Measure of Vaccine Effectiveness to Prevent Hospitalizations for Viral Respiratory Infections in Adults

Study Overview
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Brief Summary
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This study is a prospective, multicentric, observational test negative design study on adults hospitalized for Severe Acute Respiratory Infection (SARI), regardless of their vaccination status.

Detailed Description
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Participation to the study will be systematically proposed to all patients hospitalized fitting inclusion criteria. Patient's screening will be done in emergency department or hospital department with direct admission. Medical investigators explain the objectives of the studies, procedure and propose the patient to participate in the study. Socio-demographic data, clinical and virological data will be collected in an electronic clinical research form. A follow-up at 1 and 3 months after hospitalization discharge will be scheduled to evaluate health status. The remainder of respiratory samples that have been performed for care will be used for further testing depending on epidemiological situation and will be stored at -80°C.

Official Title
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Measure of Vaccine Effectiveness to Prevent Hospitalizations for Viral Respiratory Infections in Adults

Conditions
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Severe Acute Respiratory Infection (SARI), Influenza, COVID-19

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years old Admitted in a hospital for at least 24 h Presents SARI criteria within onset within the last 14 days before sampling and less than 48 h after hospitalisations: At least one of the following signs (without treatment): fever or feverishness, malaise, headache, myalgia or sign of fatigue (loss of weight or anorexia or confusion or dizziness) Associated with at least one respiratory symptom or sign (cough, sore throat or shortness of breath; or tachypnoea or signs of low oxygen saturation) completed non-opposition form Respiratory samples within 14 days after symptoms onset, in the context of care Exclusion Criteria: Contraindication of vaccination

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaccine effectiveness | Comparison of the number of virologically confirmed cases of vaccine preventable Severe Acute Respiratory Infections (SARI) among hospitalized vaccinated patients compared with unvaccinated patients. | up to 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Covid-19 vaccine effectiveness | Comparison of numbers of hospitalized cases with documented COVID-19 infection in vaccinated and unvaccinated patients according to: Age comorbidities Vaccine schedule (numbers of doses and brand) date of vaccination SARS-CoV-2 Variant | up to 48 hours | 
| Influenza vaccine effectiveness | Comparison of numbers of hospitalized cases with documented flu in vaccinated and unvaccinated according to: Age Comorbidities Vaccine brand Date of vaccination Previous vaccination Viral strain | up to 48 hours | 
| Prevalence of viral and bacterial co-infections | Prevalence of other viruses and bacteria detected by PCR, antigen tests, microbiology samples. | up to 48 hours | 
| Incidence of SARI by site | Incidence rate of SARI by sites | up to 12 months | 
| Clinical burden of SARI | European Quality of Life by 5 Dimension (EQ5D) score assessed at 1 month and 3 months after hospitalization discharge. Scale from 0 to 100 with 0 corresponding to the worst quality of life. | up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Severe acute respiratory infection (SARI), Vaccine effectiveness, Influenza, COVID-19