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A Phase III Multicentric Randomized Single Blind Study to Compare the Immunogenicity and Safety of HBI Pentavalent (DTwP-Hb-Hib[Liquid]) Combination Vaccine with Pentavac SD® Vaccine when Administered in Three Doses to 6-8 weeks old Healthy Infants - Pentavalent Phase III Clinical trial

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A Phase III Multicentric Randomized Single Blind Study to Compare the Immunogenicity and Safety of HBI Pentavalent (DTwP-Hb-Hib[Liquid]) Combination Vaccine with Pentavac SD® Vaccine when Administered in Three Doses to 6-8 weeks old Healthy Infants - Pentavalent Phase III Clinical trial

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Nov 2019

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At a glance

  • Drugs DTwP Hb Hib pentavalent vaccine Indian Immunologicals (Primary)
  • Indications Diphtheria; Haemophilus infections; Hepatitis B; Pertussis; Tetanus
  • Focus Pharmacodynamics
  • Sponsors Indian Immunologicals

    • Most Recent Events

    • 19 Jul 2019 Primary endpoint has been met. (Proportion of subjects achieving seroconversion and seroprotection against Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus influenzae type B four to six weeks after three doses of primary immunization with HBI Pentavalent (DTwP-Hb-Hib[Liquid]))
    • 19 Jul 2019 Results published in the Vaccine
    • 06 Feb 2017 Status changed from recruiting to completed.

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