ID

35328

Description

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

Keywords

  1. 2/26/19 2/26/19 -
  2. 2/28/19 2/28/19 -
Copyright Holder

GSK group of companies

Uploaded on

February 28, 2019

DOI

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License

Creative Commons BY-NC 3.0

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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)

Administrative data
Description

Administrative data

Visit Number
Description

VisitNumber

Data type

integer

Subject Number
Description

SubjectNumber

Data type

integer

CHECK FOR STUDY CONTINUATION
Description

CHECK FOR STUDY CONTINUATION

Did the subject come at visit 2 ?
Description

Study Continuation Question

Data type

boolean

Please tick the ONE most appropriate reason and skip the following pages of this visit.
Description

Reason For Discontinuation

Data type

text

If Other, please specify
Description

(e.g.: consent withdrawal, Protocol violation, …)

Data type

text

Please tick who took the decision
Description

Who made decision

Data type

text

GENERAL MEDICAL HISTORY
Description

GENERAL MEDICAL HISTORY

Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study ?
Description

General Medical History Question

Data type

boolean

Cutaneous
Description

Diagnosis

Data type

text

Status
Description

Status

Data type

text

Eyes
Description

DIAGNOSIS

Data type

text

Status
Description

Status

Data type

text

Ears-Nose-Throat
Description

DIAGNOSIS

Data type

text

Status
Description

Status

Data type

text

Cardiovascular
Description

DIAGNOSIS

Data type

text

Status
Description

Status

Data type

text

Respiratory
Description

DIAGNOSIS

Data type

text

Status
Description

Status

Data type

text

Gastrointestinal
Description

DIAGNOSIS

Data type

text

Status
Description

Status

Data type

text

Muskuloskeletal
Description

DIAGNOSIS

Data type

text

Status
Description

Status

Data type

text

Neurological
Description

DIAGNOSIS

Data type

text

Status
Description

Status

Data type

text

Genitourinary
Description

DIAGNOSIS

Data type

text

Status
Description

Status

Data type

text

Haematology
Description

DIAGNOSIS

Data type

text

Status
Description

Status

Data type

text

Allergies
Description

DIAGNOSIS

Data type

text

Status
Description

Status

Data type

text

Endocrine
Description

DIAGNOSIS

Data type

text

Status
Description

Status

Data type

text

Crying
Description

persistent crying (crying continuous and unaltered >= 3 hours)

Data type

text

Status
Description

Status

Data type

text

Other (specify)
Description

DIAGNOSIS; Please report medication(s) as specified in the protocol and fill in the Medication section.

Data type

text

Status
Description

Status

Data type

text

PHYSICAL EXAMINATION
Description

PHYSICAL EXAMINATION

Height
Description

Height

Data type

integer

Measurement units
  • cm
cm
Weight
Description

Weight

Data type

float

Measurement units
  • kg
kg
LABORATORY TESTS
Description

LABORATORY TESTS

Has a blood sample been taken ?
Description

Blood Sample Taken

Data type

boolean

If yes, please record the date
Description

Date Sample Taken

Data type

date

VACCINE ADMINISTRATION
Description

VACCINE ADMINISTRATION

Date
Description

Vaccination Date

Data type

date

Pre-Vaccination Temperature
Description

HBV+DTPw-HBV Hib/Kft. and DTPw-HBV Hib/Kft. groups

Data type

float

Measurement units
  • °C
°C
Route
Description

Temperature Route

Data type

text

Vaccine
Description

(only one box must be ticked by vaccine)

Data type

text

Vial Number For Replacement Vial
Description

Vial Number For Replacement Vial

Data type

integer

Vial Number For Wrong Vial
Description

Vial Number For Wrong Vial

Data type

integer

Side
Description

Side

Data type

text

Site
Description

Site

Data type

text

Route
Description

Route

Data type

text

Comment
Description

Comment

Data type

text

VACCINE ADMINISTRATION 2
Description

VACCINE ADMINISTRATION 2

Date
Description

Vaccination Date

Data type

date

Pre-vaccination Temperature
Description

DTPw-HBV Kft. + Hiberix™ group

Data type

float

Measurement units
  • °C
°C
Route
Description

Temperature Route

Data type

text

Vaccine
Description

(only one box must be ticked by vaccine)

Data type

text

Vial Number For Replacement Vial
Description

Vial Number For Replacement Vial

Data type

integer

Vial Number For Wrong Vial
Description

Vial Number For Wrong Vial

Data type

integer

Side
Description

Side

Data type

text

Site
Description

Site

Data type

text

Route
Description

Route

Data type

text

Vaccine
Description

(only one box must be ticked by vaccine)

Data type

text

Vial Number For Replacement Vial
Description

Vial Number For Replacement Vial

Data type

integer

Vial Number For Wrong Vial
Description

Vial Number For Wrong Vial

Data type

integer

Side
Description

Side

Data type

text

Site
Description

Site

Data type

text

Route
Description

Route

Data type

text

Comments
Description

Comments

Data type

text

VACCINE ADMINISTRATION 3
Description

VACCINE ADMINISTRATION 3

Date
Description

Vaccination Date

Data type

date

Pre-Vaccination temperature
Description

Tritanrix™-HepB/Hiberix™ group

Data type

float

Measurement units
  • °C
°C
Route
Description

Temperature Route

Data type

text

Vaccine
Description

(only one box must be ticked by vaccine)

Data type

text

Vial Number For Replacement Vial
Description

Vial Number For Replacement Vial

Data type

integer

Vial Number For Wrong Vial
Description

Vial Number For Wrong Vial

Data type

integer

Side
Description

Side

Data type

text

Site
Description

Site

Data type

text

Route
Description

Route

Data type

text

Comments
Description

Comments

Data type

text

VACCINE NON-ADMINISTRATION
Description

VACCINE NON-ADMINISTRATION

Why was the vaccine not administered?
Description

Please tick the ONE most appropriate category for non administration:

Data type

text

Please specify SAE N°
Description

SAE Number

Data type

integer

Please specify unsolicited AE N° or solicited AE code
Description

AE Number

Data type

integer

Other, please specify
Description

(e.g.: consent withdrawal, protocol violation, …)

Data type

text

Please tick who took the decision
Description

Who Made Decision

Data type

text

IMMEDIATE POST-VACCINATION OBSERVATION
Description

Post-Vaccination Observation Reminder

Data type

text

ADVERSE EVENTS
Description

ADVERSE EVENTS

Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination ?
Description

Adverse Events Occurence

Data type

text

SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS
Description

SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS

Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Description

If any of these adverse events are serious according to Protocol definition, please report event to GSK monitor by telephone or fax within 24 hours (see Protocol) and complete the Serious Adverse Event form.

Data type

text

LOCAL SYMPTOMS
Description

LOCAL SYMPTOMS

Redness
Description

Redness

Data type

boolean

Day
Description

Day

Data type

text

Size
Description

Redness Size

Data type

integer

Measurement units
  • mm
mm
Ongoing after day 3?
Description

Status Ongoing

Data type

boolean

Date of last day of symptoms
Description

Last Day Of Symptoms

Data type

date

Was the visit medically attended?
Description

Medically Attended Visit

Data type

boolean

Type of medical help:
Description

Medical Involvement

Data type

text

Swelling
Description

Swelling

Data type

boolean

Day
Description

Day

Data type

text

Size
Description

Swelling Size

Data type

integer

Measurement units
  • mm
mm
Ongoing after day 3?
Description

Status Ongoing

Data type

boolean

Date of last day of symptoms
Description

Last Day Of Symptoms

Data type

date

Was the visit medically attended?
Description

Medically Attended Visit

Data type

boolean

Type of medical help:
Description

Medical Involvement

Data type

text

Pain
Description

Pain

Data type

boolean

Intensity
Description

Pain Intensity

Data type

text

Ongoing after day 3?
Description

Status Ongoing

Data type

boolean

Date of last day of symptoms
Description

Last Day Of Symptoms

Data type

date

Was the visit medically attended?
Description

Medically Attended Visit

Data type

boolean

Type of medical help:
Description

Medical Involvement

Data type

text

SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS (vaccine specific)
Description

SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS (vaccine specific)

For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Description

AE Local Symptoms Question

Data type

text

Redness
Description

Redness

Data type

boolean

Day
Description

Day

Data type

text

Size
Description

Redness Size

Data type

integer

Measurement units
  • mm
mm
Ongoing after day 3?
Description

Status Ongoing

Data type

boolean

Date of last day of symptoms
Description

Last Day Of Symptoms

Data type

date

Was the visit medically attended?
Description

Medically Attended Visit

Data type

boolean

Type of medical help:
Description

Medical Involvement

Data type

text

Swelling
Description

Swelling

Data type

boolean

Day
Description

Day

Data type

text

Size
Description

Swelling Size

Data type

integer

Measurement units
  • mm
mm
Ongoing after day 3?
Description

Status Ongoing

Data type

boolean

Date of last day of symptoms
Description

Last Day Of Symptoms

Data type

date

Was the visit medically attended?
Description

Medically Attended Visit

Data type

boolean

Type of medical help:
Description

Medical Involvement

Data type

text

Pain
Description

Pain

Data type

boolean

Day
Description

Day

Data type

text

Intensity
Description

Pain Intensity

Data type

text

Ongoing after day 3?
Description

Status Ongoing

Data type

boolean

Date of last day of symptoms
Description

Last Day Of Symptoms

Data type

date

Was the visit medically attended?
Description

Medically Attended Visit

Data type

boolean

Type of medical help:
Description

Medical Involvement

Data type

text

DTPw-HBV Kft. vaccine
Description

DTPw-HBV Kft. vaccine

Redness
Description

Redness

Data type

boolean

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C2700396
Day
Description

Day

Data type

integer

Size
Description

size; please measure the greatest diameter

Data type

integer

Measurement units
  • mm
mm
Ongoing after day 3?
Description

Status Ongoing

Data type

boolean

Date of last day of symptoms
Description

Last Day Of Symptoms

Data type

date

Was the visit medically attended?
Description

Medically Attended Visit

Data type

boolean

Type of medical help:
Description

Medical Involvement

Data type

text

Swelling
Description

Swelling

Data type

boolean

Day
Description

Day

Data type

text

Size
Description

Swelling Size

Data type

integer

Measurement units
  • mm
mm
Ongoing after day 3?
Description

Status Ongoing

Data type

boolean

Date of last day of symptoms
Description

Last Day Of Symptoms

Data type

date

Was the visit medically attended?
Description

Medically Attended Visit

Data type

boolean

Type of medical help:
Description

Medical Involvement

Data type

text

Pain
Description

Pain

Data type

boolean

Day
Description

Day

Data type

text

Intensity
Description

Pain Intensity

Data type

text

Ongoing after day 3?
Description

Status Ongoing

Data type

boolean

Date of last day of symptoms
Description

Last Day Of Symptoms

Data type

date

Was the visit medically attended?
Description

Medically Attended Visit

Data type

boolean

Type of medical help:
Description

Medical Involvement

Data type

text

Hiberix™ vaccine
Description

Hiberix™ vaccine

Redness
Description

Redness

Data type

boolean

Day
Description

Day

Data type

integer

Size
Description

Redness Size

Data type

integer

Measurement units
  • mm
mm
Ongoing after day 3?
Description

Status Ongoing

Data type

boolean

Date of last day of symptoms
Description

Last Day Of Symptoms

Data type

date

Was the visit medically attended?
Description

Medically Attended Visit

Data type

boolean

Type of medical help:
Description

Medical Involvement

Data type

text

Swelling
Description

Swelling

Data type

boolean

Day
Description

Day

Data type

text

Size
Description

Swelling Size

Data type

integer

Measurement units
  • mm
mm
Ongoing after day 3?
Description

Status Ongoing

Data type

boolean

Date of last day of symptoms
Description

Last Day Of Symptoms

Data type

date

Was the visit medically attended?
Description

Medically Attended Visit

Data type

boolean

Type of medical help:
Description

Medical Involvement

Data type

text

Pain
Description

Pain

Data type

boolean

Day
Description

Day

Data type

text

Intensity
Description

Pain Intensity

Data type

text

Ongoing after day 3?
Description

Status Ongoing

Data type

boolean

Date of last day of symptoms
Description

Last Day Of Symptoms

Data type

date

Was the visit medically attended?
Description

Medically Attended Visit

Data type

boolean

Type of medical help:
Description

Medical Involvement

Data type

text

SOLICITED ADVERSE EVENTS – GENERAL SYMPTOMS
Description

SOLICITED ADVERSE EVENTS – GENERAL SYMPTOMS

Has the subject experienced any of the following signs/symptoms during the solicited period?
Description

General AE Symptoms Question

Data type

text

GENERAL SYMPTOMS
Description

GENERAL SYMPTOMS

Fever
Description

Fever: Axillary > 37.5 °C Rectal > 38 °C

Data type

boolean

Day
Description

Day

Data type

text

Description

temperature

Data type

float

Measurement units
  • °C
°C
t° not taken
Description

t° not taken

Data type

boolean

Route
Description

Route

Data type

text

Ongoing after day 3?
Description

Status Ongoing

Data type

boolean

Date of last day of symptoms
Description

Last day of symptoms

Data type

date

Causality
Description

Causality

Data type

boolean

Medically attended visit
Description

Medically attended visit

Data type

text

Irritability / Fussiness
Description

Irritability / Fussiness

Data type

boolean

Day
Description

Day

Data type

text

Intensity
Description

Irritability / Fussiness Intensity

Data type

text

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) ?
Description

In case of severe intensity

Data type

boolean

was the crying unaltered > 3 hours ?
Description

crying in case of severe intensity

Data type

boolean

Ongoing after day 3?
Description

Status Ongoing

Data type

boolean

Date of last day of symptoms
Description

Last day of symptoms

Data type

date

Causality
Description

Causality

Data type

boolean

Medically attended visit
Description

Medically attended visit

Data type

text

Drowsiness
Description

Drowsiness

Data type

boolean

Day
Description

Day

Data type

text

Intensity
Description

Drowsiness Intensity

Data type

text

Ongoing after day 3?
Description

Status Ongoing

Data type

boolean

Causality
Description

Causality

Data type

boolean

Medically attended visit
Description

Medically attended visit

Data type

text

Loss of appetite
Description

Loss of appetite

Data type

boolean

Day
Description

Day

Data type

text

Intensity
Description

Intensity

Data type

text

Ongoing after day 3?
Description

Status Ongoing

Data type

boolean

Date of last day of symptoms
Description

Last day of symptoms

Data type

date

Causality
Description

Causality

Data type

boolean

Medically attended visit
Description

Medically attended visit

Data type

text

Similar models

Visit 2 (Month 1.5 42 – 62 days after birth)

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
VisitNumber
Item
Visit Number
integer
SubjectNumber
Item
Subject Number
integer
Item Group
CHECK FOR STUDY CONTINUATION
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
Item
Please tick who took the decision
text
Code List
Please tick who took the decision
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
Item Group
GENERAL MEDICAL HISTORY
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
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Eyes
Item
Eyes
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Ears-Nose-Throat
Item
Ears-Nose-Throat
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Cardiovascular
Item
Cardiovascular
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Respiratory
Item
Respiratory
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Gastrointestinal
Item
Gastrointestinal
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Muskuloskeletal
Item
Muskuloskeletal
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Neurological
Item
Neurological
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Genitourinary
Item
Genitourinary
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Haematology
Item
Haematology
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Allergies
Item
Allergies
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Endocrine
Item
Endocrine
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Crying
Item
Crying
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Other Specify
Item
Other (specify)
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Item Group
PHYSICAL EXAMINATION
Height
Item
Height
integer
Weight
Item
Weight
float
Item Group
LABORATORY TESTS
Blood Sample Taken
Item
Has a blood sample been taken ?
boolean
Date Sample Taken
Item
If yes, please record the date
date
Item Group
VACCINE ADMINISTRATION
Vaccination Date
Item
Date
date
Pre-vaccinationTemperature
Item
Pre-Vaccination Temperature
float
Item
Route
text
Code List
Route
CL Item
Axillary (1)
CL Item
Rectal (2)
Item
Vaccine
text
Code List
Vaccine
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
Item
Side
text
Code List
Side
CL Item
Left (1)
CL Item
Right (2)
Item
Site
text
Code List
Site
CL Item
Thigh (1)
CL Item
Deltoid (2)
CL Item
Buttock (3)
Item
Route
text
Code List
Route
CL Item
I.M. (1)
CL Item
S.C. (2)
Comment
Item
Comment
text
Item Group
VACCINE ADMINISTRATION 2
Vaccination Date
Item
Date
date
Pre-vaccinationTemperature
Item
Pre-vaccination Temperature
float
Item
Route
text
Code List
Route
CL Item
Axillary (1)
CL Item
Rectal (2)
Item
Vaccine
text
Code List
Vaccine
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
Item
Side
text
Code List
Side
CL Item
Left (1)
CL Item
Right (2)
Item
Site
text
Code List
Site
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
Route
text
Code List
Route
CL Item
I.M. (1)
CL Item
S.C. (2)
Item
Vaccine
text
Code List
Vaccine
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
Item
Side
text
Code List
Side
CL Item
Left (1)
CL Item
Right (2)
Item
Site
text
Code List
Site
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
Route
text
Code List
Route
CL Item
I.M. (1)
CL Item
S.C. (2)
Comments
Item
Comments
text
Item Group
VACCINE ADMINISTRATION 3
Vaccination Date
Item
Date
date
Pre-Vaccination temperature
Item
Pre-Vaccination temperature
float
Item
Route
text
Code List
Route
CL Item
Axillary (1)
CL Item
Rectal (2)
Item
Vaccine
text
Code List
Vaccine
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
Item
Side
text
Code List
Side
CL Item
Left (1)
CL Item
Right (2)
Item
Site
text
Code List
Site
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
Route
text
Code List
Route
CL Item
I.M. (1)
CL Item
S.C. (2)
Comments
Item
Comments
text
Item Group
VACCINE NON-ADMINISTRATION
Item
Why was the vaccine not administered?
text
Code List
Why was the vaccine not administered?
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
Item
Please tick who took the decision
text
Code List
Please tick who took the decision
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
Item
IMMEDIATE POST-VACCINATION OBSERVATION
text
Code List
IMMEDIATE POST-VACCINATION OBSERVATION
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 Group
ADVERSE EVENTS
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 Group
SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS
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)
Item Group
LOCAL SYMPTOMS
Redness
Item
Redness
boolean
Item
Day
text
Code List
Day
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
Item
Type of medical help:
text
Code List
Type of medical help:
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Swelling
Item
Swelling
boolean
Item
Day
text
Code List
Day
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
Item
Type of medical help:
text
Code List
Type of medical help:
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Pain
Item
Pain
boolean
Item
Intensity
text
Code List
Intensity
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
Item
Type of medical help:
text
Code List
Type of medical help:
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
Item
Day
text
Code List
Day
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
Item
Type of medical help:
text
Code List
Type of medical help:
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Swelling
Item
Swelling
boolean
Item
Day
text
Code List
Day
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
Item
Type of medical help:
text
Code List
Type of medical help:
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Pain
Item
Pain
boolean
Item
Day
text
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1  (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Item
Intensity
text
Code List
Intensity
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
Item
Type of medical help:
text
Code List
Type of medical help:
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item Group
DTPw-HBV Kft. vaccine
Redness
Item
Redness
boolean
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Item
Day
integer
Code List
Day
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
Item
Type of medical help:
text
Code List
Type of medical help:
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Swelling
Item
Swelling
boolean
Item
Day
text
Code List
Day
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
Item
Type of medical help:
text
Code List
Type of medical help:
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Pain
Item
Pain
boolean
Item
Day
text
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1  (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Item
Intensity
text
Code List
Intensity
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
Item
Type of medical help:
text
Code List
Type of medical help:
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item Group
Hiberix™ vaccine
Redness
Item
Redness
boolean
Item
Day
integer
Code List
Day
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
Item
Type of medical help:
text
Code List
Type of medical help:
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Swelling
Item
Swelling
boolean
Item
Day
text
Code List
Day
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
Item
Type of medical help:
text
Code List
Type of medical help:
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Pain
Item
Pain
boolean
Item
Day
text
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1  (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Item
Intensity
text
Code List
Intensity
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
Item
Type of medical help:
text
Code List
Type of medical help:
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item Group
SOLICITED ADVERSE EVENTS – GENERAL SYMPTOMS
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)
Item Group
GENERAL SYMPTOMS
Fever
Item
Fever
boolean
Item
Day
text
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
temperature
Item
float
t° not taken
Item
t° not taken
boolean
Item
Route
text
Code List
Route
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
Item
Medically attended visit
text
Code List
Medically attended visit
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Irritability / Fussiness
Item
Irritability / Fussiness
boolean
Item
Day
text
Code List
Day
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
Item
Medically attended visit
text
Code List
Medically attended visit
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Drowsiness
Item
Drowsiness
boolean
Item
Day
text
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Item
Intensity
text
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
Item
Medically attended visit
text
Code List
Medically attended visit
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Loss of appetite
Item
Loss of appetite
boolean
Item
Day
text
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Item
Intensity
text
Code List
Intensity
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
Item
Medically attended visit
text
Code List
Medically attended visit
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)

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