5 results on '"Hector Abate"'
Search Results
2. Correction: Efficacy of Pneumococcal Nontypable Haemophilus influenzae Protein D Conjugate Vaccine (PHiD-CV) in Young Latin American Children: A Double-Blind Randomized Controlled Trial.
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Miguel W Tregnaghi, Xavier Sáez-Llorens, Pio López, Hector Abate, Enrique Smith, Adriana Pósleman, Arlene Calvo, Digna Wong, Carlos Cortes-Barbosa, Ana Ceballos, Marcelo Tregnaghi, Alexandra Sierra, Mirna Rodriguez, Marisol Troitiño, Carlos Carabajal, Andrea Falaschi, Ana Leandro, Maria Mercedes Castrejón, Alejandro Lepetic, Patricia Lommel, William P Hausdorff, Dorota Borys, Javier Ruiz Guiñazú, Eduardo Ortega-Barría, Juan P Yarzábal, Lode Schuerman, and COMPAS Group
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Medicine - Published
- 2015
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3. Efficacy of pneumococcal nontypable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in young Latin American children: A double-blind randomized controlled trial.
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Miguel W Tregnaghi, Xavier Sáez-Llorens, Pio López, Hector Abate, Enrique Smith, Adriana Pósleman, Arlene Calvo, Digna Wong, Carlos Cortes-Barbosa, Ana Ceballos, Marcelo Tregnaghi, Alexandra Sierra, Mirna Rodriguez, Marisol Troitiño, Carlos Carabajal, Andrea Falaschi, Ana Leandro, Maria Mercedes Castrejón, Alejandro Lepetic, Patricia Lommel, William P Hausdorff, Dorota Borys, Javier Ruiz Guiñazú, Eduardo Ortega-Barría, Juan P Yarzábal, Lode Schuerman, and COMPAS Group
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Medicine - Abstract
The relationship between pneumococcal conjugate vaccine-induced antibody responses and protection against community-acquired pneumonia (CAP) and acute otitis media (AOM) is unclear. This study assessed the impact of the ten-valent pneumococcal nontypable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) on these end points. The primary objective was to demonstrate vaccine efficacy (VE) in a per-protocol analysis against likely bacterial CAP (B-CAP: radiologically confirmed CAP with alveolar consolidation/pleural effusion on chest X-ray, or non-alveolar infiltrates and C-reactive protein ≥ 40 µg/ml); other protocol-specified outcomes were also assessed.This phase III double-blind randomized controlled study was conducted between 28 June 2007 and 28 July 2011 in Argentine, Panamanian, and Colombian populations with good access to health care. Approximately 24,000 infants received PHiD-CV or hepatitis control vaccine (hepatitis B for primary vaccination, hepatitis A at booster) at 2, 4, 6, and 15-18 mo of age. Interim analysis of the primary end point was planned when 535 first B-CAP episodes, occurring ≥2 wk after dose 3, were identified in the per-protocol cohort. After a mean follow-up of 23 mo (PHiD-CV, n = 10,295; control, n = 10,201), per-protocol VE was 22.0% (95% CI: 7.7, 34.2; one-sided p = 0.002) against B-CAP (conclusive for primary objective) and 25.7% (95% CI: 8.4%, 39.6%) against World Health Organization-defined consolidated CAP. Intent-to-treat VE was 18.2% (95% CI: 5.5%, 29.1%) against B-CAP and 23.4% (95% CI: 8.8%, 35.7%) against consolidated CAP. End-of-study per-protocol analyses were performed after a mean follow-up of 28-30 mo for CAP and invasive pneumococcal disease (IPD) (PHiD-CV, n = 10,211; control, n = 10,140) and AOM (n = 3,010 and 2,979, respectively). Per-protocol VE was 16.1% (95% CI: -1.1%, 30.4%; one-sided p = 0.032) against clinically confirmed AOM, 67.1% (95% CI: 17.0%, 86.9%) against vaccine serotype clinically confirmed AOM, 100% (95% CI: 74.3%, 100%) against vaccine serotype IPD, and 65.0% (95% CI: 11.1%, 86.2%) against any IPD. Results were consistent between intent-to-treat and per-protocol analyses. Serious adverse events were reported for 21.5% (95% CI: 20.7%, 22.2%) and 22.6% (95% CI: 21.9%, 23.4%) of PHiD-CV and control recipients, respectively. There were 19 deaths (n = 11,798; 0.16%) in the PHiD-CV group and 26 deaths (n = 11,799; 0.22%) in the control group. A significant study limitation was the lower than expected number of captured AOM cases.Efficacy was demonstrated against a broad range of pneumococcal diseases commonly encountered in young children in clinical practice.www.ClinicalTrials.gov NCT00466947.
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- 2014
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4. A multi-country study of intussusception in children under 2 years of age in Latin America: analysis of prospective surveillance data
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Hector Abate, Guillermo Venegas V, Thomas Verstraeten, Yolanda Cervantes, Thomas Breuer, Eduardo Ortega-Barria, Alexandre da Costa Linhares, Ana L Jimenez, Pilar Rubio, Claire Newbern, Rodrigo Vergara, Ricardo Rüttimann, Maribel Rivera, Carlos Aranza, Ernesto Nuñez, Luis Rivera, Xavier Sáez-Llorens, Pio Lopez, Vesta Richardson, Felix Espinoza, Guillermo M Ruiz Palacios, Camilo J. Acosta, Mercedes Macias-Parra, and F. Raúl Velázquez
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Male ,Rotavirus ,medicine.medical_specialty ,Pediatrics ,Rotav?rus ,Cross-sectional study ,viruses ,Am?rica Latina / epidemiologia ,medicine.disease_cause ,Multi country ,Intussusception (medical disorder) ,Epidemiology ,medicine ,Humans ,Prospective Studies ,Prospective cohort study ,Vigil?ncia Epidemiol?gica ,Children ,Intussuscep??o / epidemiologia ,Lactente ,business.industry ,Incidence (epidemiology) ,Incidence ,Vaccination ,Rotavirus Vaccines ,Gastroenterology ,Infant ,virus diseases ,General Medicine ,medicine.disease ,Rotavirus vaccine ,Vacina??o ,Cross-Sectional Studies ,Latin America ,Child, Preschool ,Female ,business ,Intussusception ,Research Article - Abstract
Hospital del Ni?o. Infectious Disease Department. Ciudad de Panam?, Panama. Instituto Mexicano del Seguro Social. Medical Research Unit on Infectious Diseases. CMN-SXXI. Mexico City, Mexico. Centro de Estudios en Infectologia Pediatrica. Clinica Materno Infantil Los Farallones. Cali, Colombia. Universidad Nacional Aut?noma de Nicaragua. Edificio Central. Le?n, Nicaragua. Minist?rio da Sa?de. Secretaria de Vigil?ncia em Sa?de. Instituto Evandro Chagas. Ananindeua, PA, Brasil. Hospital Dr. Humberto Notti. Villa Nueva de Guaymall?n, Mendoza, Argentina Universidad de Concepci?n. Concepci?n, Chile. Universidad de Concepci?n. Concepci?n, Chile. Universidad de Valpara?so. Escuela de Medicina. Valpara?so, Chile. Hospital Nacional de Ni?os. Paseo Col?n, San Jos?, Costa Rica. Organizaci?n para el Desarrollo y la Investigaci?n Salud en Honduras. Colonia Humuya, Tegucigalpa, Honduras. Hospital General de Tlanepantla ?Valle Ceyl?n?. Tlanepantla, Mexico. Hospital Infantil de Mexico. Calle Dr. M?rquez . M?xico DF, Mexico / Ministry of Health. National Center for Child and Adolescent Health. Colonia Merced Gomez, Mexico DF, Mexico. Instituto Nacional de Pediatr?a. M?xico DF, Mexico. Instituto Nacional de Ciencias M?dicas y Nutrici?n Salvador Zubir?n. Mexico DF, Mexico. Hospital Maternidad Nuestra Sra de la Altagracia. Santo Domingo, DN, Rep?blica Dominicana. Fundaci?n para el Avance de la Investigaci?n Cl?nica y Translacional, Consultorios M?dicos Am?rica. V?a Espa?a, Carrasquilla, Panama / GlaxoSmithKline Vaccines. Clayton, Panama. GlaxoSmithKline Vaccines M?xico. M?xico DF, Mexico. GlaxoSmithKline Vaccines Argentina. Buenos Aires, Argentina / Independent Medical Professional. Buenos Aires, Argentina. GlaxoSmithKline Vaccines Costa Rica. San Jose, Costa Rica / GlaxoSmithKline Vaccines. Ciudad del Saber, Clayton, Panama. GlaxoSmithKline Vaccines. Philadelphia, USA / Merck & Co., Global Health Outcomes Vaccines. Philadelphia, PA, USA. GlaxoSmithKline Vaccines. Rixensart, Belgium / Philadelphia Department of Public Health. Philadelphia, USA. GlaxoSmithKline Vaccines. Rixensart, Belgium / P95 Excellence in Pharmacovigilance and Epidemiology, Leuven, Belgium. GlaxoSmithKline Vaccines. Rixensart, Belgium / GlaxoSmithKline Vaccines, Parc de la Noire Epine. Wavre, Belgium. Background: Intussusception (IS) is a form of acute intestinal obstruction that occurs mainly in infants and is usually of unknown cause. An association between IS and the first licensed rotavirus vaccine, a reassortanttetravalent, rhesus-based rotavirus vaccine (RRV-TV), led to the withdrawal of the vaccine. New rotavirus vaccines have now been developed and extensively studied for their potential association with IS. This study aimed to describe the epidemiology and to estimate the incidence of IS in Latin American infants prior to new vaccine introduction. Methods: Children under 2 years of age representing potential IS cases were enrolled in 16 centers in 11 Latin American countries from January 2003 to May 2005. IS cases were classified as definite, probable, possible or suspected as stated on the Brighton Collaboration Working Group guidelines. Results: From 517 potential cases identified, 476 (92 per cent) cases were classified as definite, 21 probable, 10 possible and 10 suspected for intussusception. Among the 476 definite IS cases, the median age at presentation was 6.4 months with 89 per cent of cases aged 1 year. The male to female ratio was 1.5:1. The incidence of definite IS per 100,000 subject-years ranged from 1.9 in Brazil to 62.4 in Argentina for children 2 years of age, and from 3.8 in Brazil to 105.3 in Argentina for children aged 1 year. Median hospital stay was 4 days with a high prevalence of surgery as the primary treatment (65 per cent). Most cases (88 per cent) made a complete recovery, but 13 (3 per cent) died. No clear seasonal pattern of IS cases emerged. Conclusions: This study describes the epidemiology and estimates the incidence of IS in Latin American infants prior to the introduction of new rotavirus vaccines. The incidence of IS was found to vary between different countries, as observed in previous studies.
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5. Oral Human Rotavirus Vaccine RIX4414(Rotarix™) Co-administered with Routine EPI Vaccinations Including Oral Polio Vaccine(OPV) Is Highly Efficacious in Latin-America
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Alejandra Valencia, Pio Lopez, Hector Abate, J.M. Casellas, S.A. Gonzalez, Luis Rivera, P.V. Suryakiran, Igor Smolenov, D.M. Rivera-Medina, H.H. Han, Miguel Tregnaghi, T. De Leon, Themis Reverbel da Silveira, and Eduardo Ortega-Barria
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Vaccination ,Microbiology (medical) ,Latin Americans ,Infectious Diseases ,business.industry ,Human rotavirus ,Medicine ,Oral polio vaccine ,General Medicine ,business ,Virology - Full Text
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