A Study of 3 Lots of an Investigational Vaccine Against Respiratory Syncytial Virus (RSV) in Adults Aged 60 Years and Above
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Intervention: RSVPreF3 OA investigational vaccine
Intervention description: One dose of a unique combination of the RSVPreF3 antigen lots (Lot 1, Lot 2 or Lot 3) and extemporaneously reconstituted with AS01E adjuvant lots (Lot A, Lot B and Lot C), administered intramuscularly in the deltoid region of the non-dominant arm, at Day 1.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Study is double blind from start to final analysis after which the study is considered single blind.
Enrollment: 770.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Respiratory syncytial virus; Adults aged 60 years and above; Lot-to-lot consistency; Safety; Reactogenicity

Summary:

      The purpose of this study is to assess the lot-to-lot consistency in terms of immunogenicity
      and evaluate the safety and reactogenicity of 3 lots of the RSVPreF3 OA investigational
      vaccine administered as a single dose in adults ≥ 60 years of age (YOA).
    

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 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 vaccination. Participants with chronic stable medical conditions with or without
             specific treatment, such as diabetes, hypertension or cardiac disease, can 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 (no laboratory testing required).

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the study intervention(s).

          -  Hypersensitivity to latex.

          -  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.

          -  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 intervention(s) during the period beginning 30 days before study
             intervention administration and ending 30 days after study intervention
             administration, or planned use during the study period.

          -  Planned or actual administration of a vaccine not foreseen by the study protocol in
             the period starting 30 days before and ending 30 days after the study intervention
             administration, with the exception of inactivated and subunit influenza vaccines which
             can be administered up to 14 days before or from 14 days after the study vaccination.

          -  Note: In case an emergency mass vaccination for an unforeseen public health threat
             (e.g. a pandemic) 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 administration of the study intervention
             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 study intervention administration 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 vaccine/product (drug or 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 period that will prohibit participating in the study
             until study end.

          -  Bedridden participants.

          -  Participation of any study personnel or their immediate dependents, family, or
             household members.