ID

27214

Beschreibung

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 GSK’s Clinical Study Register is no longer maintained for this study.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

Stichworte

Versionen (1)
  1. 03.11.17 03.11.17 -
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Pfizer

Hochgeladen am

3. November 2017

DOI

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Meningococcal Infections Vaccination in children NCT00196976

Englisch

Workbook 1 Study Conclusion

1 Formulare  
Administrative Documentation
Beschreibung

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Follow-up studies
Beschreibung

Follow-up studies

Alias
UMLS CUI-1
C0016441
Would the subject be willing to participate in a follow-up study?
Beschreibung

Follow-up study participation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0016441
UMLS CUI [1,2]
C2348568
No, please specify the most appropriate reason
Beschreibung

Follow-up study participation

Datentyp

text

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C2348568
STUDY CONCLUSION STAGE 1
Beschreibung

STUDY CONCLUSION STAGE 1

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008976
UMLS CUI-3
C0042210
Did the subject experience any Serious Adverse Event during the study period ?
Beschreibung

Serious adverse event

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
Specify total number of SAE's
Beschreibung

Number of serious adverse events

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449788
Was the treatment blind broken during the study?
Beschreibung

Treatment blind

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347038
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C3897431
Complete date of unblinding
Beschreibung

Date of unblinding

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C3897431
Tick one reason below Complete Non-Serious Adverse Event section or Serious Adverse Event form as appropriate.
Beschreibung

Reason for unblinding

Datentyp

integer

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C3897431
Did any elimination criteria become applicable during the study ?
Beschreibung

Elimination criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
Did any elimination criteria become applicable during the study? Please specify
Beschreibung

Elimination criteria

Datentyp

text

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1521902
Was the subject withdrawn from study?
Beschreibung

Study subject participation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0422727
Please tick the ONE most appropriate category for withdrawal.
Beschreibung

Withdrawal reason

Datentyp

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1549995
Please tick who took decision:
Beschreibung

Decision

Datentyp

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
Date of last contact
Beschreibung

Date of last contact

Datentyp

date

Alias
UMLS CUI [1]
C0805839
Was the subject in good condition at date of last contact?
Beschreibung

Subject condition

Datentyp

text

Alias
UMLS CUI [1,1]
C1142435
UMLS CUI [1,2]
C0681850
UMLS CUI [1,3]
C1705415
Administrative Documentation
Beschreibung

Administrative Documentation

Alias
UMLS CUI-1
C1320722
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. Investigator's signature:
Beschreibung

Investigators signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Date
Beschreibung

Signature Date

Datentyp

date

Alias
UMLS CUI [1]
C0807937
Printed Investigator's name:
Beschreibung

Printed Investigator's name:

Datentyp

text

Alias
UMLS CUI [1]
C2826892
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Ähnliche Modelle

Workbook 1 Study Conclusion

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Documentation
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Follow-up studies
C0016441 (UMLS CUI-1)
Follow-up study participation
Item
Would the subject be willing to participate in a follow-up study?
boolean
C0016441 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
Item
No, please specify the most appropriate reason
text
C3274571 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
Follow-up study participation
Code List
No, please specify the most appropriate reason
CL Item
Adverse Events, or Serious Adverse Events, please specify: (Adverse Events, or Serious Adverse Events, please specify:)
CL Item
Other, please specify: (Other, please specify:)
Item Group
STUDY CONCLUSION STAGE 1
C1707478 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
Serious adverse event
Item
Did the subject experience any Serious Adverse Event during the study period ?
boolean
C1519255 (UMLS CUI [1])
Number of serious adverse events
Item
Specify total number of SAE's
integer
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Treatment blind
Item
Was the treatment blind broken during the study?
boolean
C2347038 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C3897431 (UMLS CUI [1,3])
Date of unblinding
Item
Complete date of unblinding
date
C0011008 (UMLS CUI [1,1])
C3897431 (UMLS CUI [1,2])
Item
Tick one reason below Complete Non-Serious Adverse Event section or Serious Adverse Event form as appropriate.
integer
C0566251 (UMLS CUI [1,1])
C3897431 (UMLS CUI [1,2])
Reason for unblinding
Code List
Tick one reason below Complete Non-Serious Adverse Event section or Serious Adverse Event form as appropriate.
CL Item
Medical emergency requiring identification of investigational product for further treatments (1)
CL Item
Other, specify: (9)
Elimination criteria
Item
Did any elimination criteria become applicable during the study ?
boolean
C0680251 (UMLS CUI [1])
Elimination criteria
Item
Did any elimination criteria become applicable during the study? Please specify
text
C0680251 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Study subject participation
Item
Was the subject withdrawn from study?
boolean
C2348568 (UMLS CUI [1,1])
C0422727 (UMLS CUI [1,2])
Item
Please tick the ONE most appropriate category for withdrawal.
text
C2349954 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])
Withdrawal reason
Code List
Please tick the ONE most appropriate category for withdrawal.
CL Item
Serious adverse event (check Serious Adverse Event form) Please specify SAE N°: (SAE)
CL Item
Non-Serious adverse event (check the Non-serious Adverse Event section) Please specify unsolicited AE N° or solicited AE code : (AEX)
CL Item
Protocol violation, please specify (PTV)
CL Item
Consent withdrawal, not due to an adverse event. (CWS)
CL Item
Migrated / moved from the study area (MIG)
CL Item
Lost to follow-up. (LFU)
CL Item
Other, please specify: (OTH)
Item
Please tick who took decision:
text
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Decision
Code List
Please tick who took decision:
CL Item
Investigator (I)
CL Item
Parents/Guardians (P)
Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Item
Was the subject in good condition at date of last contact?
text
C1142435 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C1705415 (UMLS CUI [1,3])
Subject condition
Code List
Was the subject in good condition at date of last contact?
CL Item
No, please give details within the Adverse Events section. (No, please give details within the Adverse Events section.)
CL Item
Yes (Yes)
Item Group
Administrative Documentation
C1320722 (UMLS CUI-1)
Investigators signature
Item
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. Investigator's signature:
text
C2346576 (UMLS CUI [1])
Signature Date
Item
Date
date
C0807937 (UMLS CUI [1])
Printed Investigator's name:
Item
Printed Investigator's name:
text
C2826892 (UMLS CUI [1])
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