Status:
COMPLETED
A Study to Evaluate the Different Doses of VAC52416 (ExPEC10V) in Japanese Adults
Lead Sponsor:
Janssen Pharmaceutical K.K.
Conditions:
Healthy
Eligibility:
All Genders
60-85 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety and reactogenicity of different doses of extraintestinal pathogenic Escherichia coli 10 valent (ExPEC10V) in Japanese participants greater than or e...
Eligibility Criteria
Inclusion
- Participant must be Japanese as determined by participant's verbal report
- Must be healthy or medically stable, in the investigator's clinical judgment, as confirmed by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests performed at the screening visit
- Willing and able to adhere to the lifestyle restrictions
- Agrees not to donate blood until 12 weeks after receiving the study intervention
- Must be willing to provide verifiable identification, has means to be contacted, and to contact the investigator during the study
Exclusion
- Clinically significant illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (\>=) 38.0 degree Celsius (100.4 degree Fahrenheit ) within 24 hours prior to the administration of study intervention; enrollment at a later date is permitted (provided the screening window of 28 days 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 excipients
- Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine excipients
- Contraindication to Intramuscular (IM) injections and blood draws example, bleeding disorders
Key Trial Info
Start Date :
March 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 24 2020
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04306302
Start Date
March 13 2020
End Date
December 24 2020
Last Update
January 20 2021
Active Locations (1)
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1
SOUSEIKAI PS Clinic
Fukuoka, Japan, 8120025