ID

27207

Descrizione

Study ID: 103533 Clinical Study ID: 103533 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 GSK’s Clinical Study Register is no longer maintained for this study.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

collegamento

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

Keywords

versioni (2)
  1. 26/10/17 26/10/17 -
  2. 03/11/17 03/11/17 -
Titolare del copyright

Pfizer

Caricato su

3 novembre 2017

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0
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Meningococcal Infections Vaccination in children NCT00196976

Inglese

Workbook 1 Visit 2 Part 1

1 moduli  
Administrative Documentation
Descrizione

Administrative Documentation

Alias
UMLS CUI-1
C1320722 (Administrative documentation)
SNOMED
405624007
Subject Number
Descrizione

Subject Number

Tipo di dati

integer

Alias
UMLS CUI [1]
C2348585 (Clinical Trial Subject Unique Identifier)
Date of visit
Descrizione

Date of visit

Tipo di dati

date

Alias
UMLS CUI [1]
C1320303 (Date of visit)
SNOMED
406543005
Study Continuation
Descrizione

Study Continuation

Alias
UMLS CUI-1
C0008972 (Clinical Research)
UMLS CUI-2
C0805733 (Continuation status)
LOINC
MTHU008303
Did the subject come at visit 2 ?
Descrizione

Subject return to visit

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0545082 (Visit)
UMLS CUI [1,2]
C0805733 (Continuation status)
LOINC
MTHU008303
UMLS CUI [1,3]
C0008976 (Clinical Trials)
SNOMED
110465008
LOINC
LP231796-6
Please tick the ONE most appropriate reason and skip the following pages of this visit.
Descrizione

Reason no study continuation

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0008972 (Clinical Research)
UMLS CUI [1,2]
C0805733 (Continuation status)
LOINC
MTHU008303
Please specify SAE N°; Please specify unsolicited AE N° or solicited AE code
Descrizione

Serious adverse event Number | Unsolicited Adverse Event Number | Solicited Adverse Event code

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C1519255 (Serious Adverse Event)
UMLS CUI [1,2]
C0805701 (Code)
UMLS CUI [1,3]
C1521902 (To specify)
UMLS CUI [2,1]
C0877248 (Adverse event)
LOINC
MTHU014542
UMLS CUI [2,2]
C0805701 (Code)
UMLS CUI [2,3]
C1521902 (To specify)
Please tick who took the decision
Descrizione

Decision

Tipo di dati

text

Alias
UMLS CUI [1]
C0679006 (Decision)
LABORATORY TESTS; BLOOD SAMPLE
Descrizione

LABORATORY TESTS; BLOOD SAMPLE

Alias
UMLS CUI-1
C0022885 (Laboratory Procedures)
SNOMED
269814003
UMLS CUI-2
C0005834 (Collection of blood specimen for laboratory procedure)
SNOMED
82078001
LOINC
LP125037-4
Has a blood sample been taken ?
Descrizione

Blood sample taken

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1277698 (Blood sample taken)
SNOMED
313334002
Please complete only if different from visit date:
Descrizione

Date

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0011008 (Date in time)
SNOMED
410671006
UMLS CUI [1,2]
C0005834 (Collection of blood specimen for laboratory procedure)
SNOMED
82078001
LOINC
LP125037-4
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Similar models

Workbook 1 Visit 2 Part 1

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Administrative Documentation
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Study Continuation
C0008972 (UMLS CUI-1)
C0805733 (UMLS CUI-2)
Subject return to visit
Item
Did the subject come at visit 2 ?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
Please tick the ONE most appropriate reason and skip the following pages of this visit.
text
C0008972 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
Reason no visit
Code List
Please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
Serious adverse event (complete the Serious Adverse Event form) (SAE)
CL Item
Non-Serious adverse event (complete the Non-serious Adverse Event section) (AEX)
CL Item
Other, please specify (OTH)
Serious adverse event Number | Unsolicited Adverse Event Number | Solicited Adverse Event code
Item
Please specify SAE N°; Please specify unsolicited AE N° or solicited AE code
integer
C1519255 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0877248 (UMLS CUI [2,1])
C0805701 (UMLS CUI [2,2])
C1521902 (UMLS CUI [2,3])
Item
Please tick who took the decision
text
C0679006 (UMLS CUI [1])
Decision
Code List
Please tick who took the decision
CL Item
Investigator (I)
CL Item
Parents/Guardians (P)
Item Group
LABORATORY TESTS; BLOOD SAMPLE
C0022885 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
Blood sample taken
Item
Has a blood sample been taken ?
boolean
C1277698 (UMLS CUI [1])
Date
Item
Please complete only if different from visit date:
date
C0011008 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
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