ID

36609

Beschreibung

Study ID: 105910 Clinical Study ID: 105910 Study Title: Compare Immunogenicity & Reactogenicity of 2 Formulations of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine (New vs Current) Given in Healthy Infants. The DTPa-HBV-IPV Vaccine (New Formulation) Will Also be Assessed in a 3rd Group of Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00320463 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: DTPa-HBV-IPV/Hib vaccine Trade Name: N/A Study Indication: Diphtheria, Hepatitis B, Poliomyelitis, Tetanus, Whooping Cough

Stichworte

Versionen (1)
  1. 26.05.19 26.05.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

26. Mai 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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DTPa-HBV-IPV/Hib Vaccine Given in Healthy Infants; NCT00320463

Englisch

Study Conclusion

1 Formulare  
  1. StudyEvent: ODM
    1. Study Conclusion
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Clinical Trial Subject Unique Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Follow-Up Studies
Beschreibung

Follow-Up Studies

Alias
UMLS CUI-1
C0016441
If a booster study or a follow-up study is offered in the future, would the subject/parents/guardians be willing to be contacted and learn more about it?
Beschreibung

Follow-Up Studies, Contact with, parent, Legal Guardians

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0016441
UMLS CUI [1,2]
C0332158
UMLS CUI [1,3]
C0030551
UMLS CUI [1,4]
C0023226
If No, please specify the most appropriate reason
Beschreibung

Follow-Up Studies, Contact with, parent, Legal Guardians, Reason

Datentyp

text

Alias
UMLS CUI [1,1]
C0016441
UMLS CUI [1,2]
C0332158
UMLS CUI [1,3]
C0030551
UMLS CUI [1,4]
C0023226
UMLS CUI [1,5]
C0016441
UMLS CUI [1,6]
C0566251
Occurrence of Serious Adverse Event
Beschreibung

Occurrence of Serious Adverse Event

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

Serious Adverse Event

Datentyp

boolean

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

Serious Adverse Event, Count of entities

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449788
Status of Treatment Blind
Beschreibung

Status of Treatment Blind

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

Subject Unblinding Event Record

Datentyp

boolean

Alias
UMLS CUI [1]
C3897431
Complete Date
Beschreibung

Subject Unblinding Event Record, Date in time

Datentyp

date

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

Subject Unblinding Event Record, Indication

Datentyp

text

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

Elimination Criteria

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

Exclusion Criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
Specify
Beschreibung

Exclusion Criteria

Datentyp

text

Alias
UMLS CUI [1]
C0680251
Withdraw
Beschreibung

Withdraw

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

Withdraw

Datentyp

boolean

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

Withdraw, Indication

Datentyp

text

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

Withdraw, Indication, Details

Datentyp

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C3146298
UMLS CUI [1,3]
C1522508
Who made the decision
Beschreibung

Withdraw, Decision

Datentyp

text

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

Withdraw, Date last contact

Datentyp

date

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

Withdraw, Date last contact, General physical condition

Datentyp

boolean

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

Investigator's Signature

Alias
UMLS CUI-1
C2346576
Investigator's signature
Beschreibung

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.

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Date
Beschreibung

Investigator Signature, Date in time

Datentyp

date

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

Investigator Name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
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Ähnliche Modelle

Study Conclusion

1 Formulare
  1. StudyEvent: ODM
    1. Study Conclusion
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Follow-Up Studies
C0016441 (UMLS CUI-1)
Follow-Up Studies, Contact with, parent, Legal Guardians
Item
If a booster study or a follow-up study is offered in the future, would the subject/parents/guardians be willing to be contacted and learn more about it?
boolean
C0016441 (UMLS CUI [1,1])
C0332158 (UMLS CUI [1,2])
C0030551 (UMLS CUI [1,3])
C0023226 (UMLS CUI [1,4])
Item
If No, please specify the most appropriate reason
text
C0016441 (UMLS CUI [1,1])
C0332158 (UMLS CUI [1,2])
C0030551 (UMLS CUI [1,3])
C0023226 (UMLS CUI [1,4])
C0016441 (UMLS CUI [1,5])
C0566251 (UMLS CUI [1,6])
Follow-Up Studies, Contact with, parent, Legal Guardians, Reason
Code List
If No, please specify the most appropriate reason
CL Item
Adverse Events, or Serious Adverse Events (please specify) (1)
CL Item
Other (please specify) (2)
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
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
Who made the decision
text
C2349954 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Withdraw, Decision
Code List
Who made the decision
CL Item
Investigator  (1)
CL Item
Parents/Guardians (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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