ID
36119
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 Diary card form. It has to be filled in of subject.
Link
https://clinicaltrials.gov/ct2/show/NCT00344318
Keywords
Versions (1)
- 4/15/19 4/15/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
April 15, 2019
DOI
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License
Creative Commons BY-NC 3.0
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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
Diary card
- StudyEvent: ODM
Description
Local symptoms (at injection sites)
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0205276
Description
for investigator only: Could you please check the appropriate box (side / site) for assessment. IPV Vaccine: Fill in only for Workbook 2.
Data type
integer
Alias
- UMLS CUI [1]
- C0042210
Description
for investigator only: Could you please check the appropriate box (side / site) for assessment.
Data type
text
Alias
- UMLS CUI [1,1]
- C0441987
- UMLS CUI [1,2]
- C0013153
- UMLS CUI [1,3]
- C0042210
Description
for investigator only: Could you please check the appropriate box (side / site) for assessment. Upper and Lower thigh only options for DTPw-HBV/Hib Vaccine and IPC Vaccine.
Data type
integer
Alias
- UMLS CUI [1,1]
- C1515974
- UMLS CUI [1,2]
- C0013153
- UMLS CUI [1,3]
- C0042210
Description
Local symptoms
Data type
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C2700396
Description
For Day 1-3: note in the evening. Please give information for each symptom and day mentioned.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C1457887
- UMLS CUI [1,4]
- C0332282
- UMLS CUI [1,5]
- C0042196
Description
Please measure the greatest diameter (in mm). Fulfill for Redness and swelling.
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C0456389
Description
Definition: 0: Absent 1: Minor reaction to touch 2: Cries/protests on touch 3: Cries when limb is moved / spontaneously painful
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0030193
Description
Local symptom ongoing
Data type
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C0549178
Description
day month year
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C1457887
Description
Medically attended Visit
Data type
text
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C1518404
Description
Other local symptoms
Alias
- UMLS CUI-1
- C0205394
- UMLS CUI-2
- C1457887
- UMLS CUI-3
- C0205276
Description
Other local symptoms, description
Data type
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
- UMLS CUI [2,1]
- C0441987
- UMLS CUI [2,2]
- C1457887
- UMLS CUI [2,3]
- C0205276
- UMLS CUI [3,1]
- C1515974
- UMLS CUI [3,2]
- C1457887
- UMLS CUI [3,3]
- C0205276
Description
Definition: Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. Severe: An adverse event which prevents normal, everyday activities. (In a young child, such an adverse event would, for example, prevent attendance at school/kindergarten/a day-care center and would cause the parents/guardians to seek medical advice).
Data type
integer
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
- UMLS CUI [2]
- C0518690
Description
day month year
Data type
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1457887
- UMLS CUI [1,4]
- C0205276
Description
day month year. or check box below, if continuing.
Data type
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1457887
- UMLS CUI [1,4]
- C0205276
Description
Other local symptom ongoing
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C1457887
- UMLS CUI [1,4]
- C0549178
Description
Medically attended Visit
Data type
text
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C1518404
Description
General Symptoms
Alias
- UMLS CUI-1
- C0159028
Description
General symptom
Data type
integer
Alias
- UMLS CUI [1]
- C0159028
Description
For Day 1-3: note in the evening. Please give information for each symptom and day mentioned.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0332282
- UMLS CUI [1,4]
- C0042196
Description
Body temperature, route of measurement
Data type
integer
Alias
- UMLS CUI [1,1]
- C0886414
- UMLS CUI [1,2]
- C0449444
Description
Please record the temperature every day. If temperature has been taken more than once a day, please report the highest value for the day.
Data type
float
Measurement units
- °C
Alias
- UMLS CUI [1]
- C0005903
Description
Definition: Irritability / fussiness: 0: Behavior as usual 1: Crying more than usual / no effect on normal activity 2: Crying more than usual / interferes with normal activity 3: Crying that cannot be comforted / prevents normal activity Drowsiness: 0:Behavior as usual 1:Drowsiness easily tolerated 2:Drowsiness that interferes with normal activity 3:Drowsiness that prevents normal activity Loss of appetite: 0: Appetite as usual 1: Eating less than usual / no effect on normal activity 2: Eating less than usual / interferes with normal activity 3: Not eating at all
Data type
integer
Alias
- UMLS CUI [1]
- C0518690
Description
General symptom ongoing
Data type
text
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0549178
Description
day month year
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C1457887
Description
Medically attended Visit
Data type
text
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C1518404
Description
Other general symptoms
Alias
- UMLS CUI-1
- C0029625
Description
Other local symptoms, description
Data type
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
- UMLS CUI [2,1]
- C0441987
- UMLS CUI [2,2]
- C0678257
- UMLS CUI [3,1]
- C1515974
- UMLS CUI [3,2]
- C0678257
Description
Definition: Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. Severe: An adverse event which prevents normal, everyday activities. (In a young child, such an adverse event would, for example, prevent attendance at school/kindergarten/a day-care center and would cause the parents/guardians to seek medical advice).
Data type
integer
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
- UMLS CUI [2]
- C0518690
Description
day month year
Data type
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0159028
Description
day month year. or check box below, if continuing.
Data type
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0159028
Description
Other general symptom ongoing
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0159028
- UMLS CUI [1,3]
- C0549178
Description
Medically attended Visit
Data type
text
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C1518404
Description
Medication
Alias
- UMLS CUI-1
- C0013227
Description
Trade / Generic Name of medication
Data type
text
Alias
- UMLS CUI [1,1]
- C2360065
- UMLS CUI [1,2]
- C0013227
Description
Indication of medication
Data type
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C0013227
Description
Total daily dose
Data type
text
Alias
- UMLS CUI [1]
- C2826638
Description
day month year
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Description
day month year. or check box below, if continuing.
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Description
Medication ongoing
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0549178
Similar models
Diary card
- StudyEvent: ODM
C0332156 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1547383 (UMLS CUI [1,2])
C1515258 (UMLS CUI [1,2])
C0205276 (UMLS CUI-2)
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0332282 (UMLS CUI [1,4])
C0042196 (UMLS CUI [1,5])
C0205276 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,3])
C0030193 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0441987 (UMLS CUI [2,1])
C1457887 (UMLS CUI [2,2])
C0205276 (UMLS CUI [2,3])
C1515974 (UMLS CUI [3,1])
C1457887 (UMLS CUI [3,2])
C0205276 (UMLS CUI [3,3])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0518690 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0205276 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,4])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,2])
C0332282 (UMLS CUI [1,3])
C0042196 (UMLS CUI [1,4])
C0449444 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0441987 (UMLS CUI [2,1])
C0678257 (UMLS CUI [2,2])
C1515974 (UMLS CUI [3,1])
C0678257 (UMLS CUI [3,2])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0518690 (UMLS CUI [2])
C0159028 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
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