ID

36631

Descripción

Study ID: 102394 Clinical Study ID: 102394 Study Title: A Phase IV, partially double-blind study to demonstrate non-inferiority of GSK Biologicals’ Mencevax™ ACWY (new process) versus Mencevax™ ACWY (current process) when administered as a single dose to subjects aged 2-30 yrs Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00227422 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 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 GSK’s Clinical Study Register is no longer maintained for this study.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 Vaccine Trade Name: Mencevax Study Indication: Infections, Meningococcal

Link

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

Palabras clave

Versiones (1)
  1. 26/5/19 26/5/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

26 de mayo de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0
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Mencevax™ ACWY (new process) versus Mencevax™ ACWY (current process); NCT00227422

Inglés

Visit 2 - Month 1

1 formularios  
  1. StudyEvent: ODM
    1. Visit 2 - Month 1
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Date of visit
Descripción

Date of visit

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Subject Number
Descripción

Clinical Trial Subject Unique Identifier

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Check for Study Continuation
Descripción

Check for Study Continuation

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the subject return for visit 2 ?
Descripción

Continuation status, Clinical Trials

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
If No, Please tick the ONE most appropriate reason and skip the following pages of this visit.
Descripción

Continuation status, Clinical Trials, Reason

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0566251
Specify
Descripción

Continuation status, Clinical Trials, Reason

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0566251
Please tick who made the decision
Descripción

Continuation status, Clinical Trials, Decision

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0679006
Laboratory Tests - Blood Sample
Descripción

Laboratory Tests - Blood Sample

Alias
UMLS CUI-1
C0005834
Has a blood sample been taken ?
Descripción

Collection of blood specimen for laboratory procedure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005834
Date (Please complete only if different from visit date)
Descripción

Collection of blood specimen for laboratory procedure, Date in time

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
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Similar models

Visit 2 - Month 1

1 formularios
  1. StudyEvent: ODM
    1. Visit 2 - Month 1
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Check for Study Continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Continuation status, Clinical Trials
Item
Did the subject return for visit 2 ?
boolean
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Item
If No, Please tick the ONE most appropriate reason and skip the following pages of this visit.
text
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Continuation status, Clinical Trials, Reason
Code List
If No, Please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
Serious adverse event (Please specify SAE No.) (1)
CL Item
Non-Serious adverse event (Please specify AE No. or solicited AE code) (2)
CL Item
Other, please specify (3)
Item
Specify
text
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Continuation status, Clinical Trials, Reason
Code List
Specify
Item
Please tick who made the decision
text
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
Continuation status, Clinical Trials, Reason
Code List
Please tick who made the decision
CL Item
Investigator  (1)
CL Item
Subject or Parents/Guardians (2)
Item Group
Laboratory Tests - Blood Sample
C0005834 (UMLS CUI-1)
Collection of blood specimen for laboratory procedure
Item
Has a blood sample been taken ?
boolean
C0005834 (UMLS CUI [1])
Collection of blood specimen for laboratory procedure, Date in time
Item
Date (Please complete only if different from visit date)
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Volver a la parte superior de la página 

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