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

Not Applicable

Not yet recruiting

• Conditions: Vaccination Reaction
• Interventions: Biological: Blood collection

• Registration Number: NCT06373510
• Lead Sponsor: CerbaXpert

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-04
• Study First Submitted QC: 2024-04-15
• Last Update Submitted: 2024-04-15
• Study First Posted: 2024-04-18
• Last Update Posted: 2024-04-18
• Study Start: 2024-06-20
• Primary Completion: 2027-04-03
• Study Completion: 2027-04-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Observational arm	Blood collection	-

Primary Outcome Measures

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