At a glance
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Immunogenicity, Reactogenicity and Safety Study of Pediarix®, Hiberix® and Prevenar 13® Co-administered With Two Different Formulations of GSK Biologicals' HRV Vaccine (444563) in Healthy Infants 6-12 Weeks of Age
In Brief
A Phase 3 clinical trial evaluating Rotarix, Pediarix, and 2 other interventions for Rotavirus Infection and Rotavirus Vaccines. Completed, enrolled 1,280 participants across 47 sites.
Detailed Summary
The purpose of this study is to assess if there is any immune interference between the Porcine circovirus free (PCV-free) liquid Human rotavirus (HRV) vaccine and routine infant vaccinations currently in use in the US, namely Pediarix®, Hiberix® and Prevenar 13® as compared to the currently licensed lyophilized formulation of the HRV vaccine when co-administered with the same routine vaccinations in healthy infants 6-12 weeks of age
Study Details
Timeline
Interventions
Two doses administered orally according to a 0, 2 month schedule as per the immunization schedule for HRV vaccine administration in the US.
Three doses administered intramuscularly according to a 0, 2, 4 month schedule.
Three doses administered intramuscularly according to a 0, 2, 4 month schedule.
Three doses administered intramuscularly according to a 0, 2, 4 month schedule.