Trial reportMalaria journal2011
Statistical methodology for the evaluation of vaccine efficacy in a phase III multi-centre trial of the RTS, S/AS01 malaria vaccine in African children.
Trial report in Malaria journal, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00866619 (Efficacy of GSK Biologicals' Candidate Malaria Vaccine), which is not on this map. Cited by 18 papers.
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.
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.
Efficacy of GSK Biologicals' Candidate Malaria Vaccine (257049) Against Malaria Disease Caused by P. Falciparum Infection in Infants and Children in Africa
Who cites it
18 citing papers in PubMed.
- Sustained efficacy of the RTS,S/AS01The Lancet. Global health · 2025Trial
- Could Less Be More? Accounting for Fractional-Dose Regimens and Different Number of Vaccine Doses When Measuring the Impact of the RTS,S/AS01E Malaria Vaccine.The Journal of infectious diseases · 2024Trial
- Efficacy of RTS,S/AS01The Lancet. Infectious diseases · 2022Trial
- Efficacy of a Spatial Repellent for Control of Malaria in Indonesia: A Cluster-Randomized Controlled Trial.The American journal of tropical medicine and hygiene · 2020Trial
- Trial
- Safety profile of the RTS,S/AS01 malaria vaccine in infants and children: additional data from a phase III randomized controlled trial in sub-Saharan Africa.Human vaccines & immunotherapeutics · 2019Trial
- RTS,S/AS01 Malaria Vaccine Efficacy is Not Modified by Seasonal Precipitation: Results from a Phase 3 Randomized Controlled Trial in Malawi.Scientific reports · 2017Trial
- Potential public health impact of RTS,S malaria candidate vaccine in sub-Saharan Africa: a modelling study.Malaria journal · 2015Trial
- Immunogenicity of the RTS,S/AS01 malaria vaccine and implications for duration of vaccine efficacy: secondary analysis of data from a phase 3 randomised controlled trial.The Lancet. Infectious diseases · 2015Trial
- A phase 3 trial of RTS,S/AS01 malaria vaccine in African infants.The New England journal of medicine · 2012Trial
- Design of a phase III multicenter trial to evaluate the efficacy of the RTS,S/AS01 malaria vaccine in children across diverse transmission settings in Africa.Malaria journal · 2011Trial
- Effectiveness of a single COVID-19 mRNA vaccine dose in individuals with prior SARS-CoV-2 infection: a systematic review.Communications medicine · 2025Article
- Can incorporating genotyping data into efficacy estimators improve efficiency of early phase malaria vaccine trials?Malaria journal · 2023Article
- Ultrasensitive CRISPR-based diagnostic for field-applicable detection ofProceedings of the National Academy of Sciences of the United States of America · 2020Article
- [The RTS,S/AS01 malaria vaccine in children aged 5-17 months at first vaccination].The Pan African medical journal · 2018Review
- Implications of the licensure of a partially efficacious malaria vaccine on evaluating second-generation vaccines.BMC medicine · 2013Article
- A nonintegrative lentiviral vector-based vaccine provides long-term sterile protection against malaria.PloS one · 2012Article
- What is the efficacy of the RTS,S malaria vaccine?BMJ (Clinical research ed.) · 2011Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
backgroundThere has been much debate about the appropriate statistical methodology for the evaluation of malaria field studies and the challenges in interpreting data arising from these trials.
methodsThe present paper describes, for a pivotal phase III efficacy of the RTS, S/AS01 malaria vaccine, the methods of the statistical analysis and the rationale for their selection. The methods used to estimate efficacy of the primary course of vaccination, and of a booster dose, in preventing clinical episodes of uncomplicated and severe malaria, and to determine the duration of protection, are described. The interpretation of various measures of efficacy in terms of the potential public health impact of the vaccine is discussed.
conclusionsThe methodology selected to analyse the clinical trial must be scientifically sound, acceptable to regulatory authorities and meaningful to those responsible for malaria control and public health policy.
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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.