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

Objective To evaluate the immunogenicity and safety of a diphtheria and tetanus toxoids, acellular pertussis, hepatitis B, and inactivated poliovirus-containing vaccine (DTaP-HepB-IPV) coadininistered with pneumococcal 7-valent containing vaccine (PCV-7) and Haemophilus influenzae type b vaccine (Hib), with separate vaccines concurrently, or staggered (delayed) administration of PCV-7. Study design At 2,4, and 6 months of age, infants received either DTaP-HepB-IPV plus PCV-7 and Hib (n= 199), separate vaccines(n = 188), or DTaP-HepB-IPV plus Hib with PCV-7 administered 2 weeks later (n := 188). Blood was drawn before and after vaccination. Parents reported symptoms for 4 days after each dose and adverse events throughout the entire study. Results Immunogenicity in the Combination Vaccine Group was noninferior to that of the Separate and Staggered Vaccine Groups with respect to scroprotective rates for diphtheria. tetanus. and poliovirus and to geometric mean coil concentrations for pertussis. Seroprotective rates for HepB, and Hib were not different between groups. Seropositivitv for PCV-7 was high in all groups. Administration of combination vaccine appeared to be associated with higher rates of irritability, fever >= 100.4 degrees F (38.0 degrees C) and some local symptoms compared with separate vaccines (exploratory P < .05). No group differences were observed in rates of symptoms for which parents sought medical advice. Conclusions DTaP-HepB-IPV was highly immunogenic and well tolerated when coadministered with Hib and PCV-7 at 2, 4, and 6 months of age.