Table 2.

  Fluarix™: reactogenicity data* recorded within 3 days post‐vaccination

Groups of volunteers	Number of subjects	Local adverse events		General adverse events
		Redness (%)**	Pain (%)***	Fever (%)¶	Other (%)§
Healthy children 0 to <3 years#	160 (273 doses)	0–33	8–32	13–27	N.S.
Healthy children 3 to <6 years#	115 (190 doses)	7–28	16–32	11–28	0–20·7
Healthy children 6–18 years#	263 (386 doses)	10–29	40–63	0–5	0–25
Adults 18–60 years	665	2–26	2–20	0–4	0–23
Healthy adults >60 years	610	0–31	2–38	0–2	2–19
Immunosuppressed cancer patients	23	13	9	4	5
Organ transplant adult patients	94	0	3·2	0	0–9
Diabetes mellitus type 1 adult patients	70	1	0	1	0
COPD adult patients	70	14	4	0	10

Source: Hehme et al., ¹⁸ GSK’s clinical trial registry ¹⁹ and Schmidt‐Ott et al. ²⁶

COPD, chronic obstructive pulmonary disease.

*Reactogenicity data were assessed using severity scales which differed before and after 1996. Only data dating from 1996 to 2007 are presented in this table except for diabetes mellitus type 1 adult patients for which data were collected in 1995. Numbers are minimal and maximal values obtained across all studies between 1996 and 2007.

**Data presented for redness in adults and in children >12 years are for reactions >20 mm in diameter and for reactions >5 mm in children <12 years.

***In adults, data for moderate and severe pain are presented. For children data for any pain are presented.

^¶Fever was defined as a temperature >38·0°C in children ≥3 years, adults and the elderly and >38·5°C for children <3 years.

^§Other includes malaise, fatigue, headache, myalgia and shivering.

^#Whereas adults and children >36 months received a single 0.5 ml dose of the vaccine containing 15 μg of HA per strain, children 6–35 months received a 0·25ml dose of the vaccine, followed, for unprimed children, by a second 0·25 ml dose administered at least 4 weeks later.