ID

35328

Beschrijving

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

Trefwoorden

  1. 26-02-19 26-02-19 -
  2. 28-02-19 28-02-19 -
Houder van rechten

GSK group of companies

Geüploaded op

28 februari 2019

DOI

Voor een aanvraag inloggen.

Licentie

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
Beschrijving

Administrative data

Visit Number
Beschrijving

VisitNumber

Datatype

integer

Subject Number
Beschrijving

SubjectNumber

Datatype

integer

CHECK FOR STUDY CONTINUATION
Beschrijving

CHECK FOR STUDY CONTINUATION

Did the subject come at visit 2 ?
Beschrijving

Study Continuation Question

Datatype

boolean

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

Reason For Discontinuation

Datatype

text

If Other, please specify
Beschrijving

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

Datatype

text

Please tick who took the decision
Beschrijving

Who made decision

Datatype

text

GENERAL MEDICAL HISTORY
Beschrijving

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 ?
Beschrijving

General Medical History Question

Datatype

boolean

Cutaneous
Beschrijving

Diagnosis

Datatype

text

Status
Beschrijving

Status

Datatype

text

Eyes
Beschrijving

DIAGNOSIS

Datatype

text

Status
Beschrijving

Status

Datatype

text

Ears-Nose-Throat
Beschrijving

DIAGNOSIS

Datatype

text

Status
Beschrijving

Status

Datatype

text

Cardiovascular
Beschrijving

DIAGNOSIS

Datatype

text

Status
Beschrijving

Status

Datatype

text

Respiratory
Beschrijving

DIAGNOSIS

Datatype

text

Status
Beschrijving

Status

Datatype

text

Gastrointestinal
Beschrijving

DIAGNOSIS

Datatype

text

Status
Beschrijving

Status

Datatype

text

Muskuloskeletal
Beschrijving

DIAGNOSIS

Datatype

text

Status
Beschrijving

Status

Datatype

text

Neurological
Beschrijving

DIAGNOSIS

Datatype

text

Status
Beschrijving

Status

Datatype

text

Genitourinary
Beschrijving

DIAGNOSIS

Datatype

text

Status
Beschrijving

Status

Datatype

text

Haematology
Beschrijving

DIAGNOSIS

Datatype

text

Status
Beschrijving

Status

Datatype

text

Allergies
Beschrijving

DIAGNOSIS

Datatype

text

Status
Beschrijving

Status

Datatype

text

Endocrine
Beschrijving

DIAGNOSIS

Datatype

text

Status
Beschrijving

Status

Datatype

text

Crying
Beschrijving

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

Datatype

text

Status
Beschrijving

Status

Datatype

text

Other (specify)
Beschrijving

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

Datatype

text

Status
Beschrijving

Status

Datatype

text

PHYSICAL EXAMINATION
Beschrijving

PHYSICAL EXAMINATION

Height
Beschrijving

Height

Datatype

integer

Maateenheden
  • cm
cm
Weight
Beschrijving

Weight

Datatype

float

Maateenheden
  • kg
kg
LABORATORY TESTS
Beschrijving

LABORATORY TESTS

Has a blood sample been taken ?
Beschrijving

Blood Sample Taken

Datatype

boolean

If yes, please record the date
Beschrijving

Date Sample Taken

Datatype

date

VACCINE ADMINISTRATION
Beschrijving

VACCINE ADMINISTRATION

Date
Beschrijving

Vaccination Date

Datatype

date

Pre-Vaccination Temperature
Beschrijving

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

Datatype

float

Maateenheden
  • °C
°C
Route
Beschrijving

Temperature Route

Datatype

text

Vaccine
Beschrijving

(only one box must be ticked by vaccine)

Datatype

text

Vial Number For Replacement Vial
Beschrijving

Vial Number For Replacement Vial

Datatype

integer

Vial Number For Wrong Vial
Beschrijving

Vial Number For Wrong Vial

Datatype

integer

Side
Beschrijving

Side

Datatype

text

Site
Beschrijving

Site

Datatype

text

Route
Beschrijving

Route

Datatype

text

Comment
Beschrijving

Comment

Datatype

text

VACCINE ADMINISTRATION 2
Beschrijving

VACCINE ADMINISTRATION 2

Date
Beschrijving

Vaccination Date

Datatype

date

Pre-vaccination Temperature
Beschrijving

DTPw-HBV Kft. + Hiberix™ group

Datatype

float

Maateenheden
  • °C
°C
Route
Beschrijving

Temperature Route

Datatype

text

Vaccine
Beschrijving

(only one box must be ticked by vaccine)

Datatype

text

Vial Number For Replacement Vial
Beschrijving

Vial Number For Replacement Vial

Datatype

integer

Vial Number For Wrong Vial
Beschrijving

Vial Number For Wrong Vial

Datatype

integer

Side
Beschrijving

Side

Datatype

text

Site
Beschrijving

Site

Datatype

text

Route
Beschrijving

Route

Datatype

text

Vaccine
Beschrijving

(only one box must be ticked by vaccine)

Datatype

text

Vial Number For Replacement Vial
Beschrijving

Vial Number For Replacement Vial

Datatype

integer

Vial Number For Wrong Vial
Beschrijving

Vial Number For Wrong Vial

Datatype

integer

Side
Beschrijving

Side

Datatype

text

Site
Beschrijving

Site

Datatype

text

Route
Beschrijving

Route

Datatype

text

Comments
Beschrijving

Comments

Datatype

text

VACCINE ADMINISTRATION 3
Beschrijving

VACCINE ADMINISTRATION 3

Date
Beschrijving

Vaccination Date

Datatype

date

Pre-Vaccination temperature
Beschrijving

Tritanrix™-HepB/Hiberix™ group

Datatype

float

Maateenheden
  • °C
°C
Route
Beschrijving

Temperature Route

Datatype

text

Vaccine
Beschrijving

(only one box must be ticked by vaccine)

Datatype

text

Vial Number For Replacement Vial
Beschrijving

Vial Number For Replacement Vial

Datatype

integer

Vial Number For Wrong Vial
Beschrijving

Vial Number For Wrong Vial

Datatype

integer

Side
Beschrijving

Side

Datatype

text

Site
Beschrijving

Site

Datatype

text

Route
Beschrijving

Route

Datatype

text

Comments
Beschrijving

Comments

Datatype

text

VACCINE NON-ADMINISTRATION
Beschrijving

VACCINE NON-ADMINISTRATION

Why was the vaccine not administered?
Beschrijving

Please tick the ONE most appropriate category for non administration:

Datatype

text

Please specify SAE N°
Beschrijving

SAE Number

Datatype

integer

Please specify unsolicited AE N° or solicited AE code
Beschrijving

AE Number

Datatype

integer

Other, please specify
Beschrijving

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

Datatype

text

Please tick who took the decision
Beschrijving

Who Made Decision

Datatype

text

IMMEDIATE POST-VACCINATION OBSERVATION
Beschrijving

Post-Vaccination Observation Reminder

Datatype

text

ADVERSE EVENTS
Beschrijving

ADVERSE EVENTS

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

Adverse Events Occurence

Datatype

text

SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS
Beschrijving

SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS

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

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.

Datatype

text

LOCAL SYMPTOMS
Beschrijving

LOCAL SYMPTOMS

Redness
Beschrijving

Redness

Datatype

boolean

Day
Beschrijving

Day

Datatype

text

Size
Beschrijving

Redness Size

Datatype

integer

Maateenheden
  • mm
mm
Ongoing after day 3?
Beschrijving

Status Ongoing

Datatype

boolean

Date of last day of symptoms
Beschrijving

Last Day Of Symptoms

Datatype

date

Was the visit medically attended?
Beschrijving

Medically Attended Visit

Datatype

boolean

Type of medical help:
Beschrijving

Medical Involvement

Datatype

text

Swelling
Beschrijving

Swelling

Datatype

boolean

Day
Beschrijving

Day

Datatype

text

Size
Beschrijving

Swelling Size

Datatype

integer

Maateenheden
  • mm
mm
Ongoing after day 3?
Beschrijving

Status Ongoing

Datatype

boolean

Date of last day of symptoms
Beschrijving

Last Day Of Symptoms

Datatype

date

Was the visit medically attended?
Beschrijving

Medically Attended Visit

Datatype

boolean

Type of medical help:
Beschrijving

Medical Involvement

Datatype

text

Pain
Beschrijving

Pain

Datatype

boolean

Intensity
Beschrijving

Pain Intensity

Datatype

text

Ongoing after day 3?
Beschrijving

Status Ongoing

Datatype

boolean

Date of last day of symptoms
Beschrijving

Last Day Of Symptoms

Datatype

date

Was the visit medically attended?
Beschrijving

Medically Attended Visit

Datatype

boolean

Type of medical help:
Beschrijving

Medical Involvement

Datatype

text

SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS (vaccine specific)
Beschrijving

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?
Beschrijving

AE Local Symptoms Question

Datatype

text

Redness
Beschrijving

Redness

Datatype

boolean

Day
Beschrijving

Day

Datatype

text

Size
Beschrijving

Redness Size

Datatype

integer

Maateenheden
  • mm
mm
Ongoing after day 3?
Beschrijving

Status Ongoing

Datatype

boolean

Date of last day of symptoms
Beschrijving

Last Day Of Symptoms

Datatype

date

Was the visit medically attended?
Beschrijving

Medically Attended Visit

Datatype

boolean

Type of medical help:
Beschrijving

Medical Involvement

Datatype

text

Swelling
Beschrijving

Swelling

Datatype

boolean

Day
Beschrijving

Day

Datatype

text

Size
Beschrijving

Swelling Size

Datatype

integer

Maateenheden
  • mm
mm
Ongoing after day 3?
Beschrijving

Status Ongoing

Datatype

boolean

Date of last day of symptoms
Beschrijving

Last Day Of Symptoms

Datatype

date

Was the visit medically attended?
Beschrijving

Medically Attended Visit

Datatype

boolean

Type of medical help:
Beschrijving

Medical Involvement

Datatype

text

Pain
Beschrijving

Pain

Datatype

boolean

Day
Beschrijving

Day

Datatype

text

Intensity
Beschrijving

Pain Intensity

Datatype

text

Ongoing after day 3?
Beschrijving

Status Ongoing

Datatype

boolean

Date of last day of symptoms
Beschrijving

Last Day Of Symptoms

Datatype

date

Was the visit medically attended?
Beschrijving

Medically Attended Visit

Datatype

boolean

Type of medical help:
Beschrijving

Medical Involvement

Datatype

text

DTPw-HBV Kft. vaccine
Beschrijving

DTPw-HBV Kft. vaccine

Redness
Beschrijving

Redness

Datatype

boolean

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

Day

Datatype

integer

Size
Beschrijving

size; please measure the greatest diameter

Datatype

integer

Maateenheden
  • mm
mm
Ongoing after day 3?
Beschrijving

Status Ongoing

Datatype

boolean

Date of last day of symptoms
Beschrijving

Last Day Of Symptoms

Datatype

date

Was the visit medically attended?
Beschrijving

Medically Attended Visit

Datatype

boolean

Type of medical help:
Beschrijving

Medical Involvement

Datatype

text

Swelling
Beschrijving

Swelling

Datatype

boolean

Day
Beschrijving

Day

Datatype

text

Size
Beschrijving

Swelling Size

Datatype

integer

Maateenheden
  • mm
mm
Ongoing after day 3?
Beschrijving

Status Ongoing

Datatype

boolean

Date of last day of symptoms
Beschrijving

Last Day Of Symptoms

Datatype

date

Was the visit medically attended?
Beschrijving

Medically Attended Visit

Datatype

boolean

Type of medical help:
Beschrijving

Medical Involvement

Datatype

text

Pain
Beschrijving

Pain

Datatype

boolean

Day
Beschrijving

Day

Datatype

text

Intensity
Beschrijving

Pain Intensity

Datatype

text

Ongoing after day 3?
Beschrijving

Status Ongoing

Datatype

boolean

Date of last day of symptoms
Beschrijving

Last Day Of Symptoms

Datatype

date

Was the visit medically attended?
Beschrijving

Medically Attended Visit

Datatype

boolean

Type of medical help:
Beschrijving

Medical Involvement

Datatype

text

Hiberix™ vaccine
Beschrijving

Hiberix™ vaccine

Redness
Beschrijving

Redness

Datatype

boolean

Day
Beschrijving

Day

Datatype

integer

Size
Beschrijving

Redness Size

Datatype

integer

Maateenheden
  • mm
mm
Ongoing after day 3?
Beschrijving

Status Ongoing

Datatype

boolean

Date of last day of symptoms
Beschrijving

Last Day Of Symptoms

Datatype

date

Was the visit medically attended?
Beschrijving

Medically Attended Visit

Datatype

boolean

Type of medical help:
Beschrijving

Medical Involvement

Datatype

text

Swelling
Beschrijving

Swelling

Datatype

boolean

Day
Beschrijving

Day

Datatype

text

Size
Beschrijving

Swelling Size

Datatype

integer

Maateenheden
  • mm
mm
Ongoing after day 3?
Beschrijving

Status Ongoing

Datatype

boolean

Date of last day of symptoms
Beschrijving

Last Day Of Symptoms

Datatype

date

Was the visit medically attended?
Beschrijving

Medically Attended Visit

Datatype

boolean

Type of medical help:
Beschrijving

Medical Involvement

Datatype

text

Pain
Beschrijving

Pain

Datatype

boolean

Day
Beschrijving

Day

Datatype

text

Intensity
Beschrijving

Pain Intensity

Datatype

text

Ongoing after day 3?
Beschrijving

Status Ongoing

Datatype

boolean

Date of last day of symptoms
Beschrijving

Last Day Of Symptoms

Datatype

date

Was the visit medically attended?
Beschrijving

Medically Attended Visit

Datatype

boolean

Type of medical help:
Beschrijving

Medical Involvement

Datatype

text

SOLICITED ADVERSE EVENTS – GENERAL SYMPTOMS
Beschrijving

SOLICITED ADVERSE EVENTS – GENERAL SYMPTOMS

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

General AE Symptoms Question

Datatype

text

GENERAL SYMPTOMS
Beschrijving

GENERAL SYMPTOMS

Fever
Beschrijving

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

Datatype

boolean

Day
Beschrijving

Day

Datatype

text

Beschrijving

temperature

Datatype

float

Maateenheden
  • °C
°C
t° not taken
Beschrijving

t° not taken

Datatype

boolean

Route
Beschrijving

Route

Datatype

text

Ongoing after day 3?
Beschrijving

Status Ongoing

Datatype

boolean

Date of last day of symptoms
Beschrijving

Last day of symptoms

Datatype

date

Causality
Beschrijving

Causality

Datatype

boolean

Medically attended visit
Beschrijving

Medically attended visit

Datatype

text

Irritability / Fussiness
Beschrijving

Irritability / Fussiness

Datatype

boolean

Day
Beschrijving

Day

Datatype

text

Intensity
Beschrijving

Irritability / Fussiness Intensity

Datatype

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) ?
Beschrijving

In case of severe intensity

Datatype

boolean

was the crying unaltered > 3 hours ?
Beschrijving

crying in case of severe intensity

Datatype

boolean

Ongoing after day 3?
Beschrijving

Status Ongoing

Datatype

boolean

Date of last day of symptoms
Beschrijving

Last day of symptoms

Datatype

date

Causality
Beschrijving

Causality

Datatype

boolean

Medically attended visit
Beschrijving

Medically attended visit

Datatype

text

Drowsiness
Beschrijving

Drowsiness

Datatype

boolean

Day
Beschrijving

Day

Datatype

text

Intensity
Beschrijving

Drowsiness Intensity

Datatype

text

Ongoing after day 3?
Beschrijving

Status Ongoing

Datatype

boolean

Causality
Beschrijving

Causality

Datatype

boolean

Medically attended visit
Beschrijving

Medically attended visit

Datatype

text

Loss of appetite
Beschrijving

Loss of appetite

Datatype

boolean

Day
Beschrijving

Day

Datatype

text

Intensity
Beschrijving

Intensity

Datatype

text

Ongoing after day 3?
Beschrijving

Status Ongoing

Datatype

boolean

Date of last day of symptoms
Beschrijving

Last day of symptoms

Datatype

date

Causality
Beschrijving

Causality

Datatype

boolean

Medically attended visit
Beschrijving

Medically attended visit

Datatype

text

Similar models

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

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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