ID
33963
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)
- 1/9/19 1/9/19 -
Copyright Holder
GSK group of companies
Uploaded on
January 9, 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 - 103974
Concomitant Vaccination, Concomitant Medication, Non-Serious Adverse Events, Study Conclusion Forms
Description
Concomitant Vaccination
Description
Vaccination details
Description
Trade / (Generic) Name
Data type
text
Description
Administration date
Data type
date
Description
Route
Data type
text
Description
If Other route, please specify
Data type
text
Description
Concomitant Medication
Description
Concomitant Medication Details
Description
Trade / Generic Name
Data type
text
Description
Medical Indication
Data type
text
Description
Was the medication / treatment prophylactic?
Data type
boolean
Description
Total daily dose
Data type
text
Description
Route
Data type
text
Description
If Other route, please specify
Data type
text
Description
Non-Serious Adverse Events
Description
Description of Event
Description
Adverse Event Number
Data type
integer
Description
Description
Data type
text
Description
Administration Site
Data type
boolean
Description
Vaccine?
Data type
text
Description
Non-administration site?
Data type
boolean
Description
Date Started
Data type
date
Description
immediate post-vaccination period (30 min)
Data type
boolean
Description
Date stopped
Data type
date
Description
Intensity
Data type
text
Description
Relationship to the investigational product?
Data type
boolean
Description
Outcome
Data type
text
Description
Refer to protocol for full definition
Data type
boolean
Description
medical help
Data type
text
Description
Study Conclusion
Description
Serious Adverse Event
Data type
boolean
Description
if applies
Data type
integer
Description
Status of Treatment Blind
Data type
boolean
Description
if applies
Data type
date
Description
Complete Non-Serious Adverse Event section or Serious Adverse Event Section form as appropriate
Data type
text
Description
If Other, please specify
Data type
text
Description
Elimination criteria
Data type
boolean
Description
specific elimination criteria
Data type
text
Description
Subject withdrawal
Data type
boolean
Description
Reasons for withdrawal
Data type
text
Description
SAE number
Data type
integer
Description
AE number
Data type
integer
Description
If Other, please specify
Data type
text
Description
Please tick who took decision
Data type
text
Description
Date of last contact
Data type
date
Description
If No, please give details within the Adverse Events section
Data type
boolean
Description
Investigator's confirmation
Data type
date
Description
Investigator's signature
Data type
text
Description
Printed Investigator's name
Data type
text