A Study of Ad26.COV2.S and Influenza Vaccines in Healthy Adults
Condition: COVID-19 Prevention
Intervention: Ad26.COV2.S; Placebo; Influenza Vaccine
Intervention description: Ad26.COV2.S will be administered as an IM injection.; Placebo will be administered as an IM injection.; Influenza vaccine high and standard dose will be administered as IM injection.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 861.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to demonstrate the non-inferiority (NI) of the humoral immune
      response of the 4 influenza vaccine strains after concomitant administration of the
      Ad26.COV2.S vaccine and a seasonal quadrivalent standard-dose influenza vaccine versus the
      administration of a seasonal quadrivalent standard-dose influenza vaccine administered alone;
      and to demonstrate the NI of the binding antibody response after concomitant administration
      of Ad26.COV2.S vaccine and a seasonal quadrivalent standard-dose influenza vaccine versus the
      administration of Ad26.COV2.S vaccine administered alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must be healthy, in the investigator's clinical judgment, as confirmed by
             medical history, physical examination, and vital signs performed at screening.
             Participants may have underlying illnesses, as long as the symptoms and signs are
             medically controlled

          -  Participant either received complete primary vaccination with an authorized/licensed
             coronavirus disease-2019 (COVID-19) vaccine (completed greater than or equal to [>=] 6
             months prior to the last vaccination received against COVID-19) or is COVID-19
             vaccine-naive

          -  All participants who were born female and are of childbearing potential must: a. Have
             a negative highly sensitive urine pregnancy test at screening, b. Have a negative
             highly sensitive urine pregnancy test on the day of vaccination prior to each study
             vaccine administration

          -  Participant agrees to not donate or receive bone marrow, blood, and blood products
             from the administration of the study vaccine until 3 months after receiving the study
             vaccines

          -  Participant must be willing to provide verifiable identification to be contacted and
             to contact the investigator during the study

        Exclusion Criteria:

          -  Participant has a history of malignancy within 1 year before screening (exceptions are
             squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or
             malignancies considered cured with minimal risk of recurrence per investigator's
             clinical judgment)

          -  Participant has a clinically significant acute illness (this does not include minor
             illnesses such as diarrhea or mild upper respiratory tract infection) or temperature
             >= 38.0 degrees celsius (ºC) (100.4 degrees fahrenheit [°F]) within 24 hours prior to
             the planned dose of study vaccine; randomization at a later date is permitted at the
             discretion of the investigator

          -  Participant has history of thrombosis with thrombocytopenia syndrome (TTS) or
             heparin-induced thrombocytopenia and thrombosis (HITT)

          -  Participant has history of capillary leak syndrome

          -  Participant received a licensed/registered severe acute respiratory syndrome
             coronavirus(-2) (SARS-CoV-2) vaccine less than 6 months prior to first study
             vaccination (other than study vaccination)

          -  Participant has a history of any neurological disorders or seizures including
             Guillain-Barre syndrome, with the exception of febrile seizures during childhood