ID
32337
Beschreibung
Study ID: 109563 Clinical Study ID: 109563 Study Title: COMPAS:A phase III study to demonstrate efficacy of GSK Biologicals' 10-valent pneumococcal vaccine (GSK1024850A) against Community Acquired Pneumonia and Acute Otitis Media Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier https://clinicaltrials.gov/ct2/show/NCT00466947 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) Trade Name: BIO 10PN-PD-DIT; Synflorix Study Indication: Infections, Streptococcal The Study consists of three workbooks. Workbook 1: Argentina, all subjects + immuno & reacto subset Workbook 2: Panama, all subjects + immuno & reacto subset + carriage subset + additional immuno subset Workbook 3: Colombia, all subjects The protocol number for all workbooks: 109563 (10Pn-PD-DiT-028) There are ten visits in workbook 1 and 2, eight for workbook 3 (there are no visits 4 and 7): Visit 1: month 0, dose 1, 6-16 weeks of age Visit 2: month 2, dose 2, +/- 4 months of age, 49-83 days after visit 1 Visit 3: month 4, dose 3, +/- 6 months of age, 49-83 days after visit 2 Visit 4: month 5, +/- 7 months of age, 28-42 days after visit 3. Only for immuno & reacto subset + carriage subset. Visit 5: month 10-13, 12-15 months of age Visit 6: month 13-16, booster dose, 15-18 months of age, ≥ 28 days after visit 5 Visit 7: month 14-17, 16-19 months of age, 28-42 days after visit 6. Only for immuno & reacto subset, additional immuno subset + carriage subset. Visit 8: month 16-19, 18-21 months of age, ≥ 28 days after visit 6 Visit 9: month 22-25, 24-27 months of age Visit 10: Contact This document contains the meningitis form. It has to be filled in if a meningitis case occurs during study. It's for all workbooks.
Link
https://clinicaltrials.gov/ct2/show/NCT00466947
Stichworte
Versionen (1)
- 27.10.18 27.10.18 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
27. Oktober 2018
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Vaccination against pneumonia and otitis media, NCT00466947
Meningitis
- StudyEvent: ODM
Beschreibung
SECTION 1: CLINICAL SYMPTOMS
Alias
- UMLS CUI-1
- C1457887
Beschreibung
SAE Report number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0684224
- UMLS CUI [1,3]
- C0237753
Beschreibung
Date of first symptoms
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0011008
Beschreibung
Please complete for all cases where a meningitis diagnosis is reported.
Datentyp
integer
Alias
- UMLS CUI [1]
- C0037088
Beschreibung
Please complete for all cases where a meningitis diagnosis is reported.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1441672
- UMLS CUI [1,2]
- C0037088
Beschreibung
SECTION 2: BLOOD TEST
Alias
- UMLS CUI-1
- C0018941
Beschreibung
Date of blood test
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0011008
Beschreibung
Antibiotic treatment initiated prior to blood culture
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0338237
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C0200949
Beschreibung
Haemogram
Alias
- UMLS CUI-1
- C0200949
- UMLS CUI-2
- C0018941
Beschreibung
WBC
Datentyp
integer
Maßeinheiten
- Cell/ml
Alias
- UMLS CUI [1]
- C0023508
Beschreibung
Granulocytes
Datentyp
float
Maßeinheiten
- %
Alias
- UMLS CUI [1]
- C0857490
Beschreibung
Lymphocytes
Datentyp
float
Maßeinheiten
- %
Alias
- UMLS CUI [1]
- C0024264
Beschreibung
Other tests
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0018941
Beschreibung
Serology
Alias
- UMLS CUI-1
- C0036743
- UMLS CUI-2
- C0018941
Beschreibung
Serology test: Latex
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0036743
- UMLS CUI [1,2]
- C0023115
Beschreibung
Serology test: Contra immunoelectrophoresis
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0036743
- UMLS CUI [1,2]
- C0201725
Beschreibung
Serology test: Elisa
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0036743
- UMLS CUI [1,2]
- C0014441
Beschreibung
Please specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0036743
Beschreibung
If there was a positive result please specify in following item
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0036743
- UMLS CUI [1,2]
- C1274040
Beschreibung
Haemophilus influenzae Type b
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0036743
- UMLS CUI [1,2]
- C0121772
Beschreibung
Streptococcus pneumoniae
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0036743
- UMLS CUI [1,2]
- C0038410
Beschreibung
Neisseria meningitidis
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0036743
- UMLS CUI [1,2]
- C0027575
Beschreibung
Streptococcus group B
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0036743
- UMLS CUI [1,2]
- C0579233
Beschreibung
please specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0036743
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0004611
Beschreibung
Blood culture
Alias
- UMLS CUI-1
- C0200949
Beschreibung
Pathogen organism: Staphilococcus aureus
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0450254
- UMLS CUI [1,2]
- C0038172
Beschreibung
Pathogen organism: Neisseria meningitidis
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0450254
- UMLS CUI [1,2]
- C0027575
Beschreibung
Pathogen organism: Streptoccocus pneumoniae
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0450254
- UMLS CUI [1,2]
- C0038410
Beschreibung
Pathogen organism: Haemphilus Influenzae type B
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0450254
- UMLS CUI [1,2]
- C0121772
Beschreibung
please specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0450254
- UMLS CUI [1,2]
- C0205394
Beschreibung
SECTION 3: LUMBAR PUNCTURE
Alias
- UMLS CUI-1
- C0007806
Beschreibung
Date of lumbar puncture
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0007806
- UMLS CUI [1,2]
- C0011008
Beschreibung
Antibiotic treatment prior lumbar puncture
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0338237
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C0007806
Beschreibung
Result: CSF appearance: Clear
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0007806
- UMLS CUI [1,3]
- C2963144
Beschreibung
Result: CSF appearance: Turbid
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0007806
- UMLS CUI [1,3]
- C0311420
Beschreibung
Result: CSF appearance: purulent
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0007806
- UMLS CUI [1,3]
- C0439665
Beschreibung
Result: CSF appearance: Hematic
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0007806
- UMLS CUI [1,3]
- C0333275
Beschreibung
CSF cell count: Total
Datentyp
float
Maßeinheiten
- x 10^6/L
Alias
- UMLS CUI [1]
- C4063897
Beschreibung
CSF cell count: Polymorphonuclears (PMNs)
Datentyp
float
Maßeinheiten
- x 10^6/L
Alias
- UMLS CUI [1,1]
- C1168338
- UMLS CUI [1,2]
- C0007806
Beschreibung
CSF cell count: Lymphocytes
Datentyp
float
Maßeinheiten
- x 10^6/L
Alias
- UMLS CUI [1,1]
- C0200635
- UMLS CUI [1,2]
- C0007806
Beschreibung
CSF: Protein content
Datentyp
float
Maßeinheiten
- g/L
Alias
- UMLS CUI [1,1]
- C0555903
- UMLS CUI [1,2]
- C0007806
Beschreibung
Please tick unit of measure in following item
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0337438
- UMLS CUI [1,2]
- C0007806
Beschreibung
Unit of measure, glucose content
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0337438
- UMLS CUI [1,2]
- C0007806
Beschreibung
Please tick unit of measure in following item
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0202042
Beschreibung
Unit of measure, plasma glucose concentration
Datentyp
integer
Alias
- UMLS CUI [1]
- C0202042
Beschreibung
% plasma glucose concentration
Datentyp
float
Maßeinheiten
- %
Alias
- UMLS CUI [1]
- C0369269
Beschreibung
Other blood test: Lactate
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0205394
Beschreibung
Other blood test: LDH
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0202113
Beschreibung
Other blood test: ASGOT
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0201899
Beschreibung
Other blood test: Creatine phosphokinase
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0201973
Beschreibung
GRAM stain: positive
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0061856
- UMLS CUI [1,2]
- C0430402
- UMLS CUI [1,3]
- C1446409
Beschreibung
GRAM stain: negative
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0061856
- UMLS CUI [1,2]
- C0430402
- UMLS CUI [1,3]
- C0205160
Beschreibung
GRAM stain: Negative result
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0061856
- UMLS CUI [1,2]
- C0430402
- UMLS CUI [1,3]
- C0205160
- UMLS CUI [1,4]
- C1274040
Beschreibung
GRAM stain: Not Done
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0061856
- UMLS CUI [1,2]
- C0430402
- UMLS CUI [1,3]
- C1272696
Beschreibung
Lumbar puncture: CSF Culture
Alias
- UMLS CUI-1
- C0007806
- UMLS CUI-2
- C0430400
Beschreibung
If you tick Streptoccocus pneumoniae or Haemophilus influenzae please complete following items
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0007806
- UMLS CUI [1,2]
- C0430400
- UMLS CUI [1,3]
- C0004611
Beschreibung
Other CSF culture
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0007806
- UMLS CUI [1,3]
- C0430400
Beschreibung
Streptoccocus pneumoniae: Serotype/group
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0038410
- UMLS CUI [1,2]
- C0449943
Beschreibung
Other serotype of Streptoccocus pneumoniae
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0038410
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0449943
Beschreibung
Haemophilus influenzae: Serotype/group
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0018483
- UMLS CUI [1,2]
- C0449943
Beschreibung
Other serotype of Haemophilus influenzae
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0018483
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0449943
Beschreibung
Lumbar puncture: Antigen detection
Alias
- UMLS CUI-1
- C0003320
- UMLS CUI-2
- C0007806
- UMLS CUI-3
- C0007806
Beschreibung
Antigen tests
Datentyp
integer
Alias
- UMLS CUI [1]
- C0729856
Beschreibung
Other antigen test
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0729856
Beschreibung
Positive antigen tests
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0729856
- UMLS CUI [1,2]
- C1446409
Beschreibung
Postive result confirmed
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0729856
- UMLS CUI [1,2]
- C1446409
- UMLS CUI [1,3]
- C1274040
- UMLS CUI [1,4]
- C0750484
Beschreibung
Other positive result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0729856
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1446409
- UMLS CUI [1,4]
- C1274040
Ähnliche Modelle
Meningitis
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0684224 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0037088 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,2])
C0200949 (UMLS CUI [1,3])
C0018941 (UMLS CUI [1,2])
C0023115 (UMLS CUI [1,2])
C0201725 (UMLS CUI [1,2])
C0014441 (UMLS CUI [1,2])
C0036743 (UMLS CUI [1,2])
C0121772 (UMLS CUI [1,2])
C0038410 (UMLS CUI [1,2])
C0027575 (UMLS CUI [1,2])
C0579233 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0004611 (UMLS CUI [1,3])
C0038172 (UMLS CUI [1,2])
C0027575 (UMLS CUI [1,2])
C0038410 (UMLS CUI [1,2])
C0121772 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,2])
C0007806 (UMLS CUI [1,3])
C0007806 (UMLS CUI [1,2])
C2963144 (UMLS CUI [1,3])
C0007806 (UMLS CUI [1,2])
C0311420 (UMLS CUI [1,3])
C0007806 (UMLS CUI [1,2])
C0439665 (UMLS CUI [1,3])
C0007806 (UMLS CUI [1,2])
C0333275 (UMLS CUI [1,3])
C0007806 (UMLS CUI [1,2])
C0007806 (UMLS CUI [1,2])
C0007806 (UMLS CUI [1,2])
C0007806 (UMLS CUI [1,2])
C0007806 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0202113 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0201899 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0201973 (UMLS CUI [1,3])
C0430402 (UMLS CUI [1,2])
C1446409 (UMLS CUI [1,3])
C0430402 (UMLS CUI [1,2])
C0205160 (UMLS CUI [1,3])
C0430402 (UMLS CUI [1,2])
C0205160 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
C0430402 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0430400 (UMLS CUI-2)
C0430400 (UMLS CUI [1,2])
C0004611 (UMLS CUI [1,3])
C0007806 (UMLS CUI [1,2])
C0430400 (UMLS CUI [1,3])
C0449943 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0449943 (UMLS CUI [1,3])
C0449943 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0449943 (UMLS CUI [1,3])
C0007806 (UMLS CUI-2)
C0007806 (UMLS CUI-3)
C0729856 (UMLS CUI [1,2])
C1446409 (UMLS CUI [1,2])
C1446409 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C0750484 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,2])
C1446409 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
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