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Last Updated: 04/05/2023

An evaluation of the cluster-randomised pilot implementation of RTS,S/AS01 through routine health systems in Ghana: A post-authorization observation study

Objectives

To evaluate the impact of RTS,S by collecting data to answer the following questions: 

  • What is the feasibility of administering 4 doses of RTS,S and what is its impact on uptake of other routine immunizations and use of other malaria control measures (Feasibility module)? 
  • Are there any safety signals that can be identified in the large administration of RTS,S (Safety module)? 
  • What is the impact of administration on all-cause mortality among children (Mortality modules)?
Rationale and Abstract

On 1st May 2019, the Consortium to Evaluate Mosquirix in Ghana (CEM-GH) coordinated by Kintampo Health Research Centre of Research and Development Division of Ghana Health Service in collaboration with the Ministry of Health/Ghana Health Service and World Health Organization (WHO) started the pilot evaluation of the RTS,S Malaria Vaccine in Ghana including a series of 3 household surveys, and sentinel hospital and community mortality surveillance, building on routine systems. The 31st day of December 2022, marked forty-four (44) months of active evaluation activities in six regions of Ghana (Ahafo, Bono, Bono East, Central, Volta and Oti regions).

Study Design

An observational evaluation of the pilot implementation of RTS,S/AS01 by the Ministry of Health/Ghana Health Service using a cluster-randomized design, with some areas (Districts) introducing RTS,S/AS01 malaria vaccine at the beginning of the programme (vaccinating areas) and other areas, initially without RTS,S/AS01, acting as comparison areas (non-vaccinating areas). Participants for study includes children living in the vaccinating and in non-vaccinating areas aged less than 5 years of age (Feasibility survey), who are hospitalized in 8 sentinel hospitals (sentinel hospital surveillance) and those whose deaths are reported in the vaccinating and in non-vaccinating areas (community mortality surveillance).

Date

Sep 2018 — Jun 2024

Total Project Funding

$5M

Project Site

Ghana
Kenya
Malawi

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