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Prevention of infections

Geschlecht Beides

Alter von 60 bis 80

BMI von 18.5 bis 40

Berechnen Sie Ihren BMI hier

Ort der Studie

 

Study of a new vaccine that is being developed for the prevention of infections caused by the bacteria Escherichia coli (also known as E. coli) in elderly.

 

Besonderheiten (auf Englisch)

E. coli is a common bacterium and can cause systemic infections (infection spread throughout the body).

  • Your Body Mass Index (BMI) is between 18.5 and 40.0 kg/m2. The BMI reflects the relation between your body weight in kilograms and your height in meters.
  • You have not participated in any other drug study within 90 days preceding the administration of the study vaccination (counting from the last administration in the previous study). You are not allowed to participate in another study until at least 6 months after the vaccination. After these 6 months you are allowed to participate in another study if the study investigator agrees until 3 years after the vaccination.
  • You are allowed to participate if you are medically stable and you use medication in a stable dose. You can call us for more information if you are using medication.
  • You have a history of urinary tract infection in the past 5 years.
  • As a female, you are only allowed to participate in this study if:
    • you have been postmenopausal (at least 12 months without menstruation);
    • or you were surgically sterilized at least 6 months before the start of the study.
  • To determine if you are eligible to participate in this study, you will undergo a medical screening.

 

Vergütung (auf Englisch)

You will receive a gross compensation of € 2.000,- for full participation. Travel expenses will be reimbursed based on the distance traveled (€ 0.19 net per kilometer) with a minimum of  € 12 and a maximum of € 160 (840 kilometers) per round trip, irrespective of the method of transportation.

 

Periode und Studie (auf Englisch)

This study consists of 7 ambulatory visits to our research facility in Groningen. You will receive the vaccine once during the study, on day 1.

After the study assessments you will go home, and you will receive a telephone call 2 days after the vaccination. You will return to our research facility on approximately 14 days, 29 days, 6 months, 1 year, 2 years and 3 years after the vaccination.

You need to be available for all dates of your group. If the dates change you will be notified as soon as possible.

Group 2

short visit

8 Oct 2020

22 Oct 2020

6 Nov 2020

6 Apr 2021

8 Oct 2021

8 Oct 2022

8 Oct 2023

Group 3

short visit

12 Oct 2020

26 Oct 2020

10 Nov 2020

10 Apr 2021

12 Oct 2021

12 Oct 2022

12 Oct 2023

Group 4

short visit

15 Oct 2020

29 Oct 2020

13 Nov 2020

13 Apr 2021

15 Oct 2021

15 Oct 2022

15 Oct 2023

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