ID

34703

Beschrijving

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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Versies (1)
  1. 23-01-19 23-01-19 -
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GSK group of companies

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23 januari 2019

DOI

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Licentie

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

Engels

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

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Center Number
Beschrijving

Center Number

Datatype

integer

Tracking Document
Beschrijving

Tracking Document

Previous Subject Number
Beschrijving

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

Datatype

integer

Date of Birth
Beschrijving

Date of Birth

Datatype

date

Reason for non participation
Beschrijving

Reason for non participation

Datatype

text

Please specify criteria that are not fulfilled
Beschrijving

IfSubjectNotEligible

Datatype

text

In case of SAE, specify adverse event
Beschrijving

SAE

Datatype

text

If Other, please specify
Beschrijving

Other

Datatype

text

In case of death, please specify the date
Beschrijving

DeathDate

Datatype

date

Date of Contact
Beschrijving

Date of Contact

Datatype

date

Investigator Name
Beschrijving

Print name

Datatype

text

Signature
Beschrijving

Signature

Datatype

text

Date
Beschrijving

Date

Datatype

date

Use of Human Samples by GSK
Beschrijving

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.
Beschrijving

USE OF HUMAN SAMPLES BY GSK

Datatype

text

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

StoragePeriod

Datatype

text

If Other, please specify
Beschrijving

Other

Datatype

text

ICF Effective date
Beschrijving

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

Datatype

date

Investigator's Signature
Beschrijving

Investigator's Signature

Investigator's signature:
Beschrijving

Investigator's signature:

Datatype

text

Date:
Beschrijving

Date:

Datatype

date

Printed Investigator's name:
Beschrijving

Printed Investigator's name:

Datatype

text

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

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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:
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Date:
date
Printed Investigator's name:
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Printed Investigator's name:
text
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