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

Recruiting

• Conditions: Influenza; Severe Acute Respiratory Infection (SARI); COVID-19

• Registration Number: NCT05582239
• Lead Sponsor: ANRS, Emerging Infectious Diseases

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-10-10
• Study First Submitted QC: 2022-10-12
• Study First Posted: 2022-10-17
• Study Start: 2023-01-20
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-15
• Last Update Posted: 2023-05-17
• Primary Completion: 2026-01-20
• Study Completion: 2026-01-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2400

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

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Exclusion Criteria

• Contraindication of vaccination

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vaccine effectiveness	up to 48 hours	Comparison of the number of virologically confirmed cases of vaccine preventable Severe Acute Respiratory Infections (SARI) among hospitalized vaccinated patients compared with unvaccinated patients.

Secondary Outcome Measures

Name	Time	Method
Covid-19 vaccine effectiveness	up to 48 hours	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
Prevalence of viral and bacterial co-infections	up to 48 hours	Prevalence of other viruses and bacteria detected by PCR, antigen tests, microbiology samples.
Incidence of SARI by site	up to 12 months	Incidence rate of SARI by sites
Influenza vaccine effectiveness	up to 48 hours	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
Clinical burden of SARI	up to 3 months	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.

Trial Locations

Locations (5)

CHU; 🇫🇷 Saint-Étienne, France

Groupement hospitalier Edouard Herriot; 🇫🇷 Lyon, France

Hôpital Gui de Chauliac; 🇫🇷 Montpellier, France

Hôpital Cochin; 🇫🇷 Paris, France

Hôpital Bichat; 🇫🇷 Paris, France