Measure of Vaccine Effectiveness to Prevent Hospitalizations for Viral Respiratory Infections in Adults
RESPIVAC
1 other identifier
observational
2,400
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2023
Typical duration for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2022
CompletedFirst Posted
Study publicly available on registry
October 17, 2022
CompletedStudy Start
First participant enrolled
January 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2026
CompletedMay 17, 2023
May 1, 2023
3 years
October 10, 2022
May 15, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Covid-19 vaccine effectiveness
up to 48 hours
Influenza vaccine effectiveness
up to 48 hours
Prevalence of viral and bacterial co-infections
up to 48 hours
Incidence of SARI by site
up to 12 months
Clinical burden of SARI
up to 3 months
Eligibility Criteria
Hospitalized patients presenting with SARI symptom onset in the first 14 days
You may qualify if:
- 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
You may not qualify if:
- Contraindication of vaccination
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ANRS, Emerging Infectious Diseaseslead
- P95collaborator
- I-REIVACcollaborator
- EPICONCEPTcollaborator
- Institut de Recherche en Santé Publique, Francecollaborator
Study Sites (8)
CHU
Dijon, France
Groupement hospitalier Edouard Herriot
Lyon, France
Hôpital Gui de Chauliac
Montpellier, France
CHU
Nantes, France
Hôpital Cochin
Paris, 75014, France
Hôpital Bichat
Paris, France
CHU
Rennes, France
CHU
Saint-Etienne, France
Biospecimen
Swab respiratory samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2022
First Posted
October 17, 2022
Study Start
January 20, 2023
Primary Completion
January 20, 2026
Study Completion
January 20, 2026
Last Updated
May 17, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share