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ID

33302

Beskrivning

Study ID: 109563 Clinical Study ID: 109563 Study Title: COMPAS:A phase III study to demonstrate efficacy of GSK Biologicals' 10-valent pneumococcal vaccine (GSK1024850A) against Community Acquired Pneumonia and Acute Otitis Media Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier https://clinicaltrials.gov/ct2/show/NCT00466947 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) Trade Name: BIO 10PN-PD-DIT; Synflorix Study Indication: Infections, Streptococcal The Study consists of three workbooks. Workbook 1: Argentina, all subjects + immuno & reacto subset Workbook 2: Panama, all subjects + immuno & reacto subset + carriage subset + additional immuno subset Workbook 3: Colombia, all subjects The protocol number for all workbooks: 109563 (10Pn-PD-DiT-028) There are ten visits in workbook 1 and 2, eight for workbook 3 (there are no visits 4 and 7): Visit 1: month 0, dose 1, 6-16 weeks of age Visit 2: month 2, dose 2, +/- 4 months of age, 49-83 days after visit 1 Visit 3: month 4, dose 3, +/- 6 months of age, 49-83 days after visit 2 Visit 4: month 5, +/- 7 months of age, 28-42 days after visit 3. Only for immuno & reacto subset + carriage subset. Visit 5: month 10-13, 12-15 months of age Visit 6: month 13-16, booster dose, 15-18 months of age, ≥ 28 days after visit 5 Visit 7: month 14-17, 16-19 months of age, 28-42 days after visit 6. Only for immuno & reacto subset, additional immuno subset + carriage subset. Visit 8: month 16-19, 18-21 months of age, ≥ 28 days after visit 6 Visit 9: month 22-25, 24-27 months of age Visit 10: Contact This document contains information about general study notes which includes Elimination criteria, warnings and precautions and contraindications. It's for all workbooks.

Länk

https://clinicaltrials.gov/ct2/show/NCT00466947

Nyckelord

Versioner (2)
  1. 2018-11-04 2018-11-04 -
  2. 2018-12-05 2018-12-05 - Sarah Riepenhausen
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

5 december 2018

DOI

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Licens

Creative Commons BY-NC 3.0
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    Vaccination against pneumonia and otitis media, NCT00466947

    Engelsk

    Elimination criteria, warnings and precautions, contraindication

    1 Formulär  
    Administrative data
    Beskrivning

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Beskrivning

    Subject Number

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Workbook Number
    Beskrivning

    Workbook Number

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2986015
    Date of recording
    Beskrivning

    Date of recording

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0442711
    ELIMINATION CRITERIA DURING THE STUDY
    Beskrivning

    ELIMINATION CRITERIA DURING THE STUDY

    Alias
    UMLS CUI-1
    C0013893
    Chronic administration of immunosuppressants or other immunemodifying drugs during the study period. For corticosteroids, this will mean prednisone, or equivalent, 0.5 mg/kg/day. Inhaled and topical steroids are allowed.
    Beskrivning

    Chronic administration definition: more than 14 days

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0205191
    UMLS CUI [1,2]
    C0021081
    UMLS CUI [2,1]
    C0032952
    UMLS CUI [2,2]
    C0205163
    UMLS CUI [2,3]
    C0001617
    UMLS CUI [3,1]
    C0683607
    UMLS CUI [3,2]
    C0304604
    UMLS CUI [4,1]
    C0683607
    UMLS CUI [4,2]
    C2065041
    Major congenital defects or serious chronic illness
    Beskrivning

    Major congenital defects/ serious chronic illness

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0000768
    UMLS CUI [1,2]
    C0205164
    UMLS CUI [2,1]
    C0008679
    UMLS CUI [2,2]
    C0205404
    Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required)
    Beskrivning

    Immunosuppressive/ immunodeficient condition based on medical history and physical examination

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0021051
    UMLS CUI [2,1]
    C0031809
    UMLS CUI [2,2]
    C0021051
    UMLS CUI [3,1]
    C0022885
    UMLS CUI [3,2]
    C1298908
    UMLS CUI [3,3]
    C1514873
    Administration of immunoglobulins and/or any blood derived products during the study period
    Beskrivning

    Administration of immunoglobulins and/or any blood derived products during study period

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021027
    UMLS CUI [2]
    C0456388
    Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the entire study period.
    Beskrivning

    This criteria should be checked for all subjects at each scheduled visit only, subsequent to the first visit.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0013230
    UMLS CUI [2,1]
    C0332300
    UMLS CUI [2,2]
    C1517586
    UMLS CUI [2,3]
    C0042210
    UMLS CUI [2,4]
    C1507394
    WARNINGS AND PRECAUTIONS
    Beskrivning

    WARNINGS AND PRECAUTIONS

    Alias
    UMLS CUI-1
    C1882442
    UMLS CUI-2
    C0871599
    Local reactions at injection site: pain, redness and swelling
    Beskrivning

    Local reactions at injection site: pain, redness and swelling

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0853813
    UMLS CUI [1,2]
    C2700396
    UMLS CUI [2]
    C0030193
    UMLS CUI [3]
    C0332575
    UMLS CUI [4]
    C0038999
    General reactions: irritability, crying, loss of appetite, vomiting, diarrhoea, fever, drowsiness and restlessness.
    Beskrivning

    General reactions: irritability, crying, loss of appetite, vomiting, diarrhoea, fever, drowsiness and restlessness

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0159028
    UMLS CUI [2]
    C0022107
    UMLS CUI [3]
    C0010399
    UMLS CUI [4]
    C1971624
    UMLS CUI [5]
    C0042963
    UMLS CUI [6]
    C0011991
    UMLS CUI [7]
    C0015967
    UMLS CUI [8]
    C0013144
    UMLS CUI [9]
    C3887611
    Precautions specific to Diphteria, Tetanus and Pertussis (DTPa) vaccine administration
    Beskrivning

    Precautions specific to Diphteria, Tetanus and Pertussis (DTPa) vaccine administration

    Alias
    UMLS CUI-1
    C1882442
    UMLS CUI-2
    C3526553
    UMLS CUI-3
    C2368628
    Fever within 48 hours of vaccination.
    Beskrivning

    rectal temperature equal to or more than 40.5 °C oral, axillary or tympanic temperature equal to or more than 40.0 °C

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0015967
    UMLS CUI [1,2]
    C0332282
    UMLS CUI [1,3]
    C0042196
    Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination
    Beskrivning

    Collapse, shock-like state

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0344329
    UMLS CUI [1,2]
    C0332282
    UMLS CUI [1,3]
    C0042196
    UMLS CUI [2,1]
    C0036974
    UMLS CUI [2,2]
    C0332282
    UMLS CUI [2,3]
    C0042196
    Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting equal to or more than 3 hours
    Beskrivning

    Persistent, inconsolable crying

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2721683
    UMLS CUI [1,2]
    C0332282
    UMLS CUI [1,3]
    C0042196
    Seizures with or without fever occurring within 3 days of vaccination
    Beskrivning

    Seizures with or without fever occurring within 3 days of vaccination.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0036572
    UMLS CUI [1,2]
    C0015967
    UMLS CUI [1,3]
    C0332282
    UMLS CUI [1,4]
    C0042196
    UMLS CUI [2,1]
    C0036572
    UMLS CUI [2,2]
    C0332282
    UMLS CUI [2,3]
    C0042196
    CONTRAINDICATIONS TO SUBSEQUENT VACCINATION
    Beskrivning

    CONTRAINDICATIONS TO SUBSEQUENT VACCINATION

    Alias
    UMLS CUI-1
    C0522473
    UMLS CUI-2
    C0042196
    Anaphylactic reaction following previous administration of vaccine(s)
    Beskrivning

    Anaphylactic reaction following vaccination

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0002792
    UMLS CUI [1,2]
    C0332282
    UMLS CUI [1,3]
    C0042196
    Hypersensitivity to any component of the study or co-administered vaccines (10Pn-PD-DiT, DTPa-based combination vaccines, Havrix and Engerix-B) or signs of hypersensivity following previous immunizations
    Beskrivning

    Hypersensitivity to component of the study/ co-administered vaccines, signs of hypersensivity following vaccination

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0008976
    UMLS CUI [1,3]
    C0042210
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0332282
    UMLS CUI [2,3]
    C0042196
    Acute disease at the time of vaccination. In case of acute disease, the study visit should be postponed until the illness has improved.
    Beskrivning

    Definition of acute disease: 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 fever, i.e. Oral/Axillary/Tympanic temperature below 37.5 °C / Recta l temperature below 38.0 °C

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0001314
    UMLS CUI [1,2]
    C0042196
    UMLS CUI [1,3]
    C0040223
    Febrile illness. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
    Beskrivning

    Definition of Febrile illness: oral, axillary or tympanic temperature equal to or more than 37.5 °C rectal temperature equal to or more than 38.0 °C

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0743841
    UMLS CUI [2,1]
    C0205421
    UMLS CUI [2,2]
    C0042196
    Absolute contraindication to administration of DTPa-HBV-IPV/Hib or DTPa-IPV/Hib
    Beskrivning

    Absolute contraindication to administration of DTPa-HBV-IPV/Hib or DTPa-IPV/Hib

    Alias
    UMLS CUI-1
    C0205344
    UMLS CUI-2
    C0522473
    UMLS CUI-3
    C2368628
    UMLS CUI-4
    C1121707
    UMLS CUI-5
    C0909900
    These vaccines are contra-indicated if the infant has experienced an encephalopathy occurring within 7 days following vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalized or focal seizures that persist more than a few hours, with failure to recover within 24 hours.
    Beskrivning

    Definition of encephalopathy: acute, severe central nervous system disorder

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0085584
    UMLS CUI [1,2]
    C0332282
    UMLS CUI [1,3]
    C0042196
    UMLS CUI [2]
    C0234421
    UMLS CUI [3]
    C0241526
    UMLS CUI [4]
    C0234533
    UMLS CUI [5]
    C0751495
    EXCLUSION CRITERIA FOR FURTHER STUDY PARTICIPATION
    Beskrivning

    EXCLUSION CRITERIA FOR FURTHER STUDY PARTICIPATION

    Alias
    UMLS CUI-1
    C0013893
    UMLS CUI-2
    C2348568
    Diagnosis of high risk disease for pneumococcal infections (such as HIV positive, sickle cell disease and splenectomized infants) will be evaluated according to medical judgement.
    Beskrivning

    Decision on withdrawal of the subject from the study will depend on the medical condition of the subject, the existence of a specific local vaccination program, and the availability of the registered pneumococcal vaccine. If Prevnar is made available through a targeted immunization program for these high risk groups, further participation in the COMPAS study would no longer be possible, and these subjects will need to be excluded from the study and referred to the specific Prevnar immunization program. Once excluded, subjects can not return to receive subsequent study vaccine doses, even if Prevnar would no longer be available.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0332167
    UMLS CUI [1,3]
    C0032269
    UMLS CUI [2]
    C0019699
    UMLS CUI [3]
    C0002895
    UMLS CUI [4]
    C0037995
    For each case, where by mistake, vaccines with antigens common to the antigens contained in the study or co-administered vaccines are administered outside of the context of the study, the investigator will need to evaluate whether the subject can still continue participation in the study.
    Beskrivning

    Other administration of vaccines than study vaccines.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C2368628
    UMLS CUI [1,3]
    C0347984
    UMLS CUI [1,4]
    C2347804
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    Similar models

    Elimination criteria, warnings and precautions, contraindication

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject Number
    Item
    Subject Number
    text
    C2348585 (UMLS CUI [1])
    Item
    Workbook Number
    integer
    C2986015 (UMLS CUI [1])
    Workbook Number
    Code List
    Workbook Number
    CL Item
    Workbook 1 (1)
    CL Item
    Workbook 2 (2)
    CL Item
    Workbook 3 (3)
    Date of recording
    Item
    Date of recording
    date
    C0011008 (UMLS CUI [1,1])
    C0442711 (UMLS CUI [1,2])
    Item Group
    ELIMINATION CRITERIA DURING THE STUDY
    C0013893 (UMLS CUI-1)
    Chronic use of immunosuppressants/ other immunemodifying drugs, limited dosis of prednisone (inhaled and topical steroids allowed)
    Item
    Chronic administration of immunosuppressants or other immunemodifying 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
    C0205191 (UMLS CUI [1,1])
    C0021081 (UMLS CUI [1,2])
    C0032952 (UMLS CUI [2,1])
    C0205163 (UMLS CUI [2,2])
    C0001617 (UMLS CUI [2,3])
    C0683607 (UMLS CUI [3,1])
    C0304604 (UMLS CUI [3,2])
    C0683607 (UMLS CUI [4,1])
    C2065041 (UMLS CUI [4,2])
    Major congenital defects/ serious chronic illness
    Item
    Major congenital defects or serious chronic illness
    boolean
    C0000768 (UMLS CUI [1,1])
    C0205164 (UMLS CUI [1,2])
    C0008679 (UMLS CUI [2,1])
    C0205404 (UMLS CUI [2,2])
    Immunosuppressive/ immunodeficient condition based on medical history and physical examination
    Item
    Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required)
    boolean
    C0262926 (UMLS CUI [1,1])
    C0021051 (UMLS CUI [1,2])
    C0031809 (UMLS CUI [2,1])
    C0021051 (UMLS CUI [2,2])
    C0022885 (UMLS CUI [3,1])
    C1298908 (UMLS CUI [3,2])
    C1514873 (UMLS CUI [3,3])
    Administration of immunoglobulins and/or any blood derived products during study period
    Item
    Administration of immunoglobulins and/or any blood derived products during the study period
    boolean
    C0021027 (UMLS CUI [1])
    C0456388 (UMLS CUI [2])
    Use of any investigational/non-registered product (drug or vaccine) ( except for study vaccine(s) )
    Item
    Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the entire study period.
    boolean
    C0013230 (UMLS CUI [1])
    C0332300 (UMLS CUI [2,1])
    C1517586 (UMLS CUI [2,2])
    C0042210 (UMLS CUI [2,3])
    C1507394 (UMLS CUI [2,4])
    Item Group
    WARNINGS AND PRECAUTIONS
    C1882442 (UMLS CUI-1)
    C0871599 (UMLS CUI-2)
    Local reactions at injection site: pain, redness and swelling
    Item
    Local reactions at injection site: pain, redness and swelling
    boolean
    C0853813 (UMLS CUI [1,1])
    C2700396 (UMLS CUI [1,2])
    C0030193 (UMLS CUI [2])
    C0332575 (UMLS CUI [3])
    C0038999 (UMLS CUI [4])
    General reactions: irritability, crying, loss of appetite, vomiting, diarrhoea, fever, drowsiness and restlessness
    Item
    General reactions: irritability, crying, loss of appetite, vomiting, diarrhoea, fever, drowsiness and restlessness.
    boolean
    C0159028 (UMLS CUI [1])
    C0022107 (UMLS CUI [2])
    C0010399 (UMLS CUI [3])
    C1971624 (UMLS CUI [4])
    C0042963 (UMLS CUI [5])
    C0011991 (UMLS CUI [6])
    C0015967 (UMLS CUI [7])
    C0013144 (UMLS CUI [8])
    C3887611 (UMLS CUI [9])
    Item Group
    Precautions specific to Diphteria, Tetanus and Pertussis (DTPa) vaccine administration
    C1882442 (UMLS CUI-1)
    C3526553 (UMLS CUI-2)
    C2368628 (UMLS CUI-3)
    Fever
    Item
    Fever within 48 hours of vaccination.
    boolean
    C0015967 (UMLS CUI [1,1])
    C0332282 (UMLS CUI [1,2])
    C0042196 (UMLS CUI [1,3])
    Collapse, shock-like state
    Item
    Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination
    boolean
    C0344329 (UMLS CUI [1,1])
    C0332282 (UMLS CUI [1,2])
    C0042196 (UMLS CUI [1,3])
    C0036974 (UMLS CUI [2,1])
    C0332282 (UMLS CUI [2,2])
    C0042196 (UMLS CUI [2,3])
    Persistent, inconsolable crying
    Item
    Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting equal to or more than 3 hours
    boolean
    C2721683 (UMLS CUI [1,1])
    C0332282 (UMLS CUI [1,2])
    C0042196 (UMLS CUI [1,3])
    Seizures with or without fever occurring within 3 days of vaccination.
    Item
    Seizures with or without fever occurring within 3 days of vaccination
    boolean
    C0036572 (UMLS CUI [1,1])
    C0015967 (UMLS CUI [1,2])
    C0332282 (UMLS CUI [1,3])
    C0042196 (UMLS CUI [1,4])
    C0036572 (UMLS CUI [2,1])
    C0332282 (UMLS CUI [2,2])
    C0042196 (UMLS CUI [2,3])
    Item Group
    CONTRAINDICATIONS TO SUBSEQUENT VACCINATION
    C0522473 (UMLS CUI-1)
    C0042196 (UMLS CUI-2)
    Anaphylactic reaction following vaccination
    Item
    Anaphylactic reaction following previous administration of vaccine(s)
    boolean
    C0002792 (UMLS CUI [1,1])
    C0332282 (UMLS CUI [1,2])
    C0042196 (UMLS CUI [1,3])
    Hypersensitivity to component of the study/ co-administered vaccines, signs of hypersensivity following vaccination
    Item
    Hypersensitivity to any component of the study or co-administered vaccines (10Pn-PD-DiT, DTPa-based combination vaccines, Havrix and Engerix-B) or signs of hypersensivity following previous immunizations
    boolean
    C0020517 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    C0042210 (UMLS CUI [1,3])
    C0020517 (UMLS CUI [2,1])
    C0332282 (UMLS CUI [2,2])
    C0042196 (UMLS CUI [2,3])
    Acute illness at vaccination time
    Item
    Acute disease at the time of vaccination. In case of acute disease, the study visit should be postponed until the illness has improved.
    boolean
    C0001314 (UMLS CUI [1,1])
    C0042196 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Febrile illness, deferral of vaccination
    Item
    Febrile illness. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
    boolean
    C0743841 (UMLS CUI [1])
    C0205421 (UMLS CUI [2,1])
    C0042196 (UMLS CUI [2,2])
    Item Group
    Absolute contraindication to administration of DTPa-HBV-IPV/Hib or DTPa-IPV/Hib
    C0205344 (UMLS CUI-1)
    C0522473 (UMLS CUI-2)
    C2368628 (UMLS CUI-3)
    C1121707 (UMLS CUI-4)
    C0909900 (UMLS CUI-5)
    Encephalopathy after vaccination, generally consisting of major alterations in consciousness, unresponsiveness, generalized or focal seizures
    Item
    These vaccines are contra-indicated if the infant has experienced an encephalopathy occurring within 7 days following vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalized or focal seizures that persist more than a few hours, with failure to recover within 24 hours.
    boolean
    C0085584 (UMLS CUI [1,1])
    C0332282 (UMLS CUI [1,2])
    C0042196 (UMLS CUI [1,3])
    C0234421 (UMLS CUI [2])
    C0241526 (UMLS CUI [3])
    C0234533 (UMLS CUI [4])
    C0751495 (UMLS CUI [5])
    Item Group
    EXCLUSION CRITERIA FOR FURTHER STUDY PARTICIPATION
    C0013893 (UMLS CUI-1)
    C2348568 (UMLS CUI-2)
    High risk disease for pneumococcal infection (HIV, sickle cell disease, splenectomized infants)
    Item
    Diagnosis of high risk disease for pneumococcal infections (such as HIV positive, sickle cell disease and splenectomized infants) will be evaluated according to medical judgement.
    boolean
    C0012634 (UMLS CUI [1,1])
    C0332167 (UMLS CUI [1,2])
    C0032269 (UMLS CUI [1,3])
    C0019699 (UMLS CUI [2])
    C0002895 (UMLS CUI [3])
    C0037995 (UMLS CUI [4])
    Other administration of vaccines than study vaccines.
    Item
    For each case, where by mistake, vaccines with antigens common to the antigens contained in the study or co-administered vaccines are administered outside of the context of the study, the investigator will need to evaluate whether the subject can still continue participation in the study.
    boolean
    C0205394 (UMLS CUI [1,1])
    C2368628 (UMLS CUI [1,2])
    C0347984 (UMLS CUI [1,3])
    C2347804 (UMLS CUI [1,4])
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