ID

34703

Descrição

Study ID: 103974 (primary study) Clinical Study ID: 103974 Study Title: Demonstrate non-inferiority of Men-C immune response of Hib-MenC with Infanrix™-IPV versus a licensed Men-C vaccine with Pediacel™ when given at 2, 3, 4 months and the immunogenicity of Hib-MenC when given as a booster dose at 12-15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00258700 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENC-TT; Menitorix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

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Versões (1)
  1. 23/01/2019 23/01/2019 -
Titular dos direitos

GSK group of companies

Transferido a

23 de janeiro de 2019

DOI

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Licença

Creative Commons BY-NC 3.0
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Study of Long-term Antibody Persistence After a Booster Dose of Menitorix Vaccine - 109664

Inglês

Reason for non participation - Tracking Form + Use of Samples Compliance

1 Formulários  
Administrative data
Descrição

Administrative data

Center Number
Descrição

Center Number

Tipo de dados

integer

Tracking Document
Descrição

Tracking Document

Previous Subject Number
Descrição

Previous study: 109664 (Hib-MenC-TT-027 EXT: 013 M12)

Tipo de dados

integer

Date of Birth
Descrição

Date of Birth

Tipo de dados

date

Reason for non participation
Descrição

Reason for non participation

Tipo de dados

text

Please specify criteria that are not fulfilled
Descrição

IfSubjectNotEligible

Tipo de dados

text

In case of SAE, specify adverse event
Descrição

SAE

Tipo de dados

text

If Other, please specify
Descrição

Other

Tipo de dados

text

In case of death, please specify the date
Descrição

DeathDate

Tipo de dados

date

Date of Contact
Descrição

Date of Contact

Tipo de dados

date

Investigator Name
Descrição

Print name

Tipo de dados

text

Signature
Descrição

Signature

Tipo de dados

text

Date
Descrição

Date

Tipo de dados

date

Use of Human Samples by GSK
Descrição

Use of Human Samples by GSK

In addition to the use of samples for the tests described in the protocol, samples might be used for other resarch by GSK (see protocol). Please tick what is also covered by the subject Informed Consent form of your center.
Descrição

USE OF HUMAN SAMPLES BY GSK

Tipo de dados

text

Please tick below box if a 15 years GSK storage period is covered by the subject’s Informed Consent form of your center.
Descrição

StoragePeriod

Tipo de dados

text

If Other, please specify
Descrição

Other

Tipo de dados

text

ICF Effective date
Descrição

Complete and submit a new form for each change during the study.

Tipo de dados

date

Investigator's Signature
Descrição

Investigator's Signature

Investigator's signature:
Descrição

Investigator's signature:

Tipo de dados

text

Date:
Descrição

Date:

Tipo de dados

date

Printed Investigator's name:
Descrição

Printed Investigator's name:

Tipo de dados

text

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Reason for non participation - Tracking Form + Use of Samples Compliance

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative data
Center Number
Item
Center Number
integer
Item Group
Tracking Document
Previous Subject Number
Item
Previous Subject Number
integer
Date of Birth
Item
Date of Birth
date
Item
Reason for non participation
text
Reason for non participation
Code List
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  (3)
CL Item
Subject died (4)
IfSubjectNotEligible
Item
Please specify criteria that are not fulfilled
text
SAE
Item
In case of SAE, specify adverse event
text
Other
Item
If Other, please specify
text
DeathDate
Item
In case of death, please specify the date
date
Date of Contact
Item
Date of Contact
date
Investigator Name
Item
Investigator Name
text
Signature
Item
Signature
text
Date
Item
Date
date
Item Group
Use of Human Samples by GSK
Item
In addition to the use of samples for the tests described in the protocol, samples might be used for other resarch by GSK (see protocol). Please tick what is also covered by the subject Informed Consent form of your center.
text
USE OF HUMAN SAMPLES BY GSK
Code List
In addition to the use of samples for the tests described in the protocol, samples might be used for other resarch by GSK (see protocol). Please tick what is also covered by the subject Informed Consent form of your center.
CL Item
Quality Assurance of tests described in the protocol (This may include the management of the quality of these current tests, the maintenance or (1)
CL Item
improvement of these current tests, the development of new test methods for the markers (improvement of these current tests, the development of new test methods for the markers)
CL Item
described in the protocol as well as making sure that new tests are comparable to previous (described in the protocol as well as making sure that new tests are comparable to previous)
CL Item
methods and work reliably.) (methods and work reliably.))
CL Item
Further investigation by GSK Biologicals into the ability of the vaccine to protect people if (2)
CL Item
any findings from related studies require it and further research in the disease(s) under (any findings from related studies require it and further research in the disease(s) under)
CL Item
study. These investigations excludes genetic and HIV testing. (study. These investigations excludes genetic and HIV testing.)
CL Item
Further research by GSK Biologicals that is NOT RELATED to the vaccine(s) or the disease(s) (3)
CL Item
under study done on an anonymous basis (meaning that any identification linking the subject (under study done on an anonymous basis (meaning that any identification linking the subject)
CL Item
to the sample is destroyed). This research excludes genetic and HIV testing and does not (to the sample is destroyed). This research excludes genetic and HIV testing and does not)
CL Item
affect subject participation in the study. (affect subject participation in the study.)
Item
Please tick below box if a 15 years GSK storage period is covered by the subject’s Informed Consent form of your center.
text
StoragePeriod
Code List
Please tick below box if a 15 years GSK storage period is covered by the subject’s Informed Consent form of your center.
CL Item
At least 15 years storage period by GSK Biologicals (1)
CL Item
Other (2)
Other
Item
If Other, please specify
text
ICF Effective date
Item
ICF Effective date
date
Item Group
Investigator's Signature
Investigator's signature:
Item
Investigator's signature:
text
Date:
Item
Date:
date
Printed Investigator's name:
Item
Printed Investigator's name:
text
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