NCT05084950

Brief Summary

Vaccines against the coronavirus type 2 causing severe acute respiratory syndrome Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) have been created in a short period of time due to the rapid spread of the virus. These vaccines use different and sometimes innovative technologies, such as the use of ribonucleic acid (RNA), or a non-replicating viral vector. Efficacy ranging from 70-90% in the first weeks after the second injection of these vaccines has been reported, with side effects whose causality remains to be determined.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

July 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 20, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

October 20, 2021

Status Verified

October 1, 2021

Enrollment Period

1.5 years

First QC Date

October 19, 2021

Last Update Submit

October 19, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Covid-19 Neutralizing Antibodies Measurment

    Inform any individual who has been infected with or vaccinated against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) have about their level of immune protection, through a bi-annual follow-up

    24-month period

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This is a single-centre prospective observational study in the general population of the Principality of Monaco, attending the community public health center of Monaco, for Covid testing and/or vaccination.

You may qualify if:

  • Participant must live in the Principality of Monaco
  • Deliver a written consent to participate to the study
  • And/Or Have been infected with SARS-CoV-2
  • And/Or Have been, or are about to be, vaccinated against SARS-CoV-2

You may not qualify if:

  • \- None of the above

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre National de Depistage - Espace Leo Ferre

Monaco, 98000, Monaco

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Eric VOIGLIO, MD, PhD

CONTACT

Thomas ALTHAUS, MD, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

October 19, 2021

First Posted

October 20, 2021

Study Start

July 1, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

October 20, 2021

Record last verified: 2021-10

Locations