ID
27337
Description
Study ID: 103534 Clinical Study ID: 103534 Study Title: Evaluate the immunogenicity, reactogenicity, safety of 4 different formulations of GSK Biologicals' conjugate vaccine (MenACWY) vs 1 dose of MenC-CRM197 or Mencevax™ ACWY in children aged 12-14 months & 3-5 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00196976 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed clinical study under GSK sponsorship. The product that is studied in this clinical study, together with the rights to the data and results generated, has been transferred by GSK to Pfizer. GSK’s Clinical Study Register is no longer maintained for this study. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results Generic Name: Meningococcal Serogroups A, C, W-135 and Y-Tetanus Toxoid Conjugate Vaccine Trade Name: Nimenrix Study Indication: Infections, Meningococcal Booster Vaccination (Only for subjects who are part of the group with the selected MenACWY-TT formulation and the control group.) “Subjects enrolled at 12 – 14 months of age”
Link
http://www.pfizer.com/research/clinical_trials/trial_data_and_results
Keywords
Versions (2)
- 11/8/17 11/8/17 -
- 11/8/17 11/8/17 -
Copyright Holder
Pfizer
Uploaded on
November 8, 2017
DOI
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License
Creative Commons BY-NC 3.0
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Meningococcal Infections Vaccination in children NCT00196976
Workbook 1 Non-Serious Adverse Events
- StudyEvent: ODM
Description
Non-Serious Adverse Events
Alias
- UMLS CUI-1
- C1518404
Description
Non-serious adverse event
Data type
boolean
Alias
- UMLS CUI [1]
- C1518404
Description
Adverse event Number
Data type
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
Description
Description
Data type
text
Alias
- UMLS CUI [1,1]
- C0678257
- UMLS CUI [1,2]
- C1518404
Description
Location
Data type
text
Alias
- UMLS CUI [1]
- C0450429
Description
Investigator Use
Data type
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C0457083
Description
Start date
Data type
date
Alias
- UMLS CUI [1]
- C0808070
Description
Date started
Data type
boolean
Alias
- UMLS CUI [1]
- C0808070
Description
End date
Data type
date
Alias
- UMLS CUI [1]
- C0806020
Description
Intensity
Data type
integer
Alias
- UMLS CUI [1]
- C1710066
Description
Relationship to investigational product
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0013230
Description
Outcome
Data type
integer
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1518404
Description
Medically attended visit
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C1518404
Description
Medically attended visit Type
Data type
text
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C1386497
- UMLS CUI [1,4]
- C1518404
Similar models
Workbook 1 Non-Serious Adverse Events
- StudyEvent: ODM
C0237753 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C0457083 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C1518404 (UMLS CUI [1,4])