A Study to Evaluate the Safety and Immunogenicity of Seasonal Influenza Vaccine and an Adenovirus Serotype 26- Based Vaccine Encoding for the Respiratory Syncytial Virus Pre-fusion F Protein (Ad26.RSV.preF), With and Without Co-administration, in Adults Aged 60 Years and Older in Stable Health
Condition: Healthy
Intervention: Ad26.RSV.preF; Fluarix; Placebo
Intervention description: Ad26.RSV.preF will be administered as intramuscular injection at a dose of 1*10^11 vp.; Fluarix will be administered as intramuscular injection.; Placebo will be administered as intramuscular injection of sterile 0.9 percent (%) saline for injection.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 180.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to demonstrate the non-inferiority of the concomitant
      administration of an adenovirus serotype 26- based vaccine encoding for the respiratory
      syncytial virus pre-fusion F protein (Ad26.RSV.preF) and seasonal influenza vaccine versus
      the administration of seasonal influenza vaccine alone in terms of humoral immune response
      expressed by the geometric mean titers (GMTs) of hemagglutination inhibition (HI) antibody
      titers against all four influenza vaccine strains 28 days after the administration of
      influenza vaccine, and to assess the safety and tolerability of a single dose of 1*10^11
      viral particles (vp) of Ad26.RSV.preF, administered intramuscularly to participants aged
      greater than or equal to 60 years separately or concomitantly with seasonal influenza
      vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Each participant must sign an informed consent form (ICF) indicating that he or she
             understands the purpose of and procedures required for the study, is willing to
             participate in the study and attend all scheduled visits, and is willing and able to
             comply with all study procedures and adhere to the prohibitions and restrictions
             specified in this protocol

          -  Before randomization, a woman must be:

               1. Postmenopausal (A postmenopausal state is defined as no menses for 12 months
                  without an alternative medical cause) and

               2. Not intending to conceive by any methods

          -  In the investigator's clinical judgment, participant must be either in good or stable
             health, and not at risk of serious complications from influenza. Participants may have
             underlying illnesses such as hypertension, type 2 diabetes, hyperlipoproteinemia, or
             hypothyroidism, as long as their symptoms/signs are medically controlled. If they are
             on medication for a condition, the medication dose must have been stable for at least
             12 weeks (or only small, clinically non-significant changes have been made in the
             judgement of the Principal Investigator) preceding vaccination and expected to remain
             stable for the duration of the study. Participants will be included on the basis of
             physical examination, medical history, vital signs, and 12-lead electrocardiogram
             (ECG) performed on Day 1

          -  From the time of first vaccination through 3 months after the second dose of study
             vaccine, participant agrees not to donate blood

          -  Participant must be willing to provide verifiable identification, have means to be
             contacted and to contact the investigator during the study

        Exclusion Criteria:

          -  Participant has acute illness (this does not include minor illnesses such as diarrhea)
             or temperature greater than or equal to (>=) 38.0 degree Celsius (ºC) within 24 hours
             prior to the first dose of study vaccine; enrollment at a later date is permitted

          -  Participant has a serious chronic disorder, including severe chronic obstructive
             pulmonary disease or clinically significant congestive heart failure, requirement for
             supplemental oxygen, end stage renal disease with or without dialysis, clinically
             unstable cardiac disease, Alzheimer's disease, or has any condition for which, in the
             opinion of the investigator, participation would not be in the best interest of the
             participant (for example, compromise well-being) or that could prevent, limit, or
             confound the protocol-specified assessments

          -  Participant has history of malignancy within 5 years before screening (exceptions are
             squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or
             malignancy, which is considered cured with minimal risk of recurrence)

          -  Participant has had major surgery (per the investigator's judgment), within 4 weeks
             before dosing, or will not have fully recovered from surgery, or has surgery planned
             during the time the participant is expected to participate in the study or within 6
             months after the final dose of study vaccine

          -  Participant has chronic active hepatitis B or hepatitis C infection, documented by
             hepatitis B surface antigen and hepatitis C antibody, respectively