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A Study of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years

Respiratory Syncytial Virus Prevention
Clinicaltrials.gov:
EudraCT:
J&J ID:
#CR109069
Other:
#VAC18193RSV3003
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Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Note: The criteria listed here are only a general guide. To join any trial, you must first have a medical check by a qualified doctor or healthcare professional. They will decide if the trial is a good fit and safe for your health.
Access detailed information on the trial:
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