ID
36112
Description
Study ID: 100556 (Y11) Clinical Study ID: 100556 Study Title: Long-Term Persistence Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289718 Sponsor: GlaxoSmithKline 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)
- 4/15/19 4/15/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
April 15, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers NCT00289718
Long-Term Follow Up (Year 15; Additional Vaccination) - Concomitant Vaccination; Medication; Non-Serious Adverse Experiences
Description
Concomitant Vaccination
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C2347852
Description
If Yes, please record concomitant vaccination with trade name and/or generic name, route and vaccine administration date
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C2347852
Description
Concomitant Vaccination
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C2347852
Description
Trade Name/ (Generic) Name
Data type
text
Alias
- UMLS CUI [1,1]
- C2360065
- UMLS CUI [1,2]
- C0592502
Description
Administration Route
Data type
text
Alias
- UMLS CUI [1]
- C0013153
Description
Administration Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0011008
Description
Medication
Alias
- UMLS CUI-1
- C0013227
Description
Medication
Alias
- UMLS CUI-1
- C0013227
Description
Trade/ Generic Name
Data type
text
Alias
- UMLS CUI [1]
- C2360065
Description
Medical Indication
Data type
integer
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C0013227
Description
Total daily dose
Data type
text
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0439810
Description
Administration Route
Data type
text
Alias
- UMLS CUI [1]
- C0013153
Description
Medication Start Date
Data type
date
Alias
- UMLS CUI [1]
- C2826734
Description
Medication End Date
Data type
date
Alias
- UMLS CUI [1]
- C2826744
Description
Tick box if continuing at end of study
Data type
integer
Alias
- UMLS CUI [1,1]
- C1553904
- UMLS CUI [1,2]
- C2983670
Description
Non-Serious Adverse Events
Alias
- UMLS CUI-1
- C1518404
Description
If Yes, please complete the following table
Data type
boolean
Alias
- UMLS CUI [1]
- C1518404
- UMLS CUI [2,1]
- C0687676
- UMLS CUI [2,2]
- C0042196
Description
Non-Serious Adverse Events
Alias
- UMLS CUI-1
- C1518404
Description
AE No
Data type
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
Description
Non-Serious Adverse Event Description
Data type
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0678257
Description
Non-Serious Adverse Event location
Data type
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0450429
Description
Date Non-Serious Adverse Event Started
Data type
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0808070
Description
Non-Serious Adverse Event Start Date during immediate post-vaccination period (30 minutes)
Data type
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [1,3]
- C0042196
- UMLS CUI [1,4]
- C0687676
- UMLS CUI [1,5]
- C0205253
Description
Date Non-Serious Adverse Event Stopped
Data type
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0806020
Description
Non-Serious Adverse Event Intensity
Data type
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1710066
Description
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Description
Non-Serious Adverse Event Outcome
Data type
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1705586
Similar models
Long-Term Follow Up (Year 15; Additional Vaccination) - Concomitant Vaccination; Medication; Non-Serious Adverse Experiences
C2347852 (UMLS CUI-2)
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI-2)
C0592502 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,2])
C2983670 (UMLS CUI [1,2])
C0687676 (UMLS CUI [2,1])
C0042196 (UMLS CUI [2,2])
C0237753 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0687676 (UMLS CUI [1,4])
C0205253 (UMLS CUI [1,5])
C0806020 (UMLS CUI [1,2])
C1710066 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C1705586 (UMLS CUI [1,2])