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) coadministered with pneumococcal 7-valent conjugate vaccine (PCV-7) and Haemophilus influenzae type b vaccine (Hib), with separate vaccines concurrently, or staggered (delayed) administration of PCV-7.


METHODS
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 seroprotective rates for diphtheria, tetanus, and poliovirus and to geometric mean concentrations for pertussis. Seroprotective rates for HepB and Hib were not different between groups. Seropositivity for PCV-7 was high in all groups. Administration of combination vaccine appeared to be associated with higher rates of irritability, fever > or = 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.
Pichichero
Michael E
ME
University of Rochester Medical Center, Rochester, New York 14642, USA. michael_pichichero@urmc.rochester.edu
Bernstein
Henry
H
Blatter
Mark M
MM
Schuerman
Lode
L
Cheuvart
Brigitte
B
Holmes
Sandra J
SJ
D016667:Bacterial Capsules; D016001:Confidence Intervals; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000008:administration & dosage / Q000276:immunology*; D005260:Female; D005500:Follow-Up Studies; D018073:Haemophilus Vaccines / Q000008:administration & dosage / Q000276:immunology; D017325:Hepatitis B Vaccines / Q000008:administration & dosage / Q000276:immunology*; D006801:Humans; D007109:Immunity / Q000502:physiology; D007115:Immunization Schedule; D007223:Infant; D008297:Male; D015999:Multivariate Analysis; D022242:Pneumococcal Vaccines / Q000008:administration & dosage / Q000276:immunology*; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage / Q000276:immunology*; D011135:Polysaccharides, Bacterial / Q000008:administration & dosage / Q000276:immunology; D018570:Risk Assessment; D016037:Single-Blind Method; D013745:Tetanus Toxoid / Q000008:administration & dosage / Q000276:immunology*; D014611:Vaccination / Q000009:adverse effects / Q000379:methods*; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000276:immunology; D018074:Vaccines, Conjugate / Q000008:administration & dosage / Q000276:immunology
D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D018073:Haemophilus Vaccines; C044237:Haemophilus influenzae type b polysaccharide vaccine; D017325:Hepatitis B Vaccines; D022242:Pneumococcal Vaccines; D011054:Poliovirus Vaccine, Inactivated; D011135:Polysaccharides, Bacterial; D013745:Tetanus Toxoid; D017778:Vaccines, Combined; D018074:Vaccines, Conjugate