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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00139347
Other study ID # 444563/024
Secondary ID
Status Completed
Phase Phase 3
First received August 30, 2005
Last updated October 27, 2016
Start date December 2003
Est. completion date March 2007

Study information

Verified date October 2016
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 6360
Est. completion date March 2007
Est. primary completion date March 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Weeks to 12 Weeks
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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


Locations

Country Name City State
Argentina GSK Investigational Site Colonia Caroya Córdova
Argentina GSK Investigational Site Cordoba
Argentina GSK Investigational Site Córdova
Argentina GSK Investigational Site La Plata
Argentina GSK Investigational Site Mendoza
Argentina GSK Investigational Site Rio Cuarto Córdova
Argentina GSK Investigational Site Tunuyan Mendoza
Argentina GSK Investigational Site Villanueva Mendoza
Brazil GSK Investigational Site Porto Alegre Rio Grande Do Sul
Colombia GSK Investigational Site Bogota
Colombia GSK Investigational Site Cali
Colombia GSK Investigational Site Cali Colombia
Dominican Republic GSK Investigational Site Santo Domingo
Dominican Republic GSK Investigational Site Santo Domingo, Distrito Nacional Sant Dom- Distrito Nacional
Honduras GSK Investigational Site Comayaguela
Panama GSK Investigational Site David Chiriquí
Panama GSK Investigational Site Panama

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Argentina,  Brazil,  Colombia,  Dominican Republic,  Honduras,  Panama, 

References & Publications (4)

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.

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. doi: 10.1097/INF.0b013e3182138278. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Vaccine efficacy against severe rotavirus gastroenteritis by serotypes until 1 year of age; Safety; Immunogenicity of HRV and co-administered EPI vaccines
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