NL-OMON52538
Recruiting
Not Applicable
A Randomized, Observer-blind, First-in-Human Phase 1/2a Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health - VAC52416BAC1001
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Janssen-Cilag
- Enrollment
- 80
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Must have a body mass index (BMI) of \>18\.5 to\<40kg/m2;
- •\- Before randomization, a woman must be:
- •a). postmenopausal \- A postmenopausal state is defined as no menses for 12
- •months without an alternative medical cause; or
- •b). not intending to conceive by any methods;
- •\- Must be healthy or medically stable
- •\- Must sign an ICF indicating that he or she understands the purpose of, and
- •procedures required for,the study and is willing to participate in the study;
- •\- Willing and able to adhere to the lifestyle restrictions specified in this
- •\- Agrees not to donate blood until 12 weeks after receiving the study vaccine
Exclusion Criteria
- •\- Acute illness (this does not include minor illnesses such as diarrhea or mild
- •upper respiratory tract infection) or temperature \>\=38\.0ºC (100\.4°F) within 24
- •hours prior to the administration of study vaccine, or, applicable for Cohort 2
- •only, an ongoing or suspected symptomatic UTI; enrollment at a later date is
- •permitted (provided the screening window of 28days is respected);
- •\- 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);
- •\- Known allergies, hypersensitivity, or intolerance to ExPEC10V or its
Outcomes
Primary Outcomes
Not specified
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