ID
35727
Beschrijving
Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: 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
Trefwoorden
Versies (2)
- 18-03-19 18-03-19 -
- 18-03-19 18-03-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
18 maart 2019
DOI
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Licentie
Creative Commons BY-NC 3.0
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Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565)
Long-Term Follow-Up (Month 60) - Demographics; Laboratory Tests; Follow-Up Studies; Safety Follow-Up - Serious Adverse Events; Tracking Document
Beschrijving
Demographics
Alias
- UMLS CUI-1
- C1704791
Beschrijving
First Name, Family Name
Datatype
text
Alias
- UMLS CUI [1,1]
- C1997894
- UMLS CUI [1,2]
- C2986440
Beschrijving
Date of birth
Datatype
date
Alias
- UMLS CUI [1]
- C0421451
Beschrijving
Gender
Datatype
text
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
Race
Datatype
text
Alias
- UMLS CUI [1]
- C0034510
Beschrijving
If other Race, please specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschrijving
Laboratory Tests
Alias
- UMLS CUI-1
- C0022885
Beschrijving
Follow-Up Studies
Alias
- UMLS CUI-1
- C0016441
Beschrijving
Would the subject be willing to participate in a follow-up study?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0016441
- UMLS CUI [1,2]
- C0600109
Beschrijving
If subject would not be willing to participate in a follow-up study, please specify the reason
Datatype
text
Alias
- UMLS CUI [1,1]
- C0016441
- UMLS CUI [1,2]
- C0600109
- UMLS CUI [1,3]
- C0392360
Beschrijving
If Adverse Event or Serious Adverse Event, please specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C2348235
Beschrijving
If other, please specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2348235
Beschrijving
Investigator Signature
Alias
- UMLS CUI-1
- C2346576
Beschrijving
Serious Adverse Events
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Serious Adverse Event (SAE)
Datatype
integer
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
First Name, Family Name
Datatype
text
Alias
- UMLS CUI [1]
- C0011298
- UMLS CUI [2,1]
- C1997894
- UMLS CUI [2,2]
- C2986440
Beschrijving
Date of Birth (1)
Datatype
date
Alias
- UMLS CUI [1]
- C0011298
- UMLS CUI [2]
- C0421451
Beschrijving
Subject Demography - Gender (1)
Datatype
text
Alias
- UMLS CUI [1]
- C0011298
- UMLS CUI [2]
- C0079399
Beschrijving
Adverse Event - Diagnosis (2)
Datatype
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0011900
Beschrijving
(Adverse event first symptoms)
Datatype
datetime
Alias
- UMLS CUI [1]
- C2826806
Beschrijving
(If ongoing please leave blank)
Datatype
datetime
Alias
- UMLS CUI [1]
- C2826793
Beschrijving
For GSK - Intensity of Adverse Event (5)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0518690
Beschrijving
For GSK - In your opinion, did the vaccine possibly contribute to the SAE? (6)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1880177
- UMLS CUI [1,3]
- C0042196
Beschrijving
(mark all that apply)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0085978
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C0205394
Beschrijving
(maximum)
Datatype
integer
Alias
- UMLS CUI [1]
- C1705586
Beschrijving
Action taken with respect to Study Vaccine (8)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2826626
- UMLS CUI [1,2]
- C0042210
Beschrijving
Events after further vaccination (9)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C1517331
Beschrijving
(mark all that apply)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0243161
- UMLS CUI [1,3]
- C2348235
Beschrijving
If yes, send autopsy report when available
Datatype
boolean
Alias
- UMLS CUI [1]
- C0004398
Beschrijving
If in-patient hospitalization required, enter Admission Date (10)
Datatype
date
Alias
- UMLS CUI [1]
- C2826664
- UMLS CUI [2]
- C1302393
Beschrijving
If in-patient hospitalization required, enter Discharge Date (10)
Datatype
date
Alias
- UMLS CUI [1]
- C2826664
- UMLS CUI [2]
- C2361123
Beschrijving
If prolongation of exisiting hospitalization, enter discharge date (10)
Datatype
date
Alias
- UMLS CUI [1]
- C0745041
- UMLS CUI [2]
- C2361123
Beschrijving
Was subject withdrawn due to this specific SAE? (12)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C1519255
Beschrijving
Other events (not SAE) to be reported in the same way
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0441471
- UMLS CUI [1,2]
- C0205394
Beschrijving
SAE - Study Vaccine Information (13)
Alias
- UMLS CUI-1
- C0042210
- UMLS CUI-2
- C0304229
- UMLS CUI-3
- C1533716
Beschrijving
(specify mixed or separate)
Datatype
text
Alias
- UMLS CUI [1]
- C0042210
Beschrijving
Dose No
Datatype
integer
Alias
- UMLS CUI [1]
- C1115464
Beschrijving
Lot No
Datatype
integer
Alias
- UMLS CUI [1]
- C1115660
Beschrijving
Route / Site
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0042210
Beschrijving
Date
Datatype
date
Alias
- UMLS CUI [1]
- C0011008
Beschrijving
SAE - Concomitant medication / vaccination that could have contributed to this SAE (14)
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C1519255
- UMLS CUI-3
- C1880177
- UMLS CUI-5
- C0042196
- UMLS CUI-6
- C2347852
- UMLS CUI-7
- C1519255
- UMLS CUI-8
- C1880177
Beschrijving
Drug / vaccine
Datatype
text
Alias
- UMLS CUI [1]
- C0013227
- UMLS CUI [2]
- C0042210
Beschrijving
Dosage
Datatype
text
Alias
- UMLS CUI [1]
- C0178602
Beschrijving
Frequency
Datatype
text
Alias
- UMLS CUI [1]
- C3476109
Beschrijving
Route
Datatype
text
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
Start date
Datatype
date
Alias
- UMLS CUI [1]
- C0808070
Beschrijving
End date
Datatype
date
Alias
- UMLS CUI [1]
- C0806020
Beschrijving
SAE - Relevant intercurrent illness & medical history that could have contributed to this SAE (15)
Alias
- UMLS CUI-1
- C0221423
- UMLS CUI-2
- C1519255
- UMLS CUI-3
- C1880177
- UMLS CUI-4
- C0262926
- UMLS CUI-5
- C1519255
- UMLS CUI-6
- C1880177
Beschrijving
Drug(s) used to treat this SAE (16)
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C0087111
- UMLS CUI-3
- C1519255
Beschrijving
Drug
Datatype
text
Alias
- UMLS CUI [1]
- C0013227
Beschrijving
Dosage
Datatype
text
Alias
- UMLS CUI [1]
- C0178602
Beschrijving
Frequency
Datatype
text
Alias
- UMLS CUI [1]
- C3476109
Beschrijving
Route
Datatype
text
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
Start date
Datatype
date
Alias
- UMLS CUI [1]
- C0808070
Beschrijving
End date
Datatype
date
Alias
- UMLS CUI [1]
- C0806020
Beschrijving
Surgical treatment for this SAE (17)
Alias
- UMLS CUI-1
- C0543467
- UMLS CUI-2
- C1519255
Beschrijving
Description (18)
Alias
- UMLS CUI-1
- C0678257
Beschrijving
SAE - Comments
Alias
- UMLS CUI-1
- C0947611
- UMLS CUI-2
- C1519255
Beschrijving
Tracking Document
Alias
- UMLS CUI-1
- C3889409
Beschrijving
Subject number of previous study
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2348585
- UMLS CUI [1,2]
- C2242969
Beschrijving
first name family name
Datatype
text
Alias
- UMLS CUI [1,1]
- C1997894
- UMLS CUI [1,2]
- C2986440
Beschrijving
Date of birth
Datatype
date
Alias
- UMLS CUI [1]
- C0421451
Beschrijving
Please contact the following subjects for inclusion in the long-term follow-up study and document whether or not he/she agrees to participate.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1512693
- UMLS CUI [1,2]
- C1517942
Beschrijving
Reason for Subject not willing to participate
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C1136454
Beschrijving
If other Reason for Subject not willing to participate, please specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C1136454
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Beschrijving
Date of contact
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1705415
Beschrijving
Investigator signature
Alias
- UMLS CUI-1
- C2346576
Beschrijving
Investigator Signature (1)
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Investigator Signature Date (1)
Datatype
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschrijving
Investigator Signature (2)
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Investigator Signature Date (2)
Datatype
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschrijving
Investigator Signature (3)
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Investigator Signature Date (3)
Datatype
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschrijving
Investigator Signature (4)
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Investigator Signature Date (4)
Datatype
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschrijving
Clinical Development Manager - Signature
Datatype
text
Alias
- UMLS CUI [1,1]
- C0681803
- UMLS CUI [1,2]
- C1519316
Beschrijving
Clinical Development Manager - Signature Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1519316
- UMLS CUI [1,2]
- C0681803
- UMLS CUI [1,3]
- C0011008
Beschrijving
AEGIS Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0237753
- UMLS CUI [1,2]
- C0600091
Similar models
Long-Term Follow-Up (Month 60) - Demographics; Laboratory Tests; Follow-Up Studies; Safety Follow-Up - Serious Adverse Events; Tracking Document
C0600091 (UMLS CUI [1,2])
C2986440 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0600109 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
C2348235 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1997894 (UMLS CUI [2,1])
C2986440 (UMLS CUI [2,2])
C0421451 (UMLS CUI [2])
C0079399 (UMLS CUI [2])
C0011900 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C1880177 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1517331 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C1302393 (UMLS CUI [2])
C2361123 (UMLS CUI [2])
C2361123 (UMLS CUI [2])
C1519255 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0304229 (UMLS CUI-2)
C1533716 (UMLS CUI-3)
C0042210 (UMLS CUI [1,2])
C1519255 (UMLS CUI-2)
C1880177 (UMLS CUI-3)
C0042196 (UMLS CUI-5)
C2347852 (UMLS CUI-6)
C1519255 (UMLS CUI-7)
C1880177 (UMLS CUI-8)
C0042210 (UMLS CUI [2])
C1519255 (UMLS CUI-2)
C1880177 (UMLS CUI-3)
C0262926 (UMLS CUI-4)
C1519255 (UMLS CUI-5)
C1880177 (UMLS CUI-6)
C0150312 (UMLS CUI [1,2])
C0087111 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C1519255 (UMLS CUI-2)
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C2242969 (UMLS CUI [1,2])
C2986440 (UMLS CUI [1,2])
C1517942 (UMLS CUI [1,2])
C1136454 (UMLS CUI [1,2])
C1136454 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C1705415 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1519316 (UMLS CUI [1,2])
C0681803 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,2])