Miguel Tregnaghi|Xavier Sáez?Llorens|Pío López|Héctor Abate|Enrique Smith|Adriana Pósleman|Arlene Calvo|Digna Wong|Carlos Cortes-Barbosa|Ana Ceballos|Marcelo Tregnaghi|Alexandra Sierra|Mirna Rodríguez|Marisol Troitiño|Carlos Carabajal|Andrea Falaschi|Ana Leandro|MARÍA MERCEDES CASTREJÓN|Alejandro Lepetic|Patricia Lommel|William P. Hausdorff|Dorota Borys|Javier Ruiz Guiñazú|Eduardo Ortega?Barría|Juan Pablo Yarzábal|Lode Schuerman
Efficacy of Pneumococcal Nontypable Haemophilus influenzae Protein D Conjugate Vaccine (PHiD-CV) in Young Latin American Children: A Double-Blind Randomized Controlled Trial
Hospital del Niño|Asociación Colombiana de Infectología|University of Mendoza|Instituto de Investigaciones Científicas y Servicios de Alta Tecnología|Asociación Colombiana de Infectología|Asociación Colombiana de Infectología|Instituto de Investigaciones Científicas y Servicios de Alta Tecnología|University of Mendoza|Hospital del Niño|GlaxoSmithKline (Belgium)|GlaxoSmithKline (Belgium)|GlaxoSmithKline (Belgium)|GlaxoSmithKline (Belgium)|GlaxoSmithKline (Belgium)|GlaxoSmithKline (Belgium)
relationship pneumococcal conjugate vaccineinduced antibody responses protection communityacquired pneumonia cap acute otitis media aom unclear study assessed impact tenvalent pneumococcal nontypable haemophilus influenzae protein conjugate vaccine phidcv end points primary objective demonstrate vaccine efficacy perprotocol analysis likely bacterial cap bcap radiologically confirmed cap alveolar consolidationpleural effusion chest xray nonalveolar infiltrates creactive protein 40 gml protocolspecified outcomes also assessedthis phase iii doubleblind randomized controlled study conducted 28 june 2007 28 july 2011 argentine panamanian colombian populations good access health care approximately 24000 infants received phidcv hepatitis control vaccine hepatitis b primary vaccination hepatitis booster 2 4 6 1518 mo age interim analysis primary end point planned 535 first bcap episodes occurring 2 wk dose 3 identified perprotocol cohort mean followup 23 mo phidcv n 10295 control n 10201 perprotocol 220 95 ci 77 342 onesided p 0002 bcap conclusive primary objective 257 95 ci 84 396 world health organizationdefined consolidated cap intenttotreat 182 95 ci 55 291 bcap 234 95 ci 88 357 consolidated cap endofstudy perprotocol analyses performed mean followup 2830 mo cap invasive pneumococcal disease ipd phidcv n 10211 control n 10140 aom n 3010 2979 respectively perprotocol 161 95 ci 11 304 onesided p 0032 clinically confirmed aom 671 95 ci 170 869 vaccine serotype clinically confirmed aom 100 95 ci 743 100 vaccine serotype ipd 650 95 ci 111 862 ipd results consistent intenttotreat perprotocol analyses serious adverse events reported 215 95 ci 207 222 226 95 ci 219 234 phidcv control recipients respectively 19 deaths n 11798 016 phidcv group 26 deaths n 11799 022 control group significant study limitation lower expected number captured aom casesefficacy demonstrated broad range pneumococcal diseases commonly encountered young children clinical practicewwwclinicaltrialsgov nct00466947