Vaccination With MenbVacPhase 3Exten MenbVacNCT01565577
Evaluation of Immune Response Against the Strain of Neisseria Meningitidis B: 14, P1-7, 16 Patients Vaccinated With MenBVac® (Extension MenbVac)
A Phase 3 study testing MenbVac in people with Vaccination With MenbVac, run by University Hospital, Rouen at 1 site in France.
Trial summary
This study aims to estimate the vaccinal immunity four years after four doses of MenbVac in children aged 4-8 years. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccination With MenbVac
- What is being tested?
- MenbVac
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2012to Sep 2012
- 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children born between 01/01/2000 and 06/23/2005, living in Dieppe-Est, Dieppe-Ouest and Offranville, vaccinated with four doses of MenBVac in the first MenbVac clinical trial study,
- parental authority(ies)assent.
Who cannot join
- no parental authority(ies)assent,
- no parental authority(ies)assent,
- no blood sample during the third vaccination,
- impossibility of third vaccination.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 3, Vaccinal Activity Assessment of MenBVac Against Nesseiria Menigitidis B:14,P1.7,16 Strain in Child Vaccinated With MenBVac®
This study aims to estimate the vaccinal immunity four years after four doses of MenbVac in children aged 4-8 years.
- Conditions
- Vaccination With MenbVac
- Being tested
- MenbVac
- Keywords
- Neisseria meningitidis B:14, P1-7, 16, Serum bactericidal activity, Menbvac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MenbVacBiological
Blood test
| Study group | Role | What they receive |
|---|---|---|
| Bras A | Experimental | Not described 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 with an hSBA title >= 4 four years after four doses of MenbVac
Measured: two and a half years after the fouth vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionJun 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccination With MenbVacStudies 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
- 117 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, Dieppe
- Responsible party
- Sponsor
- Investigators
- François Caron, Professor, Principal investigator, CHU - Hôpitaux de Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01565577
- Sponsor's protocol ID
- 2011/199/HP
- Other IDs
- 2011-006268-27
- Acronym
- Exten MenbVac
- Status last verified
- Sep 2014
- First submitted
- 26 Mar 2012
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 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 Nesseiria Menigitidis B:14,P1.7,16 Strain in Child Vaccinated With MenBVac®
- ClinicalTrials.gov ID
- NCT01565577
- Acronym / sponsor ID
- Exten MenbVac / 2011/199/HP
- Conditions
- Vaccination With MenbVac
- Keywords
- Neisseria meningitidis B:14, P1-7, 16, Serum bactericidal activity, Menbvac
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Collaborators
- Direction Générale de la Santé, France, Institut Pasteur, Dieppe
- Study start
- Apr 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 28 Mar 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.
This study aims to estimate the vaccinal immunity four years after four doses of MenbVac in children aged 4-8 years.
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: MenbVac |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children born between 01/01/2000 and 06/23/2005, living in Dieppe-Est, Dieppe-Ouest and Offranville, vaccinated with four doses of MenBVac in the first MenbVac clinical trial study,
- parental authority(ies)assent.
Key exclusion criteria (4 listed)
- no parental authority(ies)assent,
- no parental authority(ies)assent,
- no blood sample during the third vaccination,
- impossibility of third 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 test | Biological | Bras A |
Primary outcome
vaccine Immunity
Time frame: two and a half years after the fouth vaccination
assessment of vaccine Immunity with measure of percentage of children with an hSBA title >= 4 four years after four doses of MenbVac
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 Jun 2026.
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.
François Caron, Professor principal investigator
CHU - Hôpitaux de Rouen
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 Vaccination With MenbVac, 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 2 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 2 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: two and a half years after the fouth vaccination). 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 Jun 2026.