Status:
COMPLETED
A Study to Evaluate the Safety and Immunogenicity of Seasonal Influenza Vaccine and an Adenovirus Serotype 26- Based Vaccine Encoding for the Respiratory Syncytial Virus Pre-fusion F Protein (Ad26.RSV.preF), With and Without Co-administration, in Adults Aged 60 Years and Older in Stable Health
Lead Sponsor:
Janssen Vaccines & Prevention B.V.
Conditions:
Healthy
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to demonstrate the non-inferiority of the concomitant administration of an adenovirus serotype 26- based vaccine encoding for the respiratory syncytial virus pre-fusion F ...
Eligibility Criteria
Inclusion
- Each participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, is willing to participate in the study and attend all scheduled visits, and is willing and able to comply with all study procedures and adhere to the prohibitions and restrictions specified in this protocol
- Before randomization, a woman must be:
- Postmenopausal (A 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 either in good or stable health, and not at risk of serious complications from influenza. Participants may have underlying illnesses such as hypertension, type 2 diabetes, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms/signs are medically controlled. If they are on medication for a condition, the medication dose must have been stable for at least 12 weeks (or only small, clinically non-significant changes have been made in the judgement of the Principal Investigator) preceding vaccination and expected to remain stable for the duration of the study. Participants will be included on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed on Day 1
- From the time of first vaccination through 3 months after the second dose of study vaccine, participant agrees not to donate blood
- Participant must be willing to provide verifiable identification, have means to be contacted and to contact the investigator during the study
Exclusion
- Participant has acute illness (this does not include minor illnesses such as diarrhea) or temperature greater than or equal to (\>=) 38.0 degree Celsius (ºC) within 24 hours prior to the first dose of study vaccine; enrollment at a later date is permitted
- Participant has a serious chronic disorder, including severe chronic obstructive pulmonary disease or clinically significant congestive heart failure, requirement for supplemental oxygen, end stage renal disease with or without dialysis, clinically unstable cardiac disease, Alzheimer's disease, or has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise well-being) or that could prevent, limit, or confound the protocol-specified assessments
- Participant has history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
- Participant has had major surgery (per the investigator's judgment), within 4 weeks before dosing, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study or within 6 months after the final dose of study vaccine
- Participant has chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen and hepatitis C antibody, respectively
Key Trial Info
Start Date :
December 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 23 2018
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT03339713
Start Date
December 7 2017
End Date
July 23 2018
Last Update
February 4 2025
Active Locations (1)
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1
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States, 29464