GlaxoSmithKline Biologicals (GSK Bio)

This sponsor has funded 14 studies across 7 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
5896 Finalised EU RMP category 3 Risk of Febrile Convulsions after 1st dose MMRV vaccination in comparison to MMR and MMR+V vaccination (MMRV 1st dose) No Yes
5899 Finalised Not included in RMP 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 EU RMP category 3 116602 - Risk of Solid Organ Transplant Rejection Following Vaccination With Pandemrix in the United Kingdom Yes Yes
6086 Finalised EU RMP category 3 201327 - Boostrix® Pregnancy Registry: a prospective, exploratory, cohort study to detect and describe any abnormal pregnancy outcomes in women... Yes No
6103 Finalised EU RMP category 3 104435 - Post-Authorization Safety Study (PASS) of Post-Marketing Surveillance for Intussusception Following Rotarix Introduction into the Instituto... No No
6110 Finalised EU RMP category 3 201889 - Planned analyses related to the Post-Authorization Safety Study (PASS) of Post-Marketing Surveillance for Intussusception following Rotarix... Yes Yes
6521 Finalised EU RMP category 3 Fluarix®/ FluLaval®/ Fluarix® Quadrivalent/FluLaval® Quadrivalent Pregnancy Registry: a prospective, exploratory, cohort study to detect and describe... Yes Yes
6817 Finalised EU RMP category 3 200405 - An observational retrospective database analysis to estimate the risk of Multiple Sclerosis (MS) following vaccination with Arepanrix™ in... Yes Yes
10632 Finalised EU RMP category 3 202055 - European Medicines Agency (EMA) post-authorisation safety study of influenza vaccine Yes Yes
13332 Finalised EU RMP category 3 205639 - Meta-analysis of the risk of autoimmune thyroiditis diseases, Guillain-Barré Syndrome, and Inflammatory Bowel Disease with Cervarix... Yes Yes
13406 Finalised EU RMP category 3 203153 - A post-marketing, observational, retrospective, cohort study to assess the safety of RefortrixTM (Tdap) when administered during pregnancy in... Yes Yes
17402 Finalised Not included in RMP Burden of Herpes Zoster in selected immunocompromised populations in the German Pharmacoepidemiological Research Database (GePaRD) No No
48157 Ongoing EU RMP category 3 213825-Non-interventional (observational) post-licensure study to assess the vaccine effectiveness and safety of recombinant zoster vaccine (RZV) in... Yes No
49294 Ongoing Not included in RMP 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.