Overview

Study of Meningococcal B Vaccine and ACWY Conjugate Vaccine in Healthy Adults

Status:
Completed
Trial end date:
2012-03-01
Target enrollment:
0
Participant gender:
All
Summary
The study involves the measurement of immune response to vaccination with three doses of a meningococcal B vaccine and a single dose of a meningococcal ACYW conjugate vaccine in healthy adults (Laboratory workers). The study will be completed at the Manchester Medical Microbiology Partnership in the UK and will enrol staff who may be at potential occupational exposure to meningococci. Blood samples will be taken before and after each vaccination and used to determine if the vaccines induce protective responses.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Dr. Elizabeth Miller
Prof. Elizabeth Miller
Collaborator:
Novartis Vaccines
Treatments:
Vaccines
Criteria
Inclusion Criteria:

- Aged 18-65 years of age

- Who have given written informed consent after the nature of the study has been
explained.

- Who work within the Manchester Medical Microbiology Partnership and may be at
potential occupational exposure to meningococci.

Exclusion Criteria:

- The possibility of pregnancy

- A serious chronic disease including progressive neurological disease or seizure
disorder.

- Have a known bleeding diathesis, or any condition that may be associated with a
prolonged bleeding time.

- Have a history of severe allergic reactions after previous vaccinations such as
anaphylactic shock, asthma, urticaria, or other allergic reaction or hypersensitivity
to any vaccine component.

- Have received another investigational agent within 90 days or before completion of the
safety follow-up period in another study, whichever is longer, prior to enrollment and
unwilling to refuse participation in another investigational trial through the end of
the study.