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

Infections, Rotavirus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00139347
• Other study ID #: 444563/024
• 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

• Infections, Rotavirus
• Rotavirus Infections

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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