Informatie:
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ID
35523
Beschrijving
Study ID: 111652 Clinical Study ID: 111652 Study Title: A Study to Evaluate GSK Biologicals' Candidate Formulations of Pneumococcal Vaccines (GSK2189241A) in Elderly Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00756067 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Pneumococcal vaccine GSK2189241A Trade Name: Pneumo 23™ Study Indication: Infections, Streptococcal
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Versies (1)
- 07-03-19 07-03-19 -
Houder van rechten
GSK group of companies
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7 maart 2019
DOI
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Licentie
Creative Commons BY-NC 3.0
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Candidate Formulations of Pneumococcal Vaccines in Elderly Subjects - 111652
Visit 5 - Day 60 - Dose 2
- StudyEvent: ODM
Similar models
Visit 5 - Day 60 - Dose 2
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Subject Number
Item
Subject Number
integer
Visit Number
Item
Visit Number
text
Date of Visit
Item
Date of Visit
date
Check for Study Continuation
Item
Did the subject return for visit 1?
boolean
If No, please record ONE most appropriate reason and skip the following forms of this visit.
Item
If No, please record ONE most appropriate reason and skip the following forms of this visit.
text
Item
Has a blood sample been taken for haematology/ biochemistry testing?
text
Code List
Has a blood sample been taken for haematology/ biochemistry testing?
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (Only if Visit 1 occurred within 48 hours from blood sample taken at screening visit) (3)
Date
Item
Date
date
Laboratory Name
Item
Laboratory Name
text
Laboratory Code
Item
Laboratory Code
integer
[HB] Hemoglobin
Item
[HB] Hemoglobin
float
Red Blood Cells
Item
[RBC] Red Blood Cells
integer
Platelets
Item
[PLA] Platelets
text
White Blood Cells
Item
[WBC] White Blood Cells
text
Neutrophils
Item
[NEU] Neutrophils
text
Lymphocytes
Item
[LYM] Lymphocytes
integer
Monocytes
Item
[MON] Monocytes
text
Eosinophils
Item
[EOS] Eosinophils
text
Basophils
Item
[BAS] Basophils
text
Reticulocytes
Item
[RET] Reticulocytes
text
BUN
Item
[BUN] BUN
float
Creatinine
Item
[CREA] Creatinine
float
AST/SGOT
Item
[AST] AST/SGOT
float
ALT/SGPT
Item
[ALT] ALT/SGPT
float
Cholesterol
Item
[CHOL] Cholesterol
float
Creatine phosphokinase
Item
[CPK] Creatine phosphokinase
float
Serum Haptoglobin
Item
[HAP] Serum Haptoglobin
float
Lactate Dehydrogenase
Item
[LDH] Lactate Dehydrogenase
text
LD1
Item
LD1
text
LD2
Item
LD2
text
LD3
Item
LD3
text
LD4
Item
LD4
text
LD5
Item
LD5
text
Blood Sample for Immunogenicity Assays
Item
Has a blood sample been taken for immunogenicity assays?
boolean
Date
Item
Date
date
Urine Sample Question
Item
Has a urine sample been taken for dipstick?
boolean
Date
Item
Date
date
pH (via dipstick)
Item
pH (via dipstick)
integer
CL Item
negative (1)
CL Item
1+ (2)
CL Item
2+ (3)
CL Item
3+ (4)
CL Item
normal (1)
CL Item
1+ (2)
CL Item
2+ (3)
CL Item
3+ (4)
CL Item
4+ (5)
CL Item
negative (1)
CL Item
1+ (2)
CL Item
2+ (3)
CL Item
3+ (4)
CL Item
negative (1)
CL Item
1+ (2)
CL Item
2+ (3)
CL Item
3+ (4)
CL Item
4+ (5)
CL Item
negative (1)
CL Item
1+ (2)
CL Item
2+ (3)
CL Item
3+ (4)
CL Item
normal (1)
CL Item
1+ (2)
CL Item
2+ (3)
CL Item
3+ (4)
CL Item
4+ (5)
CL Item
negative (1)
CL Item
positive (2)
CL Item
negative (1)
CL Item
1+ (2)
CL Item
2+ (3)
CL Item
3+ (4)
Urina Sample for Diagnostic Sssay?
Item
Has a urine sample been taken for development of diagnostic assay?
boolean
Date
Item
Date
date
Treatment Number
Item
Record treatment number:
integer
Date
Item
Date
boolean
Pre-Vaccination temperature
Item
Pre-Vaccination temperature:
float
CL Item
Axillary (1)
CL Item
Oral (2)
CL Item
Rectal (3)
CL Item
Study Vaccine (1)
CL Item
Replacement vial (2)
CL Item
Not administered (3)
Replacement vial Number
Item
Replacement vial Number
integer
CL Item
Dominant (1)
CL Item
Non-dominant (2)
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
CL Item
I.M. (1)
CL Item
S.C. (2)
Comment
Item
Comment
text
Has the study vaccine been administered according to the Protocol?
Item
Has the study vaccine been administered according to the Protocol?
boolean
CL Item
Dominant (1)
CL Item
Non-dominant (2)
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
CL Item
I.M. (1)
CL Item
S.C. (2)
Comment
Item
Comment
text
CL Item
Serious adverse event (1)
CL Item
Non-Serious adverse event (2)
CL Item
Other (3)
SAE number
Item
In case of SAE, record SAE number
integer
AE number
Item
In case of AE, record AE number
integer
Specify Other
Item
In Other cases, specify
text
CL Item
Investigator (1)
CL Item
Subject (2)
Reminder AE
Item
If any adverse events occurred during the immediate post-vaccination time (30 minutes) please fill in the Solicited Adverse Events section, the Non-Serious Adverse Event section or a Serious Adverse Event report.
text
Reminder Concomitant Medication
Item
If any prophylactic medication has been administered in anticipation of study vaccine reaction, please complete the Medication section and tick prophylactic box.
text
Reminder Concomitant Vaccination
Item
Any other vaccines administered during the study period must be recorded in the Concomitant Vaccination section.
text
Item
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
text
Code List
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
CL Item
Information not available (1)
CL Item
No vaccine administered (2)
CL Item
No (3)
CL Item
Yes, please record information for all symptoms (4)
Redness
Item
Redness
boolean
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Day 4 (5)
CL Item
Day 5 (6)
CL Item
Day 6 (7)
Size
Item
Size
integer
Ongoing after day 6?
Item
Ongoing after day 6?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Medically attended visit
Item
Medically attended visit?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Swelling
Item
Swelling
boolean
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Day 4 (5)
CL Item
Day 5 (6)
CL Item
Day 6 (7)
Size
Item
Size
integer
Ongoing after day 6?
Item
Ongoing after day 6?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Medically attended visit
Item
Medically attended visit
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Pain
Item
Pain
boolean
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Day 4 (5)
CL Item
Day 5 (6)
CL Item
Day 6 (7)
CL Item
Absent (1)
CL Item
Painful on touch (2)
CL Item
Painful when limb is moved (3)
CL Item
Pain that prevents normal activity (4)
Ongoing after day 6?
Item
Ongoing after day 6?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Medically attended visit
Item
Medically attended visit
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item
Has the subject experienced any of the following signs/symptoms during the solicited period?
text
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period?
CL Item
Information not available (1)
CL Item
No vaccine administered (2)
CL Item
No (3)
CL Item
Yes, please record information for each symptom (4)
Temperature
Item
Temperature
boolean
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Day 4 (5)
CL Item
Day 5 (6)
CL Item
Day 6 (7)
t°
Item
t°
float
CL Item
Rectal (1)
CL Item
Oral (2)
CL Item
Axillary (3)
Ongoing after day 6?
Item
Ongoing after day 6?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Causality?
Item
Causality?
boolean
Medically attended visit
Item
Medically attended visit?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Fatigue
Item
Fatigue
boolean
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Day 4 (5)
CL Item
Day 5 (6)
CL Item
Day 6 (7)
CL Item
Normal (1)
CL Item
Fatigue that is easily tolerated (2)
CL Item
Fatigue that interferes with normal activity (3)
CL Item
Fatigue that prevents normal activity (4)
Ongoing after day 6?
Item
Ongoing after day 6?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Causality?
Item
Causality?
boolean
Medically attended visit
Item
Medically attended visit?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Headache
Item
Headache
boolean
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Day 4 (5)
CL Item
Day 5 (6)
CL Item
Day 6 (7)
CL Item
Normal (1)
CL Item
Headache that is easily tolerated (2)
CL Item
Headache that interferes with normal activity (3)
CL Item
Headache that prevents normal activity (4)
Ongoing after day 6?
Item
Ongoing after day 6?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Causality?
Item
Causality?
boolean
Medically attended visit
Item
Medically attended visit
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Gastrointestinal symptoms
Item
Gastrointestinal symptoms
boolean
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Day 4 (5)
CL Item
Day 5 (6)
CL Item
Day 6 (7)
CL Item
Normal (1)
CL Item
Gastrointestinal symptoms that are easily tolerated (2)
CL Item
Gastrointestinal symptoms that interfere with normal activity (3)
CL Item
Gastrointestinal symptoms that prevent normal activity (4)
Ongoing after day 6?
Item
Ongoing after day 6?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Causality?
Item
Causality?
boolean
Medically attended visit
Item
Medically attended visit
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Malaise
Item
Malaise
boolean
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Day 4 (5)
CL Item
Day 5 (6)
CL Item
Day 6 (7)
CL Item
Normal (1)
CL Item
Malaise that is easily tolerated (2)
CL Item
Malaise that interferes with normal activity (3)
CL Item
Malaise that prevents normal activity (4)
Ongoing after day 6?
Item
Ongoing after day 6?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Medically attended visit
Item
Medically attended visit
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Myalgia
Item
Myalgia
boolean
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Day 4 (5)
CL Item
Day 5 (6)
CL Item
Day 6 (7)
CL Item
Normal (1)
CL Item
Myalgia that is easily tolerated (2)
CL Item
Myalgia that interferes with normal activity (3)
CL Item
Myalgia that prevents normal activity (4)
Ongoing after day 6?
Item
Ongoing after day 6?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Causality
Item
Causality
boolean
Medically attended visit
Item
Medically attended visit
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item
Has the subject experienced any non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination or any serious adverse events or medically significant condition between dose 1 and dose 2 (Day 60)?
text
Code List
Has the subject experienced any non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination or any serious adverse events or medically significant condition between dose 1 and dose 2 (Day 60)?
CL Item
Information not available (1)
CL Item
No vaccine administered (2)
CL Item
No (3)
CL Item
Yes (4)