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OpenTrials
Completed

NCT Number: NCT04306302

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

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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Key information

Conditions

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

SOUSEIKAI PS Clinic

Fukuoka, 8120025, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ExPEC10V

Biological

Participants will receive a single IM injection of ExPEC10V.

Other names: VAC52416

Placebo

Biological

Participants will receive single IM injection of matching placebo.

Primary outcomes

  1. Number of Participants with Solicited Local Adverse Events (AEs) Collected for 14 days post-Vaccination

    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.

  2. Number of Participants with Solicited Systemic AEs Collected 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.

  3. Number of Participants with Unsolicited AEs From the Administration of Study Vaccine until 29 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.

  4. Number of Participants with Serious AEs from the Administration of the Study Vaccine until Day 181

    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.

Secondary outcomes

  1. Antibody Titers for ExPEC10V as Determined by Multiplex ECL-based Immunoassay

    Time frame: Days 15 and 30

    Antibody titers for ExPEC10V will be determined by multiplex ECL-based immunoassay.

  2. Antibody Titers for ExPEC10V as Determined by Multiplex Opsonophagocytic Assay (MOPA)

    Time frame: Day 15 and 30

    Antibody titers for ExPEC10V will be determined by MOPA.

Sponsors and collaborators

Lead sponsor

Janssen Pharmaceutical K.K.

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 12, 2020
Registry last updated
Jan 20, 2021

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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