Bulletin of the World Health Organization

Immunogenicity and safety of a DTaP–IPV//PRP~T combination vaccine given with hepatitis B vaccine: a randomized open-label trial

Maria Rosario Capeding, Josefina Cadorna-Carlos, May Book-Montellano, Esteban Ortiz

Volume 86, Number 6, June 2008, 443-451

Table 3. Incidence of local and systemic adverse reactions solicited from parents and guardians that occurred within 8 days of vaccination

Adverse reactions		Group A vaccine doses^a (n = 606)		Group B vaccine doses^b (n = 579)
Adverse reactions		DTaP–IPV//PRP~T(% of doses)	Hepatitis B(% of doses)	DTaP–IPV//PRP~T(% of doses)	Hepatitis B(% of doses)
Local adverse reactions	any	12.9	13.9	22.1	19.1
Local adverse reactions	severe	0.3	0.2	0.7	0.5
Pain	Any	12.0	13.7	21.2	18.9
Pain	severe	0.3	0.2	0.7	0.5
Redness	Any	0.5	1.2	0.4	0.2
Redness	severe	0	0	0	0
Swelling	Any	1.0	0.7	2.8	1.8
Swelling	severe	0	0	0	0
Induration	Any	2.0	0.7	3.0	1.2
Induration	severe	0	0	0	0

Systemic adverse reactions	any	22.9		25.4
Systemic adverse reactions	severe	0.5		0.7
Fever	Any	12.2		11.0
Fever	severe	0		0.5
Drowsiness	Any	5.4		5.4
Drowsiness	severe	0		0
Irritability	Any	11.6		16.6
Irritability	severe	0.5		0.2
Loss of appetite	Any	6.3		6.5
Loss of appetite	severe	0		0

DTaP–IPV//PRP~T, diphtheria–tetanus–acellular pertussis–inactivated poliovirus–Haemophilus influenzae type-b conjugate.^a Group A received the DTaP–IPV//PRP~T combination vaccine at 6, 10, 14 weeks of age and the recombinant hepatitis B vaccine at 0, 6 and 14 weeks of age.^b Group B received the DTaP–IPV//PRP~T vaccine and the recombinant hepatitis B vaccine at 6, 10 and 14 weeks of age.