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Study of 2 Doses of HRV Vaccine Given Concomitantly With Routine EPI Vaccinations Including OPV in Healthy Infants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00139347
First Posted: August 31, 2005
Last Update Posted: October 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
The main objectives of this study is to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until one year of age.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Multi-country & Multi-center Study to Assess the Efficacy, Immunogenicity & Safety of Two Doses of GSK Biologicals' Oral Live Attenuated HRV Vaccine Given Concomitantly With Routine EPI Vaccinations Including OPV in Healthy Infants

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of severe RV GE caused by the wild RV strains during the period starting from 2 weeks after Dose 2 until 1 year old.

Secondary Outcome Measures:
  • Vaccine efficacy against severe rotavirus gastroenteritis by serotypes until 1 year of age; Safety; Immunogenicity of HRV and co-administered EPI vaccines

Estimated Enrollment: 6360
Study Start Date: December 2003
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Detailed Description:
The study has two groups: Group HRV and Group Placebo. Two oral doses administered to healthy infants who are 6-12 weeks of age at the time of Dose 1, according to a 0, 1 to 2-month schedule. Routine EPI vaccinations are given at the discretion of the investigator and according to local National Plans of Immunisation schedule in each participating country.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Weeks to 12 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Healthy infants 6 -12 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00139347


Locations
Argentina
GSK Investigational Site
Colonia Caroya, Córdova, Argentina, X5223CDT
GSK Investigational Site
Rio Cuarto, Córdova, Argentina, 5800
GSK Investigational Site
Tunuyan, Mendoza, Argentina, 5560
GSK Investigational Site
Villanueva, Mendoza, Argentina, 5521
GSK Investigational Site
Cordoba, Argentina, 5000
GSK Investigational Site
Córdova, Argentina, 5016
GSK Investigational Site
La Plata, Argentina, 1900
GSK Investigational Site
Mendoza, Argentina, 5500
Brazil
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Colombia
GSK Investigational Site
Bogota, Colombia, 805
GSK Investigational Site
Cali Colombia, Colombia
GSK Investigational Site
Cali, Colombia
Dominican Republic
GSK Investigational Site
Santo Domingo, Distrito Nacional, Sant Dom- Distrito Nacional, Dominican Republic
GSK Investigational Site
Santo Domingo, Dominican Republic
Honduras
GSK Investigational Site
Comayaguela, Honduras
Panama
GSK Investigational Site
David, Chiriquí, Panama, Panamá 937, David
GSK Investigational Site
Panama, Panama
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Gonzalez Ayala et al. Co-administration with rotavirus vaccine rix4414 (rotarix™) does not interfere with the immunogenicity of oral polio vaccine (OPV). Poster presented at WSPID Bangkok, Thailand, 15-18 Nov 2007.
Lopez P et al. Immunogenicity of an Oral Polio Vaccine is Unaffected when Co-Administered with a Human Rotavirus Vaccine RIX4414 (Rotarix™) in Latin America. Poster presented at the 13th International Congress on Infectious Diseases (ICID), Kuala Lumpur, Malaysia, 19-22 June 2008.
Tregnaghi M et al. Oral Human Rotavirus Vaccine RIX4414(Rotarix™) Co-administered with Routine EPI Vaccinations Including Oral Polio Vaccine(OPV) Is Highly Efficacious in Latin-America. Poster presented at the 13th International Congress on Infectious Diseases (ICID), Kuala Lumpur, Malaysia, 19-22 June 2008.

Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 444563/024
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 444563/024
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 444563/024
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 444563/024
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 444563/024
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 444563/024
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 444563/024
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00139347     History of Changes
Other Study ID Numbers: 444563/024
First Submitted: August 30, 2005
First Posted: August 31, 2005
Last Update Posted: October 28, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Additional relevant MeSH terms:
Rotavirus Infections
Reoviridae Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs