0 Ratings
ID

36313

Description

Study ID: 107007 Clinical Study ID: 107007 Study Title: A phase IIIb randomized, double-blind, controlled study to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine compared to Prevenar™, when co-administered with DTPw-HBV/Hib and OPV or IPV vaccines as a 3-dose primary immunization course during the first 6 months of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00344318 https://clinicaltrials.gov/ct2/show/NCT00344318 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal conjugate vaccine GSK1024850A Trade Name: Prevenar, Tritanrix-HepB, Hiberix, Polio Sabin., Poliorix Study Indication: Infections, Streptococcal This study consists of 2 groups of probands (Children of 6-10-14 weeks or 2-4-6 months of age are included): One group receive a 3-dose primary vaccination with the GSK Biologicals' (10-valent) pneumococcal conjugate vaccine. The other group r eceive a 3-dose primary vaccination with Prevenar™. All probands receive DTPw-HBV/Hib and OPV or IPV vaccines. Ths study consists of 3 workbooks (WB): WB 1: The WB 1 consists 4 visits (all in active phase): Visit 1, Timing: Month 0; Age for 6-12 weeks scheduled Visit 2, Timing: Month 1; Age for 10 weeks scheduled Visit 3, Timing: Month 2; Age for 14 weeks scheduled Visit 4, Timing: Month 3; Age for +/- 4 months scheduled Intervals between the visits: Visit 1 to Visit 2: 28-42 days, Visit 2 to Visit 3: 28-42 days, Visit 3 to Visit 4: 30-42 days WB 2: The WB 2 consists 4 visits (all in active phase): Visit 1, Timing: Month 0; Age for 6-12 weeks scheduled Visit 2, Timing: Month 2; Age for +/- 4 months scheduled Visit 3, Timing: Month 4; Age for +/- 6 months scheduled Visit 4, Timing: Month 5; Age for +/- 7 months scheduled Intervals between the visits: Visit 1 to Visit 2: 49-83 days, Visit 2 to Visit 3: 49-83 days, Visit 3 to Visit 4: 30-42 days WB 3: The WB 3 consists the phone contact (6 months safety follow-up), Timing: Month 8 or 10. This document contains the Elimination criteria during the study and Contraindications form. It has to be filled in for WB 1 and WB 2 for each Visit. Note for Contraindications to subsequent vaccination: POLIO SABIN (Trademark): -POLIO SABIN (Trademark) is contra-indicated in subjects with known systemic hypersensitivity to neomycin or to any other component of the vaccine, but a history of contact dermatitis to neomycin is not a contra-indication. In general, POLIO SABIN (Trademark)(oral) should not be administered to subjects suffering from primary and secondary immunodeficiencies. For those persons it is recommended to use the enhanced inactivated polio vaccine (eIPV). However, according to the Expanded Programme on Immunization (EPI) recommendations symptomatic and asymptomatic infection with human immunodeficiency virus does not contra-indicate immunization with POLIO SABIN (Trademark) (oral). -Special warnings and special precautions for use: As with other vaccines, the administration of POLIO SABIN (Trademark)(oral) should be postponed in subjects suffering from acute severe febrile illness, or persistent diarrhea or vomiting. The presence of a minor infection, however, is not a contra-indication for immunization. Whenever POLIO SABIN (Trademark) (oral) is administered to an individual, it is good clinical practice to offer immunization to presumably susceptible close contacts (such as unvaccinated parents) at the same time because of the risk (although very small) of vaccine-contact paralytic poliomyelitis disease. Contacts of recent vaccinees should be advised to observe personal hygiene. In some populations and groups of vaccinees lower seroconversion rates have been observed. Due to various non-specific factors all three vaccines, viruses may not replicate optimally in the gut of susceptible subjects, even after three doses of the POLIO SABIN (Trademark) (oral). POLIO SABIN (Trademark) (oral) is recommended for epidemic control. It should be realized that the vaccine might not prevent or modify disease in those already infected with a wild type poliovirus. Diarrhea or vomiting (including gastrointestinal infections) may interfere with the replication ("take" rate) of the POLIO SABIN (Trademark) (oral). Care should be taken not to contaminate a multidose dropper with saliva of a vaccinee. Poliorix (Tradename): Poliorix (Tradename) should not be administered to subjects with known hypersensitivity to any component of the vaccine, or to subjects having shown signs of hypersensitivity after previous administration of inactivated polio vaccines. As with other vaccines, the administration of Poliorix (Tradename) should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection, however, is not a contraindication. Precautions: • Poliorix (Tradename) contains traces of neomycin and polymyxin. The vaccine should be used with caution in patients with known hypersensitivity to one of these antibiotics. • Poliorix (Tradename) should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects. Prevenar (Trademark): Hypersensitivity to any component of the vaccine, including diphtheria toxoid. Precautions include moderate to severe illness, with or without fever is a reason to defer routine immunization with most vaccines’. The decision to delay vaccination depends on the severity and etiology of the underlying disease.

Link

https://clinicaltrials.gov/ct2/show/NCT00344318

Keywords

Versions (1)
  1. 5/2/19 5/2/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 2, 2019

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

    No comments

    In order to download data models you must be logged in. Please log in or register for free.

    Safety, reactogenicity and immunogenicity Biologicals’ 10-valent pneumococcal conjugate vaccine compared to Prevenar™, co-administration of DTPw-HBV/Hib and OPV or IPV vaccines on children, NCT00344318

    English

    Elimination criteria during the study, Contraindications

    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)
    Visit type
    Description

    When you fill in "Elimination criteria during the study" you can tick Visit 2-4. When you fill in "Contraindications" and "Precautions" you can tick Visit 1-3.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0545082 (Visit)
    UMLS CUI [1,2]
    C0332307 (Type - attribute)
    SNOMED
    261664005
    Visit Date
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    Elimination criteria during the study
    Description

    Elimination criteria during the study

    Alias
    UMLS CUI-1
    C0680251 (Exclusion Criteria)
    Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period (active phase and 6 months safety follow-up).
    Description

    Elimination from safety and immunogenicity ATP analyses

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    UMLS CUI [1,2]
    C0013230 (Investigational New Drugs)
    UMLS CUI [2,1]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    UMLS CUI [2,2]
    C1517586 (Investigational)
    UMLS CUI [2,3]
    C0042210 (Vaccines)
    SNOMED
    787859002
    LOINC
    LA20283-0
    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 7 days after dose 1 and dose 2 or 1 month after dose 3.
    Description

    Elimination from safety and immunogenicity ATP analyses

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0332152 (Before)
    SNOMED
    236874000
    UMLS CUI [1,2]
    C2347804 (Clinical Trial Period)
    UMLS CUI [1,3]
    C0042196 (Vaccination)
    SNOMED
    33879002
    LOINC
    LP29692-8
    UMLS CUI [1,4]
    C1518384 (Non-Protocol)
    UMLS CUI [2,1]
    C0347984 (During)
    SNOMED
    371881003
    UMLS CUI [2,2]
    C2347804 (Clinical Trial Period)
    UMLS CUI [2,3]
    C0042196 (Vaccination)
    SNOMED
    33879002
    LOINC
    LP29692-8
    UMLS CUI [2,4]
    C1518384 (Non-Protocol)
    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

    Elimination from immunogenicity ATP analysis. Chron administration is defined as 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]
    C0683607 (allowing)
    UMLS CUI [2,2]
    C2065041 (inhaled steroids)
    UMLS CUI [3,1]
    C0683607 (allowing)
    UMLS CUI [3,2]
    C3897353 (Topical Steroid Therapy)
    Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
    Description

    Elimination from immunogenicity ATP analysis.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C4048329 (Immunosuppression)
    UMLS CUI [1,2]
    C0262926 (Medical History)
    SNOMED
    392521001
    LOINC
    LP6817-3
    UMLS CUI [2,1]
    C4048329 (Immunosuppression)
    UMLS CUI [2,2]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [3,1]
    C0021051 (Immunologic Deficiency Syndromes)
    SNOMED
    234532001
    LOINC
    MTHU054768
    UMLS CUI [3,2]
    C0262926 (Medical History)
    SNOMED
    392521001
    LOINC
    LP6817-3
    UMLS CUI [4,1]
    C0021051 (Immunologic Deficiency Syndromes)
    SNOMED
    234532001
    LOINC
    MTHU054768
    UMLS CUI [4,2]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    Administration of immunoglobulins and/or any blood products during the active phase of the study.
    Description

    Elimination from immunogenicity ATP analysis.

    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
    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 the administration of vaccine(s).
    Description

    Anaphylactic reaction after vaccination

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0002792 (anaphylaxis)
    SNOMED
    39579001
    UMLS CUI [1,2]
    C0042196 (Vaccination)
    SNOMED
    33879002
    LOINC
    LP29692-8
    Acute disease at the time of vaccination. Study visit should then be postponed until the illness has improved
    Description

    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/Axillary/Tympanic temperature <37.5°C/Rectal temperature <38°C.

    Data type

    boolean

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

    Definition: oral, axillary or tympanic temperature >= 37.5°C, rectal temperature >= 38.0°C.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0743842 (Acute febrile illness)
    UMLS CUI [1,2]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,3]
    C0042196 (Vaccination)
    SNOMED
    33879002
    LOINC
    LP29692-8
    Absolute contraindications for DTPw-HBV/Hib vaccine
    Description

    Absolute contraindications for DTPw-HBV/Hib vaccine

    Alias
    UMLS CUI-1
    C0522473 (Contraindication)
    SNOMED
    103306004
    UMLS CUI-2
    C0205195 (Combined)
    SNOMED
    89780004
    LOINC
    LA30596-3
    UMLS CUI-3
    C0042210 (Vaccines)
    SNOMED
    787859002
    LOINC
    LA20283-0
    UMLS CUI-4
    C0012559 (Diphtheria-Tetanus-Pertussis Vaccine)
    UMLS CUI-5
    C2240392 (Hepatitis B Vaccines)
    SNOMED
    871822003
    UMLS CUI-6
    C0199818 (Administration of Haemophilus influenzae type B vaccine)
    SNOMED
    127787002
    DTPw-HBV/Hib vaccine should not be administered to subjects with known hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B, and Hib vaccines or to any component of the vaccine.
    Description

    Hypersensitivity to diphtheria, tetanus, pertussis, hepatitis B, and Hib vaccines or vaccine components

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,2]
    C0199818 (Administration of Haemophilus influenzae type B vaccine)
    SNOMED
    127787002
    UMLS CUI [2,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [2,2]
    C0012559 (Diphtheria-Tetanus-Pertussis Vaccine)
    UMLS CUI [3,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [3,2]
    C2240392 (Hepatitis B Vaccines)
    SNOMED
    871822003
    UMLS CUI [4,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [4,2]
    C0042210 (Vaccines)
    SNOMED
    787859002
    LOINC
    LA20283-0
    UMLS CUI [4,3]
    C1705248 (Component (part))
    DTPw-HBV/Hib vaccine is contra-indicated if the infant has experienced an encephalopathy of unknown etiology, occurring within 7 days following previous vaccination with pertussis containing vaccine. In these circumstances pertussis vaccination should be discontinued and the vaccination course should be continued with diphtheria-tetanus, hepatitis B, polio, and Hib vaccines.
    Description

    Encephalopathy after pertussis vaccination

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0085584 (Encephalopathies)
    UMLS CUI [1,2]
    C0332282 (Following)
    SNOMED
    255260001
    UMLS CUI [1,3]
    C0012559 (Diphtheria-Tetanus-Pertussis Vaccine)
    UMLS CUI [2,1]
    C0012559 (Diphtheria-Tetanus-Pertussis Vaccine)
    UMLS CUI [2,2]
    C1298908 (no)
    SNOMED
    373067005
    UMLS CUI [2,3]
    C1517331 (Further)
    UMLS CUI [2,4]
    C2368628 (Administration of vaccine)
    As with other vaccines, administration of DTPw-HBV/Hib vaccine should be postponed in subjects suffering from acute moderate or severe illness.
    Description

    The presence of a mild acute illness is not a contra-indication.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450 (Communicable Diseases)
    SNOMED
    189822004
    UMLS CUI [1,2]
    C0332152 (Before)
    SNOMED
    236874000
    UMLS CUI [1,3]
    C0042196 (Vaccination)
    SNOMED
    33879002
    LOINC
    LP29692-8
    UMLS CUI [2,1]
    C1298908 (no)
    SNOMED
    373067005
    UMLS CUI [2,2]
    C0199176 (Prophylactic treatment)
    SNOMED
    360271000
    Precautions for DTPw-HBV/Hib vaccine
    Description

    Precautions for DTPw-HBV/Hib vaccine

    Alias
    UMLS CUI-1
    C1882442 (Precaution)
    UMLS CUI-2
    C0205195 (Combined)
    SNOMED
    89780004
    LOINC
    LA30596-3
    UMLS CUI-3
    C0042210 (Vaccines)
    SNOMED
    787859002
    LOINC
    LA20283-0
    UMLS CUI-4
    C0012559 (Diphtheria-Tetanus-Pertussis Vaccine)
    UMLS CUI-5
    C2240392 (Hepatitis B Vaccines)
    SNOMED
    871822003
    UMLS CUI-6
    C0199818 (Administration of Haemophilus influenzae type B vaccine)
    SNOMED
    127787002
    Fever of >= 40.0°C (axillary temperature) or >= 40.5°C (rectal temperature) within 48 hours of vaccination not due to another identifiable cause.
    Description

    Fever after Vaccination

    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 within 48 hours of vaccination.
    Description

    (hypotonic-hyporesponsive episode)

    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 lasting >= 3 hours occurring within 48 hours of vaccination.
    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

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0036572 (Seizures)
    SNOMED
    91175000
    LOINC
    LA15899-0
    UMLS CUI [1,2]
    C0332282 (Following)
    SNOMED
    255260001
    UMLS CUI [1,3]
    C0042196 (Vaccination)
    SNOMED
    33879002
    LOINC
    LP29692-8
    Contraindications for Polio Sabin (TM)
    Description

    Contraindications for Polio Sabin (TM)

    Alias
    UMLS CUI-1
    C0522473 (Contraindication)
    SNOMED
    103306004
    UMLS CUI-2
    C0032374 (Poliovirus Vaccines)
    POLIO SABIN (TM) is contra-indicated in subjects with known systemic hypersensitivity to neomycin or to any other component of the vaccine.
    Description

    a history of contact dermatitis to neomycin is not a contra-indication

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0205373 (Systemic)
    SNOMED
    31099001
    UMLS CUI [1,2]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,3]
    C0027603 (neomycin)
    SNOMED
    73093001
    UMLS CUI [2,1]
    C0205373 (Systemic)
    SNOMED
    31099001
    UMLS CUI [2,2]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [2,3]
    C0042210 (Vaccines)
    SNOMED
    787859002
    LOINC
    LA20283-0
    UMLS CUI [2,4]
    C1705248 (Component (part))
    In general, POLIO SABIN(TM) (oral) should not be administered to subjects suffering from primary and secondary immunodeficiencies. For those persons it is recommended to use the enhanced inactivated polio vaccine (eIPV).
    Description

    Primary and secondary immunodeficiencies

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0398686 (Primary immune deficiency disorder)
    SNOMED
    58606001
    UMLS CUI [2]
    C0398795 (Secondary immune deficiency disorder)
    SNOMED
    33286000
    Special warnings and special precautions for Polio sabin (TM)
    Description

    Special warnings and special precautions for Polio sabin (TM)

    Alias
    UMLS CUI-1
    C0871599 (Cautionary Warning)
    UMLS CUI-2
    C1882442 (Precaution)
    UMLS CUI-3
    C0032374 (Poliovirus Vaccines)
    As with other vaccines, the administration of POLIO SABIN(TM) (oral) should be postponed in subjects suffering from acute severe febrile illness, or persistent diarrhea or vomiting.
    Description

    The presence of a minor infection, however, is not a contra-indication for immunization.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0743842 (Acute febrile illness)
    UMLS CUI [1,2]
    C0205082 (Severe (severity modifier))
    SNOMED
    24484000
    LOINC
    LA6750-9
    UMLS CUI [2,1]
    C0011991 (Diarrhea)
    SNOMED
    62315008
    LOINC
    MTHU013347
    UMLS CUI [2,2]
    C0205322 (Persistent)
    UMLS CUI [3]
    C0042963 (Vomiting)
    SNOMED
    422400008
    LOINC
    MTHU013530
    Whenever POLIO SABIN (TM) (oral) is administered to an individual, it is good clinical practice to offer immunization to presumably susceptible close contacts (such as unvaccinated parents) at the same time because of the risk (although very small) of vaccine-contact paralytic poliomyelitis disease. Contacts of recent vaccinees should be advised to observe personal hygiene.
    Description

    Suggestion of Polio vaccination to contacts at risk of infection

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1705535 (suggestion)
    UMLS CUI [1,2]
    C0032371 (Poliomyelitis)
    SNOMED
    398102009
    LOINC
    LA17016-9
    UMLS CUI [1,3]
    C0042196 (Vaccination)
    SNOMED
    33879002
    LOINC
    LP29692-8
    UMLS CUI [1,4]
    C0582147 (At risk of infection)
    SNOMED
    78648007
    UMLS CUI [2]
    C0564673 (personal hygiene (activity))
    SNOMED
    286850002
    LOINC
    MTHU013544
    In some populations and groups of vaccinees lower seroconversion rates have been observed. Due to various non-specific factors all three vaccines, viruses may not replicate optimally in the gut of susceptible subjects, even after three doses of the POLIO SABIN (TM) (oral).
    Description

    Seroconversion Polio lower/reduced and suboptimal vaccination virus replication

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C4042908 (Seroconversion)
    UMLS CUI [1,2]
    C0032374 (Poliovirus Vaccines)
    UMLS CUI [1,3]
    C0392756 (Reduced)
    SNOMED
    260400001
    UMLS CUI [2,1]
    C2984009 (Suboptimal)
    UMLS CUI [2,2]
    C0042196 (Vaccination)
    SNOMED
    33879002
    LOINC
    LP29692-8
    UMLS CUI [2,3]
    C0042774 (Virus Replication)
    POLIO SABIN (TM) (oral) is recommended for epidemic control. It should be realized that the vaccine might not prevent or modify disease in those already infected with a wild type poliovirus.
    Description

    Vaccine not prevent/modify disease

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0042210 (Vaccines)
    SNOMED
    787859002
    LOINC
    LA20283-0
    UMLS CUI [1,2]
    C1533716 (Information)
    Diarrhea or vomiting (including gastrointestinal infections) may interfere with the replication ("take" rate) of the POLIO SABIN (TM) (oral).
    Description

    Diarrhoe/Vomiting

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0011991 (Diarrhea)
    SNOMED
    62315008
    LOINC
    MTHU013347
    UMLS CUI [1,2]
    C0392760 (Affecting)
    SNOMED
    247591002
    UMLS CUI [1,3]
    C0042774 (Virus Replication)
    UMLS CUI [2,1]
    C0042963 (Vomiting)
    SNOMED
    422400008
    LOINC
    MTHU013530
    UMLS CUI [2,2]
    C0392760 (Affecting)
    SNOMED
    247591002
    UMLS CUI [2,3]
    C0042774 (Virus Replication)
    Care should be taken not to contaminate a multidose dropper with saliva of a vaccinee.
    Description

    Contamination with saliva of a vaccinee

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2349974 (Contamination)
    UMLS CUI [1,2]
    C0444155 (Oral saliva sample)
    SNOMED
    258560004
    Contraindication and Precaution of Prevenar (TM)
    Description

    Contraindication and Precaution of Prevenar (TM)

    Alias
    UMLS CUI-1
    C1301624 (Medical contraindication)
    SNOMED
    397745006
    LOINC
    LA27164-5
    UMLS CUI-2
    C1882442 (Precaution)
    UMLS CUI-3
    C0876134 (Prevnar)
    UMLS CUI-4
    C0042196 (Vaccination)
    SNOMED
    33879002
    LOINC
    LP29692-8
    Hypersensitivity to any component of the vaccine, including diphtheria toxoid.
    Description

    Hypersensitivity to any component of the vaccine, including diphtheria toxoid

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,2]
    C0042210 (Vaccines)
    SNOMED
    787859002
    LOINC
    LA20283-0
    UMLS CUI [1,3]
    C1705248 (Component (part))
    UMLS CUI [2,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [2,2]
    C0012551 (diphtheria toxoid vaccine, inactivated)
    Precautions include moderate to severe illness, with or without fever is a reason to defer routine immunization with most vaccines’. The decision to delay vaccination depends on the severity and etiology of the underlying disease.
    Description

    Moderate to severe illness

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0205081 (Moderate (severity modifier))
    SNOMED
    6736007
    UMLS CUI [1,2]
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    UMLS CUI [2,1]
    C0205082 (Severe (severity modifier))
    SNOMED
    24484000
    LOINC
    LA6750-9
    UMLS CUI [2,2]
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    Contraindications and precautions to Poliorix (TM)
    Description

    Contraindications and precautions to Poliorix (TM)

    Alias
    UMLS CUI-1
    C1301624 (Medical contraindication)
    SNOMED
    397745006
    LOINC
    LA27164-5
    UMLS CUI-2
    C1882442 (Precaution)
    UMLS CUI-3
    C2984507 (Poliorix)
    Poliorix (TM) should not be administered to subjects with known hypersensitivity to any component of the vaccine, or to subjects having shown signs of hypersensitivity after previous administration of inactivated polio vaccines.
    Description

    Hypersensitivity to any component of the vaccine, hypersensitivity after previous administration of inactivated polio vaccines

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,2]
    C0042210 (Vaccines)
    SNOMED
    787859002
    LOINC
    LA20283-0
    UMLS CUI [1,3]
    C1705248 (Component (part))
    UMLS CUI [2,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [2,2]
    C2368628 (Administration of vaccine)
    UMLS CUI [2,3]
    C0718003 (Poliovirus Vaccine, Inactivated)
    As with other vaccines, the administration of Poliorix (TM) should be postponed in subjects suffering from acute severe febrile illness.
    Description

    The presence of a minor infection, however, is not a contraindication.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0743842 (Acute febrile illness)
    UMLS CUI [1,2]
    C0205082 (Severe (severity modifier))
    SNOMED
    24484000
    LOINC
    LA6750-9
    Poliorix (TM) contains traces of neomycin and polymyxin. The vaccine should be used with caution in patients with known hypersensitivity to one of these antibiotics.
    Description

    Hypersensitivity to neomycin and polymyxin

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,2]
    C0027603 (neomycin)
    SNOMED
    73093001
    UMLS CUI [2,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [2,2]
    C0032539 (Polymyxins)
    SNOMED
    373224006
    Poliorix (TM) should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects.
    Description

    Thrombocytopenia, bleeding disorder

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0040034 (Thrombocytopenia)
    SNOMED
    302215000
    UMLS CUI [2]
    C0005779 (Blood Coagulation Disorders)
    SNOMED
    64779008
    Back to the top of the page

    Similar models

    Elimination criteria during the study, Contraindications

    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
    WB 1 (1)
    CL Item
    WB 2 (2)
    Item
    Visit type
    integer
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Visit type
    Code List
    Visit type
    CL Item
    Visit 1 (1)
    CL Item
    Visit 2 (2)
    CL Item
    Visit 3 (3)
    CL Item
    Visit 4 (4)
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Elimination criteria during the study
    C0680251 (UMLS CUI-1)
    Other investigational drug/vaccine
    Item
    Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period (active phase and 6 months safety follow-up).
    boolean
    C0205394 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [2,1])
    C1517586 (UMLS CUI [2,2])
    C0042210 (UMLS CUI [2,3])
    Vaccination prior/during to study's vaccine time
    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 7 days after dose 1 and dose 2 or 1 month after dose 3.
    boolean
    C0332152 (UMLS CUI [1,1])
    C2347804 (UMLS CUI [1,2])
    C0042196 (UMLS CUI [1,3])
    C1518384 (UMLS CUI [1,4])
    C0347984 (UMLS CUI [2,1])
    C2347804 (UMLS CUI [2,2])
    C0042196 (UMLS CUI [2,3])
    C1518384 (UMLS CUI [2,4])
    Chronic use of Immunosuppressants/ immunemodifying drugs (excluding inhaled/topical steroids)
    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])
    C0683607 (UMLS CUI [2,1])
    C2065041 (UMLS CUI [2,2])
    C0683607 (UMLS CUI [3,1])
    C3897353 (UMLS CUI [3,2])
    Immunosuppression (based on medical hisytory and physical examination)
    Item
    Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
    boolean
    C4048329 (UMLS CUI [1,1])
    C0262926 (UMLS CUI [1,2])
    C4048329 (UMLS CUI [2,1])
    C0031809 (UMLS CUI [2,2])
    C0021051 (UMLS CUI [3,1])
    C0262926 (UMLS CUI [3,2])
    C0021051 (UMLS CUI [4,1])
    C0031809 (UMLS CUI [4,2])
    Immunoglobulins, blood products
    Item
    Administration of immunoglobulins and/or any blood products during the active phase of the study.
    boolean
    C0021027 (UMLS CUI [1])
    C0456388 (UMLS CUI [2])
    Item Group
    Contraindications to subsequent vaccination
    C0522473 (UMLS CUI-1)
    C0042196 (UMLS CUI-2)
    Anaphylactic reaction after vaccination
    Item
    Anaphylactic reaction following the administration of vaccine(s).
    boolean
    C0002792 (UMLS CUI [1,1])
    C0042196 (UMLS CUI [1,2])
    Acute disease at vaccination
    Item
    Acute disease at the time of vaccination. Study visit should then be postponed until the illness has improved
    boolean
    C0001314 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    C0042196 (UMLS CUI [1,3])
    Febrile illness
    Item
    Febrile illness. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
    boolean
    C0743842 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    C0042196 (UMLS CUI [1,3])
    Item Group
    Absolute contraindications for DTPw-HBV/Hib vaccine
    C0522473 (UMLS CUI-1)
    C0205195 (UMLS CUI-2)
    C0042210 (UMLS CUI-3)
    C0012559 (UMLS CUI-4)
    C2240392 (UMLS CUI-5)
    C0199818 (UMLS CUI-6)
    Hypersensitivity to diphtheria, tetanus, pertussis, hepatitis B, and Hib vaccines or vaccine components
    Item
    DTPw-HBV/Hib vaccine should not be administered to subjects with known hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B, and Hib vaccines or to any component of the vaccine.
    boolean
    C0020517 (UMLS CUI [1,1])
    C0199818 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0012559 (UMLS CUI [2,2])
    C0020517 (UMLS CUI [3,1])
    C2240392 (UMLS CUI [3,2])
    C0020517 (UMLS CUI [4,1])
    C0042210 (UMLS CUI [4,2])
    C1705248 (UMLS CUI [4,3])
    Encephalopathy after pertussis vaccination
    Item
    DTPw-HBV/Hib vaccine is contra-indicated if the infant has experienced an encephalopathy of unknown etiology, occurring within 7 days following previous vaccination with pertussis containing vaccine. In these circumstances pertussis vaccination should be discontinued and the vaccination course should be continued with diphtheria-tetanus, hepatitis B, polio, and Hib vaccines.
    boolean
    C0085584 (UMLS CUI [1,1])
    C0332282 (UMLS CUI [1,2])
    C0012559 (UMLS CUI [1,3])
    C0012559 (UMLS CUI [2,1])
    C1298908 (UMLS CUI [2,2])
    C1517331 (UMLS CUI [2,3])
    C2368628 (UMLS CUI [2,4])
    Infection before vaccination no prevention
    Item
    As with other vaccines, administration of DTPw-HBV/Hib vaccine should be postponed in subjects suffering from acute moderate or severe illness.
    boolean
    C0009450 (UMLS CUI [1,1])
    C0332152 (UMLS CUI [1,2])
    C0042196 (UMLS CUI [1,3])
    C1298908 (UMLS CUI [2,1])
    C0199176 (UMLS CUI [2,2])
    Item Group
    Precautions for DTPw-HBV/Hib vaccine
    C1882442 (UMLS CUI-1)
    C0205195 (UMLS CUI-2)
    C0042210 (UMLS CUI-3)
    C0012559 (UMLS CUI-4)
    C2240392 (UMLS CUI-5)
    C0199818 (UMLS CUI-6)
    Fever after Vaccination
    Item
    Fever of >= 40.0°C (axillary temperature) or >= 40.5°C (rectal temperature) within 48 hours of vaccination not due to another identifiable cause.
    boolean
    C0015967 (UMLS CUI [1,1])
    C0332282 (UMLS CUI [1,2])
    C0042196 (UMLS CUI [1,3])
    Collapse/shock-like state after Vaccination
    Item
    Collapse or shock-like state 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 lasting >= 3 hours occurring within 48 hours of vaccination.
    boolean
    C2721683 (UMLS CUI [1,1])
    C0332282 (UMLS CUI [1,2])
    C0042196 (UMLS CUI [1,3])
    Seizures
    Item
    Seizures with or without fever occurring within 3 days of vaccination.
    boolean
    C0036572 (UMLS CUI [1,1])
    C0332282 (UMLS CUI [1,2])
    C0042196 (UMLS CUI [1,3])
    Item Group
    Contraindications for Polio Sabin (TM)
    C0522473 (UMLS CUI-1)
    C0032374 (UMLS CUI-2)
    Systemic hypersensitivity to neomycin or to any other component of the vaccine
    Item
    POLIO SABIN (TM) is contra-indicated in subjects with known systemic hypersensitivity to neomycin or to any other component of the vaccine.
    boolean
    C0205373 (UMLS CUI [1,1])
    C0020517 (UMLS CUI [1,2])
    C0027603 (UMLS CUI [1,3])
    C0205373 (UMLS CUI [2,1])
    C0020517 (UMLS CUI [2,2])
    C0042210 (UMLS CUI [2,3])
    C1705248 (UMLS CUI [2,4])
    Primary and secondary immunodeficiencies
    Item
    In general, POLIO SABIN(TM) (oral) should not be administered to subjects suffering from primary and secondary immunodeficiencies. For those persons it is recommended to use the enhanced inactivated polio vaccine (eIPV).
    boolean
    C0398686 (UMLS CUI [1])
    C0398795 (UMLS CUI [2])
    Item Group
    Special warnings and special precautions for Polio sabin (TM)
    C0871599 (UMLS CUI-1)
    C1882442 (UMLS CUI-2)
    C0032374 (UMLS CUI-3)
    Acute severe febrile illness, or persistent diarrhea or vomiting
    Item
    As with other vaccines, the administration of POLIO SABIN(TM) (oral) should be postponed in subjects suffering from acute severe febrile illness, or persistent diarrhea or vomiting.
    boolean
    C0743842 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C0011991 (UMLS CUI [2,1])
    C0205322 (UMLS CUI [2,2])
    C0042963 (UMLS CUI [3])
    Suggestion of Polio vaccination to contacts at risk of infection
    Item
    Whenever POLIO SABIN (TM) (oral) is administered to an individual, it is good clinical practice to offer immunization to presumably susceptible close contacts (such as unvaccinated parents) at the same time because of the risk (although very small) of vaccine-contact paralytic poliomyelitis disease. Contacts of recent vaccinees should be advised to observe personal hygiene.
    boolean
    C1705535 (UMLS CUI [1,1])
    C0032371 (UMLS CUI [1,2])
    C0042196 (UMLS CUI [1,3])
    C0582147 (UMLS CUI [1,4])
    C0564673 (UMLS CUI [2])
    Seroconversion Polio lower/reduced and suboptimal vaccination virus replication
    Item
    In some populations and groups of vaccinees lower seroconversion rates have been observed. Due to various non-specific factors all three vaccines, viruses may not replicate optimally in the gut of susceptible subjects, even after three doses of the POLIO SABIN (TM) (oral).
    boolean
    C4042908 (UMLS CUI [1,1])
    C0032374 (UMLS CUI [1,2])
    C0392756 (UMLS CUI [1,3])
    C2984009 (UMLS CUI [2,1])
    C0042196 (UMLS CUI [2,2])
    C0042774 (UMLS CUI [2,3])
    Vaccine not prevent/modify disease
    Item
    POLIO SABIN (TM) (oral) is recommended for epidemic control. It should be realized that the vaccine might not prevent or modify disease in those already infected with a wild type poliovirus.
    boolean
    C0042210 (UMLS CUI [1,1])
    C1533716 (UMLS CUI [1,2])
    Diarrhoe/Vomiting
    Item
    Diarrhea or vomiting (including gastrointestinal infections) may interfere with the replication ("take" rate) of the POLIO SABIN (TM) (oral).
    boolean
    C0011991 (UMLS CUI [1,1])
    C0392760 (UMLS CUI [1,2])
    C0042774 (UMLS CUI [1,3])
    C0042963 (UMLS CUI [2,1])
    C0392760 (UMLS CUI [2,2])
    C0042774 (UMLS CUI [2,3])
    Contamination with saliva of a vaccinee
    Item
    Care should be taken not to contaminate a multidose dropper with saliva of a vaccinee.
    boolean
    C2349974 (UMLS CUI [1,1])
    C0444155 (UMLS CUI [1,2])
    Item Group
    Contraindication and Precaution of Prevenar (TM)
    C1301624 (UMLS CUI-1)
    C1882442 (UMLS CUI-2)
    C0876134 (UMLS CUI-3)
    C0042196 (UMLS CUI-4)
    Hypersensitivity to any component of the vaccine, including diphtheria toxoid
    Item
    Hypersensitivity to any component of the vaccine, including diphtheria toxoid.
    boolean
    C0020517 (UMLS CUI [1,1])
    C0042210 (UMLS CUI [1,2])
    C1705248 (UMLS CUI [1,3])
    C0020517 (UMLS CUI [2,1])
    C0012551 (UMLS CUI [2,2])
    Moderate to severe illness
    Item
    Precautions include moderate to severe illness, with or without fever is a reason to defer routine immunization with most vaccines’. The decision to delay vaccination depends on the severity and etiology of the underlying disease.
    boolean
    C0205081 (UMLS CUI [1,1])
    C0012634 (UMLS CUI [1,2])
    C0205082 (UMLS CUI [2,1])
    C0012634 (UMLS CUI [2,2])
    Item Group
    Contraindications and precautions to Poliorix (TM)
    C1301624 (UMLS CUI-1)
    C1882442 (UMLS CUI-2)
    C2984507 (UMLS CUI-3)
    Hypersensitivity to any component of the vaccine, hypersensitivity after previous administration of inactivated polio vaccines
    Item
    Poliorix (TM) should not be administered to subjects with known hypersensitivity to any component of the vaccine, or to subjects having shown signs of hypersensitivity after previous administration of inactivated polio vaccines.
    boolean
    C0020517 (UMLS CUI [1,1])
    C0042210 (UMLS CUI [1,2])
    C1705248 (UMLS CUI [1,3])
    C0020517 (UMLS CUI [2,1])
    C2368628 (UMLS CUI [2,2])
    C0718003 (UMLS CUI [2,3])
    Acute severe febrile illness
    Item
    As with other vaccines, the administration of Poliorix (TM) should be postponed in subjects suffering from acute severe febrile illness.
    boolean
    C0743842 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    Hypersensitivity to neomycin and polymyxin
    Item
    Poliorix (TM) contains traces of neomycin and polymyxin. The vaccine should be used with caution in patients with known hypersensitivity to one of these antibiotics.
    boolean
    C0020517 (UMLS CUI [1,1])
    C0027603 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0032539 (UMLS CUI [2,2])
    Thrombocytopenia, bleeding disorder
    Item
    Poliorix (TM) should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects.
    boolean
    C0040034 (UMLS CUI [1])
    C0005779 (UMLS CUI [2])
    Back to the top of the page 

    Help

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial