ID
25215
Description
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
Keywords
Versions (1)
- 8/28/17 8/28/17 -
Copyright Holder
GlaxoSmithKline
Uploaded on
August 28, 2017
DOI
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License
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
Description
Adverse Experiences
Alias
- UMLS CUI-1
- C0877248
Description
Experience
Alias
- UMLS CUI-1
- C0877248
Description
Adverse Event
Data type
text
Alias
- UMLS CUI [1]
- C0877248
Description
Local reaction
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0853813
- UMLS CUI [1,2]
- C2700396
Description
General reaction
Data type
boolean
Alias
- UMLS CUI [1]
- C1710276
Description
day/month/year
Data type
date
Alias
- UMLS CUI [1]
- C3173309
Description
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
Data type
time
Alias
- UMLS CUI [1]
- C0449244
Description
day/month/year
Data type
date
Alias
- UMLS CUI [1]
- C1531784
Description
hours/minutes
Data type
time
Alias
- UMLS CUI [1]
- C0449238
Description
Intensity
Data type
integer
Alias
- UMLS CUI [1]
- C0518690
Description
Relationship to Study Vaccine
Data type
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0439849
Description
Outcome
Data type
integer
Alias
- UMLS CUI [1]
- C1705586
Description
continuing at end of study
Data type
boolean
Alias
- UMLS CUI [1]
- C1553904
Description
If yes, record in the Medication Section
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Description
If yes, report experience to SB by phone within 24hrs and complete the SAEF form.
Data type
boolean
Alias
- UMLS CUI [1]
- C1547644
Description
For SB
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Description
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])