ID

42188

Beschreibung

Study ID: 110028 Clinical Study ID: 110028 Study Title: Study to Evaluate the Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine GSK 1557484A in Adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00510874 https://clinicaltrials.gov/ct2/show/NCT00510874 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine Trade Name: Pumarix, Pandemrix Study Indication: Influenza This study consists of 6 Visits and one Telephone Contact: -Visit 1: Visit „Day 0“ -Visit 2: Visit „Day 7“, Contact Window: Day 6-8, Minimum Number of Days between Successive Visits: 6 -Visit 3: Visit „Day 21“: Contact Window: Day 19-23, Minimum Number of Days between Successive Visits: 12 -Visit 4: Visit „Day 28“: Contact Window: Day 26-30, Minimum Number of Days between Successive Visits: 6 -Visit 5: Visit „Day 42“: Contact Window: Day 38-46, Minimum Number of Days between Successive Visits: 12 -Telephone Contact „Day 84“: Contact Window: Day 80-88 -Visit 6: Visit „Day 182“: Contact Window: Day 167-197 The screening can take place up to 21 days prior to Visit 1. This document contains the Eligibility criteria form. It has to be filled in for Screening (21 days prior to Day 0).

Link

https://clinicaltrials.gov/ct2/show/NCT00510874

Stichworte

Versionen (2)
  1. 20.03.19 20.03.19 -
  2. 13.04.21 13.04.21 - Dr. rer. medic Philipp Neuhaus
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

13. April 2021

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine in Adults, NCT00510874

Englisch

Eligibility criteria

1 Formulare  
  1. StudyEvent: ODM
    1. Eligibility criteria
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Visit date
Beschreibung

Day month year

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Eligibility check
Beschreibung

Eligibility check

Alias
UMLS CUI-1
C0013893
Did the subject meet all the entry criteria?
Beschreibung

If No, tick all boxes corresponding to violations of any inclusion/exclusion criteria.

Datentyp

text

Alias
UMLS CUI [1]
C1516637
Inclusion criteria
Beschreibung

Inclusion criteria

Alias
UMLS CUI-1
C1512693
Male and female adults 18 to 64 years of age at time of first vaccination, inclusive.
Beschreibung

Gender, Age at time of first vaccination

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0001779
UMLS CUI [2,2]
C0042196
Good general health as assessed by medical history and physical examination.
Beschreibung

Good general health

Datentyp

boolean

Alias
UMLS CUI [1]
C1277245
Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device (i.e., a common-use phone serving multiple rooms or apartments).
Beschreibung

Able to contact via telephone

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1822200
UMLS CUI [1,2]
C1519021
Written informed consent obtained from the subject.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.
Beschreibung

Comprehension of the study requirements

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2,1]
C0470187
UMLS CUI [2,2]
C2347804
UMLS CUI [3,1]
C2827364
UMLS CUI [3,2]
C0085732
Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study.
Beschreibung

Able to comply with the requirements of the protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C0525058
Exclusion criteria
Beschreibung

Exclusion criteria

Alias
UMLS CUI-1
C0680251
Presence of significant acute or chronic, uncontrolled medical or psychiatric illness.
Beschreibung

“Uncontrolled” is defined as requiring institution of new medical or surgical treatment or a significant alteration in the dose of an ongoing medication for uncontrolled symptoms, illness manifestations or drug toxicity within 3 months.

Datentyp

boolean

Alias
UMLS CUI [1]
C0001314
UMLS CUI [2]
C0008679
UMLS CUI [3,1]
C0001314
UMLS CUI [3,2]
C0004936
UMLS CUI [4,1]
C0008679
UMLS CUI [4,2]
C0004936
Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
Beschreibung

Substance abuse or neurological/psychiatric diagnoses

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0027765
UMLS CUI [3]
C0004936
Blood pressure abnormalities.
Beschreibung

Definition: systolic blood pressure >= 140 mmHg and/or diastolic blood pressure >= 90 mmHg.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C1704258
Diagnosed with cancer, or treatment for cancer, within 3 years.
Beschreibung

-Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible. -Persons with a history of histologically-confirmed basal cell carcinoma of the skin successfully treated with local excision only are excepted and may enroll, but other histologic types of skin cancer are exclusionary. -Women who are disease-free 3 years or more after treatment for breast cancer and receiving long-term prophylactic tamoxifen are excepted and may enroll.

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0920425
Presence of an oral temperature >= 37.8º C, or acute symptoms greater than “mild” severity on the scheduled date of first vaccination.
Beschreibung

Body temperature, acute symptoms

Datentyp

boolean

Alias
UMLS CUI [1]
C0005903
UMLS CUI [2,1]
C0205178
UMLS CUI [2,2]
C1457887
Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
Beschreibung

Immunosuppressive or immunodeficient condition, HIV

Datentyp

boolean

Alias
UMLS CUI [1]
C4048329
UMLS CUI [2]
C0021051
UMLS CUI [3]
C0019682
Receipt of systemic glucocorticoids (prednisone ≥ 10 mg/day for more than 14 consecutive days) within 1 month of study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. (Topical or inhaled glucocorticoids are allowed.)
Beschreibung

Systemic glucocorticoids, other cytotoxic/immunosuppressive drug

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C3540777
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C0304497
UMLS CUI [3,1]
C0332185
UMLS CUI [3,2]
C0205394
UMLS CUI [3,3]
C0021081
UMLS CUI [4,1]
C0683607
UMLS CUI [4,2]
C0017712
UMLS CUI [5,1]
C0683607
UMLS CUI [5,2]
C2065041
Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.
Beschreibung

(Persons receiving prophylactic antiplatelet medications, e.g., low-dose aspirin, and without a clinically-apparent bleeding tendency are eligible).

Datentyp

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2]
C0699129
UMLS CUI [3]
C0019134
Administration of any non-influenza vaccines within 30 days before study enrollment or during the study period. Subjects who receive such immunizations on an emergent basis (e.g., tetanus vaccines) after enrollment will be followed per protocol and included in the Total Vaccinated Cohort (TVC), but excluded from the According to Protocol (ATP) Cohort for both safety and immunogenicity.
Beschreibung

Non-influenza vaccines prior to study

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C2347804
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C0042196
UMLS CUI [2,3]
C0347984
UMLS CUI [2,4]
C2347804
Use of any investigational or non-registered product (drug or vaccine) or planned participation in another investigational study within 30 days prior to study enrollment, or during the study period.
Beschreibung

Use of investigational/non-registered product, planned participation in another investigational study

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C0042210
UMLS CUI [2,3]
C2348568
UMLS CUI [2,4]
C0205394
Receipt of any immunoglobulins and/or any blood products within 3 months of study enrollment or planned administration of any of these products during the study period.
Beschreibung

Immunoglobulins and/or any blood products

Datentyp

boolean

Alias
UMLS CUI [1]
C0021027
UMLS CUI [2]
C0456388
Any known or suspected allergy to any constituent of influenza vaccines (including egg proteins or the adjuvant); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
Beschreibung

Allergy to any constituent of influenza vaccines, anaphylactic-type reaction to consumption of eggs, severe adverse reaction influenza vaccine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0021403
UMLS CUI [2,1]
C0340865
UMLS CUI [2,2]
C0013710
UMLS CUI [3,1]
C0413534
UMLS CUI [3,2]
C0205082
Known pregnancy or a positive urine beta-human chorionic gonadotropin (β-hCG) test result prior to dosing on Study Days 0 or 21.
Beschreibung

Pregnancy or a positive urine beta-human chorionic gonadotropin test

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C1255526
UMLS CUI [2,2]
C1446409
Lactating or nursing.
Beschreibung

Lactating or nursing.

Datentyp

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C2828358
Women of child bearing potential (i.e., neither post-menopausal for one year nor surgicallysterilized) who lack a history of reliable contraceptive practices. The provision of this history does NOT replace the requirement to perform, and obtain negative results in pregnancy urine tests prior to treatments; all women will have urine pregnancy tests regardless of their status.
Beschreibung

Reliable practices include: -consistent abstinence from heterosexual activity -consistent use of combined or progestogen oral contraceptives -injectable progestogen -implants of levonorgestrel -oestrogenic vaginal ring -percutaneous contraceptive patches or intrauterine device (IUD) or intrauterine system (IUS) -vasectomy with documented azoospermia of ≥6 months of the sole male partner -double barrier method (condom or occlusive cap plus spermicidal agent

Datentyp

boolean

Alias
UMLS CUI [1]
C1960468
UMLS CUI [2]
C0700589
Known receipt of analgesic or antipyretic medication on the day of treatment (Study Days 0 or Day 21).
Beschreibung

Analgesic or antipyretic medication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0002771
UMLS CUI [2,1]
C2347852
UMLS CUI [2,2]
C0003419
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Ähnliche Modelle

Eligibility criteria

1 Formulare
  1. StudyEvent: ODM
    1. Eligibility criteria
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Visit date
Item
Visit date
date
C1320303 (UMLS CUI [1])
Item Group
Eligibility check
C0013893 (UMLS CUI-1)
Item
Did the subject meet all the entry criteria?
text
C1516637 (UMLS CUI [1])
Entry criteria
Code List
Did the subject meet all the entry criteria?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Inclusion criteria
C1512693 (UMLS CUI-1)
Gender, Age at time of first vaccination
Item
Male and female adults 18 to 64 years of age at time of first vaccination, inclusive.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2,1])
C0042196 (UMLS CUI [2,2])
Good general health
Item
Good general health as assessed by medical history and physical examination.
boolean
C1277245 (UMLS CUI [1])
Able to contact via telephone
Item
Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device (i.e., a common-use phone serving multiple rooms or apartments).
boolean
C1822200 (UMLS CUI [1,1])
C1519021 (UMLS CUI [1,2])
Informed Consent
Item
Written informed consent obtained from the subject.
boolean
C0021430 (UMLS CUI [1])
Comprehension of the study requirements
Item
Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0470187 (UMLS CUI [2,1])
C2347804 (UMLS CUI [2,2])
C2827364 (UMLS CUI [3,1])
C0085732 (UMLS CUI [3,2])
Able to comply with the requirements of the protocol
Item
Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study.
boolean
C0085732 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
Item Group
Exclusion criteria
C0680251 (UMLS CUI-1)
Acute/chronic medical/psychiatric disease
Item
Presence of significant acute or chronic, uncontrolled medical or psychiatric illness.
boolean
C0001314 (UMLS CUI [1])
C0008679 (UMLS CUI [2])
C0001314 (UMLS CUI [3,1])
C0004936 (UMLS CUI [3,2])
C0008679 (UMLS CUI [4,1])
C0004936 (UMLS CUI [4,2])
Substance abuse or neurological/psychiatric diagnoses
Item
Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
boolean
C0038586 (UMLS CUI [1])
C0027765 (UMLS CUI [2])
C0004936 (UMLS CUI [3])
Blood pressure abnormalities
Item
Blood pressure abnormalities.
boolean
C0005823 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Diagnosed with cancer/treatment for cancer
Item
Diagnosed with cancer, or treatment for cancer, within 3 years.
boolean
C0006826 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
Body temperature, acute symptoms
Item
Presence of an oral temperature >= 37.8º C, or acute symptoms greater than “mild” severity on the scheduled date of first vaccination.
boolean
C0005903 (UMLS CUI [1])
C0205178 (UMLS CUI [2,1])
C1457887 (UMLS CUI [2,2])
Immunosuppressive or immunodeficient condition, HIV
Item
Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
boolean
C4048329 (UMLS CUI [1])
C0021051 (UMLS CUI [2])
C0019682 (UMLS CUI [3])
Systemic glucocorticoids, other cytotoxic/immunosuppressive drug
Item
Receipt of systemic glucocorticoids (prednisone ≥ 10 mg/day for more than 14 consecutive days) within 1 month of study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. (Topical or inhaled glucocorticoids are allowed.)
boolean
C0332185 (UMLS CUI [1,1])
C3540777 (UMLS CUI [1,2])
C0332185 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0304497 (UMLS CUI [2,3])
C0332185 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
C0021081 (UMLS CUI [3,3])
C0683607 (UMLS CUI [4,1])
C0017712 (UMLS CUI [4,2])
C0683607 (UMLS CUI [5,1])
C2065041 (UMLS CUI [5,2])
Significant disorder of coagulation, treatment with Coumadin derivatives/heparin
Item
Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.
boolean
C0005779 (UMLS CUI [1])
C0699129 (UMLS CUI [2])
C0019134 (UMLS CUI [3])
Non-influenza vaccines prior to study
Item
Administration of any non-influenza vaccines within 30 days before study enrollment or during the study period. Subjects who receive such immunizations on an emergent basis (e.g., tetanus vaccines) after enrollment will be followed per protocol and included in the Total Vaccinated Cohort (TVC), but excluded from the According to Protocol (ATP) Cohort for both safety and immunogenicity.
boolean
C0205394 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
C0205394 (UMLS CUI [2,1])
C0042196 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
C2347804 (UMLS CUI [2,4])
Use of investigational/non-registered product, planned participation in another investigational study
Item
Use of any investigational or non-registered product (drug or vaccine) or planned participation in another investigational study within 30 days prior to study enrollment, or during the study period.
boolean
C0013230 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C0042210 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0205394 (UMLS CUI [2,4])
Immunoglobulins and/or any blood products
Item
Receipt of any immunoglobulins and/or any blood products within 3 months of study enrollment or planned administration of any of these products during the study period.
boolean
C0021027 (UMLS CUI [1])
C0456388 (UMLS CUI [2])
Allergy to any constituent of influenza vaccines, anaphylactic-type reaction to consumption of eggs, severe adverse reaction influenza vaccine
Item
Any known or suspected allergy to any constituent of influenza vaccines (including egg proteins or the adjuvant); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
boolean
C0020517 (UMLS CUI [1,1])
C0021403 (UMLS CUI [1,2])
C0340865 (UMLS CUI [2,1])
C0013710 (UMLS CUI [2,2])
C0413534 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
Pregnancy or a positive urine beta-human chorionic gonadotropin test
Item
Known pregnancy or a positive urine beta-human chorionic gonadotropin (β-hCG) test result prior to dosing on Study Days 0 or 21.
boolean
C0032961 (UMLS CUI [1])
C1255526 (UMLS CUI [2,1])
C1446409 (UMLS CUI [2,2])
Lactating or nursing.
Item
Lactating or nursing.
boolean
C0006147 (UMLS CUI [1])
C2828358 (UMLS CUI [2])
Child bearing potential, contraceptive methode
Item
Women of child bearing potential (i.e., neither post-menopausal for one year nor surgicallysterilized) who lack a history of reliable contraceptive practices. The provision of this history does NOT replace the requirement to perform, and obtain negative results in pregnancy urine tests prior to treatments; all women will have urine pregnancy tests regardless of their status.
boolean
C1960468 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
Analgesic or antipyretic medication
Item
Known receipt of analgesic or antipyretic medication on the day of treatment (Study Days 0 or Day 21).
boolean
C2347852 (UMLS CUI [1,1])
C0002771 (UMLS CUI [1,2])
C2347852 (UMLS CUI [2,1])
C0003419 (UMLS CUI [2,2])
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