ID

33468

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

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Versions (1)
  1. 12/10/18 12/10/18 -
Copyright Holder

GSK group of companies

Uploaded on

December 10, 2018

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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

Non-Participation Reason (Tracking document)

1 forms  
Administrative data
Description

Administrative data

Protocol Number
Description

Protocol Number

Data type

integer

Center Number
Description

Center Number

Data type

integer

Previous Study
Description

Previous Study

Data type

text

Reason for Non-Participation
Description

Reason for Non-Participation

Previous Subject Number
Description

Previous Subject Number

Data type

integer

Date of Birth
Description

Date of Birth

Data type

date

Please document reason for non participation
Description

Please document reason for non participation

Data type

text

If subject died, record date of death
Description

If subject died, record date of death

Data type

date

If any (serious) adverse events occurred, please specify
Description

If any (serious) adverse events occurred, please specify

Data type

text

If any eligibility criteria are not fulfilled, please specify
Description

If any eligibility criteria are not fulfilled, please specify

Data type

text

If other reasons for non-participation, please specify
Description

If other reasons for non-participation, please specify

Data type

text

Date of contact
Description

Date of contact

Data type

date

Investigator's Signature
Description

Investigator's Signature

Investigator's name (in print)
Description

Investigator's name (in print)

Data type

text

Signature
Description

Signature

Data type

text

Date
Description

Date

Data type

date

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Non-Participation Reason (Tracking document)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Protocol Number
Item
Protocol Number
integer
Center Number
Item
Center Number
integer
Item
Previous Study
text
Previous Study
Code List
Previous Study
CL Item
DTPw-HBV=Hib Kft-001 (101222) (1)
Item Group
Reason for Non-Participation
Previous Subject Number
Item
Previous Subject Number
integer
Date of Birth
Item
Date of Birth
date
Item
Please document reason for non participation
text
Please document reason for non participation
Code List
Please document reason for non participation
CL Item
Subject not eligible? (1)
CL Item
Subject lost to follow-up or not reached (2)
CL Item
Subject eligible but not willing to participate due to adverse events (or serious adverse events) (3)
CL Item
Subject eligible but not willing to participate due to other reasons (4)
CL Item
Subject died (5)
If subject died, record date of death
Item
If subject died, record date of death
date
If any (serious) adverse events occurred, please specify
Item
If any (serious) adverse events occurred, please specify
text
If any eligibility criteria are not fulfilled, please specify
Item
If any eligibility criteria are not fulfilled, please specify
text
If other reasons for non-participation, please specify
Item
If other reasons for non-participation, please specify
text
Date of contact
Item
Date of contact
date
Item Group
Investigator's Signature
Investigator's name (in print)
Item
Investigator's name (in print)
text
Signature
Item
Signature
text
Date
Item
Date
date
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