ID

33384

Description

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

Keywords

Versions (1)
  1. 12/7/18 12/7/18 -
Copyright Holder

GSK group of companies

Uploaded on

December 7, 2018

DOI

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License

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

English

Study Conclusion

1 forms  
  1. StudyEvent: ODM
    1. Study Conclusion
Administrative data
Description

Administrative data

Subject Number
Description

Subject Number

Data type

integer

Protocol Number
Description

Protocol Number

Data type

integer

Occurrence of Serious Adverse Event
Description

Occurrence of Serious Adverse Event

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

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

Data type

boolean

If Yes, specify total number of SAE's
Description

If Yes, specify total number of SAE's

Data type

integer

Elimination Criteria
Description

Elimination Criteria

Did any elimination criteria become applicable during the study?
Description

Did any elimination criteria become applicable during the study?

Data type

boolean

If Yes, specify
Description

If Yes, specify

Data type

text

Subject Withdrawal
Description

Subject Withdrawal

Was the subject withdrawn from study?
Description

Was the subject withdrawn from study?

Data type

boolean

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

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

Data type

text

If SAE, please specify SAE number
Description

If SAE, please specify SAE number

Data type

integer

If Non-SAE, please specify unsolicited AE number
Description

If Non-SAE, please specify unsolicited AE number

Data type

integer

If Protocol violation, please specify below
Description

If Protocol violation, please specify below

Data type

text

If Other, please specify
Description

If Other, please specify

Data type

text

Please record who took decision
Description

Please record who took decision

Data type

text

Date of last contact
Description

Date of last contact

Data type

date

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

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

Data type

boolean

Investigator's confirmation
Description

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.
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.

Data type

date

Investigator's signature
Description

Investigator's signature

Data type

text

Investigator's name (Print)
Description

Investigator's name (Print)

Data type

text

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Similar models

Study Conclusion

1 forms
  1. StudyEvent: ODM
    1. Study Conclusion
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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