title: Safety and immunogenicity of a combined diphtheria-tetanus-acellular pertussis-hepatitis B vaccine administered according to two different primary vaccination schedules. Multicenter Working Group.
abstract: The reactogenicity and immunogenicity of a tetravalent diphtheria-tetanus-acellular pertussis-hepatitis B (DTPa-HB) vaccine (SmithKline Beecham) were studied in 565 infants immunized according to one of two different schedules, at 2, 4 and 6 months of age (group A n = 208) or at 3, 5 and 11 months of age (group B n = 357). The incidences of local and general reactions within the first 8 days after vaccination were similar in the two groups of infants, the vast majority being mild in intensity and occurring within 2-3 days of vaccine administration. Severe local symptoms were rare: pain after 0.6% of all doses, redness after 0.5% and 1.3%, and swelling after 0.3% and 1.5%, in group A and B, respectively. Only one infant in group A and one in group B had a temperature > 39.0 degrees C. Both schedules proved satisfactory in obtaining high levels of antibodies against all antigens. The rates of serologic response against the different antigens reached 100% in both groups. Antibody titres against all vaccine components were elevated following both schedules, but after the third dose of vaccine geometric mean antibody titres (GMTs) against D toxoid, filamentous haemagglutinin (FHA), pertactin (PRN) and hepatitis B (HB) were significantly higher in the 3, 5, 11 group than after the 2, 4, 6 schedule. Antibody titres measured at 7 months of age in the group immunized at 2, 4 and 6 months were higher than those reached at 6 months of age in infants immunized at 3, 5 and 11 months, but FHA and PRN were within the range of DTPa vaccine with proven efficacy. We conclude that DTPa-HB vaccine was safe, well tolerated and highly immunogenic. Both vaccination schedules (2, 4, 6 and 3, 5, 11) can be considered suitable for mass immunization programmes.
authors.affiliation: Istituto di Igiene e Medicina Preventiva, Università di Catania, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Giammanco
authors.forename: A
authors.initials: A
authors.lastname: Moiraghi
authors.forename: C
authors.initials: C
authors.lastname: Zotti
authors.forename: S
authors.initials: S
authors.lastname: Pignato
authors.forename: S
authors.initials: S
authors.lastname: Li Volti
authors.forename: A
authors.initials: A
authors.lastname: Giammanco
authors.forename: R
authors.initials: R
authors.lastname: Soncini
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage* / Q000009:adverse effects* / Q000276:immunology; D005260:Female; D017325:Hepatitis B Vaccines / Q000008:administration & dosage* / Q000009:adverse effects* / Q000276:immunology; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D008297:Male; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D000914:Antibodies, Viral; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D017325:Hepatitis B Vaccines; D017778:Vaccines, Combined