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

NCT00139347 | Completed Phase 3

• 1 other identifier: 444563/024
• Study Type: interventional
• Target: 6,360
• Locations: 6 countries
• Sites: 17

Brief Summary

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.

Conditions

Infections, Rotavirus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

Interventions

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

Eligibility Criteria

• Age: 6 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy infants 6 -12 weeks old at Dose 1 with written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (17)

GSK Investigational Site

Colonia Caroya, Córdoba Province, X5223CDT, Argentina

Location

GSK Investigational Site

Córdoba, Córdoba Province, 5016, Argentina

Location

GSK Investigational Site

Río Cuarto, Córdoba Province, 5800, Argentina

Location

GSK Investigational Site

Mendoza, Mendoza Province, 5500, Argentina

Location

GSK Investigational Site

Tunuyán, Mendoza Province, 5560, Argentina

Location

GSK Investigational Site

Villanueva, Mendoza Province, 5521, Argentina

Location

GSK Investigational Site

Córdoba, 5000, Argentina

Location

GSK Investigational Site

La Plata, 1900, Argentina

Location

GSK Investigational Site

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

GSK Investigational Site

Bogotá, 805, Colombia

Location

GSK Investigational Site

Cali, Colombia

Location

GSK Investigational Site

Cali Colombia, Colombia

Location

GSK Investigational Site

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

Location

GSK Investigational Site

Santo Domingo, Dominican Republic

Location

GSK Investigational Site

Comayagüela, Honduras

Location

GSK Investigational Site

David, Chiriquí Province, Panamá 937, David, Panama

Location

GSK Investigational Site

Panama City, Panama

Location

Related Publications (5)

• 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.

  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.

  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.

  PMID: 21378594 BACKGROUND

• 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.

  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.

  PMID: 16394298 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Rotavirus Infections

Condition Hierarchy (Ancestors)

Reoviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2005
• First Posted: August 31, 2005
• Study Start: December 1, 2003
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: October 28, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

AR (8); PA (2); DO (2); BR (1); CO (3); HO (1)