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A phase IV, open-label, non-randomised, multi-centre study to assess the immunogenicity and safety of a booster dose of Infanrix hexa in healthy infants born to mothers vaccinated with Boostrix during pregnancy or immediately post-delivery.

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A phase IV, open-label, non-randomised, multi-centre study to assess the immunogenicity and safety of a booster dose of Infanrix hexa in healthy infants born to mothers vaccinated with Boostrix during pregnancy or immediately post-delivery.

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 12 Dec 2022

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At a glance

  • Drugs Hib DTaP hepatitis B poliovirus vaccine (Infanrix hexa) (Primary) ; Pneumococcal 13-valent CRM197 vaccine conjugate
  • Indications Diphtheria; Haemophilus infections; Hepatitis B; Pertussis; Pneumococcal infections; Poliomyelitis; Tetanus
  • Focus Pharmacodynamics
  • Acronyms DTPA (BOOSTRIX)-049 BST: 048
  • Sponsors GlaxoSmithKline; GSK

    • Most Recent Events

    • 18 Feb 2021 Results of a subsequent follow-up study of our maternal immunization trial, in which we evaluated whether antibody concentrations in toddlers from Tdap-vaccinated mothers remain lower after a DTaP-HepB-IPV/Hib booster dose published in the Vaccine
    • 17 May 2019 Status changed from active, no longer recruiting to completed.
    • 15 Mar 2019 This study has been completed in Czech Republic.

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