A Study to Evaluate the Different Doses of VAC52416 (ExPEC10V) in Japanese Adults

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04306302
• Other study ID #: CR108778
• Secondary ID: VAC52416BAC1002
• Status: Completed
• Phase: Phase 1
• Start date: March 13, 2020
• Est. completion date: December 24, 2020

Study information

• Verified date: January 2021
• Source: Janssen Pharmaceutical K.K.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 24, 2020
• Est. primary completion date: December 24, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• ExPEC10V
Participants will receive a single IM injection of ExPEC10V.
• Placebo
Participants will receive single IM injection of matching placebo.

Locations

Country	Name	City	State
Japan	SOUSEIKAI PS Clinic	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Pharmaceutical K.K.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Solicited Local Adverse Events (AEs) Collected for 14 days post-Vaccination	Number of participants with solicited local AEs will be reported. Solicited local AEs (pain/tenderness, erythema, and swelling at the injection site) and will be noted in the participant diary for 14 days post-vaccination.	14 days post-Vaccination (Up to Day 15)
Primary	Number of Participants with Solicited Systemic AEs Collected for 14 days post-Vaccination	Number of participants with solicited systemic AEs will be reported. Solicited systemic AEs (oral body temperature, headache, fatigue, nausea, and myalgia) will be noted in the participant diary for 14 days post-vaccination.	14 days post-Vaccination (Up to Day 15)
Primary	Number of Participants with Unsolicited AEs From the Administration of Study Vaccine until 29 Days post-Vaccination	Number of participants with unsolicited AEs will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participants diary.	From the administration of study vaccine until 29 days post-Vaccination (Up to Day 30)
Primary	Number of Participants with Serious AEs from the Administration of the Study Vaccine until Day 181	Number of participants with SAEs will be reported. A SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life threatening experience, is a congenital anomaly/birth defect, is suspected transmission of any infectious agent via a medicinal product, is medically important, and may jeopardize participant or may require medical or surgical intervention to prevent one of the outcomes listed above.	From the administration of study vaccine until 180 days post-Vaccination (Up to Day 181)
Secondary	Antibody Titers for ExPEC10V as Determined by Multiplex ECL-based Immunoassay	Antibody titers for ExPEC10V will be determined by multiplex ECL-based immunoassay.	Days 15 and 30
Secondary	Antibody Titers for ExPEC10V as Determined by Multiplex Opsonophagocytic Assay (MOPA)	Antibody titers for ExPEC10V will be determined by MOPA.	Day 15 and 30

External Links

•   To learn how to participate in this trial please click here.