Evaluation of different infant vaccination schedules incorporating pneumococcal vaccination (The Vietnam Pneumococcal Project): protocol of a randomised controlled trial

Abstract

Introduction: WHO recommends the use of pneumococcal conjugate vaccine (PCV) as a priority. However, there are many countries yet to introduce PCV, especially in Asia. This trial aims to evaluate different PCV schedules and to provide a head-to-head comparison of PCV10 and PCV13 in order to generate evidence to assist with decisions regarding PCV introduction. Schedules will be compared in relation to their immunogenicity and impact on nasopharyngeal carriage of Streptococcus pneumoniae and Haemophilus influenzae.

Methods and analysis: This randomised, single-blind controlled trial involves 1200 infants recruited at 2 months of age to one of six infant PCV schedules: PCV10 in a 3+1, 3+0, 2+1 or two-dose schedule; PCV13 in a 2+1 schedule; and controls that receive two doses of PCV10 and 18 and 24 months. An additional control group of 200 children is recruited at 18 months that receive one dose of PCV10 at 24 months. All participants are followed up until 24 months of age. The primary outcome is the post-primary series immunogenicity, expressed as the proportions of participants with serotype-specific antibody levels ≥0.35 µg/mL for each serotype in PCV10.

Ethics and dissemination: Ethical approval has been obtained from the Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research (EC00153) and the Vietnam Ministry of Health Ethics Committee. The results, interpretation and conclusions will be presented to parents and guardians, at national and international conferences, and published in peer-reviewed open access journals.

Trial registration number: NCT01953510; Pre-results.

Keywords: Clinical Trials; Epidemiology; Microbiology.

Conflict of interest statement

Competing interests: All authors receive salary support from grants from the National Health and Medical Research Council of Australia and/or the Bill and Melinda Gates Foundation. Non-financial support (in the form of PCV10 vaccine doses) and funding for opsonophagocytic assays are provided by GSK Biologicals SA. EKM is a member of the DSMB for a current Novavax trial, for which he receives consulting fees. He has received travel costs from the GSK group of companies for one international conference and an honorarium from Merck for one advisory group meeting. He does not have any paid consultancies with or receive any research funds from pharmaceutical companies. Members of CS’s team have received awards that were funded (but not assessed) by Pfizer. None of the authors have any other competing interests to declare.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.