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A Phase II/III, Multicenter, Randomized, Observer-blinded, Active Controlled Clinical Study to Assess the Safety and Immunogenicity of the Tetanus, Diphtheria and Acellular Pertussis Vaccine SIIPL Tdap in Comparison with Boostrix® in Healthy Adults, Adolescents and Children

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A Phase II/III, Multicenter, Randomized, Observer-blinded, Active Controlled Clinical Study to Assess the Safety and Immunogenicity of the Tetanus, Diphtheria and Acellular Pertussis Vaccine SIIPL Tdap in Comparison with Boostrix® in Healthy Adults, Adolescents and Children

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 17 Oct 2023

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At a glance

  • Drugs SIIPL Tdap-IPV (Primary) ; DTaP vaccine
  • Indications Diphtheria; Pertussis; Poliomyelitis; Tetanus
  • Focus Adverse reactions; Pharmacodynamics

    • Most Recent Events

    • 17 Oct 2023 New trial record
    • 10 Oct 2023 Primary end (co-primary immunogenicity outcomes: (i) seroprotection rates against diphtheria toxoid (DT) and tetanus toxoid (TT) and (ii) the booster response rates against pertussis toxoid (PT), filamentous hemagglutinin (FHA) and pertactin (PRN) 30 days post-vaccination in all study subjects) has been met, as per results published in the Vaccine.
    • 10 Oct 2023 Results published in the Vaccine.

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