Observational studyBMJ open2016
Effect of the adjuvanted (AS03) A/H1N1 2009 pandemic influenza vaccine on the risk of rejection in solid organ transplant recipients in England: a self-controlled case series.
Observational study in BMJ open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01715792 (Risk of Solid Organ Transplant Rejection Following Vaccination With Pandemrix™ in the United Kingdom), which is not on this map. Cited by 11 papers.
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.
Risk of Solid Organ Transplant Rejection Following Vaccination With Pandemrix™ in the United Kingdom
Who cites it
11 citing papers in PubMed.
- Post vaccination acute kidney injury and other renal complications after COVID-19 and influenza vaccination.World journal of nephrology · 2026Article
- Safety and Efficacy of Influenza Vaccination in Kidney Graft Recipients in Late Period After Kidney Transplantation.Vaccines · 2025Article
- Transplantation programs facing lack of empirical evidence on SARS-CoV-2 vaccination: A society recommendation consensus update.Transplant infectious disease : an official journal of the Transplantation Society · 2021Article
- All-Cause Hospitalizations after Large-Scale Hurricanes among Older Adults: A Self-Controlled Case Series Study.Prehospital and disaster medicine · 2021Article
- Effect of Influenza Vaccination Inducing Antibody Mediated Rejection in Solid Organ Transplant Recipients.Frontiers in immunology · 2020Article
- Risk of meticillin resistantBMJ (Clinical research ed.) · 2018Article
- Seasonal influenza vaccine in immunocompromised persons.Human vaccines & immunotherapeutics · 2018Review
- Respiratory Viral Infections in Solid Organ and Hematopoietic Stem Cell Transplantation.Clinics in chest medicine · 2017Review
- Adjuvanted (AS03) A/H1N1 2009 Pandemic Influenza Vaccines and Solid Organ Transplant Rejection: Systematic Signal Evaluation and Lessons Learnt.Drug safety · 2017Article
- Importance of feasibility assessments before implementing non-interventional pharmacoepidemiologic studies of vaccines: lessons learned and recommendations for future studies.Pharmacoepidemiology and drug safety · 2016Article
- Tree-temporal scan statistics for safety signal detection in vaccine clinical trials.Pharmaceutical statisticsArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo assess the risk of solid organ transplant (SOT) rejection after vaccination with the adjuvanted (AS03) A/H1N1 2009 pandemic influenza vaccine Pandemrix.
designSelf-controlled case series (SCCS) in the UK Clinical Practice Research Datalink (CPRD) and its linked component of the Hospital Episodes Statistics (HES) inpatient database. Analyses were conducted using the SCCS method for censored, perturbed or curtailed post-event exposure.
participantsOf the 184 transplant recipients having experienced at least one SOT rejection (liver, kidney, lung, heart or pancreas) during the study period from 1 October 2009 to 31 October 2010, 91 participants were included in the main analysis, of which 71 had been exposed to Pandemrix.
main outcome measuresOccurrence of SOT rejection during risk (30 and 60 days after any Pandemrix dose) and control periods. Covariates in the CPRD included time since transplantation, seasonal influenza vaccination, bacterial and viral infections, previous SOT rejections and malignancies.
resultsThe relative incidence (RI) of rejection of any one of the five transplanted organs, adjusted for time since transplantation, was 1.05 (95% CI 0.52 to 2.14) and 0.80 (95% CI 0.42 to 1.50) within 30 and 60 days after vaccination, respectively. Similar estimates were observed for rejection of a kidney only, the most commonly transplanted organ (RI within 30 days after vaccination: 0.85 (95% CI 0.38 to 1.90)). Across various models and sensitivity analyses, RI estimates remained stable and within a consistent range around 1.0.
conclusionsThese results suggest a reassuring safety profile for Pandemrix with regard to the risk of rejection in SOT recipients in England and contribute to inform the benefit-risk of AS03-adjuvanted pandemic influenza vaccines in transplanted patients in the event of future pandemics. TRIAL REGISTRATION NUMBER: NCT01715792.
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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.