ID
27337
Beschreibung
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 GSK’s Clinical Study Register is no longer maintained for this study.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
Stichworte
Versionen (2)
- 08.11.17 08.11.17 -
- 08.11.17 08.11.17 -
Rechteinhaber
Pfizer
Hochgeladen am
8. November 2017
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Meningococcal Infections Vaccination in children NCT00196976
Workbook 1 Non-Serious Adverse Events
- StudyEvent: ODM
Beschreibung
Non-Serious Adverse Events
Alias
- UMLS CUI-1
- C1518404
Beschreibung
Non-serious adverse event
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1518404
Beschreibung
Adverse event Number
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
Beschreibung
Description
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0678257
- UMLS CUI [1,2]
- C1518404
Beschreibung
Location
Datentyp
text
Alias
- UMLS CUI [1]
- C0450429
Beschreibung
Investigator Use
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C0457083
Beschreibung
Start date
Datentyp
date
Alias
- UMLS CUI [1]
- C0808070
Beschreibung
Date started
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0808070
Beschreibung
End date
Datentyp
date
Alias
- UMLS CUI [1]
- C0806020
Beschreibung
Intensity
Datentyp
integer
Alias
- UMLS CUI [1]
- C1710066
Beschreibung
Relationship to investigational product
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0013230
Beschreibung
Outcome
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1518404
Beschreibung
Medically attended visit
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C1518404
Beschreibung
Medically attended visit Type
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C1386497
- UMLS CUI [1,4]
- C1518404
Ähnliche Modelle
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])