Efficacy of Candidate Influenza Vaccine MVA-NP+M1 in Adults
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: MVA-NP+M1; Saline
Intervention description: Trial Vaccine; Sodium Chloride Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2364.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A Phase 2b Study to Determine the Efficacy of Candidate Influenza Vaccine MVA-NP+M1 in Adults
      aged 18 years and over. To assess the effect of MVA-NP+M1 on the reduction of laboratory
      confirmed influenza when given as an adjunct to licensed quadrivalent influenza vaccine (QIV)
      in adults
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male or female adults aged 18 years and over

          -  Receipt of a standard-dose licensed influenza QIV vaccine on the day of, or within 28
             days prior to, randomisation

          -  A female participant is eligible for this study if she is not pregnant or breast
             feeding and one of the following:

               1. Of non-childbearing potential (i.e. women who have had a hysterectomy or tubal
                  ligation or are postmenopausal, as defined by no menses in greater than or equal
                  to 1 year)

               2. Of childbearing potential but agrees to practice effective contraception 8 weeks
                  post-vaccination and has a negative urine pregnancy test pre-vaccination.
                  Acceptable methods of contraception include one or more of the following:

             i. Male partner who is sterile prior to the female participant's entry into the study
             and is the sole sexual partner for the female participant ii. Implants of
             levonorgestrel iii. Injectable progestogen iv. An intrauterine device with a
             documented failure rate of <1% v. Oral contraceptives vi. Double barrier methods
             including diaphragm or condom vii. Abstinence as long as it is line with the usual and
             preferred lifestyle of the participant

          -  Participant is willing and has capacity to provide written informed consent for
             participation in the study (in the Investigator's opinion)

          -  Able and willing (in the Investigator's opinion) to comply with all study requirements

          -  Willing to allow the Investigators to discuss the participant's medical history with
             their healthcare provider

          -  Present and able to visit the clinic in the event of an ILI episode during the
             influenza season

        Exclusion Criteria:

          -  Any other significant disease, disorder or finding (including blood test results),
             which, in the opinion of the Investigator, would either put the participant at risk
             because of participation in the study, or may influence the result of the study

          -  Receipt of any investigational product within 6 months prior to study, or prior
             participation in a clinical study of any Influenza vaccine and agreement not to
             participate in another clinical study for the duration of study follow-up

          -  Prior receipt of an investigational vaccine likely to impact on interpretation of the
             study data

          -  Active infection with HIV, Hepatitis B or Hepatitis C (from patient history or medical
             records)

          -  History of severe allergic reactions (e.g. anaphylaxis)

          -  History of auto-immune disease e.g. Guillain-Barré syndrome

          -  Not willing to comply with study procedures

          -  Immunosuppressed or taking immunosuppressive medications

          -  Use of warfarin or other blood thinning medications (aspirin is acceptable)

          -  Tattoos or birthmarks at the vaccination site

          -  Participant bruises easily, has haematoma or keloid scarring

          -  Receipt of a licenced inactivated vaccine (e.g. pneumococcal vaccine) within 2 weeks
             prior to vaccination

          -  Receipt of an off licensed live vaccine (e.g. herpes zoster vaccine) within 4 weeks
             prior to vaccination