NCT01565577

CompletedPhase 3

Evaluation of Immune Response Against the Strain of Neisseri...

University Hospital, Rouen Source

University Hospital, Rouen

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

2011/199/HP

Secondary identifiers

2011-006268-27

EUDRACT_NUMBER

Study Type

interventional

Actual enrollment (reported)

117

Locations

1 country

Sites

1

Timeline

Study Start

April 2012

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

June 2012

Actual (reported)

Study Completion

September 2012

Actual (reported)

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 117 participants
Study completion date: September 2012
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
March 26, 2012
Actual (reported)
First Posted
March 28, 2012
Actual (reported)
Study Start
April 2012
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
June 2012
Actual (reported)
Study Completion
September 2012
Actual (reported)

Last Updated: June 2, 2026
Status Verified: September 2014
Last Update Submitted: June 1, 2026

Conditions

Vaccination With MenbVac

Keywords

Neisseria meningitidis B:14, P1-7, 16Serum bactericidal activityMenbvac

Outcome Measures

Primary Outcomes (1)

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

Study Arms (1)

Bras A

EXPERIMENTAL

Biological: MenbVac

Interventions

MenbVacBiological

Blood test

Bras A

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age7 Years - 12 Years

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17)

You may qualify if:

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.

Sponsors & Collaborators

Dieppe
Type not reportedcollaborator
Direction Générale de la Santé, France
Othercollaborator
Institut Pasteur

Study Sites (1)

UH-rouen

Rouen, Seine Maritime, 76000, France

Study Officials

François Caron, Professor
CHU - Hôpitaux de Rouen
PRINCIPAL INVESTIGATOR

Enrollment

117 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: NA
Masking: NONE
Purpose: HEALTH SERVICES RESEARCH
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 26, 2012

First Posted

March 28, 2012

Study Start

April 2012

Date type not reported

This date has not been verified as actual or estimated.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Industrycollaborator

University Hospital, Rouen

Otherlead

Primary Completion

June 2012

Actual (reported)

Study Completion

September 2012

Actual (reported)

Last Updated

June 2, 2026

Record last verified: 2014-09

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01565577
Data provider: ClinicalTrials.gov
Source updated: 2026-06-02
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:36:14 UTC

Locations

FR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Bras A

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations