MedImmune

This sponsor has funded 4 studies across 2 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
4848 Finalised Non-EU RMP-only Postmarketing Safety Study of Q/LAIV in Subjects 2 Through 49 Years of Age Yes Yes
7626 Finalised Not included in RMP A Postmarketing Noninterventional Cohort Study of the Safety of Live Attenuated Influenza Vaccine (LAIV) in Subjects 2 Through 17 Years of Age (Flu... No No
10954 Ongoing Non-EU RMP-only A Case Control Study of the Effectiveness of Q/LAIV Versus Inactivated Influenza Vaccine and No Vaccine in Subjects 2-17 Years of Age (ICICLE) Yes No
18527 Finalised EU RMP category 3 A Postmarketing Observational Evaluation of the Safety of FLUENZ in Children and Adolescents With High-risk Conditions Yes Yes

PAS by Risk Management Plan (RMP) requirement

MedImmune

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.