title: Immunogenicity and reactogenicity of diphtheria, tetanus and pertussis toxoids combined with inactivated polio vaccine, when administered concomitantly with or as a diluent for a Hib conjugate vaccine.
abstract: In an open trial, 400 infants were randomized to vaccination with a combined diphtheria-tetanus-pertussis-inactivated polio vaccine (DTaP-IPV) either mixed with a Haemophilus influenzae type b (Hib) tetanus toxoid conjugate immediately before injection (DTaP-IPV/Hib (mix)) or given concurrently with the Hib conjugate at separate injection sites (DTaP-IPV+Hib (sep)). The pertussis component consisted of pertussis toxoid alone. The vaccines were given intramuscularly at 3, 5 and 12 months of age. No vaccine-related serious adverse events occurred. Local reactions were evaluated from diary cards completed by the parents. Infants who received DTaP-IPV/Hib (mix) experienced fewer local reactions. Sera were obtained 28-45 days after the second and third vaccinations. Total Hib capsular antibodies were similar in the two groups after the second injection but lower in the group receiving DTaP-IPV/Hib (mix) than in the group receiving DTaP-IPV+Hib (sep) after the third injection (geometric mean 6.1 vs 10.4 microg/ml). Mixing of the vaccines also led to somewhat lower diphtheria toxin antibodies (5.9 vs. 7.7 IU/ml after the third injection) while tetanus antibodies were higher (3.9 vs. 2.5 IU/ml after the third injection). Antibodies against pertussis toxin and the three polio virus types were similar in the two groups. The moderate impairment of the Hib antibody response caused by mixing of the Hib conjugate with aluminium adsorbed DTaP may be due to physicochemical interference but is probably of little clinical importance because of the ability of the Hib conjugates to induce an immunologic memory.
authors.affiliation: The Child Health Center, Vaniljgatan 28, S-424 45, Angered, Sweden. nina.knutsson@telia.com
authors.forename: N
authors.initials: N
authors.lastname: Knutsson
authors.forename: B
authors.initials: B
authors.lastname: Trollfors
authors.forename: J
authors.initials: J
authors.lastname: Taranger
authors.forename: E
authors.initials: E
authors.lastname: Bergfors
authors.forename: V
authors.initials: V
authors.lastname: Sundh
authors.forename: T
authors.initials: T
authors.lastname: Lagergård
authors.forename: E
authors.initials: E
authors.lastname: Ostergaard
authors.forename: H
authors.initials: H
authors.lastname: Cicirello
authors.forename: H
authors.initials: H
authors.lastname: Käyhty
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D005260:Female; D018073:Haemophilus Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D006801:Humans; D007231:Infant, Newborn; D007273:Injections, Intramuscular; D008297:Male; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D011897:Random Allocation; D013745:Tetanus Toxoid / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D000914:Antibodies, Viral; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D018073:Haemophilus Vaccines; C055753:Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate; D011054:Poliovirus Vaccine, Inactivated; D013745:Tetanus Toxoid; D017778:Vaccines, Combined