NCT04657263

Brief Summary

The vaccination policy is drawn up in France by the French Minister of Health, who makes public the vaccination schedule after the opinion of the High Authority of Health. Currently according to the 2019 immunization schedule, the dTP vaccine is the only mandatory in the general population with recalls in adults aged 25, 45, 65 and every 10 years. In 2011, the Ministry of Health estimated that only 50.5% of the general population was up to date against dTP. Two vaccines are recommended for person at risk of infection according to the current vaccine schedule: the flu vaccine and the pneumococcal vaccine. In fact, influenza and pneumococcal disease are more frequent and more serious in patients with chronic diseases (diabetes, cardiac insufficiency..) compared to the general population. The vaccination coverage rate of at-risk populations is dramatically below the vaccination coverage targets set by the Ministry of Health. Indeed, there are many barriers to vaccination, medical and para-medical barriers, but also individual barriers. The current COVID-19 pandemic has identified people at risk of severe infection and death risk, particularly those with co-morbidities (diabetes, cardiovascular disease, etc.). Thus, this pandemic may have contributed to change in patients' perceptions regarding both the risk of infection and the potential interest and benefit of vaccination.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 7, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 8, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
Last Updated

October 25, 2021

Status Verified

October 1, 2021

Enrollment Period

6 months

First QC Date

December 7, 2020

Last Update Submit

October 22, 2021

Conditions

Keywords

People over 18 years oldvaccinesimmunization scheduleInfection

Outcome Measures

Primary Outcomes (1)

  • number of persons at risk of infection up to date with their mandatory and recommended vaccinations during COVID19 pandemic

    number of persons at risk of infection up to date with their mandatory and recommended vaccinations during COVID19 pandemic

    1 day

Secondary Outcomes (1)

  • Number of persons at risk of infection accepting COVID19 vaccination

    1 day

Study Arms (1)

Person at risk of infection according to French 2019 immunization

Person at risk of infection according to French 2019 immunization

Other: Vaccine coverage assessment

Interventions

Vaccine coverage assessment

Person at risk of infection according to French 2019 immunization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study population was composed of person at risk of infection cared for in participating centers

You may qualify if:

  • Person at risk of infection according to french 2019 immunization schedule
  • Patients aged above 18 years old

You may not qualify if:

  • \- Patient \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

COVID-19Infections

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Cyril BREUKER

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2020

First Posted

December 8, 2020

Study Start

November 1, 2020

Primary Completion

May 1, 2021

Study Completion

May 30, 2021

Last Updated

October 25, 2021

Record last verified: 2021-10

Locations