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)

PHYSICAL EXAMINATION

Item Group

PHYSICAL EXAMINATION

Height

Item

Height

integer

Weight

Item

Weight

float

LABORATORY TESTS

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

VACCINE ADMINISTRATION

Item Group

VACCINE ADMINISTRATION

Vaccination Date

Item

Date

date

Pre-vaccinationTemperature

Item

Pre-Vaccination Temperature

float

Temperature Route

Item

Route

text

TemperatureMethod

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

VACCINE ADMINISTRATION 2

Item Group

VACCINE ADMINISTRATION 2

Vaccination Date

Item

Date

date

Pre-vaccinationTemperature

Item

Pre-vaccination Temperature

float

Temperature Route

Item

Route

text

TemperatureMethod

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

Side:

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

VACCINE ADMINISTRATION 3

Item Group

VACCINE ADMINISTRATION 3

Vaccination Date

Item

Date

date

Pre-Vaccination temperature

Item

Pre-Vaccination temperature

float

Temperature Route

Item

Route

text

TemperatureRoute

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

VACCINE NON-ADMINISTRATION

Code List

Route

CL Item

I.M. (1)

CL Item

S.C. (2)

Comments

Item

Comments

text

Item Group

VACCINE NON-ADMINISTRATION

Non Administration Reason

Item

Why was the vaccine not administered?

text

NonAdministrationReason

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

Who Made Decision

Item

Please tick who took the decision

text

WhoMadeDecision

Code List

Please tick who took the decision

CL Item

Investigator (1)

CL Item

Parents/Guardians (2)

Post-Vaccination Observation Reminder

Item

IMMEDIATE POST-VACCINATION OBSERVATION

text

PostVaccinationObservationReminder

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.)

ADVERSE EVENTS

Item Group

ADVERSE EVENTS

Adverse Events Occurence

Item

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

text

AdverseEventsOccurence

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)

SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS

Item Group

SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS

AE Local Symptoms Question

Item

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

text

AELocalSymptomsQuestion

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)

LOCAL SYMPTOMS

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

PainIntensity

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

SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS (vaccine specific)

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)

AE Local Symptoms Question

Item

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

text

AELocalSymptomsQuestion

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

PainIntensity

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)

DTPw-HBV Kft. vaccine

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)

Hiberix™ vaccine

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

SOLICITED ADVERSE EVENTS – GENERAL SYMPTOMS

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

General AE Symptoms Question

Item

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

text

General AE Symptoms Question

Code List

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

CL Item

Information not available (1)

CL Item

No vaccine administered (2)

CL Item

No (3)

CL Item

Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (4)

GENERAL SYMPTOMS

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

t°

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

Irritability / Fussiness Intensity

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

Irritability / Fussiness Intensity

Code List

Intensity

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

Irritability / Fussiness Intensity

Code List

Day

CL Item

Day 0 (1)

CL Item

Day 1 (2)

CL Item

Day 2 (3)

CL Item

Day 3 (4)

Drowsiness Intensity

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

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)

Intensity

Item

Intensity

text

Intensity

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