ID

27343

Beschreibung

Study ID: 103534 Clinical Study ID: 103534 Study Title: Evaluate the immunogenicity, reactogenicity, safety of 4 different formulations of GSK Biologicals' conjugate vaccine (MenACWY) vs 1 dose of MenC-CRM197 or Mencevax™ ACWY in children aged 12-14 months & 3-5 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00196976 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed clinical study under GSK sponsorship. The product that is studied in this clinical study, together with the rights to the data and results generated, has been transferred by GSK to Pfizer. GSK’s Clinical Study Register is no longer maintained for this study. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results Generic Name: Meningococcal Serogroups A, C, W-135 and Y-Tetanus Toxoid Conjugate Vaccine Trade Name: Nimenrix Study Indication: Infections, Meningococcal Booster Vaccination Only for subjects who are part of the group with the selected MenACWY-TT formulation and the control group.) “Subjects enrolled at 3 – 5 years of age”

Link

http://www.pfizer.com/research/clinical_trials/trial_data_and_results

Stichworte

Versionen (1)
  1. 08.11.17 08.11.17 -
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Pfizer

Hochgeladen am

8. November 2017

DOI

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Meningococcal Infections Vaccination in children NCT00196976

Englisch

Workbook 2 Visit 3 Part 2

1 Formulare  
Administrative Documentation
Beschreibung

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
GENERAL MEDICAL HISTORY / PHYSICAL EXAMINATION
Beschreibung

GENERAL MEDICAL HISTORY / PHYSICAL EXAMINATION

Alias
UMLS CUI-1
C0262926
UMLS CUI-3
C0031809
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject since the last visit of the previous study MenACWY-TT-010 (103533) ? Please tick appropriate box(es) and give diagnosis
Beschreibung

Medical History

Datentyp

boolean

Alias
UMLS CUI [1]
C0262926
UMLS CUI [2,1]
C0205476
UMLS CUI [2,2]
C0348080
UMLS CUI [3]
C1457887
GENERAL MEDICAL HISTORY / PHYSICAL EXAMINATION
Beschreibung

GENERAL MEDICAL HISTORY / PHYSICAL EXAMINATION

Alias
UMLS CUI-1
C0262926
UMLS CUI-3
C0031809
Organ system
Beschreibung

Organ system

Datentyp

integer

Alias
UMLS CUI [1]
C0678852
Diagnosis
Beschreibung

Diagnosis

Datentyp

text

Alias
UMLS CUI [1]
C0011900
Ongoing disease?
Beschreibung

currentness of disease

Datentyp

text

Alias
UMLS CUI [1,1]
C0699749
UMLS CUI [1,2]
C0037274
Vaccine History
Beschreibung

Vaccine History

Alias
UMLS CUI-1
C0042210
UMLS CUI-2
C0262926
Is the subject's previous vaccination status known or changed against meningococcal vaccines and investigational or non-registered vaccines since the last visit of the previous study MenACWY-TT-010 (103533) ?
Beschreibung

undefined item

Datentyp

text

Alias
UMLS CUI [1,1]
C1443394
UMLS CUI [1,2]
C0700144
UMLS CUI [1,3]
C0042210
UMLS CUI [1,4]
C1517586
Vaccine History
Beschreibung

Vaccine History

Alias
UMLS CUI-1
C0042210
UMLS CUI-2
C0262926
Trade / (Generic) Name
Beschreibung

Name

Datentyp

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C0042210
Route
Beschreibung

Route

Datentyp

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Administration date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0042196
For GSK
Beschreibung

Investigator Use

Datentyp

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C0457083
Medication History
Beschreibung

Medication History

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0013227
Have any medications/treatments included any investigational or non-registered product(s), any immunosuppressant(s) or other immune-modifying drug(s), immunoglobulins and/or any blood product been administered since the last visit of the previous study MenACWY-TT-010 (103533) ?
Beschreibung

Change of medication

Datentyp

text

Alias
UMLS CUI [1]
C0580105
Medication history
Beschreibung

Medication history

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0013227
Trade/Generic name
Beschreibung

Name

Datentyp

text

Alias
UMLS CUI [1]
C2360065
Medical indication
Beschreibung

Medical indication

Datentyp

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
Medical Indication
Beschreibung

Medical indication

Datentyp

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
Total daily dose
Beschreibung

Total daily dose

Datentyp

text

Alias
UMLS CUI [1]
C2348070
Route
Beschreibung

Route

Datentyp

text

Alias
UMLS CUI [1]
C0013153
Start date
Beschreibung

Start date

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
End date
Beschreibung

End date

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Tick box if continuing medication at the beginning of this study
Beschreibung

Ongoing medication

Datentyp

boolean

Alias
UMLS CUI [1]
C2826666
For GSK
Beschreibung

Investigator use

Datentyp

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C0457083
LABORATORY TESTS; BLOOD SAMPLE
Beschreibung

LABORATORY TESTS; BLOOD SAMPLE

Alias
UMLS CUI-1
C0022885
Has a blood sample been taken ?
Beschreibung

Blood sample

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1277698
Please complete only if different from visit date:
Beschreibung

Date of blood sample

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
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Ähnliche Modelle

Workbook 2 Visit 3 Part 2

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Documentation
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
GENERAL MEDICAL HISTORY / PHYSICAL EXAMINATION
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-3)
Medical History
Item
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject since the last visit of the previous study MenACWY-TT-010 (103533) ? Please tick appropriate box(es) and give diagnosis
boolean
C0262926 (UMLS CUI [1])
C0205476 (UMLS CUI [2,1])
C0348080 (UMLS CUI [2,2])
C1457887 (UMLS CUI [3])
Item Group
GENERAL MEDICAL HISTORY / PHYSICAL EXAMINATION
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-3)
Item
Organ system
integer
C0678852 (UMLS CUI [1])
Organ system
Code List
Organ system
CL Item
Cutaneous (10)
CL Item
Eyes (5)
CL Item
Ears-Nose-Throat (6)
CL Item
Cardiovascular (2)
CL Item
Respiratory (3)
CL Item
Gastrointestinal (1)
CL Item
Muskuloskeletal (7)
CL Item
Neurological (8)
CL Item
Genitourinary (12)
CL Item
Haematology  (11)
CL Item
Allergies (4)
CL Item
Endocrine (9)
CL Item
Other (specify) (99)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Item
Ongoing disease?
text
C0699749 (UMLS CUI [1,1])
C0037274 (UMLS CUI [1,2])
currentness of disease
Code List
Ongoing disease?
CL Item
Past (Past)
CL Item
Current (Current)
Item Group
Vaccine History
C0042210 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
Item
Is the subject's previous vaccination status known or changed against meningococcal vaccines and investigational or non-registered vaccines since the last visit of the previous study MenACWY-TT-010 (103533) ?
text
C1443394 (UMLS CUI [1,1])
C0700144 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C1517586 (UMLS CUI [1,4])
undefined item
Code List
Is the subject's previous vaccination status known or changed against meningococcal vaccines and investigational or non-registered vaccines since the last visit of the previous study MenACWY-TT-010 (103533) ?
CL Item
No (No)
CL Item
Unknown (Unknown)
CL Item
Yes, if yes, please complete the following table (Yes, if yes, please complete the following table)
Item Group
Vaccine History
C0042210 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
Name
Item
Trade / (Generic) Name
text
C0027365 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Route
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Date
Item
Administration date
date
C0011008 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Investigator Use
Item
For GSK
text
C0008961 (UMLS CUI [1,1])
C0457083 (UMLS CUI [1,2])
Item Group
Medication History
C0262926 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
Item
Have any medications/treatments included any investigational or non-registered product(s), any immunosuppressant(s) or other immune-modifying drug(s), immunoglobulins and/or any blood product been administered since the last visit of the previous study MenACWY-TT-010 (103533) ?
text
C0580105 (UMLS CUI [1])
Change of medication
Code List
Have any medications/treatments included any investigational or non-registered product(s), any immunosuppressant(s) or other immune-modifying drug(s), immunoglobulins and/or any blood product been administered since the last visit of the previous study MenACWY-TT-010 (103533) ?
CL Item
No (No)
CL Item
Yes, please complete the following table (Yes, please complete the following table)
Item Group
Medication history
C0262926 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
Name
Item
Trade/Generic name
text
C2360065 (UMLS CUI [1])
Medical indication
Item
Medical indication
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item
Medical Indication
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Medical indication
Code List
Medical Indication
CL Item
Prophylactic (Prophylactic)
CL Item
Non Prophylactic (Non Prophylactic)
Total daily dose
Item
Total daily dose
text
C2348070 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Start date
Item
Start date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End date
Item
End date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Ongoing medication
Item
Tick box if continuing medication at the beginning of this study
boolean
C2826666 (UMLS CUI [1])
Investigator use
Item
For GSK
text
C0008961 (UMLS CUI [1,1])
C0457083 (UMLS CUI [1,2])
Item Group
LABORATORY TESTS; BLOOD SAMPLE
C0022885 (UMLS CUI-1)
Blood sample
Item
Has a blood sample been taken ?
boolean
C0005834 (UMLS CUI [1,1])
C1277698 (UMLS CUI [1,2])
Date of blood sample
Item
Please complete only if different from visit date:
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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