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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00382772
First received: September 29, 2006
Last updated: September 29, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Gastroenteritis
 Biological: 2-dose oral live attenuated G1P[8] human rotavirus vaccine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: 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.

Resource links provided by NLM:

MedlinePlus related topics: Gastroenteritis
Drug Information available for: Rotarix
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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:
  • Assess lot-to-lot consistency in terms of reactogenicity and assess safety of HRV vaccines.

Estimated Enrollment: 1200
Study Start Date: November 2006
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: 2-dose oral live attenuated G1P[8] human rotavirus vaccine
    Other Name: 2-dose oral live attenuated G1P[8] human rotavirus vaccine
  Eligibility

Ages Eligible for Study:   11 Weeks to 17 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00382772

Locations
Finland
GSK Investigational Site
Espoo, Finland, 02100
GSK Investigational Site
Helsinki, Finland, 00930
GSK Investigational Site
Jarvenpaa, Finland, 04400
GSK Investigational Site
Kotka, Finland, 48600
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, 01600
GSK Investigational Site
Vantaa, Finland, 01300
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00382772     History of Changes
Other Study ID Numbers: 107876
Study First Received: September 29, 2006
Last Updated: September 29, 2011
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by GlaxoSmithKline:
HRV vaccine
Diarrhoea
Rotavirus

Additional relevant MeSH terms:
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 19, 2013