Clareo Health | A Study Evaluating the Immunogenicity of Different Clinical Trial Materials of Ad26.RSV.preF- Based Vaccine in Adults Aged 60 - 75 Years Old
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
Accepted
You may be eligible if
Willing and able to adhere to the prohibitions and restrictions specified in the protocol
Before randomization, a participant must be postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause); and not intending to conceive by any methods
In the investigator's clinical judgment, 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 willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
From the time of vaccination through 3 months after vaccination, agrees not to donate blood
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 condition or medication
History of acute polyneuropathy (example, Guillain-Barré syndrome) or chronic idiopathic demyelinating polyneuropathy
History of thrombosis with thrombocytopenia syndrome (TTS) or heparin-induced thrombocytopenia and thrombosis (HITT)
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
