Novavax
This sponsor has funded 5 studies across 27 countries.
This sponsor has funded 5 studies across 27 countries.
| EU PAS ID | Status | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|
| 39096 | Ongoing | COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER) | No | No |
| 42328 | Ongoing | Brand-specific COVID-19 vaccine effectiveness against severe COVID-19 disease in Europe A contribution of COVIDRIVE, a public-private partnership to... | Yes | No |
| 103858 | Planned | Safety of the Novavax COVID-19 vaccine in England using a self-controlled case series design: A post-authorisation safety study using data from the... | No | No |
| 104622 | Ongoing | Safety Profile of the NVX-CoV2373 Vaccine in Individuals ≥ 12 Years of Age in the United States | No | No |
| 105521 | Ongoing | Effectiveness of the Novavax COVID-19 Vaccine in Reducing Clinically Defined Severe SARS-CoV-2 Infection in Individuals ≥ 12 Years of Age in the... | No | No |
Novavax
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.
Novavax
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.
Novavax
27 Study countries specified are the following: