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ID

33302

Description

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.

Link

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

Keywords

Versions (2)
  1. 11/4/18 11/4/18 -
  2. 12/5/18 12/5/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

December 5, 2018

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License

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

    English

    Elimination criteria, warnings and precautions, contraindication

    1 forms  
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject Number
    Description

    Subject Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Workbook Number
    Description

    Workbook Number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2986015 (Document Version Number Text)
    Date of recording
    Description

    Date of recording

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0442711 (Protocols documentation)
    SNOMED
    258049002
    ELIMINATION CRITERIA DURING THE STUDY
    Description

    ELIMINATION CRITERIA DURING THE STUDY

    Alias
    UMLS CUI-1
    C0013893 (Eligibility Determination)
    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.
    Description

    Chronic administration definition: more than 14 days

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0205191 (chronic)
    SNOMED
    90734009
    UMLS CUI [1,2]
    C0021081 (Immunosuppressive Agents)
    SNOMED
    69431002
    UMLS CUI [2,1]
    C0032952 (prednisone)
    SNOMED
    10312003
    UMLS CUI [2,2]
    C0205163 (Equal)
    SNOMED
    258726008
    UMLS CUI [2,3]
    C0001617 (Adrenal Cortex Hormones)
    SNOMED
    21568003
    LOINC
    LP20687-7
    UMLS CUI [3,1]
    C0683607 (allowing)
    UMLS CUI [3,2]
    C0304604 (Topical form corticosteroids)
    UMLS CUI [4,1]
    C0683607 (allowing)
    UMLS CUI [4,2]
    C2065041 (inhaled steroids)
    Major congenital defects or serious chronic illness
    Description

    Major congenital defects/ serious chronic illness

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0000768 (Congenital Abnormality)
    SNOMED
    276654001
    UMLS CUI [1,2]
    C0205164 (Major)
    SNOMED
    255603008
    LOINC
    LA29634-5
    UMLS CUI [2,1]
    C0008679 (Chronic disease)
    SNOMED
    27624003
    UMLS CUI [2,2]
    C0205404 (Serious)
    SNOMED
    42745003
    LOINC
    LA30751-4
    Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required)
    Description

    Immunosuppressive/ immunodeficient condition based on medical history and physical examination

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926 (Medical History)
    SNOMED
    392521001
    LOINC
    LP6817-3
    UMLS CUI [1,2]
    C0021051 (Immunologic Deficiency Syndromes)
    SNOMED
    234532001
    LOINC
    MTHU054768
    UMLS CUI [2,1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [2,2]
    C0021051 (Immunologic Deficiency Syndromes)
    SNOMED
    234532001
    LOINC
    MTHU054768
    UMLS CUI [3,1]
    C0022885 (Laboratory Procedures)
    SNOMED
    269814003
    UMLS CUI [3,2]
    C1298908 (no)
    SNOMED
    373067005
    UMLS CUI [3,3]
    C1514873 (Requirement)
    Administration of immunoglobulins and/or any blood derived products during the study period
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021027 (Immunoglobulins)
    SNOMED
    333710000
    LOINC
    LP31769-0
    UMLS CUI [2]
    C0456388 (Blood product)
    SNOMED
    410652009
    LOINC
    LP32808-5
    Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the entire study period.
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013230 (Investigational New Drugs)
    UMLS CUI [2,1]
    C0332300 (Except for)
    SNOMED
    5185003
    UMLS CUI [2,2]
    C1517586 (Investigational)
    UMLS CUI [2,3]
    C0042210 (Vaccines)
    SNOMED
    787859002
    LOINC
    LA20283-0
    UMLS CUI [2,4]
    C1507394 (Clinical trial protocol document)
    LOINC
    LP33258-2
    WARNINGS AND PRECAUTIONS
    Description

    WARNINGS AND PRECAUTIONS

    Alias
    UMLS CUI-1
    C1882442 (Precaution)
    UMLS CUI-2
    C0871599 (Cautionary Warning)
    Local reactions at injection site: pain, redness and swelling
    Description

    Local reactions at injection site: pain, redness and swelling

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0853813 (Local reaction)
    UMLS CUI [1,2]
    C2700396 (Injection site)
    UMLS CUI [2]
    C0030193 (Pain)
    SNOMED
    22253000
    LOINC
    MTHU029813
    UMLS CUI [3]
    C0332575 (Redness)
    SNOMED
    386713009
    LOINC
    LA22439-6
    UMLS CUI [4]
    C0038999 (Swelling)
    SNOMED
    442672001
    LOINC
    LA22440-4
    General reactions: irritability, crying, loss of appetite, vomiting, diarrhoea, fever, drowsiness and restlessness.
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0159028 (General symptom)
    SNOMED
    267022002
    UMLS CUI [2]
    C0022107 (Irritable Mood)
    SNOMED
    55929007
    LOINC
    LA30516-1
    UMLS CUI [3]
    C0010399 (Crying)
    SNOMED
    28263002
    LOINC
    LA29193-2
    UMLS CUI [4]
    C1971624 (Loss of appetite (finding))
    SNOMED
    79890006
    LOINC
    LA30523-7
    UMLS CUI [5]
    C0042963 (Vomiting)
    SNOMED
    422400008
    LOINC
    MTHU013530
    UMLS CUI [6]
    C0011991 (Diarrhea)
    SNOMED
    62315008
    LOINC
    MTHU013347
    UMLS CUI [7]
    C0015967 (Fever)
    SNOMED
    50177009
    LOINC
    MTHU013518
    UMLS CUI [8]
    C0013144 (Drowsiness)
    SNOMED
    79519003
    LOINC
    LA16352-9
    UMLS CUI [9]
    C3887611 (Restlessness)
    SNOMED
    162221009
    LOINC
    LA16474-1
    Precautions specific to Diphteria, Tetanus and Pertussis (DTPa) vaccine administration
    Description

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

    Alias
    UMLS CUI-1
    C1882442 (Precaution)
    UMLS CUI-2
    C3526553 (diphtheria, tetanus toxoids and acellular pertussis vaccine)
    UMLS CUI-3
    C2368628 (Administration of vaccine)
    Fever within 48 hours of vaccination.
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0015967 (Fever)
    SNOMED
    50177009
    LOINC
    MTHU013518
    UMLS CUI [1,2]
    C0332282 (Following)
    SNOMED
    255260001
    UMLS CUI [1,3]
    C0042196 (Vaccination)
    SNOMED
    33879002
    LOINC
    LP29692-8
    Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination
    Description

    Collapse, shock-like state

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0344329 (Collapse (finding))
    SNOMED
    271787007
    LOINC
    MTHU063498
    UMLS CUI [1,2]
    C0332282 (Following)
    SNOMED
    255260001
    UMLS CUI [1,3]
    C0042196 (Vaccination)
    SNOMED
    33879002
    LOINC
    LP29692-8
    UMLS CUI [2,1]
    C0036974 (Shock)
    SNOMED
    27942005
    LOINC
    LA7473-7
    UMLS CUI [2,2]
    C0332282 (Following)
    SNOMED
    255260001
    UMLS CUI [2,3]
    C0042196 (Vaccination)
    SNOMED
    33879002
    LOINC
    LP29692-8
    Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting equal to or more than 3 hours
    Description

    Persistent, inconsolable crying

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2721683 (Persistent crying)
    UMLS CUI [1,2]
    C0332282 (Following)
    SNOMED
    255260001
    UMLS CUI [1,3]
    C0042196 (Vaccination)
    SNOMED
    33879002
    LOINC
    LP29692-8
    Seizures with or without fever occurring within 3 days of vaccination
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0036572 (Seizures)
    SNOMED
    91175000
    LOINC
    LA15899-0
    UMLS CUI [1,2]
    C0015967 (Fever)
    SNOMED
    50177009
    LOINC
    MTHU013518
    UMLS CUI [1,3]
    C0332282 (Following)
    SNOMED
    255260001
    UMLS CUI [1,4]
    C0042196 (Vaccination)
    SNOMED
    33879002
    LOINC
    LP29692-8
    UMLS CUI [2,1]
    C0036572 (Seizures)
    SNOMED
    91175000
    LOINC
    LA15899-0
    UMLS CUI [2,2]
    C0332282 (Following)
    SNOMED
    255260001
    UMLS CUI [2,3]
    C0042196 (Vaccination)
    SNOMED
    33879002
    LOINC
    LP29692-8
    CONTRAINDICATIONS TO SUBSEQUENT VACCINATION
    Description

    CONTRAINDICATIONS TO SUBSEQUENT VACCINATION

    Alias
    UMLS CUI-1
    C0522473 (Contraindication)
    SNOMED
    103306004
    UMLS CUI-2
    C0042196 (Vaccination)
    SNOMED
    33879002
    LOINC
    LP29692-8
    Anaphylactic reaction following previous administration of vaccine(s)
    Description

    Anaphylactic reaction following vaccination

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0002792 (anaphylaxis)
    SNOMED
    39579001
    UMLS CUI [1,2]
    C0332282 (Following)
    SNOMED
    255260001
    UMLS CUI [1,3]
    C0042196 (Vaccination)
    SNOMED
    33879002
    LOINC
    LP29692-8
    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
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,2]
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    UMLS CUI [1,3]
    C0042210 (Vaccines)
    SNOMED
    787859002
    LOINC
    LA20283-0
    UMLS CUI [2,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [2,2]
    C0332282 (Following)
    SNOMED
    255260001
    UMLS CUI [2,3]
    C0042196 (Vaccination)
    SNOMED
    33879002
    LOINC
    LP29692-8
    Acute disease at the time of vaccination. In case of acute disease, the study visit should be postponed until the illness has improved.
    Description

    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

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0001314 (Acute Disease)
    SNOMED
    2704003
    UMLS CUI [1,2]
    C0042196 (Vaccination)
    SNOMED
    33879002
    LOINC
    LP29692-8
    UMLS CUI [1,3]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Febrile illness. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
    Description

    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

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0743841 (Disorder characterized by fever)
    SNOMED
    416113008
    UMLS CUI [2,1]
    C0205421 (Deferred)
    LOINC
    LA7343-2
    UMLS CUI [2,2]
    C0042196 (Vaccination)
    SNOMED
    33879002
    LOINC
    LP29692-8
    Absolute contraindication to administration of DTPa-HBV-IPV/Hib or DTPa-IPV/Hib
    Description

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

    Alias
    UMLS CUI-1
    C0205344 (Absolute)
    SNOMED
    56136002
    UMLS CUI-2
    C0522473 (Contraindication)
    SNOMED
    103306004
    UMLS CUI-3
    C2368628 (Administration of vaccine)
    UMLS CUI-4
    C1121707 (DTPa-HBV-IPV combined vaccine)
    UMLS CUI-5
    C0909900 (diphtheria-tetanus-acellular pertussis-Hib-hepatitis B vaccine)
    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.
    Description

    Definition of encephalopathy: acute, severe central nervous system disorder

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0085584 (Encephalopathies)
    UMLS CUI [1,2]
    C0332282 (Following)
    SNOMED
    255260001
    UMLS CUI [1,3]
    C0042196 (Vaccination)
    SNOMED
    33879002
    LOINC
    LP29692-8
    UMLS CUI [2]
    C0234421 (Conscious)
    UMLS CUI [3]
    C0241526 (Unresponsiveness)
    UMLS CUI [4]
    C0234533 (Generalized seizures)
    SNOMED
    246545002
    UMLS CUI [5]
    C0751495 (Seizures, Focal)
    SNOMED
    29753000
    EXCLUSION CRITERIA FOR FURTHER STUDY PARTICIPATION
    Description

    EXCLUSION CRITERIA FOR FURTHER STUDY PARTICIPATION

    Alias
    UMLS CUI-1
    C0013893 (Eligibility Determination)
    UMLS CUI-2
    C2348568 (Study Subject Participation Status)
    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.
    Description

    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.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    UMLS CUI [1,2]
    C0332167 (High risk of)
    SNOMED
    15508007
    UMLS CUI [1,3]
    C0032269 (Pneumococcal Infections)
    SNOMED
    16814004
    UMLS CUI [2]
    C0019699 (HIV Seropositivity)
    SNOMED
    165816005
    UMLS CUI [3]
    C0002895 (Anemia, Sickle Cell)
    SNOMED
    127040003
    UMLS CUI [4]
    C0037995 (Splenectomy)
    SNOMED
    234319005
    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.
    Description

    Other administration of vaccines than study vaccines.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    UMLS CUI [1,2]
    C2368628 (Administration of vaccine)
    UMLS CUI [1,3]
    C0347984 (During)
    SNOMED
    371881003
    UMLS CUI [1,4]
    C2347804 (Clinical Trial Period)
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    Similar models

    Elimination criteria, warnings and precautions, contraindication

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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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