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NCT Number: NCT06373510

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood collection

Biological

Collection of blood before and after a non mandatory vaccination

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Barbara Perniconi

CONTACT

[email protected]

0671296728

Sponsors and collaborators

Lead sponsor

CerbaXpert

Other

Registry information

Official study title

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

Acronym: ELCAV

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 18, 2024
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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