NCT03207750

This Study Will Evaluate the Immunogenicity, Reactogenicity and Safety of the Routine Infant Vaccines Pediarix®, Hiberix® and Prevenar 13® When Co-administered With GlaxoSmithKline (GSK) Biologicals' Liquid Human Rotavirus Vaccine (HRV) as Compared to GSK's Licensed Lyophilized Vaccine

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,280 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Weeks – 12 Weeks
• Healthy volunteers: Accepted

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

Conditions

• Rotavirus Infection
• Rotavirus Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	Rotarix	Two doses administered orally according to a 0, 2 month schedule as per the immunization schedule for HRV vaccine administration in the US.
BIOLOGICAL	Pediarix	Three doses administered intramuscularly according to a 0, 2, 4 month schedule.
BIOLOGICAL	Hiberix	Three doses administered intramuscularly according to a 0, 2, 4 month schedule.
BIOLOGICAL	Prevenar 13	Three doses administered intramuscularly according to a 0, 2, 4 month schedule.

Timeline

• Start date: 2017-09-14
• Primary completion: 2018-10-09
• Completion: 2019-03-01
• First posted: 2017-07-05
• Last updated: 2020-12-29
• Results posted: 2019-10-31

Locations

47 sites across 1 country: United States

Regulatory

• FDA-regulated drug study