Vaccine Effectiveness, Burden and Impact Studies (VEBIS) of COVID-19 and Influenza – Tender Specifications OJ/2021/DPR/12924  DL 5.6.3. Report on the  pilot VE studies during  the emergence of an  influenza, coronavirus  or other respiratory  disease pandemic  During the emergence of a new respiratory pandemic VE studies shall be piloted  prior to, or in the initial phases of vaccine roll-out.  The deliverable includes the implementation of the study, and a report which  include a description of the implementation of studies in a small number of study  sites, with data analysis and suggestions for corrective actions in anticipation of  the roll-out of vaccination programmes. Once  Word  Task 7: Additional Study  The contractor is expected to design and perform additional studies on the population of the main study and on additional populations such as those of  individuals < 18 years of age. The objective of the studies will be agreed in advance with ECDC and could be studies detailed under this task. Deliverable (DL)  Description  Estimated  frequency/ Volume  File / form at type  DL 5.7.1. Collect blood  or serum samples from  participants for  characterisation of the  immune response  In order to better understand the immunological profiles of vaccinated and non- vaccinated individuals with or without prior infection history and for use in  further assessments the contractor may be requested to collect blood or sera  from study participants. Such collection of biological specimens will require  ethical and institutional approvals, as well as informed consent from participants,  which should be sought for this deliverable. The contractor shall also establish specimen preparation and international  transport procedures to European reference laboratories or stakeholders, as  agreed with ECDC. A minimum of 100 samples is expected to be needed on an  annual basis, with 25 each in the vaccinated and unvaccinated participants  stratified by PCR results.  Frequency to be  defined, 800  samples  Word  DL 5.7.2. Validation of  the test-negative case- control study design for  COVID-19 VE  estimation  Case-control studies with the test-negative design have been widely used for VE  studies on influenza and other pathogens, however only limited experience exists  with COVID-19. The contractor shall be requested by ECDC to validate the use of  this study design for COVID-19.  One time during  the duration of the  framework  contract  Word 