7	167	42 (25.2) 7.3–52.6	0	–	323	94 (29.1) 20.1–39.5
40–48	167	55 (32.9) 0.2–95.0	167	42 (25.2) 7.3–52.6	0	–	334	97 (29.0) 20.4–39.0
40–49	186	58 (31.2) 0.1–95.7	167	42 (25.2) 7.3–52.6	0	–	353	100 (28.3) 20.2–37.6
40–50	186	58 (31.2) 0.1–95.7	167	42 (25.2) 7.3–52.6	0	–	353	100 (28.3) 20.2–37.6
40–51	192	61 (31.8) 13.4–55.5	167	42 (25.2) 7.3–52.6	0	–	359	103 (28.7) 21.3–37.0
40–52	192	61 (31.8) 13.4–55.5	167	42 (25.2) 7.3–52.6	0	–	359	103 (28.7) 21.3–37.0

AE adverse event, ISO International Organization for Standardization, N number of participants vaccinated with GSK’s inactivated quadrivalent seasonal influenza vaccine (IIV4) in the specified ISO weeks who received an adverse drug reaction (ADR) card; n (%) number (percentage) of participants vaccinated with GSK’s IIV4 in the specified ISO week reporting at least one symptom on their ADR card, 95% CI, LL-UL 95% confidence interval (extended Clopper–Pearson exact CI for clustered data), lower limit–upper limit