ID

33468

Descrição

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

Palavras-chave

  1. 10/12/2018 10/12/2018 -
Titular dos direitos

GSK group of companies

Transferido a

10 de dezembro de 2018

DOI

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Licença

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

Non-Participation Reason (Tracking document)

Administrative data
Descrição

Administrative data

Protocol Number
Descrição

Protocol Number

Tipo de dados

integer

Center Number
Descrição

Center Number

Tipo de dados

integer

Previous Study
Descrição

Previous Study

Tipo de dados

text

Reason for Non-Participation
Descrição

Reason for Non-Participation

Previous Subject Number
Descrição

Previous Subject Number

Tipo de dados

integer

Date of Birth
Descrição

Date of Birth

Tipo de dados

date

Please document reason for non participation
Descrição

Please document reason for non participation

Tipo de dados

text

If subject died, record date of death
Descrição

If subject died, record date of death

Tipo de dados

date

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

If any (serious) adverse events occurred, please specify

Tipo de dados

text

If any eligibility criteria are not fulfilled, please specify
Descrição

If any eligibility criteria are not fulfilled, please specify

Tipo de dados

text

If other reasons for non-participation, please specify
Descrição

If other reasons for non-participation, please specify

Tipo de dados

text

Date of contact
Descrição

Date of contact

Tipo de dados

date

Investigator's Signature
Descrição

Investigator's Signature

Investigator's name (in print)
Descrição

Investigator's name (in print)

Tipo de dados

text

Signature
Descrição

Signature

Tipo de dados

text

Date
Descrição

Date

Tipo de dados

date

Similar models

Non-Participation Reason (Tracking document)

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative data
Protocol Number
Item
Protocol Number
integer
Center Number
Item
Center Number
integer
Item
Previous Study
text
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
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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