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Informing the Population of Their Level of Protection Against COVID-19 in Monaco: a Prospective Study (MonaVacc)

Sponsor
Centre Scientifique de Monaco (Other)
Overall Status
Recruiting
CT.gov ID
NCT05084950
Collaborator
Department of Health Affairs, Monaco (Other)
10,000
Enrollment
1
Location
18
Anticipated Duration (Months)
555.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    10000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Informing the Population of Their Level of Protection Against COVID-19 in Monaco: a Prospective Study (MonaVacc)
    Actual Study Start Date :
    Jul 1, 2021
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Covid-19 Neutralizing Antibodies Measurment [24-month period]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • 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

    Exclusion Criteria:
    • None of the above

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre National de Depistage - Espace Leo Ferre Monaco Monaco 98000

    Sponsors and Collaborators

    • Centre Scientifique de Monaco
    • Department of Health Affairs, Monaco

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Scientifique de Monaco
    ClinicalTrials.gov Identifier:
    NCT05084950
    Other Study ID Numbers:
    • PRO_CSM_02_2021
    First Posted:
    Oct 20, 2021
    Last Update Posted:
    Oct 20, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Oct 20, 2021