ID

26864

Beschreibung

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 GSK’s Clinical Study Register is no longer maintained for this study.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

Link

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

Stichworte

Versionen (2)
  1. 26/10/17 26/10/17 -
  2. 3/11/17 3/11/17 -
Rechteinhaber

Pfizer

Hochgeladen am

26 de octubre de 2017

DOI

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Lizenz

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

Englisch

Visit 3

1 Formulare  
  1. StudyEvent: ODM
    1. Visit 3
Administrative Documentation
Beschreibung

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Date of visit
Beschreibung

Date of visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Return of diary card
Beschreibung

Return

Datentyp

text

Alias
UMLS CUI [1,1]
C0018700
UMLS CUI [1,2]
C0332156
Study Continuation
Beschreibung

Study Continuation

Alias
UMLS CUI-1
C0008972
UMLS CUI-2
C0805733
Did the subject come at visit 3?
Beschreibung

Subject return to visit

Datentyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
Please tick the ONE most appropriate reason and skip the following pages of this visit.
Beschreibung

Reason no study continuation

Datentyp

text

Alias
UMLS CUI [1,1]
C0008972
UMLS CUI [1,2]
C0805733
Please specify SAE N°; Please specify unsolicited AE N° or solicited AE code
Beschreibung

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

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0805701
UMLS CUI [1,3]
C1521902
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C0805701
UMLS CUI [2,3]
C1521902
Please tick who took the decision
Beschreibung

Decision

Datentyp

text

Alias
UMLS CUI [1]
C0679006
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Ähnliche Modelle

Visit 3

1 Formulare
  1. StudyEvent: ODM
    1. Visit 3
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])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Return
Item
Return of diary card
text
C0018700 (UMLS CUI [1,1])
C0332156 (UMLS CUI [1,2])
Item Group
Study Continuation
C0008972 (UMLS CUI-1)
C0805733 (UMLS CUI-2)
Item
Did the subject come at visit 3?
text
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Subject return to visit
Code List
Did the subject come at visit 3?
CL Item
Yes (Please complete the date of visit) (Yes (Please complete the date of visit))
CL Item
No (Please complete below) (No (Please complete below))
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)
CL Item
Same reason and decision as previous visit (SAM)
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)
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