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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-13

Study Completion Date

2020-12-24

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Medium-dose ExPEC10V or Placebo: Group 1

Participants will be randomized to receive a single intramuscular (IM) injection of medium dose of ExPEC10V or Placebo on Day 1.

Group Type EXPERIMENTAL

ExPEC10V

Intervention Type BIOLOGICAL

Participants will receive a single IM injection of ExPEC10V.

Placebo

Intervention Type BIOLOGICAL

Participants will receive single IM injection of matching placebo.

High-dose ExPEC10V or Placebo: Group 2

Participants will be randomized to receive a single IM injection of high dose (based on safety assessment through Day 15 postvaccination of medium dose) of ExPEC10V or Placebo on Day 1.

Group Type EXPERIMENTAL

ExPEC10V

Intervention Type BIOLOGICAL

Participants will receive a single IM injection of ExPEC10V.

Placebo

Intervention Type BIOLOGICAL

Participants will receive single IM injection of matching placebo.

Interventions

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ExPEC10V

Participants will receive a single IM injection of ExPEC10V.

Intervention Type BIOLOGICAL

Placebo

Participants will receive single IM injection of matching placebo.

Intervention Type BIOLOGICAL

Other Intervention Names

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VAC52416

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes