L'essai

Cette étude est en anglais. Afin de participer à cet essai, vous devez comprendre l'anglais ou l'hollandais.

We are currently looking for 155 healthy volunteers to participate in a trial with study medication for the treatment of Influenza A (flu). The study consists of 7 groups of 20 people each. You can subscribe for multiple panels, but you can only participate in 1. When registering, please indicate all possible groups which you are available for.

The study will take about 8 months to complete. The study consists of:

  • Prescreening (VS1): Information about the study + blood sample (not fasted)
  • Screening visit (VS2): General examination (fasted)
  • Vaccination visit: Ambulant visit (± 2 hours after vaccination)
  • 3 retours (short visits to our unit)
  • 2 telephone follow-ups
  • A stay of 13 days and 12 nights in our unit
  • End of trial visit
  • A telephone follow-up

The screening exists out of 2 parts. You need to be present on both days to be able to participate in the entire study.

During this study the Influenza A flu virus will be given intranasal (through the nose) with the aid of a nasal spray. During your stay you will stay in quarantine (closed ward). Because of this you may NOT receive any visits during this stay.

INCLUSION CRITERIA

  • Healthy men/women
  • Age: between 18 and 55 years (inclusive)
  • BMI: between 19 and 32 kg/m² (inclusive)
  • Non-smoker or ex-smoker (quit at least 3 months ago)
    • You are not allowed to smoke during your stay in the unit.
  • Not using any medication, vitamin or homeopathic substances (with exception of Ibuprofen, Paracetamol and oral contraception)
  • Latest participation (visit discharge) in a clinical trial:
    • Group 3bis: 13/02/2019
    • Group 4: 05/03/2019
    • Group 5: 08/05/2019
    • Group 6: 29/05/2019
  • Birth control:
    • Women: Use of a good birth control method
      • F.e. vasectomy partner, abstinence, oral, implant, injection, spiral,…
    • Infertile Women: F.e. Hysterectomy, tubal ligation, postmenopausal (no menses since 12 months)
    • Men: If you have a fertile partner that does not use any kind of birth control, you have to use a good birth control method
      • F.e. use of a condom, vasectomy or abstinence
  • Willing to not have a flu vaccine in the 2018-2019 season
  • Willing to not receive any visit during your stay in the unit
  • Willing to not use intranasal corticosteroids for 7 days before the screening visit (VS2)
  • You did not have Influenza A (flu) 6 months before the screening visit (VS2)
  • You cannot participate in this study if
    • You or the person with whom you frequently come in contact with (whether or not during the working environment) is an individual with suppression of the immune system, patients with chronic lung diseases or elders (+65 years) or people receiving chemotherapy
  • You may not be an employee of SGS CPU Antwerp
  • You may not be a family member or an employee of SGS CPU Antwerp

Période

Group

Screening

Period 1

Period 2

Group 3bis

Screening 1

  • 01/07/2019

Screening 2

  • 04/07/2019
 

15/07/2019 - 12/08/2019

26/08/2019 - 23/12/2019

Group 4

Screening 1

  • 01/07/2019

Screening 2

  • -
 

16/07/2019 - 10/09/2019

16/09/2019 - 14/01/2020

Group 5

Screening 1

  • 01/07/2019
  • 02/07/2019
  • 03/07/2019
  • 05/07/2019
  • 08/07/2019

Screening 2

  • 18/07/2019
  • 19/07/2019
 

06/08/2019 - 01/10/2019

07/10/2019 - 04/02/2020

Group 6

Screening 1

  • 18/07/2019
  • 19/07/2019
  • 22/07/2019
  • 23/07/2019
  • 24/07/2019
  • 25/07/2019
  • 26/07/2019

Screening 2

  • 08/08/2019
  • 09/08/2019
 
27/08/2019 - 22/10/2019 28/10/2019 - 25/02/2020

For more details of the study planning, please see the PDF attached below.

Indemnité

  • € 4000 for completing the entire study (including selection visit)
  • € 1000 for reserve volunteers that come in on Day-2 (including VS1 + VS2 + vaccination + retours)
  • € 250 for back-up reserve volunteers that come for the vaccination visit, but will not be vaccinated (including VS1 + VS2 + vaccination + travel reimbursement included)
  • € 120 for VS1 and VS2 (Travel reimbursement included)
  • € 50 for the prescreening (VS1) (Travel reimbursement included)

Travel reimbursement applies to effective and reserve volunteers and is set at € 0.20/km, with a maximum of 120 km (one way).

The payment of reserve volunteers starts after D1. Effective volunteers will be paid after completion of the last visit. The payment term will take up to 4-6 weeks.

ATTENTION:

  • In the event of early study termination, the financial compensation can be adjusted based on the study duration as well as the reason for early termination. This decision will be taken by the SGS study team.
  • You will not receive any payment if you test positive for illegal substances or alcohol at the selection visit.

Informations supplémentaires

Are you a reserve volunteer?

  • You will be admitted to the unit at D-2 until approximately 2 hours after the admission of the flu virus on D1
  • You meet all inclusion criteria and you have kept all study restrictions given at the selection visit
  • You are able to participate in the entire study

 

Cette étude est en anglais. Afin de participer à cet essai, vous devez comprendre l'anglais ou néerlandais.

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