ID

27344

Description

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 GSK’s Clinical Study Register is no longer maintained for this study.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

Keywords

Versions (1)
  1. 11/8/17 11/8/17 -
Copyright Holder

Pfizer

Uploaded on

November 8, 2017

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Meningococcal Infections Vaccination in children NCT00196976

English

Workbook 2 Study Conclusion Stage 2

1 forms  
Administrative Documentation
Description

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

integer

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

Follow-up studies Stage 2

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

Follow-up study participation

Data type

boolean

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

Follow-up study participation

Data type

text

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

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 ?
Description

Elimination criteria

Data type

boolean

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

Elimination criteria

Data type

text

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

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:
Description

Investigators signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Date
Description

Signature Date

Data type

date

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

Printed Investigator's name:

Data type

text

Alias
UMLS CUI [1]
C2826892
Back to the top of the page

Similar models

Workbook 2 Study Conclusion Stage 2

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial