ID

34703

Description

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

Keywords

  1. 1/23/19 1/23/19 -
Copyright Holder

GSK group of companies

Uploaded on

January 23, 2019

DOI

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License

Creative Commons BY-NC 3.0

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Study of Long-term Antibody Persistence After a Booster Dose of Menitorix Vaccine - 109664

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

Administrative data
Description

Administrative data

Center Number
Description

Center Number

Data type

integer

Tracking Document
Description

Tracking Document

Previous Subject Number
Description

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

Data type

integer

Date of Birth
Description

Date of Birth

Data type

date

Reason for non participation
Description

Reason for non participation

Data type

text

Please specify criteria that are not fulfilled
Description

IfSubjectNotEligible

Data type

text

In case of SAE, specify adverse event
Description

SAE

Data type

text

If Other, please specify
Description

Other

Data type

text

In case of death, please specify the date
Description

DeathDate

Data type

date

Date of Contact
Description

Date of Contact

Data type

date

Investigator Name
Description

Print name

Data type

text

Signature
Description

Signature

Data type

text

Date
Description

Date

Data type

date

Use of Human Samples by GSK
Description

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.
Description

USE OF HUMAN SAMPLES BY GSK

Data type

text

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

StoragePeriod

Data type

text

If Other, please specify
Description

Other

Data type

text

ICF Effective date
Description

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

Data type

date

Investigator's Signature
Description

Investigator's Signature

Investigator's signature:
Description

Investigator's signature:

Data type

text

Date:
Description

Date:

Data type

date

Printed Investigator's name:
Description

Printed Investigator's name:

Data type

text

Similar models

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

Name
Type
Description | Question | Decode (Coded Value)
Data type
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
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
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
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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