Prevention of Lower Respiratory Tract Disease Caused by The respiratory syncytial virus (RSV)
Conditions
Sponsors
Janssen Vaccines & Prevention B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Must be =60 years old on the day of signing the ICF and expected to be available for the duration of the study. 2. 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. 3. In the investigator’s clinical judgment, the participant must be in stable health at the time of vaccination. Participants may have underlying illnesses such as hypertension, CHF, COPD, type 2 diabetes, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms and signs are stable and medically controlled in the judgement of the investigator 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 taken between ICF signature and vaccination. 4. From the time of vaccination through 3 months after vaccination, participant agrees not to donate blood. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2414 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 24726
Exclusion criteria
Exclusion criteria: 1. Has a serious clinically unstable condition, Alzheimer’s disease, or any other condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant 2. History of malignancy within 5 years before screening or revaccination not in the following categories: a. Participants with squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix may be enrolled at the discretion of the investigator. b. Participants with a history of malignancy within 5 years, which is considered cured with minimal risk of recurrence per investigator’s judgement, can be enrolled. 3. Had major surgery (eg, major cardiopulmonary or abdominal operations) as per the investigator’s judgment within 4 weeks before vaccination, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to participate in the study. 4. Has abnormal function of the immune system resulting from: a. Clinical conditions (eg, autoimmune disease or immunodeficiency) expected to have an impact on the immune response elicited by the study vaccine. b. Chronic or recurrent use of systemic corticosteroids within 2 months before administration of study vaccine and during the study. A substantially immunosuppressive steroid dose is considered to be =2 weeks of daily receipt of 20 mg of prednisone or equivalent. c. Administration of antineoplastic and immunomodulating agents, eg, cancer chemotherapeutic agents, or radiotherapy within 6 months before administration of study vaccine and during the study. 5. Received or plans to receive: a. Licensed live-attenuated vaccines within 28 days before or after planned administration of study vaccination b. Other licensed (not live) vaccines within 14 days before or after planned administration of study vaccination. 6. Has an acute illness (including acute respiratory illnesses) or body temperature of =38.0ºC (=100.4ºF) within 24 hours prior to administration of study vaccine. 7. 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. 8. Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine components (including any of the constituents of the study vaccine). Refer to the latest version of the Investigator’s Brochure for Ad26/protein preF RSV vaccine 9. History of acute polyneuropathy (eg, Guillain-Barré syndrome) or chronic idiopathic demyelinating polyneuropathy (CIDP). 10. Received hematopoietic stem cell transplant in medical history, immunoglobulins in the 2 months, immunoglobulins specific to RSV, hMPV, or parainfluenza viruses in the 12 months, apheresis therapies in the 4 months, or blood products in the 4 months before the planned administration of the study vaccine or has any plans to receive such treatment during the study. 11. Received an investigational drug or used an invasive investigational medical device within 30 days or received an investigational vaccine within 6 months before the planned administration of the study vaccine or is currently enrolled or plans to participate in another investigational study during this study. 12. Contraindication to IM injections and blood draws (eg, bleeding disorders). 13. Received an RSV vaccine in a previous RSV vaccine study. 14. For participants in the Safety Subset only: Participants w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate efficacy of the Ad26.RSV.preF-based study vaccine in the prevention of RT-PCR-confirmed RSV-mediated LRTD when compared to placebo in adults aged 60 years and above.;Secondary Objective: 1. To demonstrate the efficacy of active study vaccine in the prevention of any RT-PCR-confirmed RSV mediated acute respiratory infection (ARI) during the first RSV season when compared to placebo. 2. To demonstrate the efficacy of active study vaccine in the prevention of RT-PCR-confirmed RSV-mediated LRTD during the second year over the whole study when compared to placebo when compared to placebo in adults aged 60 years and above 3. To demonstrate the efficacy of active study vaccine in the prevention of any RT-PCR-confirmed RSV mediated ARI during the second year when compared to placebo 4. To demonstrate the efficacy of active study vaccine in the prevention of predefined clinically relevant disease associated with RT-PCR confirmed RSV mediated ARI over the whole study when compared to placebo;Primary end point(s): First occurrence of RT-PCR-confirmed, RSVmediated LRTD with onset at least 14 days after the first dose of study vaccine ;Timepoint(s) of evaluation of this end point: at least 14 days after dosing with study vaccine | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. First occurrence of any RT-PCR-confirmed RSV-mediated ARI with onset at least 14 days after dosing of study vaccine 2. First occurrence of RT-PCR-confirmed RSV mediated LRTD during the second year, with onset after study Day 365 3. First occurrence of any RT-PCR-confirmed RSV-mediated ARI during the second year, with onset after study Day 365 4. First occurrence of predefined clinically relevant disease associated with RT-PCR-confirmed RSV-mediated ARI over the whole study with onset at least 14 days after dosing of study vaccine;Timepoint(s) of evaluation of this end point: 1 and 4 - at least 14 days after dosing with study vaccine 2 and 3 - after study Day 365 | — |
Countries
Australia, Brazil, Canada, Chile, China, Estonia, Finland, Korea, Republic of, New Zealand, Poland, South Africa, Taiwan, Thailand, United Kingdom, United States
Contacts
Public ContactClinical Registry Group
Janssen Research & Development
Outcome results
None listed