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
Yes (Please choose appropriate box(es)and give diagnosis (2)
CL Item
not appropriate (1)
Cutaneous: diagnosis
Item
Cutaneous: diagnosis
text
CL Item
not appropriate (1)
Eyes: diagnosis
Item
Eyes: diagnosis
text
Item
Ears-Nose-Throat
text
Code List
Ears-Nose-Throat
CL Item
not appropriate (1)
Ears-Nose-Throat: diagnosis
Item
Ears-Nose-Throat: diagnosis
text
CL Item
not appropriate (1)
Cardiovascular: diagnosis
Item
Cardiovascular: diagnosis
text
CL Item
not appropriate (1)
Respiratory: diagnosis
Item
Respiratory: diagnosis
text
Item
Gastrointestinal
text
Code List
Gastrointestinal
CL Item
not appropriate (1)
Gastrointestinal: diagnosis
Item
Gastrointestinal: diagnosis
text
Item
Muskuloskeletal
text
Code List
Muskuloskeletal
CL Item
not appropriate (1)
Muskuloskeletal: diagnosis
Item
Muskuloskeletal: diagnosis
text
CL Item
not appropriate (1)
Neurological: diagnosis
Item
Neurological: diagnosis
text
CL Item
not appropriate (1)
Genitourinary: diagnosis
Item
Genitourinary: diagnosis
text
CL Item
not appropriate (1)
Haematology: diagnosis
Item
Haematology: diagnosis
text
CL Item
not appropriate (1)
Allergies: diagnosis
Item
Allergies: diagnosis
text
CL Item
not appropriate (1)
Endocrine: diagnosis
Item
Endocrine: diagnosis
text
Other (specify)
Item
Other (specify)
text
CL Item
not appropriate (1)
Item
Has a blood sample been taken?
text
Code List
Has a blood sample been taken?
CL Item
yes (please answer the following question if different from visit date) (1)
Date of blood sample
Item
Date of blood sample
date
Item
Has a urine sample been taken?
text
Code List
Has a urine sample been taken?
CL Item
yes (please answer the following question of different from visit date) (1)
CL Item
NA (not of childbearing potential or male) (3)
Date of pregnancy test
Item
Date of pregnancy test
date
Item
Result from pregnancy test
text
Code List
Result from pregnancy test
Date of vaccine administration
Item
Date of vaccine administration
date
Pre-vaccination temperature
Item
Pre-vaccination temperature
float
Item
Vaccacine administration
text
Code List
Vaccacine administration
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
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
Site: Deltoid (3)
CL Item
Site: Buttock (5)
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
Site: Deltoid (3)
CL Item
Site: Buttock (5)
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
Site: Deltoid (3)
CL Item
Site: Buttock (5)
Item
Why not administered?
text
Code List
Why not administered?
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)
Specification of reason for non administration
Item
Other, please specify (reason for non administration)
text
Item
Please tick who took the decision
text
Code List
Please tick who took the decision
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
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
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (4)
Item
Local symptoms: Redness
text
Code List
Local symptoms: Redness
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
Item
Local symptoms: swelling
text
Code List
Local symptoms: swelling
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
Item
Local symptoms: pain
text
Code List
Local symptoms: pain
CL Item
Yes, intensity: (please fill in next item) (2)
Item
Intensity of pain day 0
text
Code List
Intensity of pain day 0
Item
Intensity of pain day 1
text
Code List
Intensity of pain day 1
Item
Intensity of pain day 2
text
Code List
Intensity of pain day 2
Item
Intensity of pain day 3
text
Code List
Intensity of pain day 3
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
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
Item
Taking temperature
text
Code List
Taking temperature
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
Yes, please fill in next question (2)
Item
Intensity fatigue day 0
text
Code List
Intensity fatigue day 0
Item
Intensity fatigue day 1
text
Code List
Intensity fatigue day 1
Item
Intensity fatigue day 2
text
Code List
Intensity fatigue day 2
Item
Intensity fatigue day 3
text
Code List
Intensity fatigue day 3
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
Yes, intensity: please fill in the next items (2)
Item
Intensity headache day 0
text
Code List
Intensity headache day 0
Item
Intensity headache day 1
text
Code List
Intensity headache day 1
Item
Intensity headache day 2
text
Code List
Intensity headache day 2
Item
Intensity headache day 3
text
Code List
Intensity headache day 3
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
Item
Gastrointestinal symptoms
text
Code List
Gastrointestinal symptoms
CL Item
Yes, intensity: please fill in the next items (2)
Item
Intensity gastrointestinal symptoms day 0
text
Code List
Intensity gastrointestinal symptoms day 0
Item
Intensity gastrointestinal symptoms day 1
text
Code List
Intensity gastrointestinal symptoms day 1
Item
Intensity gastrointestinal symptoms day 2
text
Code List
Intensity gastrointestinal symptoms day 2
Item
Intensity gastrointestinal symptoms day 3
text
Code List
Intensity gastrointestinal symptoms day 3
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