GlaxoSmithKline Vaccines (GSK Vaccines)
This sponsor has funded 2 studies across 2 countries.
| EU PAS ID | Status | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|
| 11728 | Finalised | Post-licensure observational safety study after meningococcal B vaccine 4CMenB (Bexsero®) vaccination in routine UK care | Yes | Yes |
| 17902 | Finalised | 207644 - Meta analysis of HPV-associated CIN2, CIN2+ and CIN3+ cases in efficacy studies according to baseline cytology and DNA status. | Yes | No |
PAS by Risk Management Plan (RMP) requirement
GlaxoSmithKline Vaccines (GSK Vaccines)
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
GlaxoSmithKline Vaccines (GSK Vaccines)
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
GlaxoSmithKline Vaccines (GSK Vaccines)
2 Study countries specified are the following:
- Belgium
- United Kingdom