Information:
Fel:
ID
35727
Beskrivning
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
Nyckelord
Versioner (2)
- 2019-03-18 2019-03-18 -
- 2019-03-18 2019-03-18 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
18 mars 2019
DOI
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Licens
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
Similar models
Long-Term Follow-Up (Month 60) - Demographics; Laboratory Tests; Follow-Up Studies; Safety Follow-Up - Serious Adverse Events; Tracking Document
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Center
Item
Center
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
GSK Receipt Date
Item
GSK Receipt Date
date
C2985846 (UMLS CUI [1])
Subject initials
Item
Subject initials
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
C2986440 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
CL Item
Female (F)
CL Item
Male (M)
CL Item
White (WH)
CL Item
Black (BL)
CL Item
Oriental (OR)
CL Item
Other, please specify (OT)
If other Race, please specify
Item
If other Race, please specify
text
C0034510 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Has a blood sample been taken?
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
Would the subject be willing to participate in a follow-up study?
Item
Would the subject be willing to participate in a follow-up study?
boolean
C0016441 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,2])
Item
If subject would not be willing to participate in a follow-up study, please specify the reason
text
C0016441 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0600109 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Code List
If subject would not be willing to participate in a follow-up study, please specify the reason
CL Item
Adverse Events, or Serious Adverse Events (1)
CL Item
Other (2)
If Adverse Event or Serious Adverse Event, please specify
Item
If Adverse Event or Serious Adverse Event, please specify
text
C0877248 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
C2348235 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
If other, please specify
Item
If other, please specify
text
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Date of Investigator Signauture
Item
Date of Investigator Signauture
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Investigator Signature
Item
Investigator Signature
text
C2346576 (UMLS CUI [1])
CL Item
Initial report (1)
CL Item
Additional info (2)
CL Item
Additional info (3)
CL Item
Additional info (4)
Subject Demography - Initials (1)
Item
Subject Demography - Initials (1)
text
C0011298 (UMLS CUI [1])
C1997894 (UMLS CUI [2,1])
C2986440 (UMLS CUI [2,2])
C1997894 (UMLS CUI [2,1])
C2986440 (UMLS CUI [2,2])
Date of Birth (1)
Item
Subject Demography - Date of Birth (1)
date
C0011298 (UMLS CUI [1])
C0421451 (UMLS CUI [2])
C0421451 (UMLS CUI [2])
Item
Subject Demography - Gender (1)
text
C0011298 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0079399 (UMLS CUI [2])
CL Item
Female (F)
CL Item
Male (M)
Adverse Event - Diagnosis (2)
Item
Adverse Event - Diagnosis (2)
text
C0877248 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
For GSK - Date and Time started (3)
Item
For GSK - Date and Time started (3)
datetime
C2826806 (UMLS CUI [1])
For GSK - Date and time stopped (4)
Item
For GSK - Date and time stopped (4)
datetime
C2826793 (UMLS CUI [1])
Item
For GSK - Intensity of Adverse Event (5)
integer
C0877248 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
For GSK - In your opinion, did the vaccine possibly contribute to the SAE? (6)
Item
For GSK - In your opinion, did the vaccine possibly contribute to the SAE? (6)
boolean
C1519255 (UMLS CUI [1,1])
C1880177 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C1880177 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
Item
For GSK - Other possible contributors (11)
integer
C0085978 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
CL Item
Medical history (record in section 15) (1)
CL Item
Other medication (record in section 14) (2)
CL Item
Protocol required procedure (3)
CL Item
Other procedure (4)
CL Item
Lack of efficacy (5)
CL Item
Erroneous administration (6)
CL Item
Other, specify: (7)
CL Item
Recovered (1)
CL Item
Recovered with sequelae (2)
CL Item
Ongoing (3)
CL Item
Died (4)
Item
Action taken with respect to Study Vaccine (8)
integer
C2826626 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
Code List
Action taken with respect to Study Vaccine (8)
CL Item
None (1)
CL Item
Vaccination course postponed (2)
CL Item
Vaccination course stopped (3)
Item
Events after further vaccination (9)
integer
C0042196 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1517331 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C1517331 (UMLS CUI [1,3])
CL Item
Event reappeared (1)
CL Item
Event did not reappear (2)
CL Item
Unknown at this time (3)
CL Item
Not applicable (4)
Item
Specify criteria for considering this as a Serious Adverse Event (10)
integer
C1519255 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Code List
Specify criteria for considering this as a Serious Adverse Event (10)
CL Item
Results in Death (1)
CL Item
Life threatening (2)
CL Item
Result in persistent or significant disability/incapacity (3)
CL Item
Requires in-patient hospitalization. (4)
CL Item
Prolongation of existing hospitalization (5)
CL Item
Congenital anomaly / birth defect in the offspring of a study subject (6)
CL Item
"Medically important" event, specify (7)
If results in Death, Autopsy performed? (10)
Item
If results in Death, Autopsy performed? (10)
boolean
C0004398 (UMLS CUI [1])
If in-patient hospitalization required, enter Admission Date (10)
Item
If in-patient hospitalization required, enter Admission Date (10)
date
C2826664 (UMLS CUI [1])
C1302393 (UMLS CUI [2])
C1302393 (UMLS CUI [2])
If in-patient hospitalization required, enter Discharge Date (10)
Item
If in-patient hospitalization required, enter Discharge Date (10)
date
C2826664 (UMLS CUI [1])
C2361123 (UMLS CUI [2])
C2361123 (UMLS CUI [2])
If prolongation of exisiting hospitalization, enter discharge date (10)
Item
If prolongation of exisiting hospitalization, enter discharge date (10)
date
C0745041 (UMLS CUI [1])
C2361123 (UMLS CUI [2])
C2361123 (UMLS CUI [2])
Was subject withdrawn due to this specific SAE? (12)
Item
Was subject withdrawn due to this specific SAE? (12)
boolean
C2349954 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Item
Other events (not SAE) to be reported in the same way
integer
C0441471 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Code List
Other events (not SAE) to be reported in the same way
CL Item
Cancer (1)
Item Group
SAE - Study Vaccine Information (13)
C0042210 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
C1533716 (UMLS CUI-3)
C0304229 (UMLS CUI-2)
C1533716 (UMLS CUI-3)
Vaccine
Item
Vaccine
text
C0042210 (UMLS CUI [1])
Dose No
Item
Dose No
integer
C1115464 (UMLS CUI [1])
Lot No
Item
Lot No
integer
C1115660 (UMLS CUI [1])
Route / Site
Item
Route / Site
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item Group
SAE - Concomitant medication / vaccination that could have contributed to this SAE (14)
C2347852 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C1880177 (UMLS CUI-3)
C0042196 (UMLS CUI-5)
C2347852 (UMLS CUI-6)
C1519255 (UMLS CUI-7)
C1880177 (UMLS CUI-8)
C1519255 (UMLS CUI-2)
C1880177 (UMLS CUI-3)
C0042196 (UMLS CUI-5)
C2347852 (UMLS CUI-6)
C1519255 (UMLS CUI-7)
C1880177 (UMLS CUI-8)
Drug / vaccine
Item
Drug / vaccine
text
C0013227 (UMLS CUI [1])
C0042210 (UMLS CUI [2])
C0042210 (UMLS CUI [2])
Dosage
Item
Dosage
text
C0178602 (UMLS CUI [1])
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
End date
Item
End date
date
C0806020 (UMLS CUI [1])
Item Group
SAE - Relevant intercurrent illness & medical history that could have contributed to this SAE (15)
C0221423 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C1880177 (UMLS CUI-3)
C0262926 (UMLS CUI-4)
C1519255 (UMLS CUI-5)
C1880177 (UMLS CUI-6)
C1519255 (UMLS CUI-2)
C1880177 (UMLS CUI-3)
C0262926 (UMLS CUI-4)
C1519255 (UMLS CUI-5)
C1880177 (UMLS CUI-6)
Condition:
Item
Condition:
text
C0012634 (UMLS CUI [1])
Still present?
Item
Still present?
boolean
C0012634 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C0150312 (UMLS CUI [1,2])
Item Group
Drug(s) used to treat this SAE (16)
C0013227 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C0087111 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
Drug
Item
Drug
text
C0013227 (UMLS CUI [1])
Dosage
Item
Dosage
text
C0178602 (UMLS CUI [1])
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
End date
Item
End date
date
C0806020 (UMLS CUI [1])
Item Group
Surgical treatment for this SAE (17)
C0543467 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C1519255 (UMLS CUI-2)
Surgical treatment for this SAE
Item
Surgical treatment for this SAE
text
C0543467 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Description
Item
Description
text
C0678257 (UMLS CUI [1])
SAE - Comments
Item
SAE - Comments
text
C0947611 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Subject number of previous study
Item
Subject number of previous study
integer
C2348585 (UMLS CUI [1,1])
C2242969 (UMLS CUI [1,2])
C2242969 (UMLS CUI [1,2])
Subject initials
Item
Subject initials
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
C2986440 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Please contact the following subjects for inclusion in the long-term follow-up study and document whether or not he/she agrees to participate.
integer
C1512693 (UMLS CUI [1,1])
C1517942 (UMLS CUI [1,2])
C1517942 (UMLS CUI [1,2])
Code List
Please contact the following subjects for inclusion in the long-term follow-up study and document whether or not he/she agrees to participate.
CL Item
Subject not eligible (1)
CL Item
Subject lost to follow-up or not reached (2)
CL Item
Subject eligible but not willing to participate due to adverse events, or serious adverse event or other (3)
CL Item
Subject eligible and agreed to participate in the (4)
CL Item
long-term follow-up study (5)
Item
Reason for Subject not willing to participate
integer
C0392360 (UMLS CUI [1,1])
C1136454 (UMLS CUI [1,2])
C1136454 (UMLS CUI [1,2])
Code List
Reason for Subject not willing to participate
CL Item
adverse events, or serious adverse event: (1)
CL Item
other (2)
If other Reason for Subject not willing to participate, please specify
Item
If other Reason for Subject not willing to participate, please specify
text
C0392360 (UMLS CUI [1,1])
C1136454 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C1136454 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Date of contact
Item
Date of contact
date
C0011008 (UMLS CUI [1,1])
C1705415 (UMLS CUI [1,2])
C1705415 (UMLS CUI [1,2])
Investigator Signature (1)
Item
Investigator Signature (1)
text
C2346576 (UMLS CUI [1])
Investigator Signature Date (1)
Item
Investigator Signature Date (1)
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Investigator Signature (2)
Item
Investigator Signature (2)
text
C2346576 (UMLS CUI [1])
Investigator Signature Date (2)
Item
Investigator Signature Date (2)
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Investigator Signature (3)
Item
Investigator Signature (3)
text
C2346576 (UMLS CUI [1])
Investigator Signature Date (3)
Item
Investigator Signature Date (3)
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Investigator Signature (4)
Item
Investigator Signature (4)
text
C2346576 (UMLS CUI [1])
Investigator Signature Date (4)
Item
Investigator Signature Date (4)
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Clinical Development Manager - Signature
Item
Clinical Development Manager - Signature
text
C0681803 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
C1519316 (UMLS CUI [1,2])
Clinical Development Manager - Signature Date
Item
Clinical Development Manager - Signature Date
date
C1519316 (UMLS CUI [1,1])
C0681803 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0681803 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
AEGIS Number
Item
AEGIS Number
integer
C0237753 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])