誰が参加できますか

This study is seeking healthy male & female participants, meaning that the participants will not have the condition being studied.

In addition to the criteria listed, participants must meet the following requirements:

  • Have a minimum body weight of 50 kg
  • Have body Mass Index of 17.5 - 28.5 kg/m2
  • Be a non-smoker or a smoker who smokes a maximum of 5 cigarettes per day
  • Be able to meet all study visit requirements

There are other requirements for participation in this study. The study staff will explain these to you during the screening process.

FOR WOMEN ONLY:

Women of non-childbearing potential: You may participate in this study provided that:

• You are between 18 and 60 and

• You are post-menopausal (meaning that your last period was at least one year ago).

• OR ELSE you have been surgically sterilised (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).

• OR you have an ovarian failure

Women of childbearing potential: At each visit to the PCRU, we will check that you are using the appropriate contraception. You must fulfil one of the conditions below:

▪You have had a bilateral tubal occlusion

▪ You have a non-hormonal IUD

▪ You have a hormonal IUS

▪ You have a (progestogen-only) hormonal implant

▪ Your partner has undergone a vasectomy at least six months ago

▪ You are abstinent from heterosexual intercourse as your preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent.

Condition
Healthy
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Age
18-60 years
The age a person must be to participate in a clinical trial
Sex
Male & Female
The sex of people who may participate in a clinical trial. Sex is a person's classification based on assignment at birth. Eligibility based on sex is distinct from eligibility based on gender

Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can fully determine if you qualify to enroll in the study.

実施項目

The study is planned to last for approximately 11 weeks. There are several examinations procedures will be required in connection with the study:

  • A screening examination during which you will sign a COVID ICD and the study ICD.
  • A hospitalisation period of 18 days (17 nights)
  • A follow-up visit
  • A follow-up phone call

Each participant will have a follow-up phone call 28 to 35 days after administration of the last dose of study medicine.

You will not personally derive any benefit from your participation in this study, but the results obtained could be very important for the development of medicines and treatments which will benefit other people.

Required Overnight stay
17 nights
A participant may be required to stay overnight at the PCRU for observation and study procedures. The number and length of overnight stays is determined by the design of the study
How long is the study?
Approximately 11 weeks
The length of the study includes the time from screening until the final follow-up call or study activity. There may be up to 28 days between screening and dosing
Compensation
€ 4087, plus € 510 and plus transportation fees
Participants in clinical trials at the PCRU receive financial compensation for their participation. The amount depends on factors like length of the stay, total number of study visits, and the nature of the study procedures

Interested in participating?

この治験についての詳しい情報:

0800.99.256 (フリーダイヤル:ベルギーから)、00800.26.36.26.36(フリーダイヤル:イギリス、フランス、ドイツ、オランダから)、+32.25.66.78.46(有料ダイヤル:上記以外の国から)に電話し、担当者に詳細をお問い合わせください。または、以下の登録フォームに入力してご送信ください。

「個人情報」とは名前、生年月日、電話番号、健康状態や病状など、一個人としてのあなたに関する情報を意味します。登録フォームに登録される際に当社と共有される個人情報は、医療アンケートや関連資料を送信するためにPCRUブリュッセルによって収集されます。

あなたの個人情報は、厳密に機密扱いで取り扱われ、適応されるすべての法律、特に治験に関するEUとベルギーの法律およびEUとベルギーの個人情報保護に関する法律に準拠して処理されます。

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