title: Booster vaccination and 1-year follow-up of 4-8-year-old children with a reduced-antigen-content dTpa-IPV vaccine.
abstract: Reduced-antigen-content pertussis vaccines designed initially for booster vaccination of adolescents and adults can also be used to vaccinate pre-school age children. Combination vaccines, which reduce the number of administered injections, combine multiple antigens including inactivated poliovirus (IPV), which is recommended in this age group in some countries. This randomised, controlled study compared a combined diphtheria-tetanus-acellular pertussis-inactivated polio-containing booster vaccine, dTpa-IPV (Boostrix Polio, n=822), to separately administered dTpa (Boostrix) and IPV (IPV Mérieux, n=136) in 4-8-year-old children who had previously received four doses of DTPa. Additional serological assessment was performed 1 year after the booster dose. One month after vaccination, seroprotection/vaccine response rates were similar for both groups. At least 99.9% of the subjects had protective antibodies against diphtheria, tetanus and polio, and at least 90.1% had a vaccine response to pertussis antigens after dTpa-IPV. Reactogenicity of dTpa-IPV was comparable to dTpa + IPV. Fever and grade 3 loss of appetite occurred more commonly after dTpa-IPV, whereas swelling and grade 3 pain occurred more frequently after separately administered dTpa + IPV (P<0.05 for all). However, 95% CIs overlapped in all cases. Large swelling reactions after dTpa-IPV occurred less commonly than have been reported after a fifth dose of DTPa. One year after the booster, 98.6% of the subjects tested continued to have protective antibodies against diphtheria, tetanus and polio, and at least 81.2% were seropositive for pertussis components. The reduced-antigen-content dTpa-IPV vaccine was immunogenic, well tolerated and safe in pre-school age children. It provides immunity against four diseases in a single injection, with the potential reactogenicity benefit of a reduced-antigen dose.
authors.affiliation: GlaxoSmithKline GmbH & Co. KG, Theresienhoehe 11, 80339 Munich, Germany. roland.saenger@gsk.com
authors.forename: Roland
authors.initials: R
authors.lastname: Sänger
authors.forename: Ulrich
authors.initials: U
authors.lastname: Behre
authors.forename: Karl-Heinz
authors.initials: KH
authors.lastname: Krause
authors.forename: Hans-Peter
authors.initials: HP
authors.lastname: Loch
authors.forename: Peter
authors.initials: P
authors.lastname: Soemantri
authors.forename: Dietmar
authors.initials: D
authors.lastname: Herrmann
authors.forename: Eugenie
authors.initials: E
authors.lastname: Schmitz-Hauss
authors.forename: Joanne
authors.initials: J
authors.lastname: Wolter
authors.forename: Bernard
authors.initials: B
authors.lastname: Hoet
mesh_terms: D000917:Antibody Formation; D002648:Child; D002675:Child, Preschool; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D004311:Double-Blind Method; D006801:Humans; D007117:Immunization, Secondary; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D013997:Time Factors; D017778:Vaccines, Combined / Q000009:adverse effects / Q000276:immunology
chemical_list: C505143:Boostrix; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D011054:Poliovirus Vaccine, Inactivated; D017778:Vaccines, Combined