SARS Cov 2 Vaccination in Adolescents With Juvenile Idiopathic ArthritisVACOVAJINCT05547451
SARS Cov 2 Vaccination in Adolescents With Juvenile Idiopathic Arthritis
An observational study of SARS Cov 2 Vaccination in Adolescents With Juvenile Idiopathic Arthritis, run by Nantes University Hospital at 1 site in France.
Trial summary
Since june 2021, vaccination against the SARS-Cov2 virus is recommanded in France to all children from 12 to 18 years old. In the specific population of teenagers living with juvenile arthritis, the vaccine seems to be safe and well tolerated. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- SARS Cov 2 Vaccination in Adolescents With Juvenile Idiopathic Arthritis
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jun 2024to 30 Jun 2025
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients from 12 to 18 years old followed up from juvenile arthritis in 2021 and 2022 at Angers, Nantes and Rennes.
Who may be able to join
- Patients from 12 to 18 years old, on January the 1st 2022
- Patients followed up from juvenile arthritis
- Patients followed up in 2021 and 2022
Who cannot join
- Patients under 12 years old.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Nantes
Nantes, Loire-Atlantique, 44300
Soizic Tiriau
About this study
Official title: SARS Cov2 Vaccination in Adolescents From 12 to 18 With Juvenile Idiopathic Arthritis in Angers, Nantes and Rennes : Acceptance and Safety.
Since june 2021, vaccination against the SARS-Cov2 virus is recommanded in France to all children from 12 to 18 years old. In the specific population of teenagers living with juvenile arthritis, the vaccine seems to be safe and well tolerated. It has been shown previously that this population has a vaccine coverage lower than the global population even though few datas are available on this topic The aim of this resarch is to study the vaccination coverage against the SARS-Cov2 virus and more specifically the reasons why adolescents were or were not vaccinated in the population of adolescents with juvenile arthitis followed up in Angers, Nantes and Rennes. For this purpose, a review of the medical record will be done and a questionnaire will be adressed to the family of patients in order to collect informations about the disease, the treatments, the motives or obstacles to vaccination. Secondaries end points are safety of the vaccination, consequences on the juvenile arthritis (such as changes in the medication, flare-up of the illness) and the occurence of covid infection after vaccination.
- Keywords
- SARS Cov2 vaccination, juvenile idiopathic arthritis, paediatric, safety, acceptance
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Trial population | Children from 12 to 18 years old followed up for juvenile arthritis in Angers, Nantes and Rennes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS Cov2 vaccination coverage of this population and factors influencing the realization of the vaccination.
Percentage of patients vaccinated
Measured: From june 2021 to December 2022
Secondary outcomes (3)
Tolerance of the SARS-Cov2 vaccination
Occurrence of any side-effects
Measured: From june 2021 to December 2022
Effect of the SARS Cov2 vaccination on juvenile arthritis
Occurrence of flare up of the illness, modification of treatment
Measured: From june 2021 to December 2022
SARS-Cov 2 infection after vaccination
Occurrence and severity of the infection
Measured: From june 2021 to December 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start9 Jun 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS Cov 2 Vaccination in Adolescents With Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Angers, Rennes University Hospital, Clinique de l'Anjou
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547451
- Sponsor's protocol ID
- RC22_0237
- Acronym
- VACOVAJI
- Status last verified
- Jun 2024
- First submitted
- 12 Sep 2022
- Last updated
- 21 Jun 2024
- 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 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS Cov2 Vaccination in Adolescents From 12 to 18 With Juvenile Idiopathic Arthritis in Angers, Nantes and Rennes : Acceptance and Safety.
- ClinicalTrials.gov ID
- NCT05547451
- Acronym / sponsor ID
- VACOVAJI / RC22_0237
- Keywords
- SARS Cov2 vaccination, juvenile idiopathic arthritis, paediatric, safety, acceptance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Angers, Rennes University Hospital, Clinique de l'Anjou
- Study start
- 9 Jun 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 21 Sep 2022 (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.
Since june 2021, vaccination against the SARS-Cov2 virus is recommanded in France to all children from 12 to 18 years old. In the specific population of teenagers living with juvenile arthritis, the vaccine seems to be safe and well tolerated. It has been shown previously that this population has a vaccine coverage lower than the global population even though few datas are available on this topic The aim of this resarch is to study the vaccination coverage against the SARS-Cov2 virus and more specifically the reasons why adolescents were or were not vaccinated in the population of adolescents with juvenile arthitis followed up in Angers, Nantes and Rennes. For this purpose, a review of the medical record will be done and a questionnaire will be adressed to the family of patients in order to collect informations about the disease, the treatments, the motives or obstacles to vaccination. Secondaries end points are safety of the vaccination, consequences on the juvenile arthritis (such as changes in the medication, flare-up of the illness) and the occurence of covid infection after vaccination.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trial population | – | –Children from 12 to 18 years old followed up for juvenile arthritis in Angers, Nantes and Rennes. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients from 12 to 18 years old followed up from juvenile arthritis in 2021 and 2022 at Angers, Nantes and Rennes.
Key inclusion criteria (3 listed)
- Patients from 12 to 18 years old, on January the 1st 2022
- Patients followed up from juvenile arthritis
- Patients followed up in 2021 and 2022
Key exclusion criteria (1 listed)
- Patients under 12 years old.
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
SARS Cov2 vaccination coverage of this population and factors influencing the realization of the vaccination.
Time frame: From june 2021 to December 2022
Percentage of patients vaccinated
3 secondary outcomes
Tolerance of the SARS-Cov2 vaccination
Time frame: From june 2021 to December 2022
Effect of the SARS Cov2 vaccination on juvenile arthritis
Time frame: From june 2021 to December 2022
SARS-Cov 2 infection after vaccination
Time frame: From june 2021 to December 2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Individual participant dataSharing planned: Undecided
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 Vaccination in Adolescents With Juvenile Idiopathic Arthritis, run by Nantes University Hospital at 1 site in France.
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 3 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 21 Jun 2024. 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 France. 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 Soizic TIRIAU, Dr (02 76 64 39 57, soizic.tiriau@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SARS Cov2 vaccination coverage of this population and factors influencing the realization of the vaccination. (time frame: From june 2021 to December 2022). 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 21 Jun 2024.