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

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Versions (1)
  1. 23/01/2019 23/01/2019 -
Détendeur de droits

GSK group of companies

Téléchargé le

23 janvier 2019

DOI

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

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

1 Formulaires  
Administrative data
Description

Administrative data

Center Number
Description

Center Number

Type de données

integer

Tracking Document
Description

Tracking Document

Previous Subject Number
Description

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

Type de données

integer

Date of Birth
Description

Date of Birth

Type de données

date

Reason for non participation
Description

Reason for non participation

Type de données

text

Please specify criteria that are not fulfilled
Description

IfSubjectNotEligible

Type de données

text

In case of SAE, specify adverse event
Description

SAE

Type de données

text

If Other, please specify
Description

Other

Type de données

text

In case of death, please specify the date
Description

DeathDate

Type de données

date

Date of Contact
Description

Date of Contact

Type de données

date

Investigator Name
Description

Print name

Type de données

text

Signature
Description

Signature

Type de données

text

Date
Description

Date

Type de données

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

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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

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text

If Other, please specify
Description

Other

Type de données

text

ICF Effective date
Description

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

Type de données

date

Investigator's Signature
Description

Investigator's Signature

Investigator's signature:
Description

Investigator's signature:

Type de données

text

Date:
Description

Date:

Type de données

date

Printed Investigator's name:
Description

Printed Investigator's name:

Type de données

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

1 Formulaires
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Description | Question | Decode (Coded Value)
Type de données
Alias
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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
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Reason for non participation
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Subject not eligible (1)
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Subject lost to follow-up or not reached (2)
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Subject eligible but not willing to participate  (3)
CL Item
Subject died (4)
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Please specify criteria that are not fulfilled
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SAE
Item
In case of SAE, specify adverse event
text
Other
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If Other, please specify
text
DeathDate
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In case of death, please specify the date
date
Date of Contact
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Date of Contact
date
Investigator Name
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Investigator Name
text
Signature
Item
Signature
text
Date
Item
Date
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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.
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At least 15 years storage period by GSK Biologicals (1)
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Other (2)
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ICF Effective date
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Investigator's signature:
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