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23166
Beschreibung
Study ID: 100551 (EXT Y11) Clinical Study ID: 100551 Study Title: A double blind randomised, comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B vaccine when administered in healthy adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289770 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
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- 26.06.17 26.06.17 -
- 26.09.17 26.09.17 -
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GlaxoSmithKline
Hochgeladen am
26. Juni 2017
DOI
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Creative Commons BY-NC 3.0
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Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 22 Year 15)
Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 22 Year 15)
Ähnliche Modelle
Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 22 Year 15)
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Information
Item
Information
text
Introductory information
Item
Introductory information read
boolean
Item Group
General medical history / physical examination
Date of visit
Item
Date of visit
date
Subject number
Item
Subject number
integer
Item
Are you aware of any pre-existing conditions or or signs and/or symptoms present in the subject prior to the start of the study?
text
Code List
Are you aware of any pre-existing conditions or or signs and/or symptoms present in the subject prior to the start of the study?
CL Item
No (1)
CL Item
Yes (Please choose appropriate box(es)and give diagnosis (2)
CL Item
not appropriate (1)
CL Item
past (2)
CL Item
current (3)
Cutaneous: diagnosis
Item
Cutaneous: diagnosis
text
CL Item
not appropriate (1)
CL Item
past (2)
CL Item
current (3)
Eyes: diagnosis
Item
Eyes: diagnosis
text
CL Item
not appropriate (1)
CL Item
past (2)
CL Item
current (3)
Ears-Nose-Throat: diagnosis
Item
Ears-Nose-Throat: diagnosis
text
CL Item
not appropriate (1)
CL Item
past (2)
CL Item
current (3)
Cardiovascular: diagnosis
Item
Cardiovascular: diagnosis
text
CL Item
not appropriate (1)
CL Item
past (2)
CL Item
current (3)
Respiratory: diagnosis
Item
Respiratory: diagnosis
text
CL Item
not appropriate (1)
CL Item
past (2)
CL Item
current (3)
Gastrointestinal: diagnosis
Item
Gastrointestinal: diagnosis
text
CL Item
not appropriate (1)
CL Item
past (2)
CL Item
current (3)
Muskuloskeletal: diagnosis
Item
Muskuloskeletal: diagnosis
text
CL Item
not appropriate (1)
CL Item
past (2)
CL Item
current (3)
Neurological: diagnosis
Item
Neurological: diagnosis
text
CL Item
not appropriate (1)
CL Item
past (2)
CL Item
current (3)
Genitourinary: diagnosis
Item
Genitourinary: diagnosis
text
CL Item
not appropriate (1)
CL Item
past (2)
CL Item
current (3)
Haematology: diagnosis
Item
Haematology: diagnosis
text
CL Item
not appropriate (1)
CL Item
past (2)
CL Item
current (3)
Allergies: diagnosis
Item
Allergies: diagnosis
text
CL Item
not appropriate (1)
CL Item
past (2)
CL Item
current (3)
Endocrine: diagnosis
Item
Endocrine: diagnosis
text
Other (specify)
Item
Other (specify)
text
CL Item
not appropriate (1)
CL Item
past (2)
CL Item
current (3)
CL Item
yes (please answer the following question if different from visit date) (1)
CL Item
no (2)
Date of blood sample
Item
Date of blood sample
date
CL Item
yes (please answer the following question of different from visit date) (1)
CL Item
no (2)
CL Item
NA (not of childbearing potential or male) (3)
Date of pregnancy test
Item
Date of pregnancy test
date
CL Item
negative (1)
CL Item
positive (2)
Date of vaccine administration
Item
Date of vaccine administration
date
Pre-vaccination temperature
Item
Pre-vaccination temperature
float
CL Item
Axillary (1)
CL Item
Oral (2)
CL Item
Rectal (3)
CL Item
Twinrix™ Adult (720/20) Vaccine (1)
CL Item
Twinrix™ Adult (720/20) Vaccine: Not administered -> Please complete following page (2)
CL Item
Engerix™ (20 μg) Vaccine (3)
CL Item
Engerix™ (20 μg) Vaccine: Not administered -> Please complete following page (4)
CL Item
Havrix™ (720 EL.U)Vaccine (5)
CL Item
Havrix™ (720 EL.U)Vaccine: Not administered -> Please complete following page (6)
Item
Twinrix™ Adult (720/20) Vaccine: Has the study vaccine been administered according to the Protocol?
text
Code List
Twinrix™ Adult (720/20) Vaccine: Has the study vaccine been administered according to the Protocol?
CL Item
Yes (1)
CL Item
No (Please tick all Items that apply) (2)
Item
Twinrix™ Adult (720/20) Vaccine: specification of not administered according to the protocol
text
Code List
Twinrix™ Adult (720/20) Vaccine: specification of not administered according to the protocol
CL Item
Side: left (1)
CL Item
Side: right (2)
CL Item
Site: Deltoid (3)
CL Item
Site: Thigh (4)
CL Item
Site: Buttock (5)
CL Item
Route: I.M. (6)
CL Item
Route: S.C. (7)
Item
Engerix™ (20 μg) Vaccine: specification of not administered according to the protocol
text
Code List
Engerix™ (20 μg) Vaccine: specification of not administered according to the protocol
CL Item
Side: Left (1)
CL Item
Side: Right (2)
CL Item
Site: Deltoid (3)
CL Item
Site: Thigh (4)
CL Item
Site: Buttock (5)
CL Item
Route: I.M. (6)
CL Item
Route: S.C. (7)
Item
Havrix™ (720 EL.U)Vaccine: specification of not administered according to the protocol
text
Code List
Havrix™ (720 EL.U)Vaccine: specification of not administered according to the protocol
CL Item
Side: Left (1)
CL Item
Side: Right (2)
CL Item
Site: Deltoid (3)
CL Item
Site: Thigh (4)
CL Item
Site: Buttock (5)
CL Item
Route: I.M. (6)
CL Item
Route: S.C. (7)
CL Item
Serious adverse event (complete Serious Adverse Event form) (1)
CL Item
Non-serious adverse event (complete the Non-serious Adverse Event section) (2)
CL Item
Other (3)
Specification of reason for non administration
Item
Other, please specify (reason for non administration)
text
CL Item
Investigator (1)
CL Item
Subject (2)
Item
Has the subject experienced any serious or non-serious unsolicited adverse events within one month post-vaccination?
text
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events within one month post-vaccination?
CL Item
Information not available (1)
CL Item
No Vaccine administered (2)
CL Item
No (3)
CL Item
Yes, fill in the Non-Serious Adverse Event pages or Serious Adverse Event form. (4)
Item
Has the subject experienced any of the following sings/symptoms at the administration site during the solicited period?
text
Code List
Has the subject experienced any of the following sings/symptoms at the administration site during the solicited period?
CL Item
Information available (1)
CL Item
No Vaccine administered (2)
CL Item
No (3)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (4)
CL Item
No (1)
CL Item
Size (please fill in next item) (2)
Local symptoms day 0
Item
Local symptoms day 0
float
Local symptoms day 1
Item
Local symptoms day 1
float
Local symptoms day 2
Item
Local symptoms day 2
float
Local symptoms day 3
Item
Local symptoms day 3
float
Ongoing after Day 3
Item
Ongoing after Day 3
boolean
Date of last day of symptoms (redness)
Item
Date of last day of symptoms (redness)
date
CL Item
No (1)
CL Item
Yes (please fill in the next item) (2)
Local symptoms day 0
Item
Local symptoms day 0
float
Local symptoms day 1
Item
Local symptoms day 1
float
Local symptoms day 2
Item
Local symptoms day 2
float
Local symptoms day 3
Item
Local symptoms day 3
float
Ongoing after Day 3
Item
Ongoing after Day 3
boolean
Date of last day of symptoms (swelling)
Item
Date of last day of symptoms (swelling)
date
CL Item
No (1)
CL Item
Yes, intensity: (please fill in next item) (2)
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Ongoing after Day 3
Item
Ongoing after Day 3
boolean
Date of last day of symptoms (pain)
Item
Date of last day of symptoms (pain)
date
Item
Has the subject experienced any of the following signs/symptoms during the solicited period?
text
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period?
CL Item
Information not available (1)
CL Item
No Vaccine administered (2)
CL Item
No (3)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (4)
General symptoms: Fever
Item
General symptoms: Fever
boolean
Fever
Item
Fever: if yes, please specify amount of fever
float
CL Item
Axilary (1)
CL Item
Oral (2)
CL Item
Rectal (3)
Fever day 0
Item
Fever day 0
float
Fever not taken day 0
Item
Fever not taken day 0
boolean
Fever day 1
Item
Fever day 1
float
Fever not taken day 1
Item
Fever not taken day 1
boolean
Fever day 2
Item
Fever day 2
float
Fever not taken day 2
Item
Fever not taken day 2
boolean
Fever day 3
Item
Fever day 3
float
Fever not taken day 3
Item
Fever not taken day 3
boolean
Ongoing after Day 3
Item
Ongoing after Day 3
boolean
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
Causality
Item
Causality
boolean
CL Item
No (1)
CL Item
Yes, please fill in next question (2)
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Ongoing after Day 3
Item
Ongoing after Day 3
boolean
Date of last Day of symptoms
Item
Date of last Day of symptoms
date
Causality?
Item
Causality?
boolean
CL Item
No (1)
CL Item
Yes, intensity: please fill in the next items (2)
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Ongoing after Day 3
Item
Ongoing after Day 3
boolean
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
Causality
Item
Causality
boolean
CL Item
No (1)
CL Item
Yes, intensity: please fill in the next items (2)
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Ongoing after Day 3
Item
Ongoing after Day 3
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Causality
Item
Causality
boolean