Prevention of Meningococcus C InfectionsNCT02844088
Evaluation of Vaccinal and Natural Immunity Against Meningococcus C
A study testing Meningococcus C conjugate vaccine in people with Prevention of Meningococcus C Infections, run by University Hospital, Clermont-Ferrand at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 13 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Prevention of Meningococcus C Infections
- What is being tested?
- Meningococcus C conjugate vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2016to 30 Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 39 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- - 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)
Who cannot join
- vaccination before or after 2002 containing meningococcus C valence
- refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Prevention of Meningococcus C Infections
- Being tested
- Meningococcus C conjugate vaccine
- Keywords
- meningococcus C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meningococcus C conjugate vaccineOther
| Study group | Role | What they receive |
|---|---|---|
| vaccinated group | Experimental | evaluation of immunity's level against meningococcus C among people vaccinated in 2002 in Puy-de-Dôme Receives: Other: Meningococcus C conjugate vaccine |
| unvaccinate group | Other | Duration of vaccinal immunity, compare vaccinal immunity to possible natural immunity among unvaccinated people Receives: Other: Meningococcus C conjugate vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation in 2016 of immunity's level (antibodies) against meningococcus C among people vaccinated in 2002 in Puy-de-Dôme
Measured: at day 1
Secondary outcomes (4)
Evaluate the duration (years) of vaccinal immunity
Measured: at day 1
Compare vaccinal immunity to possible natural immunity (antibodies level) among unvaccinated people
Measured: at day 1
Determine the cutt-off (age) for which vaccinal immunity is still protective (sufficient antibodies level)
Measured: 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)
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startMar 2016
- Primary completion30 Nov 2016
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of Meningococcus C InfectionsStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean BEYTOUT, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02844088
- Sponsor's protocol ID
- CHU-0273
- Other IDs
- 2015-A01437-42
- Status last verified
- Apr 2018
- First submitted
- 12 Jul 2016
- Last updated
- 2 May 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02844088
- Acronym / sponsor ID
- CHU-0273
- Conditions
- Prevention of Meningococcus C Infections
- Keywords
- meningococcus C
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 26 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vaccinated group | Experimental | Other: Meningococcus C conjugate vaccineevaluation of immunity's level against meningococcus C among people vaccinated in 2002 in Puy-de-Dôme |
| unvaccinate group | Other | Other: Meningococcus C conjugate vaccineDuration of vaccinal immunity, compare vaccinal immunity to possible natural immunity among unvaccinated people |
Who may qualify
- Ages
- 13 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- - 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)
Key exclusion criteria (2 listed)
- vaccination before or after 2002 containing meningococcus C valence
- refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meningococcus C conjugate vaccine | Other | unvaccinate group, vaccinated group |
Primary outcome
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
4 secondary outcomes
Evaluate the duration (years) of vaccinal immunity
Time frame: at day 1
Compare vaccinal immunity to possible natural immunity (antibodies level) among unvaccinated people
Time frame: at day 1
Determine the cutt-off (age) for which vaccinal immunity is still protective (sufficient antibodies level)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean BEYTOUT principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meningococcus C conjugate vaccine in people with Prevention of Meningococcus C Infections, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2018.