Immunogenicity and Reactogenicity of a Meningococcal B Outer Membrane Vesicle Vaccine Given in a 0,6,12 Month Schedule to Health UK Adults

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00197795

Enrollment

Registered

2005-09-20

Start date

2005-01-31

Completion date

2006-12-31

Last updated

2018-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neisseria Meningitidis

Brief summary

To measure the serum bactericidal antibody levels and cell mediated immune responses before and six weeks after each dose of meningococcal outer membrane vesicle vaccine given at 0,6 and 12 weeks to healthy UK adults.

Interventions

BIOLOGICALMeningococcal outer membrane vesicle vaccine MenBVac

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Informed written consent given for three immunizations with MenBVac and five blood tests * Between the ages of 18 and 55 years inclusive at recruitment

Exclusion criteria

* Previous history of bacteriologically confirmed meningococcal disease * History of clinically significant allergic sensitivity to any vaccine received in the past * Immunodeficiency * Any other acute or chronic systemic illness or dependence or abuse of drugs or alcohol * Language difficulties sufficient to preclude adequate comprehension of the study information * Possibility of pregnancy * Receipt of any other vaccine in the previous 4 weeks * Receipt of any group B vaccine in the past * Current participation in any other clinical trial * Generalized acute systemic illness and/or temp \>38C on day of vaccination deferral

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026