The deliverable includes a protocol, data collection and a report including results  and recommendations. The study might be conducted in a representative sample  in each study site.  The protocol shall include standard operating procedures (SOPs) for recruitment  of study participants, data management, data checking and validation, reporting  and data transfers, and data analysis, as annexes of the study protocol. The  protocol shall include a statistical analysis plan for a pooled analysis. The protocol  shall include a detailed description of all testing and laboratory components  included in the study and type of frequency sampling, a codebook with a  minimum set and the full list of variables to be collected; sample size calculations,  questionnaire/s to be administered to the study participants.  DL 5.7.3. Plan and do a  random sampling study  to estimate VE against  asymptomatic COVID- 19 infection  The test-negative design also does not allow for assessing VE against  asymptomatic infection. Given the large proportion of asymptomatic infections  and the potential role they may have in transmitting the disease, the contractor  shall perform a separate small study to assess overall VE against asymptomatic  infection in a random population sample during active community transmission.  The protocol shall include: 1) A selection of a comparison method, 2) standard  operating procedures (SOPs) for recruitment of study participants, data  management, data checking and validation, reporting and data transfers, and  data analysis, as annexes of the study protocol, 3) a statistical analysis plan for a  pooled analysis, 4) a detailed description of all testing and laboratory  components included in the study and type of frequency sampling, a codebook with a minimum set and the full list of variables to be collected; sample size  calculations, questionnaire/s to be administered to the study participants.  One time during  the duration of the  framework  contract  Word  DL 5.7.4. Plan,  implement study and  report on estimated VE  against influenza or  COVID-19 among  children and  Currently healthy children are included in influenza vaccination programs only in  a few EU MS. It is possible that COVID-19 will be approved in EU for age groups  <18 years and included initially into a limited number of national vaccination  programmes. The contractor shall plan and implement a study with relevant  study sites, which may include paediatric clinics, to estimate either influenza or  COVID-19 VE among children and adolescents.  Three times during  the duration of the  framework  contract in year 2,  3 and 4  Word  Vaccine Effectiveness, Burden and Impact Studies (VEBIS) of COVID-19 and Influenza – Tender Specifications OJ/2021/DPR/12924 