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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

Longitudinal Evaluation of Antibody Kinetics Following Administration of a Non-mandatory Marketed Vaccine in the General Population, Real-life Study

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06373510
Acronym
ELCAV
Enrollment
10000
Registered
2024-04-18
Start date
2024-06-20
Completion date
2027-04-03
Last updated
2024-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaccination Reaction

Brief 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 . 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.

Interventions

BIOLOGICALBlood collection

Collection of blood before and after a non mandatory vaccination

Sponsors

CerbaXpert
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* Protected subject: major under guardianship, curatorship or other legal protection, deprived of liberty by decision judicial or administrative

Design outcomes

Primary

MeasureTime frameDescription
Quantification of specific serum antibodies (IgM, IgG) at different times before and/or after vaccination by a reference technique such as ELISA.3 yearsQuantification of specific serum antibodies (IgM, IgG) at different times before and/or after vaccination by a reference technique such as ELISA.

Contacts

Primary ContactBarbara Perniconi
bperniconi@cerbaresearch.com0671296728

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026