ID
27337
Beschrijving
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 GSK’s Clinical Study Register is no longer maintained for this study.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
Trefwoorden
Versies (2)
- 08-11-17 08-11-17 -
- 08-11-17 08-11-17 -
Houder van rechten
Pfizer
Geüploaded op
8 november 2017
DOI
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Licentie
Creative Commons BY-NC 3.0
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Meningococcal Infections Vaccination in children NCT00196976
Workbook 1 Non-Serious Adverse Events
- StudyEvent: ODM
Beschrijving
Non-Serious Adverse Events
Alias
- UMLS CUI-1
- C1518404
Beschrijving
Non-serious adverse event
Datatype
boolean
Alias
- UMLS CUI [1]
- C1518404
Beschrijving
Adverse event Number
Datatype
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
Beschrijving
Description
Datatype
text
Alias
- UMLS CUI [1,1]
- C0678257
- UMLS CUI [1,2]
- C1518404
Beschrijving
Location
Datatype
text
Alias
- UMLS CUI [1]
- C0450429
Beschrijving
Investigator Use
Datatype
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C0457083
Beschrijving
Start date
Datatype
date
Alias
- UMLS CUI [1]
- C0808070
Beschrijving
Date started
Datatype
boolean
Alias
- UMLS CUI [1]
- C0808070
Beschrijving
End date
Datatype
date
Alias
- UMLS CUI [1]
- C0806020
Beschrijving
Intensity
Datatype
integer
Alias
- UMLS CUI [1]
- C1710066
Beschrijving
Relationship to investigational product
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0013230
Beschrijving
Outcome
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1518404
Beschrijving
Medically attended visit
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C1518404
Beschrijving
Medically attended visit Type
Datatype
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])