François Haguinet
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View article: Performance of the Self‐Controlled Case Series With Active Comparators for Drug Safety Signal Detection Using the French Administrative Healthcare Database ( <scp>SNDS</scp> )
Performance of the Self‐Controlled Case Series With Active Comparators for Drug Safety Signal Detection Using the French Administrative Healthcare Database ( <span>SNDS</span> ) Open
Background The self controlled case series (SCCS) is one of the most promising methods for drug safety signal detection using real world data (RWD), and incorporating active comparators could potentially improve its performance by addressi…
View article: Performance of the Self‐Controlled Case Series With Active Comparators for Drug Safety Signal Detection Using Merative <scp>MarketScan</scp> Research Databases
Performance of the Self‐Controlled Case Series With Active Comparators for Drug Safety Signal Detection Using Merative <span>MarketScan</span> Research Databases Open
Background Despite testing of epidemiological methods in US Claims databases for signal detection, such data sources have not become a routine capability. The Self Controlled Case Series (SCCS) is one of the most promising methods for drug…
View article: Ontology-based Semantic Similarity Measures for Clustering Medical Concepts in Drug Safety
Ontology-based Semantic Similarity Measures for Clustering Medical Concepts in Drug Safety Open
Semantic similarity measures (SSMs) are widely used in biomedical research but remain underutilized in pharmacovigilance. This study evaluates six ontology-based SSMs for clustering MedDRA Preferred Terms (PTs) in drug safety data. Using t…
View article: Tree‐temporal scan statistics for safety signal detection in vaccine clinical trials
Tree‐temporal scan statistics for safety signal detection in vaccine clinical trials Open
The evaluation of safety is critical in all clinical trials. However, the quantitative analysis of safety data in clinical trials poses statistical difficulties because of multiple potentially overlapping endpoints. Tree‐temporal scan stat…
View article: Optimizing Signal Management in a Vaccine Adverse Event Reporting System: A Proof-of-Concept with COVID-19 Vaccines Using Signs, Symptoms, and Natural Language Processing
Optimizing Signal Management in a Vaccine Adverse Event Reporting System: A Proof-of-Concept with COVID-19 Vaccines Using Signs, Symptoms, and Natural Language Processing Open
View article: The futility of adverse drug event reporting systems for monitoring known safety issues: A case study of myocardial infarction with rofecoxib and other drugs
The futility of adverse drug event reporting systems for monitoring known safety issues: A case study of myocardial infarction with rofecoxib and other drugs Open
For over 50 years, spontaneous reporting systems (SRSs) were the only option for identifying unexpected effects of products once marketed.1 Their high sensitivity makes SRSs especially well-suited for identifying rare drug- or vaccine-rela…
View article: Developing an Artificial Intelligence-Guided Signal Detection in the Food and Drug Administration Adverse Event Reporting System (FAERS): A Proof-of-Concept Study Using Galcanezumab and Simulated Data
Developing an Artificial Intelligence-Guided Signal Detection in the Food and Drug Administration Adverse Event Reporting System (FAERS): A Proof-of-Concept Study Using Galcanezumab and Simulated Data Open
AI could significantly ease some of the most time-consuming and labor-intensive steps of signal detection and validation. The AI-based approach showed promising results, however, future work is needed to validate the framework.
View article: Identifying Safety Subgroups at Risk: Assessing the Agreement Between Statistical Alerting and Patient Subgroup Risk
Identifying Safety Subgroups at Risk: Assessing the Agreement Between Statistical Alerting and Patient Subgroup Risk Open
We observed low concordance between subgroup disproportionality scores and PRAC discussions of potential subgroup risk. Subgroup analyses performed better for age and sex, while for covariates not well-captured in FAERS, such as underlying…
View article: Correction to: Review of Over 15 Years Postmarketing Safety Surveillance Spontaneous Data for the Human Rotavirus Vaccine (Rotarix) on Intussusception
Correction to: Review of Over 15 Years Postmarketing Safety Surveillance Spontaneous Data for the Human Rotavirus Vaccine (Rotarix) on Intussusception Open
View article: Review of Over 15 Years Postmarketing Safety Surveillance Spontaneous Data for the Human Rotavirus Vaccine (Rotarix) on Intussusception
Review of Over 15 Years Postmarketing Safety Surveillance Spontaneous Data for the Human Rotavirus Vaccine (Rotarix) on Intussusception Open
View article: Post-Marketing Safety Surveillance for the Adjuvanted Recombinant Zoster Vaccine: Methodology
Post-Marketing Safety Surveillance for the Adjuvanted Recombinant Zoster Vaccine: Methodology Open
View article: Dengue Infection in Children in Fortaleza, Brazil: A 3-Year School-Based Prospective Cohort Study
Dengue Infection in Children in Fortaleza, Brazil: A 3-Year School-Based Prospective Cohort Study Open
Dengue is endemic in Brazil. The dengue surveillance system's reliance on passive reporting may underestimate disease incidence and cannot detect asymptomatic/pauci-symptomatic cases. In this 3-year prospective cohort study (NCT01391819) i…
View article: ADVANCE system testing: Estimating the incidence of adverse events following pertussis vaccination in healthcare databases with incomplete exposure data
ADVANCE system testing: Estimating the incidence of adverse events following pertussis vaccination in healthcare databases with incomplete exposure data Open
View article: ADVANCE system testing: Can safety studies be conducted using electronic healthcare data? An example using pertussis vaccination
ADVANCE system testing: Can safety studies be conducted using electronic healthcare data? An example using pertussis vaccination Open
The estimated IRs and IRRs were comparable with published data, therefore demonstrating that the ADVANCE system was able to combine several European healthcare databases to assess vaccine safety data for wP and aP vaccination.
View article: Enhanced safety surveillance of influenza vaccines in general practice, winter 2015-16: Feasibility study
Enhanced safety surveillance of influenza vaccines in general practice, winter 2015-16: Feasibility study Open
BACKGROUND:The European Medicines Agency (EMA) requires vaccine manufacturers to conduct enhanced real-time surveillance of seasonal influenza vaccination. The EMA has specified a list of adverse events of interest to be monitored. The EMA…
View article: Enhanced Safety Surveillance of Influenza Vaccines in General Practice, Winter 2015-16: Feasibility Study
Enhanced Safety Surveillance of Influenza Vaccines in General Practice, Winter 2015-16: Feasibility Study Open
Background The European Medicines Agency (EMA) requires vaccine manufacturers to conduct enhanced real-time surveillance of seasonal influenza vaccination. The EMA has specified a list of adverse events of interest to be monitored. The EMA…
View article: Enhanced Safety Surveillance of Influenza Vaccines in General Practice, Winter 2015-16: Feasibility Study (Preprint)
Enhanced Safety Surveillance of Influenza Vaccines in General Practice, Winter 2015-16: Feasibility Study (Preprint) Open
BACKGROUND The European Medicines Agency (EMA) requires vaccine manufacturers to conduct enhanced real-time surveillance of seasonal influenza vaccination. The EMA has specified a list of adverse events of interest to be monitored. The EM…
View article: Burden of herpes zoster in 16 selected immunocompromised populations in England: a cohort study in the Clinical Practice Research Datalink 2000–2012
Burden of herpes zoster in 16 selected immunocompromised populations in England: a cohort study in the Clinical Practice Research Datalink 2000–2012 Open
Objectives Herpes zoster (HZ) is caused by reactivation of varicella-zoster virus which remains latent in individuals after a varicella infection. It is expected that HZ will be more frequent in immunocompromised (IC) individuals than in i…
View article: Influenza vaccine effectiveness against influenza-related hospitalization during a season with mixed outbreaks of four influenza viruses: a test-negative case-control study in adults in Canada
Influenza vaccine effectiveness against influenza-related hospitalization during a season with mixed outbreaks of four influenza viruses: a test-negative case-control study in adults in Canada Open
View article: The Importance of Frailty in the Assessment of Influenza Vaccine Effectiveness Against Influenza-Related Hospitalization in Elderly People
The Importance of Frailty in the Assessment of Influenza Vaccine Effectiveness Against Influenza-Related Hospitalization in Elderly People Open
NCT01517191.
View article: Post-authorisation passive enhanced safety surveillance of seasonal influenza vaccines: protocol of a pilot study in England
Post-authorisation passive enhanced safety surveillance of seasonal influenza vaccines: protocol of a pilot study in England Open
Aim To pilot enhanced safety surveillance of seasonal influenza vaccine meeting the European Medicines Agency (EMA) requirement to rapidly detect a significant increase in the frequency or severity of adverse events of interest (AEIs), whi…
View article: Challenges in conducting post-authorisation safety studies (PASS): A vaccine manufacturer's view
Challenges in conducting post-authorisation safety studies (PASS): A vaccine manufacturer's view Open
Post-authorisation safety studies (PASS) of vaccines assess or quantify the risk of adverse events following immunisation that were not identified or could not be estimated pre-licensure. The aim of this perspective paper is to describe th…
View article: Estimates of hospitalization attributable to influenza and RSV in the US during 1997–2009, by age and risk status
Estimates of hospitalization attributable to influenza and RSV in the US during 1997–2009, by age and risk status Open
View article: Impact of Prior Season Influenza Vaccination on Seasonal Influenza Vaccine Effectiveness: An Analysis over Four Consecutive Seasons from the Serious Outcomes Surveillance (SOS) Network of the Canadian Immunization Research Network (CIRN)
Impact of Prior Season Influenza Vaccination on Seasonal Influenza Vaccine Effectiveness: An Analysis over Four Consecutive Seasons from the Serious Outcomes Surveillance (SOS) Network of the Canadian Immunization Research Network (CIRN) Open
Recent controversy has arisen from observational studies suggesting a potential negative association between prior influenza vaccination and subsequent influenza vaccine effectiveness (VE). As immunologic theories suggest this impact could…
View article: Clinical Features of Influenza and Acute Respiratory Illness in Older Adults at Least 50 Years of Age in an Outpatient Setting in the Republic of Korea: a Prospective, Observational, Cohort Study
Clinical Features of Influenza and Acute Respiratory Illness in Older Adults at Least 50 Years of Age in an Outpatient Setting in the Republic of Korea: a Prospective, Observational, Cohort Study Open
Two prospective, multi-centre, observational studies (GlaxoSmithKline [GSK] identifier No. 110938 and 112519) were performed over 2 influenza seasons (2007-2008 and 2008-2009) in the Republic of Korea (ROK) with the aim to evaluate the bur…
View article: Impact of Antivirals in the Prevention of Serious Outcomes Associated with Influenza in Hospitalized Canadian Adults: A Pooled Analysis from the Serious Outcomes Surveillance (SOS) Network of the Canadian Immunization Research Network (CIRN)
Impact of Antivirals in the Prevention of Serious Outcomes Associated with Influenza in Hospitalized Canadian Adults: A Pooled Analysis from the Serious Outcomes Surveillance (SOS) Network of the Canadian Immunization Research Network (CIRN) Open
Background Antiviral treatment of influenza in outpatient settings is associated with modest improvement in outcomes but benefit in inpatient settings remains unclear. We assessed the impact of antiviral treatment on the severe outcomes de…
View article: Model estimates of the burden of outpatient visits attributable to influenza in the United States
Model estimates of the burden of outpatient visits attributable to influenza in the United States Open
View article: Modelling estimates of age-specific influenza-related hospitalisation and mortality in the United Kingdom
Modelling estimates of age-specific influenza-related hospitalisation and mortality in the United Kingdom Open
View article: Modelling estimates of the burden of respiratory syncytial virus infection in children in the UK
Modelling estimates of the burden of respiratory syncytial virus infection in children in the UK Open
Objective The burden of respiratory syncytial virus (RSV) illness is not well characterised in primary care. We estimated the burden of disease attributable to RSV in children in the UK between 1995 and 2009. Design Time-series regression …
View article: Risk of solid organ transplant rejection following vaccination with seasonal trivalent inactivated influenza vaccines in England: A self-controlled case-series
Risk of solid organ transplant rejection following vaccination with seasonal trivalent inactivated influenza vaccines in England: A self-controlled case-series Open
This study provides reassuring evidence of the safety profile of TIIVs in SOT recipients, thus supporting current recommendations to vaccinate this risk group annually.