Neisseria MeningitidisPhase 3Exten EffivacNCT01621945
Evaluation of Immune Response Against the Strain of Neisseria Meningitidis B: 14, P1-7, 16 in Patients Having to be Vaccinated MenBVac® (Extension EFFIVAC)
A Phase 3 study testing MenBvac in people with Neisseria Meningitidis, run by University Hospital, Rouen at 1 site in France.
Trial summary
The main objective of the study is to estimate the proportion of children, born between the 06/04/2004 and the 17/004/2008, living around Neufchatel en Bray, vaccinated by MenBVac, with a serum bactericidal activity against B:14,P1-7,16 clone related to a protection (>= 4), before the fourth dose of MenBvac and after… Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Neisseria Meningitidis
- What is being tested?
- MenBvac
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2012to Sep 2013
- Phase
- Phase 3
- 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 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children born between 06/04/2004 and 17/04/2008, living in Neufchatel en Bray,and Having participated to the first study,
- children who Have to be Vaccinated MenBVac® for the four times,
- parental authority(ies)assent.
Who cannot join
- no parental authority(ies)assent,
- no blood sample,
- impossibility of fourth vaccination,
- children yet vaccinated or non eligible for vaccination.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 3, Vaccinal Activity Assessment of MenBVac Against Neisseria Meningitidis B:14,P1.7,16 Strain in Child
The main objective of the study is to estimate the proportion of children, born between the 06/04/2004 and the 17/004/2008, living around Neufchatel en Bray, vaccinated by MenBVac, with a serum bactericidal activity against B:14,P1-7,16 clone related to a protection (>= 4), before the fourth dose of MenBvac and after: 6 weeks and one year after the fourth dose.
- Conditions
- Neisseria Meningitidis
- Being tested
- MenBvac
- Keywords
- Neisseria meningitidis B:14, P1-7, 16, Serum bactericidal activity, OMV vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MenBvacBiological
Blood tests and vaccine :
- First blood sample immediatly before the fourth dose of the vaccine
- Fourth dose of MenBVac
- Second blood sample 6 weeks after the fourth dose of the vaccine
- Third blood sample 1 year after the fourth dose of the vaccine
| Study group | Role | What they receive |
|---|---|---|
| Bras A | Experimental | children, born between the 06/04/2004 and the 17/04/2008, living around Neufchatel en Bray, before the fourth dose of MenBVac Receives: Biological: MenBvac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccine Immunity
Assessment of vaccine Immunity with measure of percentage of children who have hSBA title >= 4 six weeks after the fourth dose of vaccine
Measured: after the fourth dose of MenbVac
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neisseria MeningitidisStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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 3
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Collaborators
- Direction Générale de la Santé, France, Institut Pasteur
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01621945
- Sponsor's protocol ID
- 2011/198/HP
- Other IDs
- 2011-006209-83
- Acronym
- Exten Effivac
- Status last verified
- Sep 2014
- First submitted
- 26 Mar 2012
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, Vaccinal Activity Assessment of MenBVac Against Neisseria Meningitidis B:14,P1.7,16 Strain in Child
- ClinicalTrials.gov ID
- NCT01621945
- Acronym / sponsor ID
- Exten Effivac / 2011/198/HP
- Conditions
- Neisseria Meningitidis
- Keywords
- Neisseria meningitidis B:14, P1-7, 16, Serum bactericidal activity, OMV vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Collaborators
- Direction Générale de la Santé, France, Institut Pasteur
- Study start
- Apr 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 18 Jun 2012 (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.
The main objective of the study is to estimate the proportion of children, born between the 06/04/2004 and the 17/004/2008, living around Neufchatel en Bray, vaccinated by MenBVac, with a serum bactericidal activity against B:14,P1-7,16 clone related to a protection (>= 4), before the fourth dose of MenBvac and after: 6 weeks and one year after the fourth dose.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bras A | Experimental | Biological: MenBvacchildren, born between the 06/04/2004 and the 17/04/2008, living around Neufchatel en Bray, before the fourth dose of MenBVac |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children born between 06/04/2004 and 17/04/2008, living in Neufchatel en Bray,and Having participated to the first study,
- children who Have to be Vaccinated MenBVac® for the four times,
- parental authority(ies)assent.
Key exclusion criteria (4 listed)
- no parental authority(ies)assent,
- no blood sample,
- impossibility of fourth vaccination,
- children yet vaccinated or non eligible for vaccination.
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 |
|---|---|---|
| MenBvacBlood tests and vaccine : * First blood sample immediatly before the fourth dose of the vaccine * Fourth dose of MenBVac * Second blood sample 6 weeks after the fourth dose of the vaccine * Third blood sample 1 year after the fourth dose of the vaccine | Biological | Bras A |
Primary outcome
Vaccine Immunity
Time frame: after the fourth dose of MenbVac
Assessment of vaccine Immunity with measure of percentage of children who have hSBA title >= 4 six weeks after the fourth dose of vaccine
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 12 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MenBvac in people with Neisseria Meningitidis, run by University Hospital, Rouen 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 3 inclusion and 4 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 12 Jun 2026. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Vaccine Immunity (time frame: after the fourth dose of MenbVac). 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 12 Jun 2026.