GlaxoSmithKline Biologicals (GSK Bio)

This sponsor has funded 14 studies across 7 countries.

PAS funded by this sponsor.
EU PAS ID Status Title Protocol uploaded Results uploaded
5896 Finalised Risk of Febrile Convulsions after 1st dose MMRV vaccination in comparison to MMR and MMR+V vaccination (MMRV 1st dose) No Yes
5899 Finalised Risk of Febrile Convulsions after a Second Immunization against Measles, Mumps and Rubella with MMRV as compared to MMR or MMR+V (MMRV 2nd dose) No Yes
5975 Finalised 116602 - Risk of Solid Organ Transplant Rejection Following Vaccination With Pandemrix in the United Kingdom Yes Yes
6086 Finalised 201327 - Boostrix® Pregnancy Registry: a prospective, exploratory, cohort study to detect and describe any abnormal pregnancy outcomes in women... Yes No
6103 Finalised 104435 - Post-Authorization Safety Study (PASS) of Post-Marketing Surveillance for Intussusception Following Rotarix Introduction into the Instituto... No No
6110 Finalised 201889 - Planned analyses related to the Post-Authorization Safety Study (PASS) of Post-Marketing Surveillance for Intussusception following Rotarix... Yes Yes
6521 Finalised Fluarix®/ FluLaval®/ Fluarix® Quadrivalent/FluLaval® Quadrivalent Pregnancy Registry: a prospective, exploratory, cohort study to detect and describe... Yes Yes
6817 Finalised 200405 - An observational retrospective database analysis to estimate the risk of Multiple Sclerosis (MS) following vaccination with Arepanrix™ in... Yes Yes
10632 Finalised 202055 - European Medicines Agency (EMA) post-authorisation safety study of influenza vaccine Yes Yes
13332 Finalised 205639 - Meta-analysis of the risk of autoimmune thyroiditis diseases, Guillain-Barré Syndrome, and Inflammatory Bowel Disease with Cervarix... Yes Yes
13406 Finalised 203153 - A post-marketing, observational, retrospective, cohort study to assess the safety of RefortrixTM (Tdap) when administered during pregnancy in... Yes Yes
17402 Finalised Burden of Herpes Zoster in selected immunocompromised populations in the German Pharmacoepidemiological Research Database (GePaRD) No No
48157 Ongoing 213825-Non-interventional (observational) post-licensure study to assess the vaccine effectiveness and safety of recombinant zoster vaccine (RZV) in... Yes No
49294 Ongoing 219111- A retrospective matched cohort database study in the United States to evaluate the effectiveness of recombinant zoster vaccine (RZV) in... Yes No

PAS by Risk Management Plan (RMP) requirement

GlaxoSmithKline Biologicals (GSK Bio)

The RMP for a medical product outlines strategies to identify, assess, and mitigate risks, including PAS for further evaluation.

Category 1 studies are imposed as condition of marketing authorisation.
Category 2 studies are imposed as specific obligation of marketing authorisation.
Category 3 studies are required under other circumstances.