Status:
COMPLETED
A Shedding Study of Adenovirus Serotype 26 Based Respiratory Syncytial Virus Pre-fusion F Protein (Ad26.RSV.preF) Vaccine in Adults
Lead Sponsor:
Janssen Vaccines & Prevention B.V.
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the shedding and kinetics of the Adenovirus Serotype 26 Based Respiratory Syncytial Virus Pre-fusion F Protein (Ad26.RSV.preF) vaccine after one intramuscular in...
Eligibility Criteria
Inclusion
- In the investigator's clinical judgment, participant must be in good or stable health. Participants may have underlying illnesses such as hypertension, Type 2 diabetes mellitus, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms and signs are medically controlled. If they are on medication for a condition, the medication dose must have been stable for at least 12 weeks 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 measurement and 12-lead electrocardiogram (ECG; for participants greater than \[\>\] 65 years of age only) performed at screening
- Contraceptive use by women should be consistent with local regulations regarding the use of contraceptive methods for participants in clinical studies
- All women of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening and a negative urine beta-hCG pregnancy test immediately prior to study vaccine administration
- From the time of vaccination through 3 months after vaccination, 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 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 (eg, compromise well-being) or that could prevent, limit, or confound the protocol-specified assessments
- Per medical history, participant has chronic active hepatitis B or hepatitis C infection
- Participant has 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 study vaccine or is currently enrolled or plans to participate in another investigational study during the course of this study
- Participant has received treatment with immunoglobulin in the 2 months, or blood products in the 4 months before the planned administration of study vaccine or has any plans to receive such treatment during the study
- Participant has received any RSV vaccine in any previous RSV vaccine study at any time prior to randomization
Key Trial Info
Start Date :
January 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 28 2019
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03795441
Start Date
January 7 2019
End Date
July 28 2019
Last Update
August 30 2019
Active Locations (1)
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1
Clinical Pharmacology Unit
Merksem, Belgium, 2170