Status:
COMPLETED
Pneumococcal Adult Kinetics Study - Understanding the B Cell Response to Pneumococcal Vaccines
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
Mason Medical Research Trust
Conditions:
Pneumococcal Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is an open-label phase III clinical trial. The purpose of this trial is to investigate in detail the kinetics of the immune response to Prevenar-13, a pneumococcal conjugate vaccine, compared to ...
Eligibility Criteria
Inclusion
- Above 18 years of age.
- Participant is willing and able to give informed consent for participation after the nature of the study has been explained;
- In good health as determined by:
- medical history
- history-directed physical examination
- clinical judgment of the investigator
- Able (in the Investigators opinion) and willing to comply with all study requirements including be available for all the visits scheduled in the study
- Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
Exclusion
- Have previously received a pneumococcal vaccine
- Have received vaccination with a vaccine containing either CRM197 or diphtheria toxoid within the past 12 months,
- Have had previous ascertained disease caused by C. diphtheriae, or S. pneumoniae in the past 5 years documented in their medical notes
- 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 immunostimulants
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01432158
Start Date
January 1 2012
Last Update
November 9 2015
Active Locations (1)
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1
Oxford Vaccine Group
Oxford, United Kingdom