ID

36627

Description

Study ID: 102394 Clinical Study ID: 102394 Study Title: A Phase IV, partially double-blind study to demonstrate non-inferiority of GSK Biologicals’ Mencevax™ ACWY (new process) versus Mencevax™ ACWY (current process) when administered as a single dose to subjects aged 2-30 yrs Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00227422 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 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 GSK’s Clinical Study Register is no longer maintained for this study.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 Vaccine Trade Name: Mencevax Study Indication: Infections, Meningococcal

Lien

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

Mots-clés

Versions (1)
  1. 26/05/2019 26/05/2019 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

26 mai 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
Modèle Commentaires :

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Mencevax™ ACWY (new process) versus Mencevax™ ACWY (current process); NCT00227422

Anglais

Study Conclusion

1 Formulaires  
  1. StudyEvent: ODM
    1. Study Conclusion
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Clinical Trial Subject Unique Identifier

Type de données

integer

Alias
UMLS CUI [1]
C2348585
Occurrence of Serious Adverse Event
Description

Occurrence of Serious Adverse Event

Alias
UMLS CUI-1
C1519255
Did the subject experience any Serious Adverse Event during the study period?
Description

Serious Adverse Event

Type de données

boolean

Alias
UMLS CUI [1]
C1519255
If Yes, specify total number of SAE's
Description

Serious Adverse Event, Count of entities

Type de données

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449788
Pregnancy Information
Description

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did the subject become pregnant during the study?
Description

Pregnancy, Clinical Trials

Type de données

text

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0008976
Status of Treatment Blind
Description

Status of Treatment Blind

Alias
UMLS CUI-1
C0749659
UMLS CUI-2
C2347038
Was the treatment blind broken during the study?
Description

Subject Unblinding Event Record

Type de données

boolean

Alias
UMLS CUI [1]
C3897431
Complete Date
Description

Subject Unblinding Event Record, Date in time

Type de données

date

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
Tick one reason below
Description

Subject Unblinding Event Record, Indication

Type de données

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
Elimination Criteria
Description

Elimination Criteria

Alias
UMLS CUI-1
C0680251
Did any elimination criteria become applicable during the study?
Description

Exclusion Criteria

Type de données

boolean

Alias
UMLS CUI [1]
C0680251
Specify
Description

Exclusion Criteria

Type de données

text

Alias
UMLS CUI [1]
C0680251
Withdraw
Description

Withdraw

Alias
UMLS CUI-1
C2349954
Was the subject withdrawn from the study?
Description

Withdraw

Type de données

boolean

Alias
UMLS CUI [1]
C2349954
Major reason for withdrawal (tick one box only).
Description

Withdraw, Indication

Type de données

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C3146298
UMLS CUI [1,3]
C1522508
Specifications
Description

Withdraw, Indication, Details

Type de données

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C3146298
UMLS CUI [1,3]
C1522508
Please tick who took decision
Description

Withdraw, Decision

Type de données

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0679006
Date of last contact
Description

Withdraw, Date last contact

Type de données

date

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0805839
Was the subject in good condition at date of last contact?
Description

Withdraw, Date last contact, General physical condition

Type de données

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0805839
UMLS CUI [1,3]
C1142435
Investigator's Signature
Description

Investigator's Signature

Alias
UMLS CUI-1
C2346576
Investigator's signature
Description

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.

Type de données

text

Alias
UMLS CUI [1]
C2346576
Date
Description

Investigator Signature, Date in time

Type de données

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Printed Investigator's name
Description

Investigator Name

Type de données

text

Alias
UMLS CUI [1]
C2826892
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Similar models

Study Conclusion

1 Formulaires
  1. StudyEvent: ODM
    1. Study Conclusion
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Occurrence of Serious Adverse Event
C1519255 (UMLS CUI-1)
Serious Adverse Event
Item
Did the subject experience any Serious Adverse Event during the study period?
boolean
C1519255 (UMLS CUI [1])
Serious Adverse Event, Count of entities
Item
If Yes, specify total number of SAE's
integer
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did the subject become pregnant during the study?
text
C0032961 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Pregnancy, Clinical Trials
Code List
Did the subject become pregnant during the study?
CL Item
No (1)
CL Item
Yes (2)
CL Item
Not Applicable (not of childbearing potential or male) (3)
Item Group
Status of Treatment Blind
C0749659 (UMLS CUI-1)
C2347038 (UMLS CUI-2)
Subject Unblinding Event Record
Item
Was the treatment blind broken during the study?
boolean
C3897431 (UMLS CUI [1])
Subject Unblinding Event Record, Date in time
Item
Complete Date
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Tick one reason below
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Withdraw, Decision
Code List
Tick one reason below
CL Item
Medical emergency requiring identification of investigational product for further treatments. (1)
CL Item
Other, specify (2)
Item Group
Elimination Criteria
C0680251 (UMLS CUI-1)
Exclusion Criteria
Item
Did any elimination criteria become applicable during the study?
boolean
C0680251 (UMLS CUI [1])
Exclusion Criteria
Item
Specify
text
C0680251 (UMLS CUI [1])
Item Group
Withdraw
C2349954 (UMLS CUI-1)
Withdraw
Item
Was the subject withdrawn from the study?
boolean
C2349954 (UMLS CUI [1])
Item
Major reason for withdrawal (tick one box only).
text
C2349954 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
Withdraw, Indication
Code List
Major reason for withdrawal (tick one box only).
CL Item
Serious adverse event (Please specify SAE N°) (1)
CL Item
Non-Serious adverse event (Please specify unsolicited AE N° or solicited AE code) (2)
CL Item
Protocol violation, please specify (3)
CL Item
Consent withdrawal, not due to an adverse event. (4)
CL Item
Migrated / moved from the study area (5)
CL Item
Lost to follow-up. (6)
CL Item
Other, please specify (7)
Withdraw, Indication, Details
Item
Specifications
text
C2349954 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
Item
Please tick who took decision
text
C2349954 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Withdraw, Decision
Code List
Please tick who took decision
CL Item
Investigator (1)
CL Item
Subject (2)
Withdraw, Date last contact
Item
Date of last contact
date
C2349954 (UMLS CUI [1,1])
C0805839 (UMLS CUI [1,2])
Withdraw, Date last contact, General physical condition
Item
Was the subject in good condition at date of last contact?
boolean
C2349954 (UMLS CUI [1,1])
C0805839 (UMLS CUI [1,2])
C1142435 (UMLS CUI [1,3])
Item Group
Investigator's Signature
C2346576 (UMLS CUI-1)
Investigator Signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Investigator Signature, Date in time
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator Name
Item
Printed Investigator's name
text
C2826892 (UMLS CUI [1])
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