Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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.

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 15 Oct 2018

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

    • 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.
    • 08 Mar 2018 Planned primary completion date changed from 30 Oct 2018 to 28 Sep 2018.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top