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)
- 5/2/19 5/2/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
May 2, 2019
DOI
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License
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
Elimination criteria during the study, Contraindications
- StudyEvent: ODM
Description
Elimination criteria during the study
Alias
- UMLS CUI-1
- C0680251
Description
Elimination from safety and immunogenicity ATP analyses
Data type
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
Description
Elimination from safety and immunogenicity ATP analyses
Data type
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
Description
Elimination from immunogenicity ATP analysis. Chron administration is defined as more than 14 days.
Data type
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
Description
Elimination from immunogenicity ATP analysis.
Data type
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
Description
Elimination from immunogenicity ATP analysis.
Data type
boolean
Alias
- UMLS CUI [1]
- C0021027
- UMLS CUI [2]
- C0456388
Description
Contraindications to subsequent vaccination
Alias
- UMLS CUI-1
- C0522473
- UMLS CUI-2
- C0042196
Description
Anaphylactic reaction after vaccination
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0002792
- UMLS CUI [1,2]
- C0042196
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
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0042196
Description
Definition: oral, axillary or tympanic temperature >= 37.5°C, rectal temperature >= 38.0°C.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0743842
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0042196
Description
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
Description
Hypersensitivity to diphtheria, tetanus, pertussis, hepatitis B, and Hib vaccines or vaccine components
Data type
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
Description
Encephalopathy after pertussis vaccination
Data type
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
Description
The presence of a mild acute illness is not a contra-indication.
Data type
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
Description
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
Description
Fever after Vaccination
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0015967
- UMLS CUI [1,2]
- C0332282
- UMLS CUI [1,3]
- C0042196
Description
(hypotonic-hyporesponsive episode)
Data type
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
Description
Persistent, inconsolable crying
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2721683
- UMLS CUI [1,2]
- C0332282
- UMLS CUI [1,3]
- C0042196
Description
Seizures
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0036572
- UMLS CUI [1,2]
- C0332282
- UMLS CUI [1,3]
- C0042196
Description
Contraindications for Polio Sabin (TM)
Alias
- UMLS CUI-1
- C0522473
- UMLS CUI-2
- C0032374
Description
a history of contact dermatitis to neomycin is not a contra-indication
Data type
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
Description
Primary and secondary immunodeficiencies
Data type
boolean
Alias
- UMLS CUI [1]
- C0398686
- UMLS CUI [2]
- C0398795
Description
Special warnings and special precautions for Polio sabin (TM)
Alias
- UMLS CUI-1
- C0871599
- UMLS CUI-2
- C1882442
- UMLS CUI-3
- C0032374
Description
The presence of a minor infection, however, is not a contra-indication for immunization.
Data type
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
Description
Suggestion of Polio vaccination to contacts at risk of infection
Data type
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
Description
Seroconversion Polio lower/reduced and suboptimal vaccination virus replication
Data type
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
Description
Vaccine not prevent/modify disease
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0042210
- UMLS CUI [1,2]
- C1533716
Description
Diarrhoe/Vomiting
Data type
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
Description
Contamination with saliva of a vaccinee
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2349974
- UMLS CUI [1,2]
- C0444155
Description
Contraindication and Precaution of Prevenar (TM)
Alias
- UMLS CUI-1
- C1301624
- UMLS CUI-2
- C1882442
- UMLS CUI-3
- C0876134
- UMLS CUI-4
- C0042196
Description
Hypersensitivity to any component of the vaccine, including diphtheria toxoid
Data type
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
Description
Moderate to severe illness
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0205081
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [2,1]
- C0205082
- UMLS CUI [2,2]
- C0012634
Description
Contraindications and precautions to Poliorix (TM)
Alias
- UMLS CUI-1
- C1301624
- UMLS CUI-2
- C1882442
- UMLS CUI-3
- C2984507
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
- 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
Description
The presence of a minor infection, however, is not a contraindication.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0743842
- UMLS CUI [1,2]
- C0205082
Description
Hypersensitivity to neomycin and polymyxin
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0027603
- UMLS CUI [2,1]
- C0020517
- UMLS CUI [2,2]
- C0032539
Description
Thrombocytopenia, bleeding disorder
Data type
boolean
Alias
- UMLS CUI [1]
- C0040034
- UMLS CUI [2]
- C0005779
Similar models
Elimination criteria during the study, Contraindications
- StudyEvent: ODM
C0013230 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
C0042210 (UMLS CUI [2,3])
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])
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])
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])
C0456388 (UMLS CUI [2])
C0042196 (UMLS CUI-2)
C0042196 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0205195 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
C0012559 (UMLS CUI-4)
C2240392 (UMLS CUI-5)
C0199818 (UMLS CUI-6)
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])
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])
C0332152 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C1298908 (UMLS CUI [2,1])
C0199176 (UMLS CUI [2,2])
C0205195 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
C0012559 (UMLS CUI-4)
C2240392 (UMLS CUI-5)
C0199818 (UMLS CUI-6)
C0332282 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
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])
C0332282 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0332282 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0032374 (UMLS CUI-2)
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])
C0398795 (UMLS CUI [2])
C1882442 (UMLS CUI-2)
C0032374 (UMLS CUI-3)
C0205082 (UMLS CUI [1,2])
C0011991 (UMLS CUI [2,1])
C0205322 (UMLS CUI [2,2])
C0042963 (UMLS CUI [3])
C0032371 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0582147 (UMLS CUI [1,4])
C0564673 (UMLS CUI [2])
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])
C1533716 (UMLS CUI [1,2])
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])
C0444155 (UMLS CUI [1,2])
C1882442 (UMLS CUI-2)
C0876134 (UMLS CUI-3)
C0042196 (UMLS CUI-4)
C0042210 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0012551 (UMLS CUI [2,2])
C0012634 (UMLS CUI [1,2])
C0205082 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C1882442 (UMLS CUI-2)
C2984507 (UMLS CUI-3)
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])
C0205082 (UMLS CUI [1,2])
C0027603 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0032539 (UMLS CUI [2,2])
C0005779 (UMLS CUI [2])
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