Evaluation of Immune Response Against the Strain of Neisseria Meningitidis B: 14, P1-7, 16 in Patients Having to be Vaccinated MenBVac® (Extension EFFIVAC)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01054053

Vaccination

COMPLETED

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

NCT01565577

Vaccination With MenbVac

COMPLETED PHASE3

Immunogenicity After Two Doses of Meningococcal Outer Membrane Vesicle Vaccine MenBVac

NCT00450554

Vaccination

COMPLETED

Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

NCT00381615

Healthy

COMPLETED PHASE2

Safety and Immunogenicity Study of Two Doses of Novartis Meningococcal Serogroup B Recombinant Vaccine in Adolescents Aged 11-17 Years.

NCT01973218

Meningococcal Disease

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neisseria Meningitidis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bras A

children, born between the 06/04/2004 and the 17/04/2008, living around Neufchatel en Bray, before the fourth dose of MenBVac

MenBvac

Intervention Type BIOLOGICAL

Blood test

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MenBvac

Blood test

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* no parental authority(ies)assent,
* no blood sample,
* impossibility of fourth vaccination,
* children yet vaccinated or non eligible for vaccination.

Minimum Eligible Age

4 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes