ID

33880

Beschreibung

Study ID:103860/269 Clinical Study ID:103860/269 (HBV-269) Study Title: Phase II study to evaluate the immunogenicity of GSK Biologicals' preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™-B and evaluate safety and reactogenicity of each vaccine when administered intramuscularly according to a 0, 1, 6 month schedule in healthy volunteers Patient Level Data:Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix-B Study Indication: Hepatitis B

Stichworte

Versionen (1)
  1. 05.01.19 05.01.19 -
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GlaxoSmithKline

Hochgeladen am

5. Januar 2019

DOI

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Immunogenicity, safety and reactogenicity of preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™️-B

Englisch

Eligibility Checklist

1 Formulare  
  1. StudyEvent: ODM
    1. Eligibility Checklist
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
A male or female between, and including, 18 and 50 years of age at the time of the first vaccination.
Beschreibung

Gender, Age

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0001779
Written informed consent obtained from the subject.
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 into the study.
Beschreibung

Health Status

Datentyp

boolean

Alias
UMLS CUI [1]
C0018759
If the subject is female, she must be of non-childbearing, i.e., either surgically sterilised or one year post- menopausal; or, if 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

Childbearing Potential, Pregnancy test negative

Datentyp

text

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
Exclusion Criteria for Enrollment
Beschreibung

Exclusion Criteria for Enrollment

Alias
UMLS CUI-1
C0680251
UMLS CUI-2
C1516879
Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Beschreibung

Pharmaceutical Preparations, Vaccines

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0042210
Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine.
Beschreibung

Administration of vaccine, Planned

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1301732
Previous vaccination against hepatitis B.
Beschreibung

Hepatitis B vaccination, Previous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0474232
UMLS CUI [1,2]
C0205156
History of non-response to previous hepatitis B vaccination.
Beschreibung

Hepatitis B vaccination, Previous, Absent response to treatment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0474232
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0438286
Known exposure to hepatitis B within the previous 6 weeks.
Beschreibung

Hepatitis B, Exposure to

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C0332157
History of hepatitis B infection.
Beschreibung

Hepatitis B, Medical History

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

Immunosuppression, Immunologic Deficiency Syndromes, HIV

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4048329
UMLS CUI [1,2]
C0021051
UMLS CUI [1,3]
C0019682
A family history of congenital or hereditary immunodeficiency.
Beschreibung

Immunodeficiency congenital, Immunologic Deficiency Syndromes, Hereditary, Family history

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0853602
UMLS CUI [1,2]
C0021051
UMLS CUI [1,3]
C0439660
UMLS CUI [1,4]
C0241889
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Beschreibung

Hypersensitivity, Medical History

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0262926
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, Enrollment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001314
UMLS CUI [1,2]
C1516879
Hepatomegaly, right upper quadrant abdominal pain or tenderness.
Beschreibung

Hepatomegaly, Right upper quadrant pain, Right upper quadrant abdominal tenderness

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019209
UMLS CUI [1,2]
C0235299
UMLS CUI [1,3]
C0238571
Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
Beschreibung

Immunoglobulins, Blood product

Datentyp

boolean

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

Pregnancy, Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
Elimination Criteria During the Study
Beschreibung

Elimination Criteria During the Study

Alias
UMLS CUI-1
C0680251
UMLS CUI-2
C0347984
UMLS CUI-3
C0008976
Subjects being found to be positive for any hepatitis B marker (anti-HBs, anti-HBc, HBsAg) tested at pre-vaccination.
Beschreibung

Hepatitis B positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0856706
Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period.
Beschreibung

Pharmaceutical Preparations, Vaccines

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0042210
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

Vaccines, Administration procedure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C1533734
Administration of immunoglobulins and/or any blood products during the study
Beschreibung

Immunoglobulins, Blood product

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021027
UMLS CUI [1,2]
C0456388
Female deciding to become pregnant.
Beschreibung

Pregnancy, Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0032992
Contraindications to vaccination
Beschreibung

Contraindications to vaccination

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

Hepatomegaly, Right upper quadrant pain, Right upper quadrant abdominal tenderness

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019209
UMLS CUI [1,2]
C0235299
UMLS CUI [1,3]
C0238571
Anaphylactic reaction following the administration of vaccine(s).
Beschreibung

Anaphylaxis, Vaccination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0002792
UMLS CUI [1,2]
C0042196
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 diarrhoea, mild upper respiratory infection with or without low-grade febrile illness (at the investigator's discretion)
Beschreibung

Acute Disease, Vaccination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001314
UMLS CUI [1,2]
C0042196
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Ähnliche Modelle

Eligibility Checklist

1 Formulare
  1. StudyEvent: ODM
    1. Eligibility Checklist
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Gender, Age
Item
A male or female between, and including, 18 and 50 years of age at the time of the first vaccination.
boolean
C0079399 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
Informed Consent
Item
Written informed consent obtained from the subject.
boolean
C0021430 (UMLS CUI [1])
Health Status
Item
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
boolean
C0018759 (UMLS CUI [1])
Childbearing Potential, Pregnancy test negative
Item
If the subject is female, she must be of non-childbearing, i.e., either surgically sterilised or one year post- menopausal; or, if 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.
text
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Item Group
Exclusion Criteria for Enrollment
C0680251 (UMLS CUI-1)
C1516879 (UMLS CUI-2)
Pharmaceutical Preparations, Vaccines
Item
Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
boolean
C0013227 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Administration of vaccine, Planned
Item
Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine.
boolean
C2368628 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Hepatitis B vaccination, Previous
Item
Previous vaccination against hepatitis B.
boolean
C0474232 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Hepatitis B vaccination, Previous, Absent response to treatment
Item
History of non-response to previous hepatitis B vaccination.
boolean
C0474232 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0438286 (UMLS CUI [1,3])
Hepatitis B, Exposure to
Item
Known exposure to hepatitis B within the previous 6 weeks.
boolean
C0019163 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
Hepatitis B, Medical History
Item
History of hepatitis B infection.
boolean
C0019163 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Immunosuppression, Immunologic Deficiency Syndromes, HIV
Item
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
boolean
C4048329 (UMLS CUI [1,1])
C0021051 (UMLS CUI [1,2])
C0019682 (UMLS CUI [1,3])
Immunodeficiency congenital, Immunologic Deficiency Syndromes, Hereditary, Family history
Item
A family history of congenital or hereditary immunodeficiency.
boolean
C0853602 (UMLS CUI [1,1])
C0021051 (UMLS CUI [1,2])
C0439660 (UMLS CUI [1,3])
C0241889 (UMLS CUI [1,4])
Hypersensitivity, Medical History
Item
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
boolean
C0020517 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Acute Disease, Enrollment
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 [1,1])
C1516879 (UMLS CUI [1,2])
Hepatomegaly, Right upper quadrant pain, Right upper quadrant abdominal tenderness
Item
Hepatomegaly, right upper quadrant abdominal pain or tenderness.
boolean
C0019209 (UMLS CUI [1,1])
C0235299 (UMLS CUI [1,2])
C0238571 (UMLS CUI [1,3])
Immunoglobulins, Blood product
Item
Administration of immunoglobulins and/or 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 [1,1])
C0456388 (UMLS CUI [1,2])
Pregnancy, Breast Feeding
Item
Pregnant or lactating female.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
Item Group
Elimination Criteria During the Study
C0680251 (UMLS CUI-1)
C0347984 (UMLS CUI-2)
C0008976 (UMLS CUI-3)
Hepatitis B positive
Item
Subjects being found to be positive for any hepatitis B marker (anti-HBs, anti-HBc, HBsAg) tested at pre-vaccination.
boolean
C0856706 (UMLS CUI [1])
Pharmaceutical Preparations, Vaccines
Item
Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period.
boolean
C0013227 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Vaccines, Administration procedure
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])
C1533734 (UMLS CUI [1,2])
Immunoglobulins, Blood product
Item
Administration of immunoglobulins and/or any blood products during the study
boolean
C0021027 (UMLS CUI [1,1])
C0456388 (UMLS CUI [1,2])
Pregnancy, Planned
Item
Female deciding to become pregnant.
boolean
C0032992 (UMLS CUI [1])
Item Group
Contraindications to vaccination
C0042196 (UMLS CUI-1)
C0522473 (UMLS CUI-2)
Hepatomegaly, Right upper quadrant pain, Right upper quadrant abdominal tenderness
Item
Hepatomegaly, right upper quadrant abdominal pain or tenderness.
boolean
C0019209 (UMLS CUI [1,1])
C0235299 (UMLS CUI [1,2])
C0238571 (UMLS CUI [1,3])
Anaphylaxis, Vaccination
Item
Anaphylactic reaction following the administration of vaccine(s).
boolean
C0002792 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Pregnancy
Item
Pregnancy.
boolean
C0032961 (UMLS CUI [1])
Acute Disease, Vaccination
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 diarrhoea, mild upper respiratory infection with or without low-grade febrile illness (at the investigator's discretion)
boolean
C0001314 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
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