Evidence map›Paper›PMID 35468801›Full record

ArticleMalaria journal2022

Assessing the safety, impact and effectiveness of RTS,S/AS01

Nicolas Praet, Kwaku Poku Asante, Marie-Cecile Bozonnat, Elaine Jacqueline Akité, Patrick Odum Ansah, Laurence Baril, Owusu Boahen, Yolanda Guerra Mendoza, Valerie Haine, Simon Kariuki and 18 more

3 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Malaria journal, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
5.5field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02251704 phase4completednot on this map

An Epidemiology Study to Assess Plasmodium Falciparum Parasite Prevalence and Malaria Control Measures in Catchment Areas of Two Interventional Studies Pre- and Post RTS,S/AS01E Introduction (EPI MAL-002 and EPI-MAL-003) to Assess, in Field Conditions, Vaccine Benefit: Risk in Children in Sub Saharan Africa

TypeinterventionalSponsorGlaxoSmithKlineRan2014 to 2024Enrolled54,115ConditionsMalaria, Malaria VaccinesArmsAssessment of body temperature, Blood sampling
NCT02374450 completednot on this map

A Prospective Study to Estimate the Incidence of Diseases Specified as Adverse Events of Special Interest, of Other Adverse Events Leading to Hospitalisation or Death, and of Meningitis in Infants and Young Children in Sub-Saharan Africa Prior to Implementation of the RTS,S/AS01E Candidate Vaccine

TypeobservationalSponsorGlaxoSmithKlineRan2015 to 2022Enrolled36,366ConditionsMalariaArmsBlood collection
NCT03855995 completednot on this map

A Prospective Study to Evaluate the Safety, Effectiveness and Impact of the RTS, S/AS01E Vaccine in Young Children in Sub-Saharan Africa

TypeobservationalSponsorGlaxoSmithKlineRan2019 to 2025Enrolled77,953ConditionsMalaria, Malaria VaccinesArmsWhole blood sample
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 41 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
  7. Frontiers in cellular and infection microbiology · 2024
    Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

28 authors at 9 institutions in 6 countries.

Nicolas PraetGSK, Wavre, Belgium. npraet9@gmail.com.
Kwaku Poku AsanteKintampo Health Research Centre, Research and Development Division, Ghana Health Service, Kintampo North Municipality, Kintampo, Ghana.
Marie-Cecile BozonnatClinics C/O GSK, Wavre, Belgium.
Elaine Jacqueline AkitéGSK, Wavre, Belgium.
Patrick Odum AnsahNavrongo Health Research Centre, Research and Development Division, Ghana Health Service, Navrongo, Ghana.
Laurence BarilInstitut Pasteur, Phnom Penh, Cambodia.
Owusu BoahenKintampo Health Research Centre, Research and Development Division, Ghana Health Service, Kintampo North Municipality, Kintampo, Ghana.
Yolanda Guerra MendozaGSK, Wavre, Belgium.
Valerie HaineGSK, Wavre, Belgium.
Simon KariukiKenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya.
Mathieu LamyAixial C/O GSK, Wavre, Belgium.
Kenneth MaletaUniversity of Malawi College of Medicine, Mangochi, Malawi.
Randy MungwiraUniversity of Malawi College of Medicine, Mangochi, Malawi.
Latif NdeketaMalawi Liverpool Wellcome Trust Clinical Research Programme, Kamuzu University of Health Sciences, Blantyre, Malawi.
Abraham OduroNavrongo Health Research Centre, Research and Development Division, Ghana Health Service, Navrongo, Ghana.
Bernhards OgutuCentre for Research in Therapeutic Sciences (CREATES), Strathmore University, Nairobi, Kenya.
Fredrick OleweCentre for Research in Therapeutic Sciences (CREATES), Strathmore University, Nairobi, Kenya.
Martina OnekoKenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya.
Mattéa OrsiniClinics C/O GSK, Wavre, Belgium.
Francois RomanGSK, Wavre, Belgium.
Edith Roset BahmanyarHQ Global Clinical, Organon International GmbH, Luzern, Switzerland.
Dominique RosillonGSK, Wavre, Belgium.
Lode SchuermanGSK, Wavre, Belgium.
Valentine Sing'oeiKEMRI-Walter Reed Project, US Army Medical Research Directorate-Kenya, Kombewa, Kenya.
Dianne J TerlouwMalawi Liverpool Wellcome Trust Clinical Research Programme, Kamuzu University of Health Sciences, Blantyre, Malawi.
Stéphanie WéryGSK, Wavre, Belgium.
Walter OtienoKEMRI-Walter Reed Project, US Army Medical Research Directorate-Kenya, Kombewa, Kenya.
Jean-Yves PirçonGSK, Wavre, Belgium.
GlaxoSmithKline (Belgium) · BEKenya Medical Research Institute · KEGhana Health Service · GHUniversity of Liverpool · GBUniversity of Malawi · MWInstitut Pasteur du Cambodge · KHKintampo Health Research Centre · GHStrathmore University · KEUnited States Army Medical Research Directorate - Africa · KE

Funding

Wellcome Trust
6 · The paper itself

Abstract

backgroundFollowing a 30-year development process, RTS,S/AS01

methodsEPI-MAL-002 (NCT02374450) is a pre-implementation safety surveillance study that is establishing the background incidence rates of protocol-defined adverse events of special interest. EPI-MAL-003 (NCT03855995) is an identically designed post-implementation safety and vaccine impact study. EPI-MAL-005 (NCT02251704) is a cross-sectional pre- and post-implementation study to measure malaria transmission intensity and monitor the use of other malaria control interventions in the study areas, and EPI-MAL-010 (EUPAS42948) will evaluate the P. falciparum genetic diversity in the periods before and after vaccine implementation.

conclusionGSK's post-approval plan has been designed to address important knowledge gaps in RTS,S/AS01

Indexed as

MalariaMalaria, FalciparumMalaria VaccinesChildCross-Sectional StudiesHumansInfantKenyaPlasmodium falciparumMalaria VaccinesEffectivenessImpactMalariaPlasmodium falciparumProtocolRTS,S/AS01ESafety

Identifiers

PMID35468801
PMCPMC9036501
OpenAlexW4224863926

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.