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)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Risk communication
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Web-based questionnaires with subsequent quantitative and qualitative analysis, and semi-structured telephone or online interviews

Study drug and medical condition

• Medical condition to be studied:
  Thrombosis with thrombocytopenia syndrome

Population studied

• Short description of the study population:
  The study cohort included: Work package 1, which involved six EU member states: Denmark, Greece, Latvia, Netherlands, Portugal, and Slovenia.; Work package 2 involved an inventory to identify participants for interviews, including those treating thrombosis with thrombocytopenia syndrome (TTS) in each country. It also included an inventory to recruit relevant professionals.; Work package 3 selected the most suitable strategy to obtain a sample of their adult population, aimed to recruit diverse responders from different sociodemographic subgroups.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with thrombosis with thrombocytopenia syndrome
• Estimated number of subjects:
  1400

Study design details

• Main study objective:
  To determine: 1) how regulatory actions for TTS have changed national vaccination policy, 2) level of HCP awareness and knowledge of the risk of TTS and adherence to SmPC recommendations for SARS-CoV2 adenovirus vaccines, 3) the extent of change in HCPs' attitudes towards COVID-19 national vaccination campaigns, 4) extent of change in citizens’ attitudes towards vaccination against SARS-COV2.
• Outcomes:
  The impact of the 2021 EU regulatory actions for Vaxzevria and for COVID-19 Vaccine Janssen following the 2021 review namely: Alterations to national COVID-19 vaccination policies, Awareness and knowledge among HCP about the risk of TTS when administering these vaccines, Changes to attitudes of HCPs and general public towards national COVID-19 vaccination programmes.
• Data analysis plan:
  Each National Team will provide the overview and timeline of COVID-19 vaccination policies to the Study Coordinator for compilation according to a standardised and agreed format. The surveys will generate descriptive statistics with univariate and bivariate analyses of variables. Given the variation in vaccination policies, survey data will be analysed at national level. For the qualitative data, the analysis involves a deductive content analysis based on a line-by-line reading of the responses and developing a conceptual coding scheme based on major themes in the interview. Transcripts will be coded individually by two researchers in each country in their native languages. Processing of personal data will comply with the EU data protection legislation and GDPR. Citizens and HCPs will participate anonymously in the questionnaires and interviews. Only fully anonymised data will be shared with the coordinating team. Ethical approval and participants’ informed consent will be acquired.

Documents

Study results

RiskAware TTS Summary ENCEPP_SA