Overview

Improved Novel VaccIne CombinaTion InflUenza Study

Status:
Terminated
Trial end date:
2018-10-31
Target enrollment:
0
Participant gender:
All
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-administration of a viral vectored vaccine, MVA- NP+M1, and the annual recommended licensed inactivated influenza vaccine (IIV). Within the main cohort 100 participants will be recruited to an immunology sub-cohort.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Vaccitech (UK) Limited
Vaccitech Limited
Collaborator:
University of Oxford
Treatments:
Vaccines
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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