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RESEARCH PRODUCT

Safety, reactogenicity and immunogenicity of a combined hexavalent tetanus, diphtheria, acellular pertussis, hepatitis B, inactivated poliovirus vaccine and Haemophilus influenzae type b conjugate vaccine, for primary immunization of infants.

Alix CollardUlrich HeiningerP. HabermehlRoland SängerK. JahnMarkus KnufFred ZeppLode Schuerman

subject

MaleHaemophilus InfectionsDiphtheria ToxoidWhooping Coughmedicine.disease_causecomplex mixturesHaemophilus influenzaeConjugate vaccinemedicineTetanus ToxoidHumansHepatitis B VaccinesVaccines CombinedBacterial CapsulesDiphtheria-Tetanus-Pertussis VaccineHaemophilus VaccinesPertussis VaccineReactogenicityTetanusGeneral VeterinaryGeneral Immunology and Microbiologybusiness.industryImmunogenicityDiphtheriaPolysaccharides BacterialVaccinationPublic Health Environmental and Occupational HealthInfantDiphtheriamedicine.diseaseHepatitis BVirologyPoliovirus Vaccine InactivatedInfectious DiseasesHib vaccineImmunizationImmunologyInactivated Poliovirus VaccineMolecular MedicineFemalebusinessPoliomyelitis

description

Safety, reactogenicity and immunogenicity of GSK Biologicals` hexavalent DTPa-HBV-IPV/Hib vaccine (Infanrix(R)hexa) was assessed when used for primary vaccination at 3, 4 and 5 months of age (N = 2163), compared to the separate administration of DTPa-IPV/Hib and HBV vaccines (N = 720). A similar safety and reactogenicity profile was demonstrated for both vaccine regimens, as well as a good immune response for all antigen components. By offering protection against six diseases in it series of single injections, the hexavalent DTPa-HBV-IPV/Hib vaccine was shown to be a safe, well tolerated and immunogenic alternative to primary immunization with licensed separately administered vaccines. (C) 2003 Elsevier Ltd. All rights reserved.

10.1016/j.vaccine.2003.11.044https://pubmed.ncbi.nlm.nih.gov/15149781