Trial reportThe Lancet. Global health2025
Sustained efficacy of the RTS,S/AS01
Trial report in The Lancet. Global health, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03276962 (Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled 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.
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, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or With-out Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of Age
Who cites it
2 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Transplacental transfer of anti-malarial antibodies: a systematic review.Frontiers in immunology · 2026Pooled it
- Evaluating the effectiveness of insecticide-treated net use in preventing malaria among children under five: a quasi-experimental study.Tropical medicine and health · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
24 authors.
Funding
Abstract
backgroundWe conducted a phase 2b trial evaluating fractional-dose and full-dose regimens of the RTS,S/AS01
methodsThis open-label, randomised controlled trial was conducted at two research centres in Agogo (Ghana) and Siaya County (Kenya) between Sept 28, 2017, and Nov 14, 2022. Children aged 5-17 months were randomly assigned (1:1:1:1:1) to one of five groups to receive rabies vaccine (the control group) at months 0, 1, and 2; or full doses of RTS,S at months 0, 1, and 2, followed by either full doses (R) at month 20 (group R012-20) or months 14, 26, and 38 (R012-14-26-38); or full doses at months 0 and 1, followed by fractional doses (Fx; one-fifth of full dose) at months 2, 14, 26, and 38 (Fx012-14-26-38) or months 7, 20, and 32 (Fx017-20-32). We present results of secondary objectives, evaluating vaccine efficacy, impact, immunogenicity, and harms up to month 50. Endpoints were the occurrence of clinical malaria meeting the primary and secondary case definitions and antibody responses at predefined timepoints, and the occurrence of solicited adverse events within 7 days from vaccination and serious adverse events and adverse events of special interest up to study end. This trial is registered at ClinicalTrials.gov (NCT03276962) and is complete.
findingsBetween Sept 28, 2017, and Sept 25, 2018, 2157 children were enrolled, of whom 1609 were randomly assigned (322 to each RTS,S group and 321 to the control group). Of these 1609 children, 1500 received at least one study vaccine dose (exposed set), and 1333 were included in the per-protocol set for efficacy. Among children in the exposed set, to month 50, vaccine efficacy against all episodes of clinical malaria was 36% (95% CI 19-50), 51% (37-61), 43% (28-55), and 41% (26-53) in groups R012-20, R012-14-26-38, Fx012-14-26-38, and Fx017-20-32, respectively (p<0·001 for all). The numbers of cases averted per 1000 RTS,S full-dose equivalents were 353 (R012-20 group), 544 (R012-14-26-38 group), 1151 (Fx012-14-26-38 group), and 1134 (Fx017-20-32 group). Vaccine efficacy and impact and immune responses were maintained over 50 months of follow-up in groups who received additional vaccine doses after the fourth dose. The vaccine was well tolerated; only five serious adverse events were considered to be related to vaccination. There were no deaths considered to be related to vaccination.
interpretationAll RTS,S regimens provided substantial protection against clinical malaria, with additional yearly doses maintaining vaccine efficacy and impact up to 50 months. Using fractional-dose regimens could increase the availability of RTS,S and reduce vaccination cost.
fundingGSK; PATH (through the Bill & Melinda Gates Foundation and the German Federal Ministry of Education and Research).
Indexed as
Identifiers
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.