ID

27207

Description

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 GSK’s Clinical Study Register is no longer maintained for this study.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

Keywords

Versions (2)
  1. 10/26/17 10/26/17 -
  2. 11/3/17 11/3/17 -
Copyright Holder

Pfizer

Uploaded on

November 3, 2017

DOI

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License

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

English

Workbook 1 Visit 2 Part 1

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
Date of visit
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Study Continuation
Description

Study Continuation

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

Subject return to visit

Data type

boolean

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.
Description

Reason no study continuation

Data type

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
Description

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

Data type

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
Description

Decision

Data type

text

Alias
UMLS CUI [1]
C0679006
LABORATORY TESTS; BLOOD SAMPLE
Description

LABORATORY TESTS; BLOOD SAMPLE

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0005834
Has a blood sample been taken ?
Description

Blood sample taken

Data type

boolean

Alias
UMLS CUI [1]
C1277698
Please complete only if different from visit date:
Description

Date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0005834
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Similar models

Workbook 1 Visit 2 Part 1

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])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Study Continuation
C0008972 (UMLS CUI-1)
C0805733 (UMLS CUI-2)
Subject return to visit
Item
Did the subject come at visit 2 ?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
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)
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)
Item Group
LABORATORY TESTS; BLOOD SAMPLE
C0022885 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
Blood sample taken
Item
Has a blood sample been taken ?
boolean
C1277698 (UMLS CUI [1])
Date
Item
Please complete only if different from visit date:
date
C0011008 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
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