Impact of EU label changes and regulatory communication on SARS-CoV-2 adenovirus vector vaccines in context of thrombosis with thrombocytopenia syndrome (TTS): risk awareness and adherence (RiskAwareTTS)

First published 05/01/2022

Last updated 02/07/2024

EU PAS number:

EUPAS44970

Study

Finalised

Documents

Study protocol

Initial protocol

Protocol ROC24_COVID-19_vaccines_TTS 4

English (759.72 KB - PDF)View document

Updated protocol

080422 Protocol RiskAware TTS version 3.0 final2

First published: 22/02/2024

English (1.28 MB - PDF)View document

Study results

RiskAware TTS Summary ENCEPP_SA

English (334 KB - PDF)View document

Study report

Other information

ENCePP Seal

This study has been awarded the ENCePP seal

ENCePP Seal documents

Conflicts of interest of investigators

All COI forms-Annex5

English (2.17 MB - PDF)View document

Composition of steering group and observers

Teams in RiskAware TTS project

English (104.33 KB - PDF)View document

Signed code of conduct

empty_file.pdf

English (11.35 KB - PDF)View document

Signed code of conduct checklist

empty_file.pdf

English (11.35 KB - PDF)View document

Signed checklist for study protocols

empty_file.pdf

English (11.35 KB - PDF)View document

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