E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10016790 |
E.1.2 | Term | Flu |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10022000 |
E.1.2 | Term | Influenza |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the efficacy of MVA-NP+M1 in combination with licensed inactivated influenza vaccine in adults ≥65 years. |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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.
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E.5.1.1 | 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. |
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E.5.2 | 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
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E.5.2.1 | 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
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 14 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 14 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial is one week after the last data capture of the last volunteer. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 4 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 4 |