Vaccination ReactionELCAVNCT06373510
Longitudinal Evaluation of Antibody Kinetics of Vaccinated Patients With Non-mandatory Vaccine Following Administration of a Non-public Marketed Vaccine in the General Population, Real-life Study
A study testing Blood collection in people with Vaccination Reaction, run by CerbaXpert.
Trial summary
The study would make it possible to document more explicitly the evolution of antibody titers at following a non-public vaccination over a large post-vaccination period in the French population . Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccination Reaction
- What is being tested?
- Blood collection
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2024to 3 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject over 18 years of age
- Subject presenting to the investigation centre as part of its usual management (prevention, screening, tracking)
- Subject who has been vaccinated and/or wishes to be vaccinated
- Subject able to understand the purpose of research that has given free and informed express consent
- Member or beneficiary of a social security scheme
Who cannot join
- Protected subject: major under guardianship, curatorship or other legal protection, deprived of liberty by decision judicial or administrative
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Longitudinal Evaluation of Antibody Kinetics Following Administration of a Non-mandatory Marketed Vaccine in the General Population, Real-life Study
The study would make it possible to document more explicitly the evolution of antibody titers at following a non-public vaccination over a large post-vaccination period in the French population .
Analysis of real-life data would enhance knowledge of vaccine response kinetics It would be useful to identify possible early declines requiring doses Similarly, by analyzing antibody kinetics by age, sex, and vaccination status, the would be possible to determine whether there are differences in the immune response between these different sub-groups. In addition, it would provide additional information to assess the real impact of these non-public vaccines in public health and guide vaccine policies.
- Conditions
- Vaccination Reaction
- Being tested
- Blood collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collectionBiological
Collection of blood before and after a non mandatory vaccination
| Study group | Role | What they receive |
|---|---|---|
| Observational arm | Other | Not described Receives: Biological: Blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of specific serum antibodies (IgM, IgG) at different times before and/or after vaccination by a reference technique such as ELISA.
Quantification of specific serum antibodies (IgM, IgG) at different times before and/or after vaccination by a reference technique such as ELISA.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start20 Jun 2024 (estimated)
- Primary completion3 Apr 2027 (estimated)
- Study completion3 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccination ReactionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CerbaXpert
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373510
- Sponsor's protocol ID
- ELCAV
- Acronym
- ELCAV
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2024
- Last updated
- 18 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Evaluation of Antibody Kinetics Following Administration of a Non-mandatory Marketed Vaccine in the General Population, Real-life Study
- ClinicalTrials.gov ID
- NCT06373510
- Acronym / sponsor ID
- ELCAV / ELCAV
- Conditions
- Vaccination Reaction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- CerbaXpertUniversity, hospital or other
- Study start
- 20 Jun 2024 (estimated)
- Primary completion
- 3 Apr 2027 (estimated)
- Study completion
- 3 Apr 2027 (estimated)
- First posted
- 18 Apr 2024 (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.
The study would make it possible to document more explicitly the evolution of antibody titers at following a non-public vaccination over a large post-vaccination period in the French population .
Analysis of real-life data would enhance knowledge of vaccine response kinetics It would be useful to identify possible early declines requiring doses Similarly, by analyzing antibody kinetics by age, sex, and vaccination status, the would be possible to determine whether there are differences in the immune response between these different sub-groups. In addition, it would provide additional information to assess the real impact of these non-public vaccines in public health and guide vaccine policies.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational arm | Other | Biological: Blood collection |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject over 18 years of age
- Subject presenting to the investigation centre as part of its usual management (prevention, screening, tracking)
- Subject who has been vaccinated and/or wishes to be vaccinated
- Subject able to understand the purpose of research that has given free and informed express consent
- Member or beneficiary of a social security scheme
Key exclusion criteria (1 listed)
- Protected subject: major under guardianship, curatorship or other legal protection, deprived of liberty by decision judicial or administrative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood collectionCollection of blood before and after a non mandatory vaccination | Biological | Observational arm |
Primary outcome
Quantification of specific serum antibodies (IgM, IgG) at different times before and/or after vaccination by a reference technique such as ELISA.
Time frame: 3 years
Quantification of specific serum antibodies (IgM, IgG) at different times before and/or after vaccination by a reference technique such as ELISA.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Blood collection in people with Vaccination Reaction, run by CerbaXpert.
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 5 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: opening soon, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barbara Perniconi (0671296728, bperniconi@cerbaresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of specific serum antibodies (IgM, IgG) at different times before and/or after vaccination by a reference technique such as ELISA. (time frame: 3 years). 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 18 Apr 2024.