Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Janssen Vaccines & Prevention B.V.
Age
60–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Before randomization, a participant must be: a) postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause); and b) not intending to conceive by any methods
From the time of vaccination through 3 months after vaccination, agrees not to donate blood
In the investigator's clinical judgment, a participant must be in stable health at the time of vaccination. Participants may have underlying illnesses such as hypertension, congestive heart failure, chronic obstructive pulmonary disease, Type 2 diabetes, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms and signs are stable at the time of vaccination, and these conditions receive routine follow-up by the participant's healthcare provider. Participants will be included on the basis of medical history and vital signs performed between informed consent form (ICF) signature and vaccination
Must be able to read, understand, and complete questionnaires in the electronic diary (eDiary)
Must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
Must be able to work with smartphones/tablets/computers
You may not be if
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)
Abnormal function of the immune system resulting from clinical conditions or medication
Per medical history, participant has chronic active hepatitis B or hepatitis C infection
History of acute polyneuropathy (example, Guillain-Barré syndrome) or chronic idiopathic demyelinating polyneuropathy
Has had major surgery (per the investigator's judgment) within 4 weeks before administration of the study vaccine or will not have recovered from surgery per the investigator's judgment at time of vaccination
Has had major psychiatric illness and/or drug or alcohol abuse which in the investigator's opinion would compromise the participant's safety and/or compliance with the study procedures
Clareo Health | A Study of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years
