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

NCT ID: NCT00139347

Last Updated: 2016-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

6360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2007-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Infections, Rotavirus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

6 Weeks

Maximum Eligible Age

12 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Colonia Caroya, Córdoba Province, Argentina

Site Status

GSK Investigational Site

Córdoba, Córdoba Province, Argentina

Site Status

GSK Investigational Site

Río Cuarto, Córdoba Province, Argentina

Site Status

GSK Investigational Site

Mendoza, Mendoza Province, Argentina

Site Status

GSK Investigational Site

Tunuyán, Mendoza Province, Argentina

Site Status

GSK Investigational Site

Villanueva, Mendoza Province, Argentina

Site Status

GSK Investigational Site

Córdoba, , Argentina

Site Status

GSK Investigational Site

La Plata, , Argentina

Site Status

GSK Investigational Site

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

GSK Investigational Site

Bogotá, , Colombia

Site Status

GSK Investigational Site

Cali, , Colombia

Site Status

GSK Investigational Site

Cali Colombia, , Colombia

Site Status

GSK Investigational Site

Santo Domingo, Distrito Nacional, Sant Dom- Distrito Nacional, Dominican Republic

Site Status

GSK Investigational Site

Santo Domingo, , Dominican Republic

Site Status

GSK Investigational Site

Comayagüela, , Honduras

Site Status

GSK Investigational Site

David, Chiriquí Province, Panama

Site Status

GSK Investigational Site

Panama City, , Panama

Site Status

Countries

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Argentina Brazil Colombia Dominican Republic Honduras Panama

References

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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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

Tregnaghi MW, Abate HJ, Valencia A, Lopez P, Da Silveira TR, Rivera L, Rivera Medina DM, Saez-Llorens X, Gonzalez Ayala SE, De Leon 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. doi: 10.1097/INF.0b013e3182138278.

Reference Type BACKGROUND
PMID: 21378594 (View on PubMed)

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.

Reference Type BACKGROUND

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. doi: 10.1056/NEJMoa052434.

Reference Type DERIVED
PMID: 16394298 (View on PubMed)

Study Documents

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Document Type: Individual Participant Data Set

View Document

Document Type: Study Protocol

View Document

Document Type: Clinical Study Report

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Document Type: Dataset Specification

View Document

Document Type: Annotated Case Report Form

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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444563/024

Identifier Type: -

Identifier Source: org_study_id