title: Assessment of the immunogenicity and reactogenicity of a quadrivalent diphtheria, tetanus, acellular pertussis and hepatitis B (DTPa-HBV) vaccine administered in a single injection with Haemophilus influenzae type b conjugate vaccine, to infants at 2, 4 and 6 months of age.
abstract: This double-blind, randomised study was performed to assess the immunogenicity and reactogenicity of three lots of a quadrivalent diphtheria-tetanus-acellular pertussis-hepatitis B vaccine (DTPa-HBV) co-administered with three lots of Haemophilus influenzae type b conjugate (Hib) vaccine in one injection, as a primary vaccination course in healthy infants at 2, 4 and 6 months of age. 269 infants (8-11 weeks of age) were randomly allocated to three groups to receive DTPa-HBV/Hib vaccines, concomitantly with oral polio vaccine. Blood samples for antibody determinations were taken before vaccination and 1 month after the third dose in 262 subjects. Local and general symptoms were recorded by parents on diary cards. All vaccinees had post-vaccination protective anti-D and anti-T (> or = 0.1 IU ml-1) antibodies, and 98% had protective anti-HBs antibody titres (> or = 10 mIU ml-1). There were no statistically significant differences between groups in post-vaccination anti-D, anti-T, anti-HBs antibody geometric mean titres (GMT), these being 3.49 IU ml-1, 5.92 IU ml-1 and 1109 mIU ml-1, respectively. All subjects responded to three pertussis components, i.e. pertussis toxin (PT), filamentous haemagglutinin (FHA) and pertactin (PRN). Although statistically significant differences in GMTs of anti-PT, anti-FHA and anti-PRN were found between groups, these were not believed to be of any clinical relevance as the minimum GMTs were 60, 193 and 230 EL.U ml-1 for anti-PT, anti-FHA and anti-PRN, respectively. There were no statistically significant differences in anti-PRP antibody GMT (4.05 micrograms ml-1) between groups, 100% and 85% of subjects having titres > or = 0.15 and 1.0 microgram ml-1, respectively. No symptoms were reported for one third of the subjects. Fever (> 38 degrees C) was reported after 16% of doses, with < 1% having > 39.5 degrees C. Almost all local and general symptoms were mild or moderate, and lasted less than 48 h. No subject dropped out due to a severe adverse reaction. The administration of an experimental mix of DTPa-HBV and Hib vaccines in a single injection is safe, well-tolerated and immunogenic for all vaccine components.
authors.affiliation: Department of Pediatrics, Basurto Hospital, Bilbao, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Arístegui
authors.forename: R
authors.initials: R
authors.lastname: Dal-Ré
authors.forename: E
authors.initials: E
authors.lastname: Garrote
authors.forename: A
authors.initials: A
authors.lastname: González
authors.forename: J P
authors.initials: JP
authors.lastname: Arrate
authors.forename: A
authors.initials: A
authors.lastname: Pérez
mesh_terms: D000907:Antibodies, Bacterial / Q000096:biosynthesis; D000914:Antibodies, Viral / Q000096:biosynthesis; D015331:Cohort Studies; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000276:immunology*; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D004311:Double-Blind Method; D005260:Female; D018073:Haemophilus Vaccines / Q000276:immunology*; D017325:Hepatitis B Vaccines / Q000276:immunology*; D006801:Humans; D007223:Infant; D008297:Male; D011055:Poliovirus Vaccine, Oral / Q000276:immunology; D011322:Primary Prevention; D017778:Vaccines, Combined / Q000276:immunology*; D018074:Vaccines, Conjugate / Q000276:immunology*
chemical_list: D000907:Antibodies, Bacterial; D000914:Antibodies, Viral; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D018073:Haemophilus Vaccines; D017325:Hepatitis B Vaccines; D011055:Poliovirus Vaccine, Oral; D017778:Vaccines, Combined; D018074:Vaccines, Conjugate