Trial reportVaccine2020
Immunogenicity and safety of the RTS,S/AS01 malaria vaccine co-administered with measles, rubella and yellow fever vaccines in Ghanaian children: A phase IIIb, multi-center, non-inferiority, randomized, open, controlled trial.
Trial report in Vaccine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02699099 (Immunogenicity and Safety Study of GSK Biologicals' Candidate Malaria Vaccine), which is not on this map. Cited by 8 papers, 1 of them a synthesis 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.
Immunogenicity and Safety Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Given at 6, 7.5 and 9 Months of Age in Co-administration With Measles, Rubella and Yellow Fever Vaccines Followed by a Booster of the Malaria Vaccine.
Who cites it
8 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.
- Duration of Protection After Vaccination Against Yellow Fever: A Systematic Review and Meta-Analysis.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022Pooled it
- Current Developments in Malaria Vaccination: A Concise Review on Implementation, Challenges, and Future Directions.Clinical pharmacology : advances and applications · 2025Review
- Malaria vaccine efficacy, safety, and community perception in Africa: a scoping review of recent empirical studies.Infection · 2024Article
- Acceptance, availability, and feasibility of RTS, S/AS01 malaria vaccine: A review.Immunity, inflammation and disease · 2023Review
- Systematic Review of Safety of RTS,S with AS01 and AS02 Adjuvant Systems Using Data from Randomized Controlled Trials in Infants, Children, and Adults.Clinical pharmacology : advances and applications · 2023Review
- Vaccine dilemma for children at risk: Recently approved malaria vaccine versus ongoing COVID-19 vaccination campaign.Annals of medicine and surgery (2012) · 2022Article
- RTS,S/AS01 malaria vaccine (MosquirixDrugs & therapy perspectives : for rational drug selection and use · 2022Review
- Advancements in protein nanoparticle vaccine platforms to combat infectious disease.Wiley interdisciplinary reviews. Nanomedicine and nanobiotechnology · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
27 authors at 4 institutions in 3 countries.
Funding
Abstract
backgroundTo optimize vaccine implementation visits for young children, it could be efficient to administer the first RTS,S/AS01 malaria vaccine dose during the Expanded Programme on Immunization (EPI) visit at 6 months of age together with Vitamin A supplementation and the third RTS,S/AS01 dose on the same day as yellow fever (YF), measles and rubella vaccines at 9 months of age. We evaluated the safety and immunogenicity of RTS,S/AS01 when co-administered with YF and combined measles-rubella (MR) vaccines.
methodsIn this phase 3b, open-label, controlled study (NCT02699099), 709 Ghanaian children were randomized (1:1:1) to receive RTS,S/AS01 at 6, 7.5 and 9 months of age, and YF and MR vaccines at 9 or 10.5 months of age (RTS,S coad and RTS,S alone groups, respectively). The third group received YF and MR vaccines at 9 months of age and will receive RTS,S/AS01 at 10.5, 11.5 and 12.5 months of age (Control group). All children received Vitamin A at 6 months of age. Non-inferiority of immune responses to the vaccine antigens was evaluated 1 month following co-administration versus RTS,S/AS01 or EPI vaccines (YF and MR vaccines) alone using pre-defined non-inferiority criteria. Safety was assessed until Study month 4.5.
resultsNon-inferiority of antibody responses to the anti-circumsporozoite and anti-hepatitis B virus surface antigens when RTS,S/AS01 was co-administered with YF and MR vaccines versus RTS,S/AS01 alone was demonstrated. Non-inferiority of antibody responses to the measles, rubella, and YF antigens when RTS,S/AS01 was co-administered with YF and MR vaccines versus YF and MR vaccines alone was demonstrated. The safety profile of all vaccines was clinically acceptable in all groups.
conclusionsRTS,S/AS01 can be co-administered with Vitamin A at 6 months and with YF and MR vaccines at 9 months of age during EPI visits, without immune response impairment to any vaccine antigen or negative safety effect.
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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.