ID
25215
Beskrivning
Adverse Experiences - Continued form Study ID: 208127/125 Clinical Study ID: 208127/125 (Ext-HAB-038 Month 90) Study Title: A double-blind, randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' combined hepatitis A / hepatitis B vaccine in healthy children between 6 and 15 years of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B
Nyckelord
Versioner (1)
- 2017-08-28 2017-08-28 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
28 augusti 2017
DOI
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Licens
Creative Commons BY-NC 3.0
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Adverse Experiences - Continued Biologicals HepA/HepB vaccine 208127/125
Adverse Experiences - Continued Biologicals HepA/HepB vaccine 208127/125
Beskrivning
Adverse Experiences
Alias
- UMLS CUI-1
- C0877248
Beskrivning
Experience
Alias
- UMLS CUI-1
- C0877248
Beskrivning
Adverse Event
Datatyp
text
Alias
- UMLS CUI [1]
- C0877248
Beskrivning
Local reaction
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0853813
- UMLS CUI [1,2]
- C2700396
Beskrivning
General reaction
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1710276
Beskrivning
day/month/year
Datatyp
date
Alias
- UMLS CUI [1]
- C3173309
Beskrivning
hours/minutes if the experience is observed during the immediate post vaccination period specified in the protocol, the exact time of onset has to be specified
Datatyp
time
Alias
- UMLS CUI [1]
- C0449244
Beskrivning
day/month/year
Datatyp
date
Alias
- UMLS CUI [1]
- C1531784
Beskrivning
hours/minutes
Datatyp
time
Alias
- UMLS CUI [1]
- C0449238
Beskrivning
Intensity
Datatyp
integer
Alias
- UMLS CUI [1]
- C0518690
Beskrivning
Relationship to Study Vaccine
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0439849
Beskrivning
Outcome
Datatyp
integer
Alias
- UMLS CUI [1]
- C1705586
Beskrivning
continuing at end of study
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1553904
Beskrivning
If yes, record in the Medication Section
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Beskrivning
If yes, report experience to SB by phone within 24hrs and complete the SAEF form.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1547644
Beskrivning
For SB
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Beskrivning
Administrative Data
Alias
- UMLS CUI-1
- C1320722
Similar models
Adverse Experiences - Continued Biologicals HepA/HepB vaccine 208127/125
C0877248 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])