ID

27344

Beschrijving

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 GSK’s Clinical Study Register is no longer maintained for this study.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 Booster Vaccination Only for subjects who are part of the group with the selected MenACWY-TT formulation and the control group.) “Subjects enrolled at 3 – 5 years of age”

Link

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

Trefwoorden

Versies (1)
  1. 08-11-17 08-11-17 -
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8 november 2017

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Meningococcal Infections Vaccination in children NCT00196976

Engels

Workbook 2 Study Conclusion Stage 2

1 Formulieren  
Administrative Documentation
Beschrijving

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject Number
Beschrijving

Subject Number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Follow-up studies Stage 2
Beschrijving

Follow-up studies Stage 2

Alias
UMLS CUI-1
C0016441
Would the subject be willing to participate in a follow-up study?
Beschrijving

Follow-up study participation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0016441
UMLS CUI [1,2]
C2348568
No, please specify the most appropriate reason
Beschrijving

Follow-up study participation

Datatype

text

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C2348568
STUDY CONCLUSION STAGE 2
Beschrijving

STUDY CONCLUSION STAGE 2

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008976
UMLS CUI-3
C0042210
Did any elimination criteria become applicable during the study ?
Beschrijving

Elimination criteria

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
Did any elimination criteria become applicable during the study? Please specify
Beschrijving

Elimination criteria

Datatype

text

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1521902
Administrative Documentation
Beschrijving

Administrative Documentation

Alias
UMLS CUI-1
C1320722
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below. Investigator's signature:
Beschrijving

Investigators signature

Datatype

text

Alias
UMLS CUI [1]
C2346576
Date
Beschrijving

Signature Date

Datatype

date

Alias
UMLS CUI [1]
C0807937
Printed Investigator's name:
Beschrijving

Printed Investigator's name:

Datatype

text

Alias
UMLS CUI [1]
C2826892
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Similar models

Workbook 2 Study Conclusion Stage 2

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Documentation
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Follow-up studies Stage 2
C0016441 (UMLS CUI-1)
Follow-up study participation
Item
Would the subject be willing to participate in a follow-up study?
boolean
C0016441 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
Item
No, please specify the most appropriate reason
text
C3274571 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
Follow-up study participation
Code List
No, please specify the most appropriate reason
CL Item
Adverse Events, or Serious Adverse Events, please specify: (Adverse Events, or Serious Adverse Events, please specify:)
CL Item
Other, please specify: (Other, please specify:)
Item Group
STUDY CONCLUSION STAGE 2
C1707478 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
Elimination criteria
Item
Did any elimination criteria become applicable during the study ?
boolean
C0680251 (UMLS CUI [1])
Elimination criteria
Item
Did any elimination criteria become applicable during the study? Please specify
text
C0680251 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item Group
Administrative Documentation
C1320722 (UMLS CUI-1)
Investigators signature
Item
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below. Investigator's signature:
text
C2346576 (UMLS CUI [1])
Signature Date
Item
Date
date
C0807937 (UMLS CUI [1])
Printed Investigator's name:
Item
Printed Investigator's name:
text
C2826892 (UMLS CUI [1])
Terug naar het begin van de pagina 

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