Clinical trial NCT02844088: Evaluation of Vaccinal and Natural Immunity Against Meningococcus C
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prevention of Meningococcus C Infections
Keywords: meningococcus C
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2016-07-26
Enrollment: 184
Sex: ALL
Minimum age (years): 13
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation in 2016 of immunity's level (antibodies) against meningococcus C among people vaccinated in 2002 in Puy-de-Dôme
timeFrame: at day 1
Secondary outcomes:
measure: Evaluate the duration (years) of vaccinal immunity
timeFrame: at day 1
measure: Compare vaccinal immunity to possible natural immunity (antibodies level) among unvaccinated people
timeFrame: at day 1
measure: Determine the cutt-off (age) for which vaccinal immunity is still protective (sufficient antibodies level)
timeFrame: at day 1
measure: Adjust results on sociodemographic data (age, sex, city, number of years spent in Puy de Dôme, Auvergne, France and abroad from 2002 to 2016)
timeFrame: at day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Jean BEYTOUT
role: PRINCIPAL_INVESTIGATOR
References: