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.
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
- 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.