SOUSEIKAI PS Clinic
Fukuoka, 8120025, Japan
NCT Number: NCT04306302
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.
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Notify Me60 year–85 year
All sexes
Interventional
Phase 1
Fukuoka, 8120025, Japan
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive a single IM injection of ExPEC10V.
Other names: VAC52416
Participants will receive single IM injection of matching placebo.
Time frame: 14 days post-Vaccination (Up to Day 15)
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.
Time frame: 14 days post-Vaccination (Up to Day 15)
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.
Time frame: From the administration of study vaccine until 29 days post-Vaccination (Up to Day 30)
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.
Time frame: From the administration of study vaccine until 180 days post-Vaccination (Up to 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.
Time frame: Days 15 and 30
Antibody titers for ExPEC10V will be determined by multiplex ECL-based immunoassay.
Time frame: Day 15 and 30
Antibody titers for ExPEC10V will be determined by MOPA.
Janssen Pharmaceutical K.K.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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