Clinical trial NCT04306302: A Study to Evaluate the Different Doses of VAC52416 (ExPEC10V) in Japanese Adults
Official title: A Randomized, Double-blind, Phase 1 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Different Doses of VAC52416 (ExPEC10V) in Japanese Adults Aged 60 to 85 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2020-03-12
Enrollment: 24
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

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 equal to (\>=) 60 to less than or equal to (\<=) 85 years of age.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Number of Participants with Solicited Local Adverse Events (AEs) Collected for 14 days post-Vaccination
timeFrame: 14 days post-Vaccination (Up to Day 15)
measure: Number of Participants with Solicited Systemic AEs Collected for 14 days post-Vaccination
timeFrame: 14 days post-Vaccination (Up to Day 15)
measure: Number of Participants with Unsolicited AEs From the Administration of Study Vaccine until 29 Days post-Vaccination
timeFrame: From the administration of study vaccine until 29 days post-Vaccination (Up to Day 30)
measure: Number of Participants with Serious AEs from the Administration of the Study Vaccine until Day 181
timeFrame: From the administration of study vaccine until 180 days post-Vaccination (Up to Day 181)
Secondary outcomes:
measure: Antibody Titers for ExPEC10V as Determined by Multiplex ECL-based Immunoassay
timeFrame: Days 15 and 30
measure: Antibody Titers for ExPEC10V as Determined by Multiplex Opsonophagocytic Assay (MOPA)
timeFrame: Day 15 and 30
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: SOUSEIKAI PS Clinic
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: STUDY_DIRECTOR
References: