ID

27322

Descrizione

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 GSK’s Clinical Study Register is no longer maintained for this study.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

collegamento

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

Keywords

versioni (2)
  1. 03/11/17 03/11/17 -
  2. 08/11/17 08/11/17 -
Titolare del copyright

Pfizer

Caricato su

8 novembre 2017

DOI

Per favore, per richiedere un accesso.

Licenza

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

Inglese

Workbook 2 Vaccination 1 Part 1 Group MenACWY

1 moduli  
Administrative Documentation
Descrizione

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject Number
Descrizione

Subject Number

Tipo di dati

integer

Alias
UMLS CUI [1]
C2348585
VACCINE ADMINISTRATION
Descrizione

VACCINE ADMINISTRATION

Alias
UMLS CUI-1
C2368628
Date (fill in only if different from visit date) :
Descrizione

Date of vaccination

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0042196
Pre-Vaccination temperature:
Descrizione

temperature

Tipo di dati

float

Unità di misura
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0332152
°C
Pre-Vaccination temperature: Route:
Descrizione

Route of Measurement

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0449687
Vaccine administration (only one box must be ticked by vaccine)
Descrizione

Vaccine administration

Tipo di dati

text

(*) Why not administered ? Please tick the ONE most appropriate category for non administration :
Descrizione

Reason Vaccine not administered

Tipo di dati

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C1272696
Please tick who made the decision
Descrizione

Decision

Tipo di dati

text

Alias
UMLS CUI [1]
C0679006
Side / Site Route: Left Deltoid I.M.
Descrizione

undefined item

Tipo di dati

text

Has the study vaccine been administered according to the Protocol?
Descrizione

Vaccine administration

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2368628
Side
Descrizione

Vaccine administration Side

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0441987
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
Site
Descrizione

Vaccine administration site

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
Route
Descrizione

Vaccine administration route

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
IMMEDIATE POST-VACCINATION OBSERVATION If any adverse events occurred during the immediate post-vaccination time (30 minutes) please fill in the Solicited Adverse Events section, the Non-Serious Adverse Event section or a Serious Adverse Event form. If any prophylactic medication has been administered in anticipation of study vaccine reaction, please complete the Medication section and tick prophylactic box. Any other vaccines administered during the study period must be recorded in the Concomitant Vaccination section
Descrizione

Post vaccination observation

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1443955
UMLS CUI [1,2]
C0700325
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Similar models

Workbook 2 Vaccination 1 Part 1 Group MenACWY

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Administrative Documentation
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
VACCINE ADMINISTRATION
C2368628 (UMLS CUI-1)
Date of vaccination
Item
Date (fill in only if different from visit date) :
date
C0011008 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
temperature
Item
Pre-Vaccination temperature:
float
C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Item
Pre-Vaccination temperature: Route:
text
C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0449687 (UMLS CUI [1,3])
Route of Measurement
Code List
Pre-Vaccination temperature: Route:
CL Item
Axillary (A)
CL Item
Rectal (R)
CL Item
Oral (O)
CL Item
Tympanic (oral conversion) (X)
CL Item
Tympanic (rectal conversion) (Y)
Item
Vaccine administration (only one box must be ticked by vaccine)
text
Vaccine administration
Code List
Vaccine administration (only one box must be ticked by vaccine)
CL Item
MenACWY-TT Vaccine (4 different formulations) (S)
CL Item
Replacement vial (R)
CL Item
Wrong vial number (W)
CL Item
Not administered (Please complete below (*) ) (N)
Item
(*) Why not administered ? Please tick the ONE most appropriate category for non administration :
text
C2368628 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Reason Vaccine not administered
Code List
(*) Why not administered ? Please tick the ONE most appropriate category for non administration :
CL Item
Serious adverse event (complete the Serious Adverse Event form) Please specify SAE N° (SAE)
CL Item
Non-Serious adverse event (complete the Non-serious Adverse Event section) Please specify unsolicited AE N° or Solicited AE code (AEX)
CL Item
Other, please specify (OTH)
Item
Please tick who made the decision
text
C0679006 (UMLS CUI [1])
Decision
Code List
Please tick who made the decision
CL Item
Investigator (I)
CL Item
Parents/Guardians (P)
undefined item
Item
Side / Site Route: Left Deltoid I.M.
text
Vaccine administration
Item
Has the study vaccine been administered according to the Protocol?
boolean
C2368628 (UMLS CUI [1])
Item
Side
text
C0441987 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Vaccine administration Side
Code List
Side
CL Item
Left (L)
CL Item
Right (R)
Item
Site
integer
C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Vaccine administration site
Code List
Site
CL Item
Deltoid (1)
CL Item
Thigh (3)
CL Item
Buttock (6)
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Vaccine administration route
Code List
Route
CL Item
I.M. (M)
CL Item
S.C. (SC)
Post vaccination observation
Item
IMMEDIATE POST-VACCINATION OBSERVATION If any adverse events occurred during the immediate post-vaccination time (30 minutes) please fill in the Solicited Adverse Events section, the Non-Serious Adverse Event section or a Serious Adverse Event form. If any prophylactic medication has been administered in anticipation of study vaccine reaction, please complete the Medication section and tick prophylactic box. Any other vaccines administered during the study period must be recorded in the Concomitant Vaccination section
text
C1443955 (UMLS CUI [1,1])
C0700325 (UMLS CUI [1,2])
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