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VaccinationPhase 4EFFIVACNCT01054053

Evaluation of Immune Response Against the Strain of Neisseria Meningitidis B: 14, P1-7, 16 Patients Have to be Vaccinated MenBVac®

A Phase 4 study testing MenBVac Vaccination in people with Vaccination, run by University Hospital, Rouen at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 first vaccination (T0), after the… Read more about this study

Who is it for?
Ages 1 year to 5 yearsHealthy volunteers can take part
Conditions the study is for
Vaccination
What is being tested?
MenBVac Vaccination
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
218 participants
Where
1 siteFrance
Study dates
Apr 2009to Jan 2011
Phase
Phase 4
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 1 year to 5 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, vaccinated five times by MenBVac
  • parental authority(ies)assent

Who cannot join

  • no parental authority(ies)assent
  • no blood sample during the third vaccination
  • impossibility of third vaccination
  • children with guardianship
  • children yet vaccinated or non eligible for vaccination

Trial locations and contacts

1 site in 1 country.

France1 site

  • Maison Du Département

    Neufchâtel-en-Bray, 76270

Other trials in France

About this study

Official title: Phase 3, Vaccinal Activity Assessment of MenBVac Against Nesseiria Menigitidis 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 first vaccination (T0), after the second MenBvac vaccination (6 weeks after the second vaccination), before the third MenBvac vaccination and after the third MenBvac vaccination (6 weeks after the second vaccination) and one year after the third menBvac vaccination.

Conditions
Vaccination
Being tested
MenBVac Vaccination
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.

  • MenBVac VaccinationBiological

    • First blood sample prior to vaccination with MenBVac
    • First and second doses of MenBVac
    • Second blood sample 6 weeks after the second dose of the vaccine
    • Third blood sample immediatly before the third dose of the vaccine
    • Third dose of MenBVac
    • Fourth blood sample 6 weeks after the third dose of the vaccine
    • Fifth blood sample one year after the third dose of the vaccine
Study groups in NCT01054053
Study groupRoleWhat they receive
MenBVac Vaccination GroupExperimentalChildren born between 06/04/2004 and 17/04/2008 and called to menBvac vaccination and living around Neufchatel en Bray.
Receives: Biological: MenBVac Vaccination

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. assessment of natural Immunity with measure of percent of children who have hSBA title >= 4 at TO. assessment of antibodies blood persistence during measurement of percent of children who have hSBA title >= 4

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2010 (estimated)
  2. Study startApr 2009
  3. Primary completionOct 2010
  4. Study completionJan 2011

Resources

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 4
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
218 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01054053
Sponsor's protocol ID
2009/042/HP
Acronym
EFFIVAC
Status last verified
Mar 2012
First submitted
26 Nov 2009
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Caron F, Delbos V, Houivet E, Deghmane AE, Leroy JP, Hong E, Benichou J, Taha MK. Evolution of immune response against Neisseria meningitidis B:14:P1.7,16 before and after the outer membrane vesicle vaccine MenBvac. Vaccine. 2012 Jul 20;30(34):5059-62. doi: 10.1016/j.vaccine.2012.05.051. Epub 2012 May 30.

    PubMed 22658929

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing MenBVac Vaccination in people with Vaccination, 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 5 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

assessment of natural Immunity with measure of percent of children who have hSBA title >= 4 at TO. assessment of antibodies blood persistence during measurement of percent of children who have hSBA title >= 4 (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01054053, which also lists 1 linked publication.

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.

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