A Study on the Immune Response and Safety Elicited by a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Influenza in Adults Aged 60 Years and Above
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Intervention: RSVPreF3 OA investigational vaccine; FLU-QIV
Intervention description: RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm.; FLU-QIV administered intramuscularly in the deltoid region of the dominant (Co-Ad Group) arm or the non-dominant (Control Group) arm.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 976.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the
      RSVPreF3 OA investigational vaccine when co-administered with the seasonal quadrivalent
      influenza vaccine (FLU-QIV) in adults aged 60 years and above compared to separate
      administration of the vaccines.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants, who, in the opinion of the investigator, can and will comply with the
             requirements of the protocol A male or female ≥60 YOA at the time of the first study
             intervention administration.

          -  Participants living in the general community or in an assisted-living facility that
             provides minimal assistance, such that the participant is primarily responsible for
             self-care and activities of daily living.

          -  Written or witnessed informed consent obtained from the participant prior to
             performance of any study-specific procedure.

          -  Participants who are medically stable in the opinion of the investigator at the time
             of first vaccination. Participants with chronic stable medical conditions with or
             without specific treatment are allowed to participate in this study if considered by
             the investigator as medically stable.

        Exclusion Criteria:

        Medical conditions

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition resulting
             from disease or immunosuppressive/cytotoxic therapy based on medical history and
             physical examination.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccines.

          -  Hypersensitivity to latex.

          -  History of GBS, anaphylaxis, febrile seizures, Bell's palsy and narcolepsy.

          -  Serious or unstable chronic illness.

          -  Any history of dementia or any medical condition that moderately or severely impairs
             cognition.

          -  Recurrent or un-controlled neurological disorders or seizures. Participants with
             medically-controlled active or chronic neurological diseases can be enrolled in the
             study as per investigator assessment, provided that their condition will allow them to
             comply with the requirements of the protocol (e.g. completion of diary cards, attend
             regular phone calls/study site visits).

          -  Significant underlying illness that in the opinion of the investigator would be
             expected to prevent completion of the study

          -  Any medical condition that in the judgment of the investigator would make
             intramuscular injection unsafe.

        Prior/Concomitant therapy

          -  Use of any investigational or non-registered product (drug, vaccine or medical device)
             other than the study interventions during the period beginning 30 days before the
             first dose of study vaccines and ending 30 days after the last vaccine administration,
             or planned use during the study period.

          -  Administration of an influenza vaccine during the 6 months preceding the study FLU-QIV
             administration.

          -  Planned or actual administration of a vaccine not foreseen by the study protocol in
             the period starting 30 days before the first study intervention administration and
             ending 30 days after the last study intervention administration.

        Note: In case an emergency mass vaccination for an unforeseen public health threat is
        recommended and/or organized by the public health authorities, outside the routine
        immunization program, the time period described above can be reduced if necessary for that
        vaccine provided it is used according to the local governmental recommendations and that
        the Sponsor is notified accordingly.

          -  Previous vaccination with an RSV vaccine.

          -  Administration of long-acting immune-modifying drugs or planned administration at any
             time during the study period).

          -  Administration of immunoglobulins and/or any blood products or plasma derivatives
             during the period starting 90 days before the first dose of study vaccine or planned
             administration during the study period.

          -  Chronic administration (defined as more than 14 consecutive days in total) of
             immunosuppressants or other immune-modifying drugs during the period starting 90 days
             prior to the first study vaccination or planned administration during the study
             period. For corticosteroids, this will mean prednisone ≥20 mg/day, or equivalent.
             Inhaled and topical steroids are allowed.

        Prior/Concurrent clinical study experience

        • Concurrently participating in another clinical study, at any time during the study
        period, in which the participant has been or will be exposed to an investigational or a
        non-investigational intervention (drug/invasive medical device).

        Other exclusions

          -  History of chronic alcohol consumption and/or drug abuse as deemed by the investigator
             to render the potential participant unable/unlikely to provide accurate safety reports
             or comply with study procedures.

          -  Planned move during the study conduct that prohibits participation until 1 month
             post-last vaccine administration.

          -  Bedridden participants.

          -  Participation of any study personnel or their immediate dependents, family, or
             household members.