Evaluation of Vaccinal and Natural Immunity Against Meningococcus C

Prevention of Meningococcus C Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02844088
• Other study ID #: CHU-0273
• Secondary ID: 2015-A01437-42
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: November 30, 2016

Study information

• Verified date: April 2018
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: November 30, 2016
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Prevention of Meningococcus C Infections

Intervention

Other:
• Meningococcus C conjugate vaccine

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation in 2016 of immunity's level (antibodies) against meningococcus C among people vaccinated in 2002 in Puy-de-Dôme		at day 1
Secondary	Evaluate the duration (years) of vaccinal immunity		at day 1
Secondary	Compare vaccinal immunity to possible natural immunity (antibodies level) among unvaccinated people		at day 1
Secondary	Determine the cutt-off (age) for which vaccinal immunity is still protective (sufficient antibodies level)		at day 1
Secondary	Adjust results on sociodemographic data (age, sex, city, number of years spent in Puy de Dôme, Auvergne, France and abroad from 2002 to 2016)		at day 1