A Phase III, observer-blind, randomized, multicenter study to evaluate immunogenicity, reactogenicity and safety of GlaxoSmithKline (GSK) Biologicals' Rotarix Porcine circovirus (PCV)-free liquid as compared to GSK's Rotarix liquid, given in 2 doses in healthy Chinese infants starting at age 6-16 weeks
Latest Information Update: 11 May 2025
At a glance
- Drugs RIX 4414 (Primary)
- Indications Rotavirus infections
- Focus Pharmacodynamics; Registrational
- Acronyms ROTA-097
- Sponsors GlaxoSmithKline Biologicals; GSK
Most Recent Events
- 26 Oct 2024 Status changed from recruiting to completed.
- 04 Mar 2024 Planned End Date changed from 1 Oct 2024 to 18 Nov 2024.
- 04 Mar 2024 Planned primary completion date changed from 22 Apr 2024 to 19 Jun 2024.