A phase IIb study to determine the safety and efficacy of candidate influenza vaccine (MVA-NP+M1) in combination with licensed inactivated influenza vaccine in adults aged 65 years and above

Phase 1

• Conditions: Influenza; MedDRA version: 20.0 Level: LLT Classification code 10016790 Term: Flu System Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0 Level: PT Classification code 10022000 Term: Influenza System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2017-001103-77-GB
• Lead Sponsor: Vaccitech Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-15
• Study Completion: 2018-10-31
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 862

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

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2030

Exclusion Criteria

-Any history of anaphylaxis in reaction to vaccination, history of allergic disease or 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified