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:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 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.