ID

27205

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 GSK’s Clinical Study Register is no longer maintained for this study.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

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
Concomitant Vaccination
Description

Concomitant Vaccination

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol ?
Description

Concomitant vaccination

Data type

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2347852
Concomitant Vaccination
Description

Concomitant Vaccination

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
Trade / (Generic) Name
Description

Trade name

Data type

text

Alias
UMLS CUI [1]
C0013227
Route
Description

Route

Data type

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Administration date
Description

Administration date

Data type

date

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0042210
For GSK
Description

Investigator Use

Data type

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C0457083
Medication
Description

Medication

Alias
UMLS CUI-1
C0013227
Have any medications/treatments been administered during study period?
Description

Concomitant Medication

Data type

text

Alias
UMLS CUI [1]
C2347852
Medication
Description

Medication

Alias
UMLS CUI-1
C0013227
Trade/Generic Name
Description

Trade/Generic Name

Data type

text

Alias
UMLS CUI [1]
C0013227
Medical indication
Description

Indication

Data type

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
Total daily dose
Description

Daily dose

Data type

text

Alias
UMLS CUI [1]
C2348070
Route
Description

Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Start date
Description

Start date

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0013227
End date
Description

End date

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0013227
tick box if continuing at end of study
Description

Continuing

Data type

boolean

Alias
UMLS CUI [1]
C2826666
For GSK
Description

Investigator Use

Data type

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C0457083
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Similar models

Workbook 1 Other medical information

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
Concomitant Vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Item
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol ?
text
C0042196 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Concomitant vaccination
Code List
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol ?
CL Item
No (No)
CL Item
Yes, please record concomitant vaccination with trade name and / or generic name, route and vaccine (Yes, please record concomitant vaccination with trade name and / or generic name, route and vaccine)
CL Item
administration date. (administration date.)
Item Group
Concomitant Vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Trade name
Item
Trade / (Generic) Name
text
C0013227 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Administration date
Item
Administration date
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Investigator Use
Item
For GSK
text
C0008961 (UMLS CUI [1,1])
C0457083 (UMLS CUI [1,2])
Item Group
Medication
C0013227 (UMLS CUI-1)
Item
Have any medications/treatments been administered during study period?
text
C2347852 (UMLS CUI [1])
Concomitant Medication
Code List
Have any medications/treatments been administered during study period?
CL Item
No (No)
CL Item
Yes, please complete the following table. (Yes, please complete the following table.)
Item Group
Medication
C0013227 (UMLS CUI-1)
Trade/Generic Name
Item
Trade/Generic Name
text
C0013227 (UMLS CUI [1])
Item
Medical indication
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Indication
Code List
Medical indication
CL Item
Specify (Specify)
CL Item
Prophylactic (Prophylactic)
Daily dose
Item
Total daily dose
text
C2348070 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Start date
Item
Start date
date
C0808070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
End date
Item
End date
date
C0806020 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Continuing
Item
tick box if continuing at end of study
boolean
C2826666 (UMLS CUI [1])
Investigator Use
Item
For GSK
text
C0008961 (UMLS CUI [1,1])
C0457083 (UMLS CUI [1,2])
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