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