ID

27241

Descripción

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 GSK’s Clinical Study Register is no longer maintained for this study.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

Palabras clave

Versiones (2)
  1. 3/11/17 3/11/17 -
  2. 4/11/17 4/11/17 -
Titular de derechos de autor

Pfizer

Subido en

4 de noviembre de 2017

DOI

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Licencia

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

Inglés

Tracking Document Reason for non participation

1 formularios  
Administrative Documentation
Descripción

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Center
Descripción

Center Number

Tipo de datos

integer

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

Investigator Name

Tipo de datos

text

Alias
UMLS CUI [1]
C2826892
Signature
Descripción

Investigator signature

Tipo de datos

text

Alias
UMLS CUI [1]
C2346576
Date
Descripción

Signature date

Tipo de datos

date

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

Tracking Document Reason for non participation

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

Previous subject number

Tipo de datos

integer

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

Date of birth

Tipo de datos

date

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

Reason for non participation

Tipo de datos

text

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

Reason for non participation

Tipo de datos

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
Descripción

Date of contact

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1705415
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Similar models

Tracking Document Reason for non participation

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Volver a la parte superior de la página 

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