Evaluation of Vaccinal and Natural Immunity Against Meningococcus C

April 30, 2018 updated by: University Hospital, Clermont-Ferrand

Evaluation of the Persistence in 2016 of Vaccinal Immunity Against Meningococcus C Among Children and Teenagers Who Received Meningococcus C Conjugate Vaccine in January 2002 During the Puy-de-Dôme Campaign and of Natural Immunity Among Unvaccinated People

Meningococcus C vaccine was first used in France to prevent epidemics. It was a success in Puy-de-Dôme, Landes, Pyrénées Atlantiques and Hautes Pyrénées. Following many European countries, France introduced meningococcus C conjugate vaccine in 2009 but this recommendation was not suffiicently applied (6,6% of the 20-25 years-old were vaccinated in 2015).

The situation in France is very different from UK and there is no data on the subject. The vaccination campaign in 2002 in Puy-de-Dôme offers much more detachment, possible comparison between vaccinated and unvaccinated people, among which meningococcus circulation could maintain immunity. This is the reason why we have decided to assess in 2016 the vaccinal and natural immunity among Puy-de-Dôme population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

People were recruited during hospitalisation or consultation of Pediatric, Occupational Medecine, Infectiology departments of Clermont Ferrand Hospital or Health Service of Auvergne's University, from March to September 2016.

Doctors gave informations about the study and collected consents before blood tests were done (two tubes of 4,5mL each).

Blood tests were daily collected and freezed. Then they were analysed at Meningococcus National Reference Center, in Paris.

Study Type

Interventional

Enrollment (Actual)

184

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • CHU Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 39 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • - people from 13 to 39 years old
  • who received meningococcus C conjugate vaccine in 2002 in Puy-de-Dôme (vaccinated group) or not (unvaccinated group)

Exclusion Criteria:

  • vaccination before or after 2002 containing meningococcus C valence
  • refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: vaccinated group
evaluation of immunity's level against meningococcus C among people vaccinated in 2002 in Puy-de-Dôme
Other: Meningococcus C conjugate vaccine
Other: unvaccinate group
Duration of vaccinal immunity, compare vaccinal immunity to possible natural immunity among unvaccinated people
Other: Meningococcus C conjugate vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation in 2016 of immunity's level (antibodies) against meningococcus C among people vaccinated in 2002 in Puy-de-Dôme
Time Frame: at day 1
at day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate the duration (years) of vaccinal immunity
Time Frame: at day 1
at day 1
Compare vaccinal immunity to possible natural immunity (antibodies level) among unvaccinated people
Time Frame: at day 1
at day 1
Determine the cutt-off (age) for which vaccinal immunity is still protective (sufficient antibodies level)
Time Frame: at day 1
at day 1
Adjust results on sociodemographic data (age, sex, city, number of years spent in Puy de Dôme, Auvergne, France and abroad from 2002 to 2016)
Time Frame: at day 1
at day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Jean BEYTOUT, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

November 30, 2016

Study Completion (Actual)

November 30, 2016

Study Registration Dates

First Submitted

July 12, 2016

First Submitted That Met QC Criteria

July 21, 2016

First Posted (Estimate)

July 26, 2016

Study Record Updates

Last Update Posted (Actual)

May 2, 2018

Last Update Submitted That Met QC Criteria

April 30, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHU-0273
  • 2015-A01437-42 (Other Identifier: 2015-A01437-42)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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