title: Safety and immunogenicity of a DTaP-IPV(Vero) (serum-free) combination vaccine in comparison to DTaP-IPV(Mkc) when administered simultaneously with Haemophilus influenzae type B conjugate vaccine (PRP-T) in children at 2, 3.5, 5 and 16 months of age.
abstract: In a phase III, double blind, randomized, noninferiority, multi-centre clinical trial, 817 infants were included and randomly assigned to vaccination with DTaP-IPV(Vero) (N=410) or DTaP-IPV(Mkc) (N=407) vaccines (Statens Serum Institut (SSI), Denmark) in the right thigh. All infants were vaccinated with Act-HIB (Sanofi Pasteur, France) in the left thigh at the same time. The vaccination schedule was 2, 3.5, 5 and 16 months and serum samples were obtained at 6, 16 and 17 months. The primary objective was to demonstrate noninferiority of DTaP-IPV(Vero) to DTaP-IPV(Mkc) as regards immunological protection against polio virus types 1, 2 and 3. Furthermore, the immunogenicity of all vaccine antigens and the safety profile of the vaccines were assessed. The study demonstrated that DTaP-IPV(Vero) was noninferior to DTaP-IPV(Mkc). All antibody concentrations/titres remained at an acceptable level from the end of the primary vaccination series (i.e. 2, 3.5 and 5 months) until the time of the booster vaccination at 16 months. A good booster response was, furthermore, demonstrated for all antigens. No vaccine-related serious adverse events and no injection site granulomas or swelling of the entire thigh occurred. The frequencies of local injection site erythema and swelling as well as systemic adverse events such as fever, irritability, somnolence and decreased appetite were low and acceptable in both treatment groups. In conclusion, DTaP-IPV(Vero) is immunogenic and safe for primary vaccination and for booster vaccination of healthy children.
authors.affiliation: Jagellonian University, Medical College, Institute of Pediatrics, Department of Pediatrics, Wielicka 265, 30-663 Krakow, Poland.
authors.forename: Jacek J
authors.initials: JJ
authors.lastname: Pietrzyk
authors.forename: Jacek
authors.initials: J
authors.lastname: Wysocki
authors.forename: Jerzy
authors.initials: J
authors.lastname: Pejcz
authors.forename: Andrzej
authors.initials: A
authors.lastname: Galaj
authors.forename: Ewa
authors.initials: E
authors.lastname: Majda-Stanislawska
authors.forename: Helena
authors.initials: H
authors.lastname: Käyhty
authors.forename: Birgit
authors.initials: B
authors.lastname: Thierry-Carstensen
authors.forename: Anders Mørup
authors.initials: AM
authors.lastname: Jensen
mesh_terms: D002648:Child; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D005260:Female; D018073:Haemophilus Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D006801:Humans; D007115:Immunization Schedule; D007117:Immunization, Secondary; D007223:Infant; D008297:Male; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D013745:Tetanus Toxoid / Q000276:immunology*; D017778:Vaccines, Combined / Q000009:adverse effects / Q000276:immunology; D018074:Vaccines, Conjugate / Q000008:administration & dosage
chemical_list: D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; C055753:Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate; D011054:Poliovirus Vaccine, Inactivated; D013745:Tetanus Toxoid; D017778:Vaccines, Combined; D018074:Vaccines, Conjugate