- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00962624
Study of Meningococcal B Vaccine and ACWY Conjugate Vaccine in Healthy Adults (MenOccy)
September 17, 2018 updated by: Prof. Elizabeth Miller
A Phase 2, Open-label Study of the Safety, Tolerability and Immunogenicity of a Meningococcal B Vaccine When Administered at a 0, 2, 6 Months and of a Single Dose of Meningococcal ACWY Conjugate Vaccine in Healthy Adults Aged 18-65 Years
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Laboratory staff at the Manchester Medical Microbiology Partnership may be at potential occupational exposure to meningococci.
No licensed vaccine is available against serogroup B meningococci and the available plain polysaccharide serogroup ACYW vaccine is poorly immunogenic.
Novartis Vaccines have developed an investigational serogroup B vaccine and a conjugated ACYW vaccine.
This study will investigate these vaccines ability to induce a protective response in laboratory staff from the Manchester Medical Microbiology Partnership.
Three doses of the meningococcal B vaccine will be administered at 0, 2 and 6 months and a single dose will be administered at 0 months.
Blood samples will be taken before and after each vaccination and functional antibodies determined.
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Manchester, United Kingdom, M13 9WZ
- Manchester Medical Microbiology Partnership
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of subjects attaining putative protective antibody concentrations against meningococci in the serum bactericidal antibody assay
Time Frame: one month following the last vaccination
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one month following the last vaccination
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ray Borrow, PhD, Public Health England
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
March 1, 2012
Study Registration Dates
First Submitted
August 19, 2009
First Submitted That Met QC Criteria
August 19, 2009
First Posted (Estimate)
August 20, 2009
Study Record Updates
Last Update Posted (Actual)
September 19, 2018
Last Update Submitted That Met QC Criteria
September 17, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- Infections
- Central Nervous System Infections
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Meningitis, Bacterial
- Central Nervous System Bacterial Infections
- Meningococcal Infections
- Neisseriaceae Infections
- Meningitis, Meningococcal
- Meningitis
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
Other Study ID Numbers
- MenOccy
- I72P1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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