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Upstate Active Clinical Trials

Study Title:

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 PCV-free liquid formulation of GSK Biologicals’ oral live attenuated HRV vaccine
as compared to the currently licensed lyophilized formulation of the HRV vaccine in healthy infants 6-12
weeks of age.

What is the purpose of the study?

Rotavirus infection is the leading cause of severely inflamed stomach or gut (gastroenteritis) and severe diarrhea in infants and young children less than 5 years of age. However, it can be prevented by vaccination. GlaxoSmithKline (GSK) Biologicals’ Rotarix is one of the vaccines which has been proven highly effective in preventing severe rotavirus diarrhea and severe gastroenteritis.

Upstate Institutional Review Board (IRB) Number:

1087284

Study/Protocol ID:

201663 (ROTA-090)

Study Phase:

Phase III

Patient Age Group:

Children

Principal Investigator:

Joseph B Domachowske

Who can I contact for more information?

Name: Jodi Halczyn
Phone: 315-464-1992
Email: halczynj@upstate.edu

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