ID

29294

Beschreibung

Screening Study ID: 101695 Ext. Mth30 Clinical Study ID: 101695 Study Title: Long-term study of immune response persistence of GSK Biologicals' 2-dose thiomersal-free Engerix™-B and 3-dose preservative-free Engerix™-B vaccines in subjects aged 11-15 yrs Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00343915 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: BIO HBV; Engerix-B Study Indication: Hepatitis B

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  1. 16.03.18 16.03.18 -
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GlaxoSmithKline (GSK)

Hochgeladen am

16. März 2018

DOI

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GSK Biologicals' 2-dose thiomersal-free Engerix™-B and 3-dose preservative-free Engerix™-B vaccines Study ID: 101695 NCT00343915

Englisch

Screening: Eligibility Check and Vaccination contraindications

1 Formulare  
Inclusion criteria
Beschreibung

Inclusion criteria

Alias
UMLS CUI-1
C1512693
A male or female between and including, 11 and 15 years of age at the time of the first vaccination.
Beschreibung

Gender and Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
Written informed consent obtained from the subject and subject’s parent/guardian.
Beschreibung

Informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Free of obvious health problems as established by medical history and clinical examination before entering the study.
Beschreibung

Health problems

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1446390
UMLS CUI [1,2]
C0332296
If the subject is female and of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (e.g., intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant® or DepoProvera®) for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
Beschreibung

Contraception or Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0700589
Subjects should be seronegative for HBs antigen, anti-HBc antibodies and anti-HBs antibodies.
Beschreibung

HBs antigen, anti-HBc antibodies and anti-HBs antibodies

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0201478
UMLS CUI [1,2]
C0201480
UMLS CUI [1,3]
C0201477
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned to use during the study period.
Beschreibung

Use of other study drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0013230
Administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine.
Beschreibung

Other vaccines

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C1444655
UMLS CUI [1,3]
C2348563
Previous vaccination against hepatitis B.
Beschreibung

Previous Hep B vaccination

Datentyp

boolean

Alias
UMLS CUI [1]
C0474232
Known exposure to hepatitis B within the previous 6 weeks.
Beschreibung

Hep B Exposure

Datentyp

boolean

Alias
UMLS CUI [1]
C0019163
History of hepatitis B infection.
Beschreibung

History of hepatitis B infection

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C0262926
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
Beschreibung

Immunosuppressive or immunodeficient condition

Datentyp

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2]
C0021051
A family history of congenital or hereditary immunodeficiency.
Beschreibung

Family history of congenital or hereditary immunodeficiency

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C0853602
UMLS CUI [2,1]
C0439660
UMLS CUI [2,2]
C0021051
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Beschreibung

Allergies, Hypersensitivity to vaccine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0042210
Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, at the investigator's discretion)
Beschreibung

Acute disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0001314
Hepatomegaly, right upper quadrant abdominal pain or tenderness.
Beschreibung

Hepatic disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0023895
Administration of immunoglobulins and any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
Beschreibung

Immunoglobulins and blood products

Datentyp

boolean

Alias
UMLS CUI [1]
C0021027
UMLS CUI [2]
C0456388
Pregnant or lactating female.
Beschreibung

Pregnancy or breast feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, > 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
Beschreibung

Immunosuppressants or other immune-modifying drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2]
C0279021
Any chronic drug therapy to be continued during the study period.
Beschreibung

Chronic drug therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0013216
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Beschreibung

Comorbidities

Datentyp

boolean

Alias
UMLS CUI [1]
C4061114
UMLS CUI [2]
C0008679
Major congenital defects or serious chronic illness.
Beschreibung

Congenital defects or serious chronic illness

Datentyp

boolean

Alias
UMLS CUI [1]
C0220810
UMLS CUI [2]
C0008679
History of chronic alcohol consumption and/or intravenous drug abuse.
Beschreibung

Alcohol or drug abuse

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
Female planning to become pregnant
Beschreibung

Planned pregnancy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0032992
Elimination criteria during the study
Beschreibung

Elimination criteria during the study

Alias
UMLS CUI-1
C0680251
Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period.
Beschreibung

Use of other study drug

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0013230
Intravenous drug abuse.
Beschreibung

Intravenous drug abuse

Datentyp

boolean

Alias
UMLS CUI [1]
C0086181
Female deciding to become pregnant.
Beschreibung

Pregnancy planned

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0032992
Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after.
Beschreibung

Other vaccines

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C1444655
UMLS CUI [1,3]
C2348563
Administration of immunoglobulins and/or any blood products during the study period.
Beschreibung

Immunoglobulins and/or blood products

Datentyp

boolean

Alias
UMLS CUI [1]
C0021027
UMLS CUI [2]
C0456388
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period. (For corticosteroids, this will mean prednisone, or equivalent, > 0.5 mg/kg/day. Inhaled and topical steroids are allowed.).
Beschreibung

Immunosuppressants or other immune-modifying drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2]
C0279021
Contraindications to vaccination
Beschreibung

Contraindications to vaccination

Alias
UMLS CUI-1
C0522473
UMLS CUI-2
C0042196
Hepatomegaly, right upper quadrant abdominal pain or tenderness.
Beschreibung

Hepatic disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0023895
Anaphylactic reaction following the administration of vaccine.
Beschreibung

Anaphylactic reaction to vaccination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0002792
UMLS CUI [1,2]
C0042196
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
Beschreibung

Immunosuppressive or immunodeficient condition

Datentyp

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2]
C0021051
Pregnancy.
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
Acute disease at the time of vaccination. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e., oral temperature < 99.5°F (37.5°C) / axillary temperature < 99.5°F (37.5°C).
Beschreibung

The following adverse events constitute contraindications to administration of the study vaccine at that point in time; if any one of these adverse events occurs at the time scheduled for vaccination, the subject may be vaccinated at a later date, within the time window specified in the protocol, or withdrawn at the discretion of the investigator. The subject must be followed until resolution of the event, as with any adverse event.

Datentyp

boolean

Alias
UMLS CUI [1]
C0001314
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Ähnliche Modelle

Screening: Eligibility Check and Vaccination contraindications

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inclusion criteria
C1512693 (UMLS CUI-1)
Gender and Age
Item
A male or female between and including, 11 and 15 years of age at the time of the first vaccination.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Informed consent
Item
Written informed consent obtained from the subject and subject’s parent/guardian.
boolean
C0021430 (UMLS CUI [1])
Health problems
Item
Free of obvious health problems as established by medical history and clinical examination before entering the study.
boolean
C1446390 (UMLS CUI [1,1])
C0332296 (UMLS CUI [1,2])
Contraception or Pregnancy
Item
If the subject is female and of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (e.g., intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant® or DepoProvera®) for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
boolean
C0032961 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
HBs antigen, anti-HBc antibodies and anti-HBs antibodies
Item
Subjects should be seronegative for HBs antigen, anti-HBc antibodies and anti-HBs antibodies.
boolean
C0201478 (UMLS CUI [1,1])
C0201480 (UMLS CUI [1,2])
C0201477 (UMLS CUI [1,3])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Use of other study drugs
Item
Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned to use during the study period.
boolean
C2348568 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Other vaccines
Item
Administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine.
boolean
C0042210 (UMLS CUI [1,1])
C1444655 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Previous Hep B vaccination
Item
Previous vaccination against hepatitis B.
boolean
C0474232 (UMLS CUI [1])
Hep B Exposure
Item
Known exposure to hepatitis B within the previous 6 weeks.
boolean
C0019163 (UMLS CUI [1])
History of hepatitis B infection
Item
History of hepatitis B infection.
boolean
C0019163 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Immunosuppressive or immunodeficient condition
Item
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
boolean
C0021079 (UMLS CUI [1])
C0021051 (UMLS CUI [2])
Family history of congenital or hereditary immunodeficiency
Item
A family history of congenital or hereditary immunodeficiency.
boolean
C0241889 (UMLS CUI [1,1])
C0853602 (UMLS CUI [1,2])
C0439660 (UMLS CUI [2,1])
C0021051 (UMLS CUI [2,2])
Allergies, Hypersensitivity to vaccine
Item
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
boolean
C0020517 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Acute disease
Item
Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, at the investigator's discretion)
boolean
C0001314 (UMLS CUI [1])
Hepatic disease
Item
Hepatomegaly, right upper quadrant abdominal pain or tenderness.
boolean
C0023895 (UMLS CUI [1])
Immunoglobulins and blood products
Item
Administration of immunoglobulins and any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
boolean
C0021027 (UMLS CUI [1])
C0456388 (UMLS CUI [2])
Pregnancy or breast feeding
Item
Pregnant or lactating female.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Immunosuppressants or other immune-modifying drugs
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, > 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
boolean
C0021081 (UMLS CUI [1])
C0279021 (UMLS CUI [2])
Chronic drug therapy
Item
Any chronic drug therapy to be continued during the study period.
boolean
C0013216 (UMLS CUI [1])
Comorbidities
Item
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
boolean
C4061114 (UMLS CUI [1])
C0008679 (UMLS CUI [2])
Congenital defects or serious chronic illness
Item
Major congenital defects or serious chronic illness.
boolean
C0220810 (UMLS CUI [1])
C0008679 (UMLS CUI [2])
Alcohol or drug abuse
Item
History of chronic alcohol consumption and/or intravenous drug abuse.
boolean
C0038586 (UMLS CUI [1])
Planned pregnancy
Item
Female planning to become pregnant
boolean
C0032961 (UMLS CUI [1,1])
C0032992 (UMLS CUI [1,2])
Item Group
Elimination criteria during the study
C0680251 (UMLS CUI-1)
Use of other study drug
Item
Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period.
boolean
C2348568 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Intravenous drug abuse
Item
Intravenous drug abuse.
boolean
C0086181 (UMLS CUI [1])
Pregnancy planned
Item
Female deciding to become pregnant.
boolean
C0032961 (UMLS CUI [1,1])
C0032992 (UMLS CUI [1,2])
Other vaccines
Item
Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after.
boolean
C0042210 (UMLS CUI [1,1])
C1444655 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Immunoglobulins and/or blood products
Item
Administration of immunoglobulins and/or any blood products during the study period.
boolean
C0021027 (UMLS CUI [1])
C0456388 (UMLS CUI [2])
Immunosuppressants or other immune-modifying drugs
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period. (For corticosteroids, this will mean prednisone, or equivalent, > 0.5 mg/kg/day. Inhaled and topical steroids are allowed.).
boolean
C0021081 (UMLS CUI [1])
C0279021 (UMLS CUI [2])
Item Group
Contraindications to vaccination
C0522473 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
Hepatic disease
Item
Hepatomegaly, right upper quadrant abdominal pain or tenderness.
boolean
C0023895 (UMLS CUI [1])
Anaphylactic reaction to vaccination
Item
Anaphylactic reaction following the administration of vaccine.
boolean
C0002792 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Immunosuppressive or immunodeficient condition
Item
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
boolean
C0021079 (UMLS CUI [1])
C0021051 (UMLS CUI [2])
Pregnancy
Item
Pregnancy.
boolean
C0032961 (UMLS CUI [1])
Acute disease
Item
Acute disease at the time of vaccination. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e., oral temperature < 99.5°F (37.5°C) / axillary temperature < 99.5°F (37.5°C).
boolean
C0001314 (UMLS CUI [1])
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