A Study of an Ad26.RSV.preF-based Vaccine and High-dose Seasonal Influenza Vaccine, With and Without Coadministration, in Adults Aged 65 Years and Older
Condition: Influenza, Human Prevention; Respiratory Syncytial Viruses Prevention
MeSH terms: Influenza, Human
Intervention: Ad26.RSV.preF-based vaccine; Quadrivalent High-dose Influenza Vaccine; Placebo
Intervention description: Ad26.RSV.preF-based vaccine will be administered as single IM injection.; Quadrivalent High-dose Influenza Vaccine will be administered as IM injection.; Placebo will be administered as IM injection to Ad26.RSV.preF-based vaccine.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 777.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the immunogenicity and safety of Ad26.RSV.preF-based
      vaccine and quadrivalent high-dose seasonal influenza vaccine when administered either
      concomitantly or separately.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing and able to adhere to the prohibitions and restrictions specified in this
             protocol

          -  In the investigator's clinical judgment, the participant must be in stable health at
             the time of vaccination. Participants will be included on the basis of medical history
             and vital signs performed between informed consent from (ICF) signature and
             vaccination

          -  Before randomization, a participant must be not intending to conceive by any methods,
             postmenopausal or surgically sterile

          -  From the time of vaccination through 3 months after vaccination, agrees not to donate
             blood

          -  Must be willing to provide verifiable identification, have means to be contacted and
             to contact the investigator during the study

          -  Participant must be able to work with smartphones/tablets/computers

        Exclusion Criteria:

          -  History of malignancy within 5 years before screening not in the following categories:
             a) participants with squamous and basal cell carcinomas of the skin and carcinoma in
             situ of the cervix may be enrolled at the discretion of the investigator; b)
             participants with a history of malignancy within 5 years before screening, with
             minimal risk of recurrence per investigator's judgement, can be enrolled

          -  Known or suspected allergy or history of anaphylaxis or other serious adverse
             reactions to vaccines or their excipients (including specifically the excipients of
             the study vaccine)

          -  History of severe allergic reactions (example, anaphylaxis) to any component of the
             Quadrivalent high-dose influenza vaccine, including egg protein, or following a
             previous dose of any influenza vaccine

          -  Has abnormal function of the immune system resulting from either clinical condition,
             chronic or recurrent use of systemic corticosteroids within 2 months prior to study
             vaccination, or immunomodulating agents within 6 months prior to study vaccination

          -  Per medical history, participant has chronic active hepatitis B or hepatitis C
             infection

          -  History of acute polyneuropathy (example, Guillain-Barre syndrome) or chronic
             idiopathic demyelinating polyneuropathy

          -  Has a serious chronic disorder, example, chronic obstructive pulmonary disease or
             congestive heart failure, end-stage renal disease with or without dialysis, clinically
             unstable cardiac disease, Alzheimer's disease, or has any condition, including
             conditions placing the participant at high risk for severe influenza, for which, in
             the opinion of the investigator, participation would not be in the best interest of
             the participant or that could prevent, limit, or confound the protocol-specified
             assessments

          -  Received vaccination with seasonal influenza vaccine for the current influenza season
             in the Northern Hemisphere