Institution identification

PURI

https://redirect.ema.europa.eu/resource/3331435

Institution ID

3331435

Institution full name and acronym

GlaxoSmithKline (GSK)

ENCePP partner

No
Institution details
Experience with collecting data directly from individual patients or respondents:
No
Interest in carrying out research that is funded by pharmaceutical companies:
No

Studies conducted by the institution

115055-A prospective study to estimate the incidence of diseases specified as adverse events of special interest, of other adverse events leading to hospitalisation or death, and of meningitis in infants and young children in sub-Saharan Africa prior to implementation of the RTS,S/AS01E candidate vaccine (EPI-MALARIA 002 VS AME)
115056 - A prospective study to evaluate the safety, effectiveness and impact of the RTS, S/AS01E vaccine in young children in sub-Saharan Africa (EPI-MALARIA-003 VS AME)
116602 - Risk of Solid Organ Transplant Rejection Following Vaccination With Pandemrix in the United Kingdom
116682 - An epidemiology study to assess Plasmodium falciparum parasite prevalence and malaria control measures in catchment areas of two studies pre- and post RTS,S/AS01E introduction (EPI MAL-002 and EPI-MAL-003) to assess, in field conditions, vaccine benefit:risk in children in sub Saharan Africa. (EPI-MALARIA-005 BOD AME)
201327 - Boostrix® Pregnancy Registry: a prospective, exploratory, cohort study to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with Boostrix® during pregnancy or within 28 days preceding conception
201889 - Planned analyses related to the Post-Authorization Safety Study (PASS) of Post-Marketing Surveillance for Intussusception following Rotarix introduction into the Instituto Mexicano del Seguro Social (IMSS) in Mexico.
205071 - A phase IV, longitudinal, cross-sectional, retrospective, ancillary epidemiology study of the EPI-MAL-005 study to evaluate the genetic diversity in the Plasmodium falciparum parasite circumsporozoite sequences before and after the implementation of the RTS,S/AS01E vaccine in malaria-positive subjects ranging from 6 months to less than 5 years of age (EPI-MALARIA-010 VS AME)
205639 - Meta-analysis of the risk of autoimmune thyroiditis diseases, Guillain-Barré Syndrome, and Inflammatory Bowel Disease with Cervarix Vaccination
207221 - An observational, retrospective cohort database study to assess the safety of Boostrix (U.S. formulation), a reduced tetanus, diphtheria, acellular pertussis vaccine (Tdap), following routine immunization of pregnant women in the United States.
207644 - Meta analysis of HPV-associated CIN2, CIN2+ and CIN3+ cases in efficacy studies according to baseline cytology and DNA status.
212853 - Shingrix for intramuscular injection Drug Use Investigation
213825-Non-interventional (observational) post-licensure study to assess the vaccine effectiveness and safety of recombinant zoster vaccine (RZV) in the rheumatoid arthritis (RA) and inflammatory bowel disease (IBD) patient populations in adults 18 years of age and older (EPI-ZOSTER-044 VE US)
219111- A retrospective matched cohort database study in the United States to evaluate the effectiveness of recombinant zoster vaccine (RZV) in patients with autoimmune diseases (AIDs) (EPI-ZOSTER-097 VE US DB)
A post-authorisation safety study (PASS) to describe real-world safety and effectiveness of NUCALA (mepolizumab) in paediatric eosinophilic granulomatosis with polyangiitis (EGPA) patients in Europe (218065)
A retrospective matched cohort study on the association between herpes zoster vaccination and dementia and mild cognitive impairment using electronic health records (ZOSTER-122 AIML 222419)
An Observational Study of the Risk of Acute Pancreatitis in Subjects Exposed to Albiglutide, Other GLP-1 Agonists or DPP-4 Inhibitors Compared to Other Antidiabetic Agents (201804)
An Observational Study of the Risk of Malignant Neoplasms and Malignant Neoplasms of Special Interest (Thyroid and Pancreatic Cancer) in Subjects Treated with Albiglutide Compared to Those Treated with Other Antidiabetic Agents (201805)
An open label, multi-centre, post marketing surveillance (PMS) to monitor the safety and effectiveness of ANORO administered in Korean subjects with chronic obstructive pulmonary disease (COPD) in usual practice (204511)
An open label, multi-centre, post marketing surveillance (PMS) to monitor the safety and efficacy of INCRUSE administered in Korean subjects with chronic obstructive pulmonary disease (COPD) in usual practice (205163)
An open-label, non-comparator, multicenter study to describe the pharmacokinetics (PK), pharmacodynamics (PD; viral load) and safety following a single intravenous or intramuscular dose of sotrovimab in pediatric participants with mild to moderate COVID-19 at high risk of disease progression (COMET-PACE) (215226)
BEL116559 Pooled Analysis of Belimumab Elderly Patients
BLENREP Effectiveness and Safety in Multiple Myeloma (BEaMM) – Real-World Evidence on Patients Taking Belantamab Mafodotin in Europe (217240)
Can social listening data be used to provide meaningful insights into abuse or inappropriate use of bupropion? (A feasibility analysis) (202115)
Cohort study to estimate incidence of pneumonia in users of Trelegy 100 or multiple inhaler triple therapy among patients with chronic obstructive pulmonary disease using health insurance claims data provided by Medical Data Vision Co., Ltd. in Japan (212606)
Drug Use Investigation of ANORO ELLIPTA inhaler (200311)
Drug utilisation study of new users of fluticasone furoate / vilanterol (FF/VI) in the primary care setting: UK Clinical Practice Research Datalink (CPRD) study (205052)
Efficacy/Effectiveness of Cervarix against grade 3 cervical intraepithelial neoplasia or worse (CIN3, CIN3+) and cervical cancer. A systematic review and meta-regression analysis (EPI-HPV-101 VE DB 221785)
Encruse Ellipta Drug Use Investigation (201450)
Evaluating the effectiveness of the revised alli® pack information in helping pharmacy staff within the EU supply alli® appropriately (204675)
Fluarix®/ FluLaval®/ Fluarix® Quadrivalent/FluLaval® Quadrivalent Pregnancy Registry: a prospective, exploratory, cohort study to detect and describe abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with Fluarix® or Fluarix® Quadrivalent or FluLaval® or FluLaval® Quadrivalent during pregnancy or within 28 days preceding conception
Meta-Analysis Plan for MID207941: A Study to Evaluate Risk Factors for Pneumonia and Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in a COPD Population of Patients Treated with GW685698 + GW642444 (Fluticasone Furoate + Vilanterol); GW642444 (Vilanterol); CCI18781 (Fluticasone Propionate); GR33343 (Salmeterol); CCI18781+ GR33343 (Fluticasone Propionate + Salmeterol) and Placebo
Meta-Analysis Plan for Study Number 201182, GSK1550188, SLE, Pregnancy Analysis
Non-interventional (observational) post-licensure study to assess the effectiveness and safety of recombinant zoster vaccine in adults aged =18 years with psoriasis or psoriatic arthritis (EPI-ZOSTER-045 VE US 216976)
Nucala Subcutaneous Injection Special Drug Use Investigation (Long-Term) (204524)
Observational study to assess frailty of subjects during ZOSTER-006 and ZOSTER-022 and HZ efficacy, immunogenicity and safety of HZ/su by frailty status (ZOSTER-064)
PGx447:Exploratory genetic analysis of pazopanib (GW786034) related diarrhea in patient with RCC(VEG102616,VEG105192,VEG107769) (116054)
PGx6652: Genetic Evaluation of Pazopanib –Related Hepatotoxicity (117365)
PGX7550: PGx Investigation of Pyrexia by Meta-Analysis of Dabrafenib/Trametinib Melanoma Studies BRF113710, BRF113929, BRF113683 and MEK115306 (200997)
PGx7607: PGx evaluation of pyrexia by meta-analysis of melanoma subjects from BRF113710, BRF113929, BRF113683, MEK115306 and MEK116513 (202050)
PGx7610: Genetic Evaluation of Hepatotoxicity in Pazopanib Studies (201761)
PGx7612: Pharmacogenetic investigation of the association of the ADRB2 rare variant, Thr164Ile with severe asthma exacerbation (204661)
Physician Adherence to Fondaparinux Prescribing Information for Patients with Superficial Vein Thrombosis (SVT) of the Lower Limbs (115280)
Post-marketing study of ropinirole prolonged release tablets in Parkinson’s disease: Evaluation outcomes associated with long term use of Ropinirole-PR using the clinical practice research datalink (CPRD) (111981)
Postmarketing commitment safety study of HZ/su to evaluate pregnancy exposures and outcomes in immunodeficient or immunosuppressed women between 18 and 49 years of age (EPI-ZOSTER-039 VS US DB 214420)
PRJ2215: Assessment of Bupropion Misuse/Abuse 2004-2011 (201235)
Prospective cohort study to monitor the emergence of SARSCoV-2 spike viral variants in immunocompromised nonhospitalised patients exposed to sotrovimab in Great Britain: LUNAR study (218407)
Safety and effectiveness of RZV in adults ?18 years of age with Systemic lupus erythematosus (SLE) or Multiple sclerosis (MS) (EPI-ZOSTER-041 VS US DB 215104)
Survey of prescriber understanding of specific risks associated with TROBALT (201426)
The Belimumab Pregnancy Exposure Study: An OTIS Autoimmune Diseases in Pregnancy Project (213928)
Trelegy Ellipta general drug use investigation (asthma)
Use of benzodiazepines and risk of hip/femur fracture. A methodological comparison across data sources and epidemiological design.
Votrient Liver Data Meta-analysis (200276)
Votrient liver data meta-analysis of phase II and III RCC and STS studies (200277)
XEVUDY General Drug Use Investigation (SARS-CoV-2 Infection) - COVID-19 (217893)
Zagallo Capsules Drug Use Investigation (202029)