ID
36105
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 Eligibility criteria form. It has to be filled in for Visit 1.
Link
https://clinicaltrials.gov/ct2/show/NCT00344318
Keywords
Versions (2)
- 4/9/19 4/9/19 -
- 4/15/19 4/15/19 - Sarah Riepenhausen
Copyright Holder
GlaxoSmithKline
Uploaded on
April 15, 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.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Safety, reactogenicity and immunogenicity 10-valent pneumococcal conjugate vaccine compared to Prevenar™, co-administration of DTPw-HBV/Hib and OPV or IPV vaccines in infants, NCT00344318
Eligibility criteria
- StudyEvent: ODM
Description
Eligibility check
Alias
- UMLS CUI-1
- C0013893
Description
Inclusion criteria
Alias
- UMLS CUI-1
- C1512693
Description
Gender, Age
Data type
boolean
Alias
- UMLS CUI [1]
- C0079399
- UMLS CUI [2]
- C0001779
Description
Compliance to requirements of the protocol
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0525058
- UMLS CUI [1,2]
- C0030551
- UMLS CUI [2,1]
- C0525058
- UMLS CUI [2,2]
- C0023226
Description
Informed consent
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0030551
- UMLS CUI [2,1]
- C0021430
- UMLS CUI [2,2]
- C0023226
Description
No Disease (medical history and clinical examination)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C3898900
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [2,1]
- C3898900
- UMLS CUI [2,2]
- C1456356
Description
Born after a gestation period
Data type
boolean
Alias
- UMLS CUI [1]
- C3814420
Description
Exclusion Criterion
Alias
- UMLS CUI-1
- C0680251
Description
Other investigational drug/vaccine
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
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
Administration of other vaccine
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C1518384
- UMLS CUI [1,3]
- C0750503
- UMLS CUI [1,4]
- C0042196
Description
Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, Bacillus Calmette-Guérin (BCG), and/or S. pneumoniae (excepted hepatitis B vaccination)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0205156
- UMLS CUI [1,2]
- C0012559
- UMLS CUI [2,1]
- C0205156
- UMLS CUI [2,2]
- C0199809
- UMLS CUI [3,1]
- C0205156
- UMLS CUI [3,2]
- C0199818
- UMLS CUI [4,1]
- C0205156
- UMLS CUI [4,2]
- C0004886
- UMLS CUI [5,1]
- C0205156
- UMLS CUI [5,2]
- C0042196
- UMLS CUI [5,3]
- C0038410
- UMLS CUI [6,1]
- C0332300
- UMLS CUI [6,2]
- C0474232
Description
History of/intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0012546
- UMLS CUI [2,1]
- C0277557
- UMLS CUI [2,2]
- C0012546
- UMLS CUI [3,1]
- C0262926
- UMLS CUI [3,2]
- C0039614
- UMLS CUI [4,1]
- C0277557
- UMLS CUI [4,2]
- C0039614
- UMLS CUI [5,1]
- C0262926
- UMLS CUI [5,2]
- C0043167
- UMLS CUI [6,1]
- C0277557
- UMLS CUI [6,2]
- C0043167
- UMLS CUI [7,1]
- C0262926
- UMLS CUI [7,2]
- C0019163
- UMLS CUI [8,1]
- C0277557
- UMLS CUI [8,2]
- C0019163
- UMLS CUI [9,1]
- C0262926
- UMLS CUI [9,2]
- C0032371
- UMLS CUI [10,1]
- C0277557
- UMLS CUI [10,2]
- C0032371
- UMLS CUI [11,1]
- C0262926
- UMLS CUI [11,2]
- C0121772
- UMLS CUI [12,1]
- C0277557
- UMLS CUI [12,2]
- C0121772
Description
Allergic disease/reactions to vaccine component (including diphtheria toxoid)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1527304
- UMLS CUI [1,2]
- C0042210
- UMLS CUI [1,3]
- C1705248
- UMLS CUI [2,1]
- C0020517
- UMLS CUI [2,2]
- C0042210
- UMLS CUI [2,3]
- C1705248
- UMLS CUI [3,1]
- C0332257
- UMLS CUI [3,2]
- C0012551
Description
History of seizures/neurological disease
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0036572
- UMLS CUI [2,1]
- C0262926
- UMLS CUI [2,2]
- C0027765
Description
Definition: 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 or mild upper respiratory infections with or without lowgrade febrile illness, i.e. oral/axillary/tympanic temperature <37.5°C / rectal temperature <38.0°C.
Data type
boolean
Alias
- UMLS CUI [1]
- C0001314
Description
Immunosuppression (based on medical hisytory and physical examination)
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
Family history of congenital or hereditary immunodeficiency
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0241889
- UMLS CUI [1,2]
- C0853602
- UMLS CUI [2,1]
- C0241889
- UMLS CUI [2,2]
- C0439660
- UMLS CUI [2,3]
- C0021051
Description
Major congenital defects/serious chronic illness
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0000768
- UMLS CUI [1,2]
- C0205164
- UMLS CUI [2,1]
- C0008679
- UMLS CUI [2,2]
- C0205404
Description
Immunoglobulins, blood products
Data type
boolean
Alias
- UMLS CUI [1]
- C0021027
- UMLS CUI [2]
- C0456388
Similar models
Eligibility criteria
- StudyEvent: ODM
C0001779 (UMLS CUI [2])
C0030551 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0023226 (UMLS CUI [2,2])
C0030551 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0023226 (UMLS CUI [2,2])
C0262926 (UMLS CUI [1,2])
C3898900 (UMLS CUI [2,1])
C1456356 (UMLS CUI [2,2])
C0013230 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
C0042210 (UMLS CUI [2,3])
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])
C1518384 (UMLS CUI [1,2])
C0750503 (UMLS CUI [1,3])
C0042196 (UMLS CUI [1,4])
C0012559 (UMLS CUI [1,2])
C0205156 (UMLS CUI [2,1])
C0199809 (UMLS CUI [2,2])
C0205156 (UMLS CUI [3,1])
C0199818 (UMLS CUI [3,2])
C0205156 (UMLS CUI [4,1])
C0004886 (UMLS CUI [4,2])
C0205156 (UMLS CUI [5,1])
C0042196 (UMLS CUI [5,2])
C0038410 (UMLS CUI [5,3])
C0332300 (UMLS CUI [6,1])
C0474232 (UMLS CUI [6,2])
C0012546 (UMLS CUI [1,2])
C0277557 (UMLS CUI [2,1])
C0012546 (UMLS CUI [2,2])
C0262926 (UMLS CUI [3,1])
C0039614 (UMLS CUI [3,2])
C0277557 (UMLS CUI [4,1])
C0039614 (UMLS CUI [4,2])
C0262926 (UMLS CUI [5,1])
C0043167 (UMLS CUI [5,2])
C0277557 (UMLS CUI [6,1])
C0043167 (UMLS CUI [6,2])
C0262926 (UMLS CUI [7,1])
C0019163 (UMLS CUI [7,2])
C0277557 (UMLS CUI [8,1])
C0019163 (UMLS CUI [8,2])
C0262926 (UMLS CUI [9,1])
C0032371 (UMLS CUI [9,2])
C0277557 (UMLS CUI [10,1])
C0032371 (UMLS CUI [10,2])
C0262926 (UMLS CUI [11,1])
C0121772 (UMLS CUI [11,2])
C0277557 (UMLS CUI [12,1])
C0121772 (UMLS CUI [12,2])
C0042210 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0042210 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
C0332257 (UMLS CUI [3,1])
C0012551 (UMLS CUI [3,2])
C0036572 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0027765 (UMLS CUI [2,2])
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])
C0853602 (UMLS CUI [1,2])
C0241889 (UMLS CUI [2,1])
C0439660 (UMLS CUI [2,2])
C0021051 (UMLS CUI [2,3])
C0205164 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0456388 (UMLS CUI [2])
No comments