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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

NCT03207750 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1280

Last updated 2020-12-29

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
12 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-14
Primary Completion
2018-10-09
Completion
2019-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03207750 on ClinicalTrials.gov