Who is sponsoring NCT02398396?

NCT02398396 is sponsored by University of Oxford.

What condition does NCT02398396 study?

NCT02398396 studies Meningococcal Vaccines, Meningococcal Infections, Neisseria Meningitidis, Factor H-binding Protein, Neisseria Meningitidi.

What drugs are being tested in NCT02398396?

Interventions: 4CMenB (Bexsero®) - Novartis Vaccines and Diagnostics.

What is the status of NCT02398396?

NCT02398396 is currently COMPLETED.

Last reviewed 2021-10-26 · How we verify

Investigating Meningococcal Vaccines in Adults - An Exploratory, Open-label, Immunogenicity Study of a Licensed Meningococcal Capsular Group B Vaccine (4CMenB, Bexsero®) in Adults

NCT02398396 NA COMPLETED

This study will be an open label, exploratory immunogenicity study conducted by the Oxford Vaccine Group, University of Oxford. This study will investigate the breadth of protective activity of serum anti-FHbp antibody responses of adults immunized with 4CMenB (Bexsero®) vaccine as well as investigating the nature of the B-cell and T-cell responses induced by vaccination. The investigators aim to enroll 15 to 20 healthy adults aged 18 to 60, who will be immunized with two doses of 4CMenB (Bexsero®) two months apart according to the licensed schedule. Blood samples will be obtained at baseline and after each dose of vaccine.

Details

Lead sponsor	University of Oxford
Phase	NA
Status	COMPLETED
Enrolment	15
Start date	2015-04
Completion	2019-06-13

Conditions

Meningococcal Vaccines
Meningococcal Infections
Neisseria Meningitidis
Factor H-binding Protein, Neisseria Meningitidi

Interventions

4CMenB (Bexsero®) - Novartis Vaccines and Diagnostics

Primary outcomes

To characterise the breadth of protective activity of serum anti-FHbp antibody responses of adults immunised with 4CMenB (Bexsero) vaccine — 3 months
As measured by IgG antibody responses to FHbp as measured by serum bactericidal activity against a panel of genetically diverse meningococcal strains

Countries

United Kingdom