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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Pneumococcal vaccine schedules (PVS) study: a cluster-randomised, non-inferiority trial of an alternative versus standard schedule for pneumococcal conjugate vaccination—statistical analysis plan
Trials, Volume 23, No. 1, Article 1058, Year 2022
Notification
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Description
Rationale: The effectiveness of universal immunisation with pneumococcal conjugate vaccine (PCV) has been evident in many countries. However, the global impact of PCV is limited by its cost, which has prevented its introduction in several countries. Reducing the cost of PCV programmes may facilitate vaccine introduction in some countries and improve the sustainability of PCV in EPIs in low-income countries when they transition away from subsidised vaccine supply. Methods and design: PVS is a real-world field trial of an alternative schedule of one dose of PCV scheduled at age 6 weeks with a booster dose at age 9 months (i.e. the alternative ‘1+1’ schedule) compared to the standard schedule of three primary doses scheduled at 6, 10, and 14 weeks of age (i.e. the standard ‘3+0’ schedule). Delivery of the interventions began in late 2019 in 68 geographic clusters and will continue for 4 years. The primary endpoint is the prevalence of nasopharyngeal vaccine-type pneumococcal carriage in children aged 2–260 weeks with clinical pneumonia in year 4. Secondary endpoints are the prevalence of vaccine-type pneumococcal carriage among all ages in year 4 and the incidence of radiological pneumonia in children enrolled to receive the interventions. Additional disease and carriage endpoints are included. Purpose: This statistical analysis plan (SAP) describes the cohorts and populations, and follow-up criteria, to be used in different analyses. The SAP defines the endpoints and describes how adherence to the interventions will be presented. We describe how analyses will account for the effect of clustering and stratified randomisation. The SAP defines the approach to non-inferiority and other analyses. Defining the SAP early in the trial will avoid bias in analyses that may arise from prior knowledge of trial findings. © 2022, The Author(s).
Available Materials
https://efashare.b-cdn.net/share/pmc/articles/PMC9798555/bin/13063_2022_6900_MOESM1_ESM.docx
Authors & Co-Authors
MacKenzie, Grant Austin
United Kingdom, London
London School of Hygiene & Tropical Medicine
Australia, Melbourne
Murdoch Children's Research Institute
Australia, Melbourne
University of Melbourne
Palmu, Arto A.I.
Finland, Helsinki
Terveyden ja Hyvinvoinnin Laitos
Jokinen, Jukka T.
Finland, Helsinki
Terveyden ja Hyvinvoinnin Laitos
Osei, Isaac
United Kingdom, London
London School of Hygiene & Tropical Medicine
Flasche, Stefan
United Kingdom, London
London School of Hygiene & Tropical Medicine
Greenwood, Brian M.
United Kingdom, London
London School of Hygiene & Tropical Medicine
Mulholland, Kim
Australia, Melbourne
Murdoch Children's Research Institute
Australia, Melbourne
University of Melbourne
United Kingdom, London
London School of Hygiene & Tropical Medicine
Nguyen, Cattram Duong
Australia, Melbourne
Murdoch Children's Research Institute
Statistics
Citations: 2
Authors: 8
Affiliations: 4
Identifiers
Doi:
10.1186/s13063-022-06900-x
ISSN:
17456215
Research Areas
Maternal And Child Health
Study Design
Cross Sectional Study
Cohort Study
Study Approach
Quantitative