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ID

36313

Descrição

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

Palavras-chave

Versões (1)
  1. 02/05/2019 02/05/2019 -
Titular dos direitos

GlaxoSmithKline

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2 de maio de 2019

DOI

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Licença

Creative Commons BY-NC 3.0
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    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

    Inglês

    Elimination criteria during the study, Contraindications

    1 Formulários  
    Administrative data
    Descrição

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Descrição

    Subject Number

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2348585
    Workbook Number
    Descrição

    Workbook Number

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C2986015
    Visit type
    Descrição

    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.

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    Visit Date
    Descrição

    day month year

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C1320303
    Elimination criteria during the study
    Descrição

    Elimination criteria during the study

    Alias
    UMLS CUI-1
    C0680251
    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).
    Descrição

    Elimination from safety and immunogenicity ATP analyses

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C0013230
    UMLS CUI [2,1]
    C0205394
    UMLS CUI [2,2]
    C1517586
    UMLS CUI [2,3]
    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 7 days after dose 1 and dose 2 or 1 month after dose 3.
    Descrição

    Elimination from safety and immunogenicity ATP analyses

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0332152
    UMLS CUI [1,2]
    C2347804
    UMLS CUI [1,3]
    C0042196
    UMLS CUI [1,4]
    C1518384
    UMLS CUI [2,1]
    C0347984
    UMLS CUI [2,2]
    C2347804
    UMLS CUI [2,3]
    C0042196
    UMLS CUI [2,4]
    C1518384
    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.)
    Descrição

    Elimination from immunogenicity ATP analysis. Chron administration is defined as more than 14 days.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0205191
    UMLS CUI [1,2]
    C0021081
    UMLS CUI [2,1]
    C0683607
    UMLS CUI [2,2]
    C2065041
    UMLS CUI [3,1]
    C0683607
    UMLS CUI [3,2]
    C3897353
    Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
    Descrição

    Elimination from immunogenicity ATP analysis.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C4048329
    UMLS CUI [1,2]
    C0262926
    UMLS CUI [2,1]
    C4048329
    UMLS CUI [2,2]
    C0031809
    UMLS CUI [3,1]
    C0021051
    UMLS CUI [3,2]
    C0262926
    UMLS CUI [4,1]
    C0021051
    UMLS CUI [4,2]
    C0031809
    Administration of immunoglobulins and/or any blood products during the active phase of the study.
    Descrição

    Elimination from immunogenicity ATP analysis.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021027
    UMLS CUI [2]
    C0456388
    Contraindications to subsequent vaccination
    Descrição

    Contraindications to subsequent vaccination

    Alias
    UMLS CUI-1
    C0522473
    UMLS CUI-2
    C0042196
    Anaphylactic reaction following the administration of vaccine(s).
    Descrição

    Anaphylactic reaction after vaccination

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0002792
    UMLS CUI [1,2]
    C0042196
    Acute disease at the time of vaccination. Study visit should then be postponed until the illness has improved
    Descrição

    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.

    Tipo de dados

    boolean

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

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

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0743842
    UMLS CUI [1,2]
    C0040223
    UMLS CUI [1,3]
    C0042196
    Absolute contraindications for DTPw-HBV/Hib vaccine
    Descrição

    Absolute contraindications for DTPw-HBV/Hib vaccine

    Alias
    UMLS CUI-1
    C0522473
    UMLS CUI-2
    C0205195
    UMLS CUI-3
    C0042210
    UMLS CUI-4
    C0012559
    UMLS CUI-5
    C2240392
    UMLS CUI-6
    C0199818
    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.
    Descrição

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

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0199818
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0012559
    UMLS CUI [3,1]
    C0020517
    UMLS CUI [3,2]
    C2240392
    UMLS CUI [4,1]
    C0020517
    UMLS CUI [4,2]
    C0042210
    UMLS CUI [4,3]
    C1705248
    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.
    Descrição

    Encephalopathy after pertussis vaccination

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0085584
    UMLS CUI [1,2]
    C0332282
    UMLS CUI [1,3]
    C0012559
    UMLS CUI [2,1]
    C0012559
    UMLS CUI [2,2]
    C1298908
    UMLS CUI [2,3]
    C1517331
    UMLS CUI [2,4]
    C2368628
    As with other vaccines, administration of DTPw-HBV/Hib vaccine should be postponed in subjects suffering from acute moderate or severe illness.
    Descrição

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

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C0332152
    UMLS CUI [1,3]
    C0042196
    UMLS CUI [2,1]
    C1298908
    UMLS CUI [2,2]
    C0199176
    Precautions for DTPw-HBV/Hib vaccine
    Descrição

    Precautions for DTPw-HBV/Hib vaccine

    Alias
    UMLS CUI-1
    C1882442
    UMLS CUI-2
    C0205195
    UMLS CUI-3
    C0042210
    UMLS CUI-4
    C0012559
    UMLS CUI-5
    C2240392
    UMLS CUI-6
    C0199818
    Fever of >= 40.0°C (axillary temperature) or >= 40.5°C (rectal temperature) within 48 hours of vaccination not due to another identifiable cause.
    Descrição

    Fever after Vaccination

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0015967
    UMLS CUI [1,2]
    C0332282
    UMLS CUI [1,3]
    C0042196
    Collapse or shock-like state within 48 hours of vaccination.
    Descrição

    (hypotonic-hyporesponsive episode)

    Tipo de dados

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

    Persistent, inconsolable crying

    Tipo de dados

    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.
    Descrição

    Seizures

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0036572
    UMLS CUI [1,2]
    C0332282
    UMLS CUI [1,3]
    C0042196
    Contraindications for Polio Sabin (TM)
    Descrição

    Contraindications for Polio Sabin (TM)

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

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

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0205373
    UMLS CUI [1,2]
    C0020517
    UMLS CUI [1,3]
    C0027603
    UMLS CUI [2,1]
    C0205373
    UMLS CUI [2,2]
    C0020517
    UMLS CUI [2,3]
    C0042210
    UMLS CUI [2,4]
    C1705248
    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).
    Descrição

    Primary and secondary immunodeficiencies

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0398686
    UMLS CUI [2]
    C0398795
    Special warnings and special precautions for Polio sabin (TM)
    Descrição

    Special warnings and special precautions for Polio sabin (TM)

    Alias
    UMLS CUI-1
    C0871599
    UMLS CUI-2
    C1882442
    UMLS CUI-3
    C0032374
    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.
    Descrição

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

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0743842
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [2,1]
    C0011991
    UMLS CUI [2,2]
    C0205322
    UMLS CUI [3]
    C0042963
    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.
    Descrição

    Suggestion of Polio vaccination to contacts at risk of infection

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1705535
    UMLS CUI [1,2]
    C0032371
    UMLS CUI [1,3]
    C0042196
    UMLS CUI [1,4]
    C0582147
    UMLS CUI [2]
    C0564673
    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).
    Descrição

    Seroconversion Polio lower/reduced and suboptimal vaccination virus replication

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C4042908
    UMLS CUI [1,2]
    C0032374
    UMLS CUI [1,3]
    C0392756
    UMLS CUI [2,1]
    C2984009
    UMLS CUI [2,2]
    C0042196
    UMLS CUI [2,3]
    C0042774
    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.
    Descrição

    Vaccine not prevent/modify disease

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0042210
    UMLS CUI [1,2]
    C1533716
    Diarrhea or vomiting (including gastrointestinal infections) may interfere with the replication ("take" rate) of the POLIO SABIN (TM) (oral).
    Descrição

    Diarrhoe/Vomiting

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0011991
    UMLS CUI [1,2]
    C0392760
    UMLS CUI [1,3]
    C0042774
    UMLS CUI [2,1]
    C0042963
    UMLS CUI [2,2]
    C0392760
    UMLS CUI [2,3]
    C0042774
    Care should be taken not to contaminate a multidose dropper with saliva of a vaccinee.
    Descrição

    Contamination with saliva of a vaccinee

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C2349974
    UMLS CUI [1,2]
    C0444155
    Contraindication and Precaution of Prevenar (TM)
    Descrição

    Contraindication and Precaution of Prevenar (TM)

    Alias
    UMLS CUI-1
    C1301624
    UMLS CUI-2
    C1882442
    UMLS CUI-3
    C0876134
    UMLS CUI-4
    C0042196
    Hypersensitivity to any component of the vaccine, including diphtheria toxoid.
    Descrição

    Hypersensitivity to any component of the vaccine, including diphtheria toxoid

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0042210
    UMLS CUI [1,3]
    C1705248
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0012551
    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.
    Descrição

    Moderate to severe illness

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0205081
    UMLS CUI [1,2]
    C0012634
    UMLS CUI [2,1]
    C0205082
    UMLS CUI [2,2]
    C0012634
    Contraindications and precautions to Poliorix (TM)
    Descrição

    Contraindications and precautions to Poliorix (TM)

    Alias
    UMLS CUI-1
    C1301624
    UMLS CUI-2
    C1882442
    UMLS CUI-3
    C2984507
    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.
    Descrição

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

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0042210
    UMLS CUI [1,3]
    C1705248
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C2368628
    UMLS CUI [2,3]
    C0718003
    As with other vaccines, the administration of Poliorix (TM) should be postponed in subjects suffering from acute severe febrile illness.
    Descrição

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

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0743842
    UMLS CUI [1,2]
    C0205082
    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.
    Descrição

    Hypersensitivity to neomycin and polymyxin

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0027603
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0032539
    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.
    Descrição

    Thrombocytopenia, bleeding disorder

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0040034
    UMLS CUI [2]
    C0005779
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    Elimination criteria during the study, Contraindications

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    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])
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