Conflicts of interest
J. C. Salazar is a consultant for Boehringer Ingelheim, Merck and Pfizer. He is also a speaker for the Merck vaccine division. Neither Dr Salazar nor any member of his immediate family has any individual stock or financial interest in any pharmaceutical companies.
P. Cahn has no conflict of interests.
R. Yogev has no conflict of interests.
M. Della Negra is not a shareholder of any pharmaceutical industry. She has been a temporary consultant for Abbott and receives funding through clinical research contracts with Boehringer Ingelheim.
G. Castelli-Gattinara has no conflict of interests.
C. Fortuny is not a shareholder of any company. She has been a consultant to GlaxoSmithKline and Gilead. She also served as speaker for Abbott, Boehringer Ingelheim, Roche, Bristol-Myers-Squibb and Gilead.
P. Flynn has clinical trial agreements with MedImmune and Tibotec Pharmaceuticals.
C. Giaquinto is a consultant and speaker for GlaxoSmithKline, Abbott, Tibotec, Boehringer Ingelheim, Pfizer, Sanofi Pasteur. He has received funding for research from GlaxoSmithKline, Abbott, BMS, Tibotec, Gilead, Boehringer Ingelheim, Pfizer, Sanofi Pasteur.
P. Ruan has no conflict of interests.
J. Mikl and A. Jelaska are employees of Boehringer Ingelheim.
Grant Support: The PACTG/IMPAACT was supported by Grant Number U01AI068632 and 1U01AI068616 from the National Institute of Allergy and Infectious Diseases. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Allergy and Infectious Diseases or the National Institutes of Health. Juan C. Salazar also had support from the University of Connecticut Health Center′s Clinical Research Center Grant M01RR06192 and R. Yogev from PACTG 2# 5U01AI069512
All authors contributed to the acquisition of data and interpretation, drafting of the manuscript and approval of the version submitted for publication. Statistical analysis was provided by Boehringer Ingelheim.
The authors would like to acknowledge all investigators who participated in the BI 1182.14 trial: Argentina: Pedro Cahn, MD, Fundación Huésped, Buenos Aires; Brazil: Marinella Della Negra, MD, Instituto de Infectologia Hospital Emílio Ribas, Sao Paulo, Maria Zilda de Aquino, MD, PhD, Faculdade de Medicina da Universidade de São Paulo, Sao Paulo; Canada: Normand Lapointe, MD, Hopital Ste-Justine, Montreal, Quebec, Stanley Read, MD, Hospital for Sick Children, Toronto; France: Francoise Mechinaud, MD, Hopital Mere-Enfant, Nantes, Albert Faye, MD, Hopital Robert Debre, Paris, Daniel Floret, MD, Hopital Edouard Herriot, Lyon; Germany: Richard Kreuz, MD, Universitaet Frankfurt, Frankfurt, Gundula Notheis, MD, Klinikum Innenstadt der LMU, Munich, Ilse Grosch-Worner, MD, Cornelia Feiterna-Sperling, MD, Virchow Klinik, Berlin; Italy: Guido Castelli-Gattinara, MD, Ospedale Pediatrica Bambino Gesu, Roma, Carlo Giaquinto, MD, Azienda Ospedaliera di Padova, Padova; Mexico: Luis Xochihua, MD, Instituto Nacional Pediatria, Mexico; Spain: Claudia Fortuny, MD, Hospital San Juan de Dios, Esplugues de Llobregat, Jose-Thomas Ramos, MD, Hospital 12 de Octubre, Madrid; United States: Patricia M. Flynn, MD, St. Jude′s Children′s Research Hospital, Memphis, TN (PACTG/IMPAACT), Katherine Ruiz Luzuriaga, MD, UMass Memorial Medical Center, North Worcester, MA (PACTG/IMPAACT), Ram Yogev, MD, Children′s Memorial Hospital, Chicago, IL (PACTG/IMPAACT), Juan Salazar, MD, Connecticut Children′s Medical Center, Hartford, CT (PACTG/IMPAACT), Eleanor Jimenez, MD, FAAP, San Juan Hospital, San Juan, PR (PACTG/IMPAACT), Grace McComsey, MD, Rainbow Babies and Children′s Hospital, Cleveland, OH, Andrea Kovacs, MD, LaShonda Spencer, MD, LAC + USC Medical Center, Los Angeles, CA (PACTG/IMPAACT), William T. Shearer, MD, Texas Children′s Hospital, Houston, TX (PACTG/IMPAACT), Barbara W. Stechenberg, MD, Baystate Medical Center, Springfield, MA (PACTG/IMPAACT), Joseph Church, MD, Children′s Hospital of Los Angeles, Los Angeles, CA
The PACTG/IMPAACT team would like to thank Jennifer Gardella for her administrative and management support of the study.
Boehringer Ingelheim Pharmaceuticals provided funding for editorial assistance. Editorial assistance was provided by Euro RSCG Life UK.