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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00139347
First received: August 30, 2005
Last updated: November 21, 2012
Last verified: November 2012
  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
Rotavirus Gastroenteritis
Biological: 2-dose oral live attenuated G1P[8] human rotavirus vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


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
Primary Completion Date: March 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
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

Ages Eligible for Study:   6 Weeks to 12 Weeks
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
GSK Investigational Site
Cali Colombia, 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

No publications provided by GlaxoSmithKline

Additional 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
Study First Received: August 30, 2005
Last Updated: November 21, 2012
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Additional relevant MeSH terms:
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 20, 2014