ID
33997
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
Versions (1)
- 1/10/19 1/10/19 -
Copyright Holder
GSK group of companies
Uploaded on
January 10, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Primary & Booster Immunogenicity of Hib-MenC vs a Licensed Men-C Vaccine - 104056
Study Conclusion + Non-Participation Form
- StudyEvent: ODM
Description
Reason for non participation
Description
Previous Subject Number
Data type
integer
Description
Date of birth
Data type
date
Description
Reason for non participation
Data type
text
Description
death date
Data type
date
Description
not willing to participate due to
Data type
text
Description
Specify reasons
Data type
text
Description
failed eligibility criteria
Data type
text
Description
Date of Contact
Data type
date
Description
Investigator's Signature
Description
Study Conclusion
Description
Status of treatment blind
Description
treatment blind broken?
Data type
boolean
Description
If Yes, please record the date
Data type
date
Description
TreatmentNotBlindedReportReason
Data type
text
Description
If Other, specify
Data type
text
Description
Subject Withdrawal
Description
subject withdrawal from study
Data type
boolean
Description
Subject study withdrawal reason
Data type
text
Description
If Other specify
Data type
text
Description
If Protocol Violation specify
Data type
text
Description
In case of SAEnumber
Data type
integer
Description
If Non-SAE- number
Data type
integer
Description
Decision-making
Description
Last Contact
Description
Investigator's Signature
Description
Investigator's Confirmation
Data type
date
Description
Investigator's Signature
Data type
text
Description
Printed Investigator's Name
Data type
text
Similar models
Study Conclusion + Non-Participation Form
- StudyEvent: ODM