Skip to main content
OpenTrials
Completed

NCT Number: NCT02844088

Evaluation of Vaccinal and Natural Immunity Against Meningococcus C

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prevention of Meningococcus C Infections

Age range

13 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Meningococcus C conjugate vaccine

Other

Primary outcomes

  1. 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

Secondary outcomes

  1. Evaluate the duration (years) of vaccinal immunity

    Time frame: at day 1

  2. Compare vaccinal immunity to possible natural immunity (antibodies level) among unvaccinated people

    Time frame: at day 1

  3. Determine the cutt-off (age) for which vaccinal immunity is still protective (sufficient antibodies level)

    Time frame: at day 1

  4. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 26, 2016
Registry last updated
May 2, 2018

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.