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ID
35328
Beschreibung
Study ID: 101222 Clinical Study ID: 101222 Study Title: Study to demonstrate the non-inferiority of GSK Biologicals' DTPw-HBV/Hib Kft. vaccine compared to GSK Biologicals' Tritanrix™-HepB/Hiberix™ vaccine and to separate administration of DTPw-HBV Kft. and Hiberix™ vaccines with respect to the immunogenicity of all antigens, when administered to healthy infants. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine (KFT) Trade Name:Zilbrix/Hib Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis
Stichworte
Versionen (2)
- 26.02.19 26.02.19 -
- 28.02.19 28.02.19 -
Rechteinhaber
GSK group of companies
Hochgeladen am
28. Februar 2019
DOI
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Immunogenicity of TPw-HBV/Hib Kft. Vaccine in healthy infants 101222
Visit 2 (Month 1.5 42 – 62 days after birth)
- StudyEvent: ODM
Ähnliche Modelle
Visit 2 (Month 1.5 42 – 62 days after birth)
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
VisitNumber
Item
Visit Number
integer
SubjectNumber
Item
Subject Number
integer
Study Continuation Question
Item
Did the subject come at visit 2 ?
boolean
Item
Please tick the ONE most appropriate reason and skip the following pages of this visit.
text
Code List
Please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
Serious adverse event (complete the Serious Adverse Event form) (1)
CL Item
Other (2)
Other Specify
Item
If Other, please specify
text
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
General Medical History Question
Item
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study ?
boolean
Cutaneous
Item
Cutaneous
text
CL Item
Past (1)
CL Item
Current (2)
Eyes
Item
Eyes
text
CL Item
Past (1)
CL Item
Current (2)
Ears-Nose-Throat
Item
Ears-Nose-Throat
text
CL Item
Past (1)
CL Item
Current (2)
Cardiovascular
Item
Cardiovascular
text
CL Item
Past (1)
CL Item
Current (2)
Respiratory
Item
Respiratory
text
CL Item
Past (1)
CL Item
Current (2)
Gastrointestinal
Item
Gastrointestinal
text
CL Item
Past (1)
CL Item
Current (2)
Muskuloskeletal
Item
Muskuloskeletal
text
CL Item
Past (1)
CL Item
Current (2)
Neurological
Item
Neurological
text
CL Item
Past (1)
CL Item
Current (2)
Genitourinary
Item
Genitourinary
text
CL Item
Past (1)
CL Item
Current (2)
Haematology
Item
Haematology
text
CL Item
Past (1)
CL Item
Current (2)
Allergies
Item
Allergies
text
CL Item
Past (1)
CL Item
Current (2)
Endocrine
Item
Endocrine
text
CL Item
Past (1)
CL Item
Current (2)
Crying
Item
Crying
text
CL Item
Past (1)
CL Item
Current (2)
Other Specify
Item
Other (specify)
text
CL Item
Past (1)
CL Item
Current (2)
Height
Item
Height
integer
Weight
Item
Weight
float
Blood Sample Taken
Item
Has a blood sample been taken ?
boolean
Date Sample Taken
Item
If yes, please record the date
date
Vaccination Date
Item
Date
date
Pre-vaccinationTemperature
Item
Pre-Vaccination Temperature
float
CL Item
Axillary (1)
CL Item
Rectal (2)
CL Item
DTPw-HBV/Hib Kft. Vaccine (1)
CL Item
Replacement vial (2)
CL Item
Wrong vial number (3)
CL Item
Not administered (4)
Vial Number For Replacement Vial
Item
Vial Number For Replacement Vial
integer
Vial Number For Wrong Vial
Item
Vial Number For Wrong Vial
integer
CL Item
Left (1)
CL Item
Right (2)
CL Item
Thigh (1)
CL Item
Deltoid (2)
CL Item
Buttock (3)
CL Item
I.M. (1)
CL Item
S.C. (2)
Comment
Item
Comment
text
Vaccination Date
Item
Date
date
Pre-vaccinationTemperature
Item
Pre-vaccination Temperature
float
CL Item
Axillary (1)
CL Item
Rectal (2)
CL Item
DTPw-HBV Kft. Vaccine (1)
CL Item
Replacement vial (2)
CL Item
Wrong vial number (3)
CL Item
Not administered (4)
Vial Number For Replacement Vial
Item
Vial Number For Replacement Vial
integer
Vial Number For Wrong Vial
Item
Vial Number For Wrong Vial
integer
CL Item
Left (1)
CL Item
Right (2)
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
CL Item
I.M. (1)
CL Item
S.C. (2)
CL Item
Hiberix™ Vaccine (1)
CL Item
Replacement vial (2)
CL Item
Wrong vial number (3)
CL Item
Not administered (4)
Vial Number For Replacement Vial
Item
Vial Number For Replacement Vial
integer
Vial Number For Wrong Vial
Item
Vial Number For Wrong Vial
integer
CL Item
Left (1)
CL Item
Right (2)
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
CL Item
I.M. (1)
CL Item
S.C. (2)
Comments
Item
Comments
text
Vaccination Date
Item
Date
date
Pre-Vaccination temperature
Item
Pre-Vaccination temperature
float
CL Item
Axillary (1)
CL Item
Rectal (2)
CL Item
Tritanrix™-HepB/Hiberix™Vaccine (1)
CL Item
Replacement vial (2)
CL Item
Wrong vial number (3)
CL Item
Not administered (4)
Vial Number For Replacement Vial
Item
Vial Number For Replacement Vial
integer
Vial Number For Wrong Vial
Item
Vial Number For Wrong Vial
integer
CL Item
Left (1)
CL Item
Right (2)
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
CL Item
I.M. (1)
CL Item
S.C. (2)
Comments
Item
Comments
text
CL Item
Serious adverse event (complete the Serious Adverse Event form) (1)
CL Item
Non-Serious adverse event (complete the Non-serious Adverse Event section) (2)
CL Item
Other (3)
SAE Number
Item
Please specify SAE N°
integer
AE Number
Item
Please specify unsolicited AE N° or solicited AE code
integer
Other Specify
Item
Other, please specify
text
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
CL Item
If any adverse events occurred during the immediate post-vaccination time (30 minutes) please fill in the (1)
CL Item
Solicited Adverse Events section, the Non-Serious Adverse Event section or a Serious Adverse Event (Solicited Adverse Events section, the Non-Serious Adverse Event section or a Serious Adverse Event)
CL Item
form. (form.)
CL Item
If any prophylactic medication has been administered in anticipation of study vaccine reaction, (2)
CL Item
please complete the Medication section and tick prophylactic box. (please complete the Medication section and tick prophylactic box.)
CL Item
Any other vaccines administered during the study period must be recorded in the Concomitant Vaccination (3)
CL Item
section. (section.)
Item
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination ?
text
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) 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 signs/symptoms at the administration site during the solicited period?
text
Code List
Has the subject experienced any of the following signs/symptoms at the administration site 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)
Redness
Item
Redness
boolean
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Redness Size
Item
Size
integer
Status Ongoing
Item
Ongoing after day 3?
boolean
Last Day Of Symptoms
Item
Date of last day of symptoms
date
Medically Attended Visit
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Swelling
Item
Swelling
boolean
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Swelling Size
Item
Size
integer
Status Ongoing
Item
Ongoing after day 3?
boolean
Last Day Of Symptoms
Item
Date of last day of symptoms
date
Medically Attended Visit
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Pain
Item
Pain
boolean
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Status Ongoing
Item
Ongoing after day 3?
boolean
Last Day Of Symptoms
Item
Date of last day of symptoms
date
Medically Attended Visit
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item Group
SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS (vaccine specific)
Item
For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
text
Code List
For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
CL Item
No (1)
CL Item
Information not available (2)
CL Item
No vaccine administered (3)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (4)
Redness
Item
Redness
boolean
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Redness Size
Item
Size
integer
Status Ongoing
Item
Ongoing after day 3?
boolean
Last Day Of Symptoms
Item
Date of last day of symptoms
date
Medically Attended Visit
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Swelling
Item
Swelling
boolean
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Swelling Size
Item
Size
integer
Status Ongoing
Item
Ongoing after day 3?
boolean
Last Day Of Symptoms
Item
Date of last day of symptoms
date
Medically Attended Visit
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Pain
Item
Pain
boolean
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Status Ongoing
Item
Ongoing after day 3?
boolean
Last Day Of Symptoms
Item
Date of last day of symptoms
date
Medically Attended Visit
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Redness
Item
Redness
boolean
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,2])
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Redness
Item
Size
integer
Status Ongoing
Item
Ongoing after day 3?
boolean
Last Day Of Symptoms
Item
Date of last day of symptoms
date
Medically Attended Visit
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Swelling
Item
Swelling
boolean
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Swelling Size
Item
Size
integer
Status Ongoing
Item
Ongoing after day 3?
boolean
Last Day Of Symptoms
Item
Date of last day of symptoms
date
Medically Attended Visit
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Pain
Item
Pain
boolean
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Status Ongoing
Item
Ongoing after day 3?
boolean
Last Day Of Symptoms
Item
Date of last day of symptoms
date
Medically Attended Visit
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Redness
Item
Redness
boolean
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Redness Size
Item
Size
integer
Status Ongoing
Item
Ongoing after day 3?
boolean
Last Day Of Symptoms
Item
Date of last day of symptoms
date
Medically Attended Visit
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Swelling
Item
Swelling
boolean
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Swelling Size
Item
Size
integer
Status Ongoing
Item
Ongoing after day 3?
boolean
Last Day Of Symptoms
Item
Date of last day of symptoms
date
Medically Attended Visit
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Pain
Item
Pain
boolean
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Status Ongoing
Item
Ongoing after day 3?
boolean
Last Day Of Symptoms
Item
Date of last day of symptoms
date
Medically Attended Visit
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
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)
Fever
Item
Fever
boolean
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
temperature
Item
t°
float
t° not taken
Item
t° not taken
boolean
CL Item
Axillary (1)
CL Item
Rectal (2)
Status Ongoing
Item
Ongoing after day 3?
boolean
Last day of symptoms
Item
Date of last day of symptoms
date
Causality
Item
Causality
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Irritability / Fussiness
Item
Irritability / Fussiness
boolean
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
In case of severe intensity
Item
In case of severe intensity, was the crying continuous( i.e. not episodic, not interrupted within the time period of 3 hours by e.g. naps) ?
boolean
crying in case of severe intensity
Item
was the crying unaltered > 3 hours ?
boolean
Status Ongoing
Item
Ongoing after day 3?
boolean
Last day of symptoms
Item
Date of last day of symptoms
date
Causality
Item
Causality
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Drowsiness
Item
Drowsiness
boolean
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Status Ongoing
Item
Ongoing after day 3?
boolean
Causality
Item
Causality
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Loss of appetite
Item
Loss of appetite
boolean
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Status Ongoing
Item
Ongoing after day 3?
boolean
Last day of symptoms
Item
Date of last day of symptoms
date
Causality
Item
Causality
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)