Status:
COMPLETED
Understanding the Immune Response to Meningitis Vaccines
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
Novartis Vaccines
Conditions:
Meningitis
Septicemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to evaluate and compare the immune response to two vaccines against 4 related bacteria: meningococcal serogroups A, C, W-135 and Y. These bacteria can cause meningitis and ...
Detailed Description
In this single centre, open-label, randomised, controlled study of 150 healthy adults aged 18-70 years we will be evaluating the immune response to immunisation with 2 different vaccines against 4 rel...
Eligibility Criteria
Inclusion
- Participant is willing and able to give informed consent for participation after the nature of the study has been explained
- Male or Female, aged 18- 70 years inclusive
- In good health as determined by:
- Medical history
- History-directed physical examination
- Clinical judgment of the investigator
- Female participants of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter
- Able (in the Investigator's opinion) and willing to comply with all study requirements
- Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study
Exclusion
- Are unwilling or unable to give written informed consent to participate in the study
- Have previously received any meningococcal vaccine (this will be confirmed with the participant's general practitioner after enrolment)
- Have previously been diagnosed with laboratory confirmed meningococcal disease
- Have a history of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component
- Have a known or suspected autoimmune disease or impairment /alteration of immune function resulting from (for example):
- Receipt of any immunosuppressive therapy
- Congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months or long-term systemic corticosteroid therapy\* (\*prednisolone or equivalent for more than two consecutive weeks within the past 3 months).
- Have a suspected or known HIV infection or HIV related disease
- Have received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 3 months
- Have a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time
- Have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
- Participation in another clinical trial investigating a vaccine, a drug, a medical device, or a medical procedure
- Pregnancy as confirmed by a positive pregnancy test
- Currently breast-feeding
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00901940
Start Date
June 1 2009
End Date
October 1 2010
Last Update
December 5 2014
Active Locations (1)
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1
University of Oxford, Centre for Clinical Vaccinology and Tropical Medicine
Oxford, United Kingdom, OX3 7LJ