We investigated immediate immunization pain in 12-month-old children randomized to receive a booster dose of either the 10- (PCV-10) or the 13-valent (PCV-13) pneumococcal conjugate vaccine. Pain was assessed using validated pain assessment tools and crying time. PCV-13 recipients had significantly higher scores on the observer-rated modified behavioral pain scale than did those receiving PCV-10, but the differences were small.
Clinical trial registration at Clinicaltrials.gov (NCT01443416)
Financial support: This work was sponsored by the University of Oxford and funded by the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre and GSK Biologicals. The Oxford Vaccine Group acknowledges the support of the National Institute for Health Research Clinical Research Network. J.T. was supported by an ESPID Fellowship Award. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. #8232;
Conflicts of interest: AJP has previously conducted studies on behalf of Oxford University funded by vaccine manufacturers, including the present study, but currently does not undertake industry funded clinical trials. AJP chairs the UK Department of Health’s (DH) Joint Committee on Vaccination and Immunisation (JCVI); the views expressed in this manuscript do not necessarily reflect the views of JCVI or DH. M.D.S. acts as chief or principal investigators for clinical trials conducted by the University of Oxford, sponsored by vaccine manufacturers, but receives no personal payments from them. M.D.S. has participated in advisory boards and industry sponsored symposia for vaccine manufacturers, but receives no personal payments for this work. M.D.S. and J.T. have received financial assistance from vaccine manufacturers to attend scientific conferences. The other authors have no conflicts of interest to disclose.
*Corresponding author: Johannes Trück MD, DPhil, Division of Immunology and the Children’s Research Center, University Children's Hospital, University of Zurich, Zurich, Switzerland; tel.: +41 44 266 7111; fax: +41 44 266 7311. E-mail: firstname.lastname@example.org
Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.