Status:
TERMINATED
Improved Novel VaccIne CombinaTion InflUenza Study
Lead Sponsor:
Barinthus Biotherapeutics
Collaborating Sponsors:
University of Oxford
Conditions:
Influenza
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief Summary
A Phase IIb randomised, participant-blinded, placebo-controlled, multi-centre phase IIb efficacy study in 2030 volunteers aged 65 and over. The study will assess the safety and efficacy of the co-admi...
Detailed Description
The efficacy of current seasonal influenza vaccines is limited in the face of antigenic mismatch between circulating viral strains and those in the given vaccine. Additionally vaccination in older adu...
Eligibility Criteria
Inclusion
- Volunteer is willing and has capacity to provide written informed consent for participation in the trial (in the Investigator's opinion).
- Male or female adults, aged 65 years and above
- Able and willing (in the Investigator's opinion) to comply with all study requirements
- Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner
- Eligible to receive seasonal influenza vaccine
Exclusion
- Any history of anaphylaxis in reaction to vaccination or history of allergic reactions likely to be exacerbated by any component of the vaccine (e.g. egg allergy)
- Ongoing terminal illness with a life expectancy estimated to be approximately \<6 months.
- Continuous use of oral anticoagulants, such as coumarins and related anticoagulants (i.e. warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban)
- Any other significant disease, disorder or finding (including blood test results), which, in the opinion of the Investigators, would either put the volunteer at risk because of participation in the study, or may influence the result of the study
- Participation in another clinical trial of an investigational medicinal product in the 30 days preceding enrolment, or planned use during the study period
- Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data
- Receipt of annual seasonal influenza vaccine prior to enrolment (for the same influenza season volunteers are recruited in)
- Not willing to comply with study procedures
Key Trial Info
Start Date :
October 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2018
Estimated Enrollment :
862 Patients enrolled
Trial Details
Trial ID
NCT03300362
Start Date
October 13 2017
End Date
October 31 2018
Last Update
November 23 2018
Active Locations (5)
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1
The Boathouse Surgery
Pangbourne, Berkshire, United Kingdom, RG8 7DF
2
Wokingham Medical Centre
Wokingham, Berkshire, United Kingdom, RG40 1XS
3
Bicester Health Centre
Bicester, Oxfordshire, United Kingdom, OX26 6AT
4
Centre for Clinical Vaccinology and Tropical Medicine (CCVTM
Oxford, Oxfordshire, United Kingdom, OX3 7LJ