ID

27337

Descrizione

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 GSK’s Clinical Study Register is no longer maintained for this study.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 12 – 14 months of age”

collegamento

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

Keywords

versioni (2)
  1. 08/11/17 08/11/17 -
  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 1 Non-Serious Adverse Events

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
Non-Serious Adverse Events
Descrizione

Non-Serious Adverse Events

Alias
UMLS CUI-1
C1518404
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
Descrizione

Non-serious adverse event

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1518404
AE No.
Descrizione

Adverse event Number

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Description
Descrizione

Description

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C1518404
Location of adverse event
Descrizione

Location

Tipo di dati

text

Alias
UMLS CUI [1]
C0450429
For GSK
Descrizione

Investigator Use

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C0457083
Date started
Descrizione

Start date

Tipo di dati

date

Alias
UMLS CUI [1]
C0808070
Did it start during immediate post-vaccination period (30 minutes)?
Descrizione

Date started

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0808070
Date stopped
Descrizione

End date

Tipo di dati

date

Alias
UMLS CUI [1]
C0806020
Intensity
Descrizione

Intensity

Tipo di dati

integer

Alias
UMLS CUI [1]
C1710066
Relationship to investigational products: Is there a reasonable possibility that the AE may have been caused by the investigational product?
Descrizione

Relationship to investigational product

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C0013230
Outcome
Descrizione

Outcome

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1518404
Medically attended visit
Descrizione

Medically attended visit

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
Medically attended visit Type
Descrizione

Medically attended visit Type

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1386497
UMLS CUI [1,4]
C1518404
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Similar models

Workbook 1 Non-Serious Adverse Events

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
Non-Serious Adverse Events
C1518404 (UMLS CUI-1)
Non-serious adverse event
Item
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
boolean
C1518404 (UMLS CUI [1])
Adverse event Number
Item
AE No.
text
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Description
Item
Description
text
C0678257 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Location of adverse event
text
C0450429 (UMLS CUI [1])
Administration site
Code List
Location of adverse event
CL Item
Administration site (L)
CL Item
Non-administration site (G)
Investigator Use
Item
For GSK
text
C0008961 (UMLS CUI [1,1])
C0457083 (UMLS CUI [1,2])
Start date
Item
Date started
date
C0808070 (UMLS CUI [1])
Date started
Item
Did it start during immediate post-vaccination period (30 minutes)?
boolean
C0808070 (UMLS CUI [1])
End date
Item
Date stopped
date
C0806020 (UMLS CUI [1])
Item
Intensity
integer
C1710066 (UMLS CUI [1])
Intensity
Code List
Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Relationship to investigational product
Item
Relationship to investigational products: Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C1518404 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
Item
Outcome
integer
C1705586 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Outcome
Code List
Outcome
CL Item
Recovered / Resolved (1)
CL Item
Recovering / resolving (2)
CL Item
Not recovered / not resolved (3)
CL Item
Recovered with sequelae / Resolved with sequelae (4)
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C1518404 (UMLS CUI [1,4])
Medically attended visit Type
Code List
Medically attended visit Type
CL Item
Emergency room (ER)
CL Item
Hospitalization (HO)
CL Item
Medical doctor (MD)
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