Clinical trial NCT00139347: Study of 2 Doses of HRV Vaccine Given Concomitantly With Routine EPI Vaccinations Including OPV in Healthy Infants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Rotavirus
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-08-31
Enrollment: 6360
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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.

Primary outcomes:
measure: 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:
measure: Vaccine efficacy against severe rotavirus gastroenteritis by serotypes until 1 year of age; Safety; Immunogenicity of HRV and co-administered EPI vaccines
Other outcomes:
Locations:
city: Colonia Caroya
country: Argentina
facility: GSK Investigational Site
state: Córdova
city: Rio Cuarto
country: Argentina
facility: GSK Investigational Site
state: Córdova
city: Tunuyan
country: Argentina
facility: GSK Investigational Site
state: Mendoza
city: Villanueva
country: Argentina
facility: GSK Investigational Site
state: Mendoza
city: Cordoba
country: Argentina
facility: GSK Investigational Site
city: Córdova
country: Argentina
facility: GSK Investigational Site
city: La Plata
country: Argentina
facility: GSK Investigational Site
city: Mendoza
country: Argentina
facility: GSK Investigational Site
city: Porto Alegre
country: Brazil
facility: GSK Investigational Site
state: Rio Grande Do Sul
city: Bogota
country: Colombia
facility: GSK Investigational Site
city: Cali Colombia
country: Colombia
facility: GSK Investigational Site
city: Cali
country: Colombia
facility: GSK Investigational Site
city: Santo Domingo, Distrito Nacional
country: Dominican Republic
facility: GSK Investigational Site
state: Sant Dom- Distrito Nacional
city: Santo Domingo
country: Dominican Republic
facility: GSK Investigational Site
city: Comayaguela
country: Honduras
facility: GSK Investigational Site
city: David
country: Panama
facility: GSK Investigational Site
state: Chiriquí
city: Panama
country: Panama
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.