ID

33468

Beschrijving

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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Versies (1)
  1. 10-12-18 10-12-18 -
Houder van rechten

GSK group of companies

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10 december 2018

DOI

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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

Engels

Non-Participation Reason (Tracking document)

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Protocol Number
Beschrijving

Protocol Number

Datatype

integer

Center Number
Beschrijving

Center Number

Datatype

integer

Previous Study
Beschrijving

Previous Study

Datatype

text

Reason for Non-Participation
Beschrijving

Reason for Non-Participation

Previous Subject Number
Beschrijving

Previous Subject Number

Datatype

integer

Date of Birth
Beschrijving

Date of Birth

Datatype

date

Please document reason for non participation
Beschrijving

Please document reason for non participation

Datatype

text

If subject died, record date of death
Beschrijving

If subject died, record date of death

Datatype

date

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

If any (serious) adverse events occurred, please specify

Datatype

text

If any eligibility criteria are not fulfilled, please specify
Beschrijving

If any eligibility criteria are not fulfilled, please specify

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text

If other reasons for non-participation, please specify
Beschrijving

If other reasons for non-participation, please specify

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text

Date of contact
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Date of contact

Datatype

date

Investigator's Signature
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Investigator's Signature

Investigator's name (in print)
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Investigator's name (in print)

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text

Signature
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Signature

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text

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date

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Non-Participation Reason (Tracking document)

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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