A Study in Infants to Test Two Preparations (Freeze-dried or Liquid) of the Rotavirus Vaccine (HRV Vaccine).

GlaxoSmithKline1,200 enrolled

Overview

The aim of this this study is to evaluate the lot-to-lot consistency of the liquid formulation of GSK Biologicals' HRV vaccine and to evaluate the liquid formulation compared to the lyophilised formulation of GSK Biologicals' HRV vaccine when administered concomitantly with a combination childhood vaccine.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

1,200

Conditions

Infections, Rotavirus

Interventions

2-dose oral live attenuated G1P[8] human rotavirus vaccineBIOLOGICAL

Eligibility

Sex: ALLMin age: 11 WeeksMax age: 17 WeeksHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy infants birth weigh \>2000 g, 11 -17 weeks old at Dose 1 with written informed consent. Exclusion Criteria: * Allergic reaction to vaccine components; clinically significant history of chronic GI disease (uncorrected GI congenital malformation) or other serious medical condition per investigator, received vaccines or treatment prohibited by the protocol; immunocompromised.

Locations (12)

GSK Investigational Site

Espoo, Finland

GSK Investigational Site

Helsinki, Finland

GSK Investigational Site

Helsinki, Finland

GSK Investigational Site

Outcomes

Primary Outcomes

Demonstrate lot-to-lot consistency of HRV vaccine liquid formulation and non-inferiority of liquid formulation versus the lyophilised formulation of the HRV vaccine.

Secondary Outcomes

Assess lot-to-lot consistency in terms of reactogenicity and assess safety of HRV vaccines.

Data from ClinicalTrials.gov

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