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A phase IIIA, randomized, single-blind, multi-centric study to evaluate the immunogenicity, reactogenicity and safety of three doses of Pediarix, Hiberix and Prevenar 13 when co-administered with two doses of the Porcine Circovirus (PCV)-free liquid formulation of GlaxoSmithKline Biologicals' oral live attenuated Human Rota Virus (HRV) vaccine as compared to the currently licensed lyophilized formulation of the HRV vaccine in healthy infants 6-12 weeks of age.

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Trial Profile

A phase IIIA, randomized, single-blind, multi-centric study to evaluate the immunogenicity, reactogenicity and safety of three doses of Pediarix, Hiberix and Prevenar 13 when co-administered with two doses of the Porcine Circovirus (PCV)-free liquid formulation of GlaxoSmithKline Biologicals' oral live attenuated Human Rota Virus (HRV) vaccine as compared to the currently licensed lyophilized formulation of the HRV vaccine in healthy infants 6-12 weeks of age.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Nov 2019

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At a glance

  • Drugs DTaP-hepatitis B-poliovirus vaccine (Primary) ; Hib vaccine conjugate (Primary) ; Pneumococcal 13-valent CRM197 vaccine conjugate (Primary) ; RIX 4414 (Primary) ; RIX 4414
  • Indications Rotavirus infections
  • Focus Pharmacodynamics
  • Acronyms ROTA-090
  • Sponsors GlaxoSmithKline

    • Most Recent Events

    • 17 May 2019 Status changed from active, no longer recruiting to completed.
    • 08 Oct 2018 Planned primary completion date changed from 28 Sep 2018 to 9 Oct 2018.
    • 08 Mar 2018 Planned End Date changed from 10 Apr 2019 to 8 Mar 2019.
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