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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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| Authors: | 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 Troiti?o Carlos Carabajal Andrea Falaschi Ana Leandro Maria Mercedes Castrejón Alejandro Lepetic Patricia Lommel William P Hausdorff Dorota Borys Javier Ruiz Gui?azú Eduardo Ortega-Barría Juan P Yarzábal Lode Schuerman on behalf of the COMPAS Group |
| Institution: | 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 Troiti?o,Carlos Carabajal,Andrea Falaschi,Ana Leandro,Maria Mercedes Castrejón,Alejandro Lepetic,Patricia Lommel,William P. Hausdorff,Dorota Borys,Javier Ruiz Gui?azú, Eduardo Ortega-Barría,Juan P. Yarzábal,Lode Schuerman,on behalf of the COMPAS Group |
| Abstract: | BackgroundThe 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.ConclusionsEfficacy was demonstrated against a broad range of pneumococcal diseases commonly encountered in young children in clinical practice.Trial registrationwww.ClinicalTrials.gov NCT00466947Please see later in the article for the Editors'' Summary |
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