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
Conditions
Interventions
Product Name: MVA-NP+M1
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration o
Sponsors
Vaccitech Limited
Eligibility
Sex/Gender
All
Inclusion 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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of MVA-NP+M1 in combination with licensed inactivated influenza vaccine in adults =65 years.; Primary end point(s): The primary outcome measure will be the number of days with moderate or severe influenza-like symptoms throughout the influenza season recorded using electronic or paper diaries of self-reported symptoms. ;Timepoint(s) of evaluation of this end point: Number of days with moderate or severe influenza-like symptoms will be assessed throughout the influenza season. ; Secondary Objective: To assess the incidence of Influenza-Like-Illness (ILI) in adults aged 65 years and above vaccinated with MVA NP+M1 in combination with the recommended annual licensed inactivated vaccine. To assess the severity of influenza-like symptoms in adults aged 65 years and above vaccinated with MVA NP+M1 in combination with the recommended annual licensed inactivated vaccine To assess the duration of ILI in adults aged 65 years and above vaccinated with MVA NP+M1 in combination with the recommended annual licensed inactivated vaccine To assess the occurrence of GP consultations from respiratory illness in adults aged 65 years and above vaccinated with MVA NP+M1 in combination with the recommended annual licensed inactivated vaccine To assess the hospitalisations and deaths due to respiratory illness in adults aged 65 years and above vaccinated with MVA NP+M1 in combination with the recommended annual licensed inactivated vaccine To assess the safety and reactogenicity of MV | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1. Incidence of influenza-like-illness: throughout the influenza season 2. Severity of influenza-like symptoms: throughout the influenza season 3. Duration of influenza-like-illness: throughout the influenza season 4. Occurrence of GP consultations from respiratory illness: throughout the influenza season 5. Occurrence of hospitalisations and deaths due to respiratory illness: throughout the influenza season 6. Occurrence of solicited local and systemic reactogenicity signs and symptoms for 7 days following vaccination: Day 0-7 following vaccination 7. Occurrence of unsolicited adverse events for 28 days following vaccination: Day 0-28 following vaccination 8. Occurrence of serious adverse events throughout volunteers’ participation in the trial: Day 1-3, Day 7-9, every 3-4 weeks ; Secondary end point(s): 1. Incidence of influenza-like-illness 2. Severity of influenza-like symptoms 3. Duration of influenza-like-illness 4. Occurrence of GP consultations from respiratory illness 5. Occurrence of hospitalisations and deaths due to respiratory illness 6. Occurrence of solicited local and systemic reactogenicity signs and symptoms for 7 days following vaccination 7. Occurrence of unsolicited adverse events for 28 days following vaccination 8. Occurrence of serious adverse events throughout volunteers’ participation in the trial 9. Breadth of influenza-specific T-cells and antibodies 10. Incidence rate of laboratory confirmed influenza using RT-PCR | — |
Countries
United Kingdom
Contacts
Public ContactJulie Allen
University of Oxford
Outcome results
None listed