SARS-CoV-2MonaVaccNCT05084950
Informing the Population of Their Level of Protection Against COVID-19 in Monaco: a Prospective Study (MonaVacc)
An observational study of SARS-CoV-2 and COVID-19, run by Centre Scientifique de Monaco at 1 site in Monaco.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2, COVID-19, Vaccines
- How many people
- 10,000 participants
- Where
- 1 siteMonaco
- Study dates
- 1 Jul 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- None of the above
Trial locations and contacts
1 site in 1 country.
Monaco1 site, 1 recruiting
- Recruiting
Centre National de Depistage - Espace Leo Ferre
Monaco, 98000
Eric VOIGLIO, MD, PhD, +37798984850, evoiglio@gouv.mc
Thomas ALTHAUS, MD, PhD, talthaus@gouv.mc
About this study
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.
Read the detailed description
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
- Conditions
- SARS-CoV-2, COVID-19, Vaccines, Antibody
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24-month period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start1 Jul 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Scientifique de Monaco
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health Affairs, Monaco
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084950
- Sponsor's protocol ID
- PRO_CSM_02_2021
- Acronym
- MonaVacc
- Status last verified
- Oct 2021
- First submitted
- 19 Oct 2021
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Informing the Population of Their Level of Protection Against COVID-19 in Monaco: a Prospective Study (MonaVacc)
- ClinicalTrials.gov ID
- NCT05084950
- Acronym / sponsor ID
- MonaVacc / PRO_CSM_02_2021
- Conditions
- SARS-CoV-2, COVID-19, Vaccines, Antibody
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Centre Scientifique de MonacoUniversity, hospital or other
- Collaborators
- Department of Health Affairs, Monaco
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 20 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None of the above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Covid-19 Neutralizing Antibodies Measurment
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2 and COVID-19, run by Centre Scientifique de Monaco at 1 site in Monaco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Monaco. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric VOIGLIO, MD, PhD (+37798984850, evoiglio@gouv.mc), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Covid-19 Neutralizing Antibodies Measurment (time frame: 24-month period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.