Primary vaccination of infants with diphtheria-tetanus-acellular pertussis-hepatitis B virus- inactivated polio virus and Haemophilus influenzae type b vaccines given as either separate or mixed injections.
OBJECTIVE
The aim of this open, multicenter, randomized trial was to evaluate the immunogenicity and reactogenicity of a candidate combined diphtheria-tetanus-acellular pertussis-hepatitis B virus-inactivated polio virus (DTaP-HBV-IPV) vaccine when given as either a mixed or as separate concomitant injections with Haemophilus influenzae type b (Hib) vaccine.


METHODS
A total of 359 subjects were randomized to receive either DTaP-HBV-IPV/Hib (mixed administration - 180 subjects) or DTaP-HBV-IPV + Hib (separate administration in opposite limbs - 179 subjects) at 2, 3, and 4 months of age.


RESULTS
After vaccination, seroprotective antibody concentrations against diphtheria, tetanus, hepatitis B, and polio viruses and a high (> or = 97%) pertussis vaccine response were seen in almost all study participants. All subjects except one in the mixed administration group had postvaccination Hib anti-PRP antibody concentrations > or = 0.15 microg/mL. Of subjects in the mixed and separate group, 77.2% (geometric mean antibody concentration, 2. 62 microg/mL) and 88.6% (geometric mean antibody concentration, 4.45 microg/mL) had Hib anti-PRP concentrations > or = 1 microg/mL, respectively. The addition of the Hib component to the 5-component vaccine did not increase the incidence of local or general reactions.


CONCLUSIONS
Both administrations of the candidate vaccine were found to be safe, immunogenic, and well tolerated. Although anti-PRP geometric mean antibody concentrations and the percent of subjects achieving the 1 microg/mL seroprotective level were lower after the mixed administration, they were in the range seen with monovalent Hib vaccines or with other DTaP-based/Hib combinations licensed in some European countries. Therefore both administrations have the potential to simplify childhood immunization.
Schmitt
H J
HJ
Department of Pediatrics, Pediatric Infectious Diseases, Christian-Albrechts-Universität zu Kiel, Kiel, Germany.
Knuf
M
M
Ortiz
E
E
Sänger
R
R
Uwamwezi
M C
MC
Kaufhold
A
A
D000917:Antibody Formation; D004165:Diphtheria / Q000276:immunology; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage* / Q000276:immunology; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D005240:Feasibility Studies; D018073:Haemophilus Vaccines / Q000008:administration & dosage* / Q000276:immunology; D006514:Hepatitis B Surface Antigens / Q000276:immunology; D017325:Hepatitis B Vaccines / Q000008:administration & dosage* / Q000276:immunology; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D007273:Injections, Intramuscular; D017955:Poliovirus / Q000276:immunology; D013745:Tetanus Toxoid / Q000276:immunology; D018074:Vaccines, Conjugate / Q000008:administration & dosage* / Q000276:immunology; D014614:Vaccines, Synthetic / Q000008:administration & dosage* / Q000276:immunology; D014917:Whooping Cough / Q000276:immunology
C104289:COMVAX; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D018073:Haemophilus Vaccines; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D013745:Tetanus Toxoid; D018074:Vaccines, Conjugate; D014614:Vaccines, Synthetic