Trial reportHuman vaccines & immunotherapeutics2019
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.
Trial report in Human vaccines & immunotherapeutics, 2019. 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 35 papers, 2 of them syntheses that pooled it.
What it found
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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
35 citing papers in PubMed, 2 syntheses or guidelines pooled it, 66 citations in OpenAlex.
- A systematic review on malaria and Tuberculosis (TB) vaccine challenges in sub-Saharan African clinical trials.PloS one · 2025Pooled it
- Pooled it
- Efficacy of RTS,S/AS01The Lancet. Infectious diseases · 2022Trial
- Safety and immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in children in Sierra Leone: a randomised, double-blind, controlled trial.The Lancet. Infectious diseases · 2022Trial
- Efficacy of a low-dose candidate malaria vaccine, R21 in adjuvant Matrix-M, with seasonal administration to children in Burkina Faso: a randomised controlled trial.Lancet (London, England) · 2021Trial
- Trial
- Trial
- Article
- Estimating the impact of the RTS,S/AS01 malaria vaccine in Benin: A mathematical modelling study.PLOS global public health · 2026Article
- Knowledge, attitudes and factors associated with the awareness of caregivers of under-five children regarding the malaria vaccine in the Tiko Health District, Cameroon: A community-based cross-sectional study.PLOS global public health · 2026Article
- Malaria vaccines: Current developments and immunological insights.New microbes and new infections · 2025Article
- Emerging Molecular Mechanisms in Malaria Pathogenesis and Novel Therapeutic Approaches: A Focus onBiomolecules · 2025Review
- Malaria Vaccines and Global Equity: A Scoping Review of Current Progress and Future Directions.Biomedicines · 2025Review
- Current Developments in Malaria Vaccination: A Concise Review on Implementation, Challenges, and Future Directions.Clinical pharmacology : advances and applications · 2025Review
- Safety of RTS,S/AS01E vaccine for malaria in African children aged 5 to 17 months: A systematic review and meta-analysis of randomized controlled trials.PLOS global public health · 2025Article
- Malaria vaccine efficacy, safety, and community perception in Africa: a scoping review of recent empirical studies.Infection · 2024Article
- Protein Structure Predictions, Atomic Model Building, and Validation Using a Cryo-EM Density Map from Hepatitis B Virus Spherical Subviral Particle.Bio-protocol · 2023Article
- Acceptance, availability, and feasibility of RTS, S/AS01 malaria vaccine: A review.Immunity, inflammation and disease · 2023Review
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- Current advances in nanodrug delivery systems for malaria prevention and treatment.Discover nano · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
41 authors at 13 institutions in 12 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
A phase III, double-blind, randomized, controlled trial (NCT00866619) in sub-Saharan Africa showed RTS,S/AS01 vaccine efficacy against malaria. We now present in-depth safety results from this study. 8922 children (enrolled at 5-17 months) and 6537 infants (enrolled at 6-12 weeks) were 1:1:1-randomized to receive 4 doses of RTS,S/AS01 (R3R) or non-malaria control vaccine (C3C), or 3 RTS,S/AS01 doses plus control (R3C). Aggregate safety data were reviewed by a multi-functional team. Severe malaria with Blantyre Coma Score ≤2 (cerebral malaria [CM]) and gender-specific mortality were assessed
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What OpenQuestion holds
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.