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

NCT ID: NCT06373510

Last Updated: 2024-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

10000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-20

Study Completion Date

2027-04-03

Brief Summary

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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

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Conditions

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Vaccination Reaction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Observational arm

Group Type OTHER

Blood collection

Intervention Type BIOLOGICAL

Collection of blood before and after a non mandatory vaccination

Interventions

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Blood collection

Collection of blood before and after a non mandatory vaccination

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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CerbaXpert

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Barbara Perniconi

Role: CONTACT

0671296728

Other Identifiers

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ELCAV

Identifier Type: -

Identifier Source: org_study_id

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