P95
This sponsor has funded 2 studies across 13 countries.
| EU PAS ID | Status | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|
| 8502 | Finalised | Background rates of disease in Latin American children in view of future vaccine safety assessment | No | Yes |
| 15696 | Finalised | Pilot study: reactogenicity surveillance in Belgium following immunization with seasonal influenza vaccines | No | No |
PAS by Risk Management Plan (RMP) requirement
P95
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.
PAS by study status
P95
The study status is defined according to the timeline dates specified.
Planned studies have not collected any data yet.
Ongoing studies collect data and should publish protocols as soon as possible.
Finalised studies should publish results in the first two weeks after finalisation.
Countries
P95
13 Study countries specified are the following:
- Argentina
- Belgium
- Brazil
- Chile
- Colombia
- Dominican Republic
- Finland
- Honduras
- Mexico
- Nicaragua
- Panama
- Peru
- Venezuela, Bolivarian Republic of