ID

27241

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 GSK’s Clinical Study Register is no longer maintained for this study.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

Link

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

Stichworte

Versionen (2)
  1. 03.11.17 03.11.17 -
  2. 04.11.17 04.11.17 -
Rechteinhaber

Pfizer

Hochgeladen am

4. November 2017

DOI

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Lizenz

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

Englisch

Tracking Document Reason for non participation

1 Formulare  
Administrative Documentation
Beschreibung

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Center
Beschreibung

Center Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0805701
Investigator name: (please PRINT name)
Beschreibung

Investigator Name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Signature
Beschreibung

Investigator signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Date
Beschreibung

Signature date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2346576
Tracking Document Reason for non participation
Beschreibung

Tracking Document Reason for non participation

Alias
UMLS CUI-1
C3889409
UMLS CUI-2
C2348568
UMLS CUI-3
C0392360
Previous subject number
Beschreibung

Previous subject number

Datentyp

integer

Alias
UMLS CUI [1,1]
C2348585
UMLS CUI [1,2]
C0205156
Date of birth
Beschreibung

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Please document reason for non participation
Beschreibung

Reason for non participation

Datentyp

text

Alias
UMLS CUI [1,1]
C0558080
UMLS CUI [1,2]
C0679823
UMLS CUI [1,3]
C0392360
Please document reason for non participation, Specification
Beschreibung

Reason for non participation

Datentyp

text

Alias
UMLS CUI [1,1]
C0558080
UMLS CUI [1,2]
C0679823
UMLS CUI [1,3]
C0392360
UMLS CUI [1,4]
C2348235
Date of contact
Beschreibung

Date of contact

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1705415
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Ähnliche Modelle

Tracking Document Reason for non participation

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Documentation
C1320722 (UMLS CUI-1)
Center Number
Item
Center
integer
C1301943 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Investigator Name
Item
Investigator name: (please PRINT name)
text
C2826892 (UMLS CUI [1])
Investigator signature
Item
Signature
text
C2346576 (UMLS CUI [1])
Signature date
Item
Date
date
C0011008 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
Item Group
Tracking Document Reason for non participation
C3889409 (UMLS CUI-1)
C2348568 (UMLS CUI-2)
C0392360 (UMLS CUI-3)
Previous subject number
Item
Previous subject number
integer
C2348585 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Please document reason for non participation
text
C0558080 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Reason for non participation
Code List
Please document reason for non participation
CL Item
Subject not eligible? - please specify criteria that are not fullfilled: (1)
CL Item
Subject lost to follow-up or not reached (2)
CL Item
Subject eligible but not willing to participate due to:adverse events, or serious adverse event: please specify: (3)
CL Item
Subject eligible but not willing to participate due to other: please specify: (4)
CL Item
Subject died on  (5)
Reason for non participation
Item
Please document reason for non participation, Specification
text
C0558080 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Date of contact
Item
Date of contact
date
C0011008 (UMLS CUI [1,1])
C1705415 (UMLS CUI [1,2])
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