Table 4.

Percentage of subjects with solicited general adverse events during the 4-day (Days 1–4) period after dTpa vaccination by age group (total vaccinated cohort)

dTpa Group subset with age <6 years, (N = 18)			dTpa Group subset with age ≥6 years, (N = 429)
Adverse event	Type	% (95% CI)	Adverse event	Type	% (95% CI)
Drowsiness	All	5.6 (0.1; 27.3)	Fatigue	All	29.4 (25.1; 33.9)
	Related	5.6 (0.1; 27.3)		Related	21.4 (17.7; 25.6)
	Grade 3 Related	0.0 (0.0; 18.5)		Grade 3 Related	1.4 (0.5; 3.0)
Irritability/Fussiness	All	27.8 (9.7; 53.5)	Gastrointestinal symptoms	All	7.9 (5.6; 10.9)
	Related	22.2 (6.4; 47.6)		Related	3.5 (2.0; 5.7)
	Grade 3 Related	0.0 (0.0; 18.5)		Grade 3 Related	0.2 (0.0; 1.3)
Loss of appetite	All	16.7 (3.6; 41.4)	Headache	All	24.9 (20.9; 29.3)
	Related	16.7 (3.6; 41.4)		Related	18.9 (15.3; 22.9)
	Grade 3 Related	0.0 (0.0; 18.5)		Grade 3 Related	2.1 (1.0; 3.9)
Fever	All	0.0 (0.0; 0.0)	Fever	All	2.2 (1.1; 4.1)
	Related	0.0 (0.0; 0.0)		Related	2.2 (1.1; 4.1)
	Grade 3 Related	0.0 (0.0; 0.0)		Grade 3 Related	0.0 (0.0; 0.8)

N; number of participants with the documented dose; %, percentage of participants reporting the specified adverse event at least once; 95% CI; exact 95% confidence interval; dTpa, diphtheria-tetanus-acellular pertussis; related; adverse events, which is assessed by the investigator as related to vaccination; all, all reports of the specified adverse event irrespective of intensity grade and relationship to vaccination.

Fever was defined as temperature ≥38.0°C. The preferred location for measuring temperature in this study was the axilla.

Grade 3 irritability was defined as crying that could not be comforted or irritability preventing normal activity; grade 3 drowsiness as drowsiness preventing normal activity; grade 3 loss of appetite as not eating at all; grade 3 fever was defined as temperature ≥40.0°C; fatigue, gastrointestinal symptoms and headache were considered grade 3 if they prevented normal activity.