Evaluation of Immune Response Against the Strain of Neiss... | NCT01565577

Studies
Evaluation of Immune Response Against the Strain of Neisseria Meningitidis B: 14, P1-7, 16 Patients Vaccinated With MenBVac® (Extension MenbVac)

NCT01565577

Sponsor

University Hospital, Rouen

Status

Completed

Last Update Posted

Jun 2, 2026Actual

Enrollment

117Actual

Phase

Phase 3

Conditions

Vaccination With MenbVac

Interventions

MenbVac

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2011-006268-27	EudraCT Number

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Jun 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

Mar 26, 2012

First Submission Date that Met QC Criteria

Mar 26, 2012

First Posted Date

Mar 28, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2026

Last Update Posted Date

Jun 2, 2026Actual

Name	Class
Direction Générale de la Santé, France	OTHER
Institut Pasteur	INDUSTRY
Dieppe	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to estimate the vaccinal immunity four years after four doses of MenbVac in children aged 4-8 years.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

117Actual

Label	Type	Description	Intervention Names
Bras A	Experimental		Biological: MenbVac

Name	Type	Description	Arm Group Labels	Other Names
MenbVac	Biological	Blood test	Bras A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
vaccine Immunity	assessment of vaccine Immunity with measure of percentage of children with an hSBA title >= 4 four years after four doses of MenbVac	two and a half years after the fouth vaccination

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

no parental authority(ies)assent,
no parental authority(ies)assent,
no blood sample during the third vaccination,
impossibility of third vaccination.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
François Caron, Professor	CHU - Hôpitaux de Rouen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UH-rouen		Rouen	Seine Maritime	76000	France