Safety of a combination diphtheria, tetanus toxoid, acellular pertussis, hepatitis B, and inactivated polio vaccine coadministered with a 7-valent pneumococcal conjugate vaccine and a Haemophilus influenzae type b conjugate vaccine

The safety of DTaP–HepB–IPV vaccine coadministered with PCV and Hib was compared with separate administration of DTaP, HepB, IPV, Hib, and PCV at 2, 4, and 6 months of age. Healthy 2-month-old infants (N = 1008) were randomized to the two groups. Following dose 1, there was no significant difference between the groups in the incidence of fever >101.3 °F. After each dose, the incidence of any fever (≥100.4 °F) was significantly higher in the Combination Vaccine Group. The rate of fever >103.1 °F was ≤1.4% in both groups after any of the doses. Medical advice visits for fever were infrequent in both groups (≤1.2%). DTaP–HepB–IPV was safe and well tolerated when coadministered with PCV and Hib.