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.

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.

Recruiting
Phase of Trial: Phase III

Latest Information Update: 17 Jan 2018

At a glance

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

    • 22 Nov 2017 Planned End Date changed from 11 Aug 2019 to 24 Sep 2019.
    • 22 Nov 2017 Planned primary completion date changed from 4 Mar 2019 to 15 Apr 2019.
    • 22 Nov 2017 Status changed from not yet recruiting to recruiting.
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