ID

33384

Descripción

Study ID: 104065 Clinical Study ID: 104065 Study Title: Immune memory of GSK's DTPw-HBV/Hib vaccine by giving Plain PRP polysaccharide at 10 mths. Immuno & reacto of a booster dose of DTPw-HBV/Hib or DTPw-HBV or DTPw-HBV+Hib at 15-18 mths in infants previously primed with DTPw-HBV/Hib Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00169442  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completet Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine (KFT) Trade Name: Zilbrix/Hib Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

Palabras clave

Versiones (1)
  1. 7/12/18 7/12/18 -
Titular de derechos de autor

GSK group of companies

Subido en

7 de diciembre de 2018

DOI

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Licencia

Creative Commons BY-NC 3.0
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Immune memory of Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine at infants (15 to 18 mths) - 104065

Inglés

Study Conclusion

1 formularios  
  1. StudyEvent: ODM
    1. Study Conclusion
Administrative data
Descripción

Administrative data

Subject Number
Descripción

Subject Number

Tipo de datos

integer

Protocol Number
Descripción

Protocol Number

Tipo de datos

integer

Occurrence of Serious Adverse Event
Descripción

Occurrence of Serious Adverse Event

Did the subject experience any Serious Adverse Event during the study period?
Descripción

Did the subject experience any Serious Adverse Event during the study period?

Tipo de datos

boolean

If Yes, specify total number of SAE's
Descripción

If Yes, specify total number of SAE's

Tipo de datos

integer

Elimination Criteria
Descripción

Elimination Criteria

Did any elimination criteria become applicable during the study?
Descripción

Did any elimination criteria become applicable during the study?

Tipo de datos

boolean

If Yes, specify
Descripción

If Yes, specify

Tipo de datos

text

Subject Withdrawal
Descripción

Subject Withdrawal

Was the subject withdrawn from study?
Descripción

Was the subject withdrawn from study?

Tipo de datos

boolean

If Yes, please tick the ONE most appropriate category for withdrawal
Descripción

If Yes, please tick the ONE most appropriate category for withdrawal

Tipo de datos

text

If SAE, please specify SAE number
Descripción

If SAE, please specify SAE number

Tipo de datos

integer

If Non-SAE, please specify unsolicited AE number
Descripción

If Non-SAE, please specify unsolicited AE number

Tipo de datos

integer

If Protocol violation, please specify below
Descripción

If Protocol violation, please specify below

Tipo de datos

text

If Other, please specify
Descripción

If Other, please specify

Tipo de datos

text

Please record who took decision
Descripción

Please record who took decision

Tipo de datos

text

Date of last contact
Descripción

Date of last contact

Tipo de datos

date

Was the subject in good condition at the date of last contact?
Descripción

If No, please give details in the Adverse Events form!

Tipo de datos

boolean

Investigator's confirmation
Descripción

Investigator's confirmation

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.
Descripción

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.

Tipo de datos

date

Investigator's signature
Descripción

Investigator's signature

Tipo de datos

text

Investigator's name (Print)
Descripción

Investigator's name (Print)

Tipo de datos

text

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Similar models

Study Conclusion

1 formularios
  1. StudyEvent: ODM
    1. Study Conclusion
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Protocol Number
Item
Protocol Number
integer
Item Group
Occurrence of Serious Adverse Event
Did the subject experience any Serious Adverse Event during the study period?
Item
Did the subject experience any Serious Adverse Event during the study period?
boolean
If Yes, specify total number of SAE's
Item
If Yes, specify total number of SAE's
integer
Item Group
Elimination Criteria
Did any elimination criteria become applicable during the study?
Item
Did any elimination criteria become applicable during the study?
boolean
If Yes, specify
Item
If Yes, specify
text
Item Group
Subject Withdrawal
Was the subject withdrawn from study?
Item
Was the subject withdrawn from study?
boolean
Item
If Yes, please tick the ONE most appropriate category for withdrawal
text
If Yes, please tick the ONE most appropriate category for withdrawal
Code List
If Yes, please tick the ONE most appropriate category for withdrawal
CL Item
Serious Adverse Event (1)
CL Item
Non-Serious Adverse Event (2)
CL Item
Protocol violation (3)
CL Item
Consent withdrawal, not due to adverse event (4)
CL Item
Migrated/moved from the study area (5)
CL Item
Lost to follow-up (6)
CL Item
Other (7)
If SAE, please specify SAE number
Item
If SAE, please specify SAE number
integer
If Non-SAE, please specify unsolicited AE number
Item
If Non-SAE, please specify unsolicited AE number
integer
If Protocol violation, please specify below
Item
If Protocol violation, please specify below
text
If Other, please specify
Item
If Other, please specify
text
Item
Please record who took decision
text
Please record who took decision
Code List
Please record who took decision
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
Date of last contact
Item
Date of last contact
date
Was the subject in good condition at the date of last contact?
Item
Was the subject in good condition at the date of last contact?
boolean
Item Group
Investigator's confirmation
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.
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.
date
Investigator's signature
Item
Investigator's signature
text
Investigator's name (Print)
Item
Investigator's name (Print)
text
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