Status:
TERMINATED
A Study of Various Respiratory Syncytial Virus (RSV) Pre-Fusion (preF)-Based Vaccine Formulations in Adults Aged 60 Years and Older
Lead Sponsor:
Janssen Vaccines & Prevention B.V.
Conditions:
Respiratory Syncytial Virus-associated Lower Respiratory Tract Disease Prevention
Eligibility:
All Genders
60+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of the study is to evaluate safety and immunogenicity of various respiratory syncytial virus (RSV) pre-Fusion (preF)-based vaccine components followed by expanded safety evaluation and dur...
Detailed Description
RSV is an important cause of serious respiratory infections in adults aged 60 years and older. The current study is divided into four cohorts, evaluating various doses and combinations of RSV preF-bas...
Eligibility Criteria
Inclusion
- 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 (COPD), Type 2 diabetes mellitus, 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 physical examination, medical history, and vital signs performed between informed consent form (ICF) signature and vaccination
- For participants in Cohorts 1 and 2 only: Participant must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the laboratory screening tests are outside the laboratory normal reference ranges and additionally within the limits of toxicity Grade 2 according to the United States Food and Drug Administration (US FDA) toxicity tables (that is, for tests in the FDA table), the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant and appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
- Agrees not to donate blood from the time of vaccination through 3 months after vaccination
- Must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
Exclusion
- History of malignancy within 5 years before screening 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 before screening, with minimal risk of recurrence per investigator's judgment, can be enrolled
- Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine components
- Per medical history, participant has chronic active hepatitis B or hepatitis C infection, human immunodeficiency viruses (HIV) type 1 or type 2 infection, acute polyneuropathy (example, Guillain-Barré syndrome) or chronic idiopathic demyelinating polyneuropathy
- Participant is in receipt of, or planning to receive, licensed live attenuated vaccine within 28 days before and after study vaccinations; other licensed vaccines (that is, not live such as, influenza, tetanus, hepatitis A or B, rabies) within 14 days before and after study vaccinations
- Received treatment with immunoglobulins expected to impact the vaccine-induced immune response (including monoclonal antibodies \[MAbs\] for chronic underlying conditions) in the 2 months; immunoglobulins specific to respiratory syncytial virus (RSV), human metapneumovirus, or parainfluenza viruses in the 12 months; apheresis therapies in the 4 months; or blood products in the 4 months prior to study vaccination or has any plans to receive such treatment during the study
Key Trial Info
Start Date :
April 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2023
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT05327816
Start Date
April 13 2022
End Date
February 14 2023
Last Update
May 25 2025
Active Locations (11)
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1
Ark Clinical Research
Long Beach, California, United States, 90815
2
Accel Research Sites
DeLand, Florida, United States, 32720
3
Floridian Clinical Research LLC
Miami Lakes, Florida, United States, 33016
4
Heartland Research Associates, an AMR Company
Wichita, Kansas, United States, 67207