ID

36313

Beschreibung

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

Stichworte

Versionen (1)
  1. 02.05.19 02.05.19 -
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GlaxoSmithKline

Hochgeladen am

2. Mai 2019

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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

Englisch

Elimination criteria during the study, Contraindications

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Workbook Number
Beschreibung

Workbook Number

Datentyp

integer

Alias
UMLS CUI [1]
C2986015
Visit type
Beschreibung

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.

Datentyp

integer

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

day month year

Datentyp

date

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

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).
Beschreibung

Elimination from safety and immunogenicity ATP analyses

Datentyp

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.
Beschreibung

Elimination from safety and immunogenicity ATP analyses

Datentyp

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.)
Beschreibung

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

Datentyp

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).
Beschreibung

Elimination from immunogenicity ATP analysis.

Datentyp

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.
Beschreibung

Elimination from immunogenicity ATP analysis.

Datentyp

boolean

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

Contraindications to subsequent vaccination

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

Anaphylactic reaction after vaccination

Datentyp

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
Beschreibung

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.

Datentyp

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.
Beschreibung

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

Datentyp

boolean

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

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Encephalopathy after pertussis vaccination

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

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.
Beschreibung

Fever after Vaccination

Datentyp

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.
Beschreibung

(hypotonic-hyporesponsive episode)

Datentyp

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.
Beschreibung

Persistent, inconsolable crying

Datentyp

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.
Beschreibung

Seizures

Datentyp

boolean

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

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.
Beschreibung

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

Datentyp

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).
Beschreibung

Primary and secondary immunodeficiencies

Datentyp

boolean

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

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Suggestion of Polio vaccination to contacts at risk of infection

Datentyp

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).
Beschreibung

Seroconversion Polio lower/reduced and suboptimal vaccination virus replication

Datentyp

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.
Beschreibung

Vaccine not prevent/modify disease

Datentyp

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).
Beschreibung

Diarrhoe/Vomiting

Datentyp

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.
Beschreibung

Contamination with saliva of a vaccinee

Datentyp

boolean

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

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.
Beschreibung

Hypersensitivity to any component of the vaccine, including diphtheria toxoid

Datentyp

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.
Beschreibung

Moderate to severe illness

Datentyp

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)
Beschreibung

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.
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Hypersensitivity to neomycin and polymyxin

Datentyp

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.
Beschreibung

Thrombocytopenia, bleeding disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0040034
UMLS CUI [2]
C0005779
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Ähnliche Modelle

Elimination criteria during the study, Contraindications

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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