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

November 3, 2016 updated by: GlaxoSmithKline

Study to Evaluate Clinical Consistency of the Liquid Formulation of GSK Biologicals' HRV Vaccine and to Evaluate Liquid Formulation Compared to Lyophilised Formulation of the HRV Vaccine Administered as a Two-dose Primary Vaccination.

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 Overview

Status

Completed

Conditions

Infections, Rotavirus

Intervention / Treatment

Biological: 2-dose oral live attenuated G1P[8] human rotavirus vaccine

Study Type

Interventional

Enrollment

1200

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Finland
- - Espoo, Finland, 02100
    - GSK Investigational Site
  - Helsinki, Finland, 00100
    - GSK Investigational Site
  - Helsinki, Finland, 00930
    - GSK Investigational Site
  - Jarvenpaa, Finland, 04400
    - GSK Investigational Site
  - Kotka, Finland, 48600
    - GSK Investigational Site
  - Lahti, Finland, 15140
    - GSK Investigational Site
  - Oulu, Finland, 90100
    - GSK Investigational Site
  - Pori, Finland, 28120
    - GSK Investigational Site
  - Seinajoki, Finland, 60100
    - GSK Investigational Site
  - Turku, Finland, 20520
    - GSK Investigational Site
  - Vantaa, Finland, 01300
    - GSK Investigational Site
  - Vantaa, Finland, 01600
    - GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 3 months (Child)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Vesikari T, Karvonen A, Bouckenooghe A, Suryakiran PV, Smolenov I, Han HH. Immunogenicity, reactogenicity and safety of the human rotavirus vaccine RIX4414 oral suspension (liquid formulation) in Finnish infants. Vaccine. 2011 Mar 3;29(11):2079-84. doi: 10.1016/j.vaccine.2011.01.004. Epub 2011 Jan 14.

Helpful Links

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

September 29, 2006

First Submitted That Met QC Criteria

September 29, 2006

First Posted (Estimate)

October 2, 2006

Study Record Updates

Last Update Posted (Estimate)

November 4, 2016

Last Update Submitted That Met QC Criteria

November 3, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

107876

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

Statistical Analysis Plan
Information identifier: 107876

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification
Information identifier: 107876

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol
Information identifier: 107876

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form
Information identifier: 107876

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set
Information identifier: 107876

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report
Information identifier: 107876

Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.