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

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:

MedlinePlus related topics: Gastroenteritis

Drug Information available for: Rotarix

U.S. FDA Resources

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:

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

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):

Tregnaghi MW, Abate HJ, Valencia A, Lopez P, Da Silveira TR, Rivera L, Rivera Medina DM, Saez-Llorens X, Gonzalez Ayala SE, De León T, Van Doorn LJ, Pilar Rubio MD, Suryakiran PV, Casellas JM, Ortega-Barria E, Smolenov IV, Han HH; Rota-024 Study Group. Human rotavirus vaccine is highly efficacious when coadministered with routine expanded program of immunization vaccines including oral poliovirus vaccine in Latin America. Pediatr Infect Dis J. 2011 Jun;30(6):e103-8.

Ruiz-Palacios GM, Perez-Schael I, Velazquez FR, Abate H, Breuer T, Clemens SC, Cheuvart B, Espinoza F, Gillard P, Innis BL, Cervantes Y, Linhares AC, Lopez P, Macias-Parra M, Ortega-Barria E, Richardson V, Rivera-Medina DM, Rivera L, Salinas B, Pavia-Ruz N, Salmeron J, Ruttimann R, Tinoco JC, Rubio P, Nunez E, Guerrero ML, Yarzabal JP, Damaso S, Tornieporth N, Saez-Llorens X, Vergara RF, Vesikari T, Bouckenooghe A, Clemens R, De Vos B, O'Ryan M; Human Rotavirus Vaccine Study Group. Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. N Engl J Med. 2006 Jan 5;354(1):11-22.

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 June 17, 2013