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Visit 2: Vaccine Administration, Symptoms, Adverse Events Forms

1 forms  
Administrative data
Description

Administrative data

Visit Number
Description

Visit Number

Data type

integer

Day
Description

Day

Data type

text

Dose
Description

Dose

Data type

text

Subject Number
Description

Subject Number

Data type

integer

Date of Visit
Description

Date of Visit

Data type

date

Check for Study Continuation
Description

Check for Study Continuation

Did the subject return for Visit 2?
Description

Did the subject return for Visit 2?

Data type

boolean

If No, please tick ONE most appropriate reason
Description

and skip the following sections

Data type

text

If Other, please specify
Description

If Other, please specify

Data type

text

If SAE, record the SAE number
Description

If SAE, record the SAE number

Data type

integer

If non-SAE, please record the AE number
Description

If non-SAE, please record the AE number

Data type

integer

Please tick who took the decision
Description

Please tick who took the decision

Data type

text

Vaccine Administration - Vaccine 1
Description

Vaccine Administration - Vaccine 1

Date
Description

fill in only if different from visit date

Data type

date

Pre-Vaccination temperature
Description

Pre-Vaccination temperature

Data type

float

Measurement units
  • °C
°C
Route
Description

Route

Data type

integer

Tick ONLY one box by vaccine
Description

Tick ONLY one box by vaccine

Data type

text

If replacement vial, please record the number
Description

If replacement vial, please record the number

Data type

integer

If wrong vial, please record the number
Description

If wrong vial, please record the number

Data type

integer

Side
Description

According to Protocol

Data type

text

Site
Description

According to Protocol

Data type

text

Route
Description

According to Protocol

Data type

text

Has the study vaccine been administered according to the Protocol?
Description

If No, please tick below all items that apply

Data type

boolean

Side
Description

Side

Data type

text

Site
Description

Site

Data type

text

Route
Description

Route

Data type

text

Vaccine Administration - Vaccine 2
Description

Vaccine Administration - Vaccine 2

Tick ONLY one box by vaccine
Description

Tick ONLY one box by vaccine

Data type

text

If Replacement vial, please record the number
Description

If Replacement vial, please record the number

Data type

integer

If Wrong vial number, please record the number
Description

If Wrong vial number, please record the number

Data type

integer

Side
Description

According to Protocol

Data type

text

Site
Description

According to Protocol

Data type

text

Route
Description

According to Protocol

Data type

text

Has the study vaccine been administered according to protocol?
Description

If No, please tick below all items that apply

Data type

text

Side
Description

Side

Data type

text

Site
Description

Site

Data type

text

Route
Description

Route

Data type

text

Comment
Description

Comment

Data type

text

Non-administration
Description

Non-administration

If vaccine not administered, choose ONE most appropriate reason
Description

If any AE occurred during the immediate post-vaccination time (30 min) please fill in the Solicited AE section, the Non-SAE section or a SAE form. If any prophylactic medication has been administered in anticipation of study vaccine reaction, please complete the Medication section and tick prophylactic box. Any other vaccines administered during the study period must be recorded in the Concomitant Vaccination section.

Data type

text

If Other, please specify
Description

If Other, please specify

Data type

text

If SAE, record the SAE number
Description

If SAE, record the SAE number

Data type

integer

If non-SAE, please record the AE number
Description

If non-SAE, please record the AE number

Data type

integer

Unsolicited Adverse Events
Description

Unsolicited Adverse Events

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

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

Data type

text

Solicited Adverse Events - Local Symptoms
Description

Solicited Adverse Events - Local Symptoms

Local Symptom
Description

Hib-MenC vaccine or MeningitecTM vaccine

Data type

integer

Day
Description

Day

Data type

integer

If Redness, record size
Description

If Redness, record size

Data type

float

Measurement units
  • mm
mm
If Swelling, record size
Description

If Swelling, record size

Data type

float

Measurement units
  • mm
mm
If Pain, record Intensity
Description

If Pain, record Intensity

Data type

text

Ongoing after day 3?
Description

Ongoing after day 3?

Data type

boolean

Date of last day of symptoms
Description

Date of last day of symptoms

Data type

date

Was the visit medically attended?
Description

Medically attended visit?

Data type

boolean

If Yes, please record type
Description

If Yes, please record type

Data type

text

Solicited Adverse Events - Local Symptoms - Vaccine 2
Description

Solicited Adverse Events - Local Symptoms - Vaccine 2

Local Symptom
Description

InfanrixTM-IPV vaccine or PediacelTM vaccine

Data type

text

Day
Description

Day

Data type

text

If Redness, record size
Description

If Redness, record size

Data type

float

Measurement units
  • mm
mm
If Swelling, record size
Description

If Swelling, record size

Data type

float

Measurement units
  • mm
mm
If Pain, record Intensity
Description

If Pain, record Intensity

Data type

text

Ongoing after day 3?
Description

Ongoing after day 3?

Data type

boolean

Date of last day of symptoms
Description

Date of last day of symptoms

Data type

date

Was the visit medically attended?
Description

medically attended visit?

Data type

boolean

If Yes, please record type
Description

If Yes, please record type

Data type

text

Solicited Adverse Events
Description

Solicited Adverse Events

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

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

Data type

text

General Symptoms
Description

General Symptoms

Symptom
Description

Symptom

Data type

integer

Day
Description

Day

Data type

integer

If Fever, record t°
Description

preferably axillary! Axillary >= 37.5°C Rectal >=38°C

Data type

float

Measurement units
  • °C
°C
If Irritability / Fussiness, record intensity
Description

If Irritability / Fussiness, record intensity

Data type

text

If Drowsiness, record intensity
Description

If Drowsiness, record intensity

Data type

integer

If Loss of appetite, record intensity
Description

If Loss of appetite, record intensity

Data type

text

Ongoing after day 3?
Description

Ongoing after day 3?

Data type

boolean

Date of last day of symptoms
Description

Date of last day of symptoms

Data type

date

Causality
Description

Causality

Data type

boolean

Medically attended visit?
Description

Medically attended visit?

Data type

boolean

If Yes, record the type
Description

If Yes, record the type

Data type

text

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Visit 2: Vaccine Administration, Symptoms, Adverse Events Forms

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Item
Visit Number
integer
Visit Number
Code List
Visit Number
CL Item
Visit 2 (1)
Item
Day
text
Day
Code List
Day
CL Item
28-42 days after Visit 1 (1)
Item
Dose
text
Dose
Code List
Dose
CL Item
Dose 2 (1)
Subject Number
Item
Subject Number
integer
Date of Visit
Item
Date of Visit
date
Item Group
Check for Study Continuation
Did the subject return for Visit 2?
Item
Did the subject return for Visit 2?
boolean
Item
If No, please tick ONE most appropriate reason
text
If No, please tick ONE most appropriate reason
Code List
If No, please tick ONE most appropriate reason
CL Item
Serious Adverse Event (SAE) (1)
CL Item
Non-Serious Adverse Event (Non-SAE) (2)
CL Item
Other (e.g.withdrawal,protocol violation) (3)
If Other, please specify
Item
If Other, please specify
text
If SAE, record the SAE number
Item
If SAE, record the SAE number
integer
If non-SAE, please record the AE number
Item
If non-SAE, please record the AE number
integer
Item
Please tick who took the decision
text
Please tick who took the decision
Code List
Please tick who took the decision
CL Item
Investigator (1)
CL Item
Parents / Guardians (2)
Item Group
Vaccine Administration - Vaccine 1
Date
Item
Date
date
Pre-Vaccination temperature
Item
Pre-Vaccination temperature
float
Item
Route
integer
Route
Code List
Route
CL Item
Axillary (1)
CL Item
Rectal (2)
Item
Tick ONLY one box by vaccine
text
Tick ONLY one box by vaccine
Code List
Tick ONLY one box by vaccine
CL Item
Hib-MenC Vaccine (1)
CL Item
MeningitecTM Vaccine (2)
CL Item
Replacement vial (3)
CL Item
Wrong vial number (4)
CL Item
Not administered -> please complete following section (5)
If replacement vial, please record the number
Item
If replacement vial, please record the number
integer
If wrong vial, please record the number
Item
If wrong vial, please record the number
integer
Item
Side
text
Side
Code List
Side
CL Item
Right (1)
Item
Site
text
Site
Code List
Site
CL Item
Thigh (1)
Item
Route
text
Route
Code List
Route
CL Item
I.M. (1)
Has the study vaccine been administered according to the Protocol?
Item
Has the study vaccine been administered according to the Protocol?
boolean
Item
Side
text
Side
Code List
Side
CL Item
Left (1)
CL Item
Right (2)
Item
Site
text
Site
Code List
Site
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
text
Route
Code List
Route
CL Item
I.M. (1)
CL Item
S.C. (2)
Item Group
Vaccine Administration - Vaccine 2
Item
Tick ONLY one box by vaccine
text
Tick ONLY one box by vaccine
Code List
Tick ONLY one box by vaccine
CL Item
InfanrixTM-IPV Vaccine (1)
CL Item
PediacelTM Vaccine (2)
CL Item
Replacement vial (3)
CL Item
Wrong vial number (4)
CL Item
Not administered -> please complete following section (5)
If Replacement vial, please record the number
Item
If Replacement vial, please record the number
integer
If Wrong vial number, please record the number
Item
If Wrong vial number, please record the number
integer
Item
Side
text
Side
Code List
Side
CL Item
Left (1)
Item
Site
text
Site
Code List
Site
CL Item
Thigh (1)
Item
Route
text
Route
Code List
Route
CL Item
I.M. (1)
Has the study vaccine been administered according to protocol?
Item
Has the study vaccine been administered according to protocol?
text
Item
Side
text
Side
Code List
Side
CL Item
Left (1)
CL Item
Right (2)
Item
Site
text
Site
Code List
Site
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
Route
text
Route
Code List
Route
CL Item
I.M. (1)
CL Item
S.C. (2)
Comment
Item
Comment
text
Item Group
Non-administration
Item
If vaccine not administered, choose ONE most appropriate reason
text
If vaccine not administered, choose ONE most appropriate reason
Code List
If vaccine not administered, choose ONE most appropriate reason
CL Item
Serious Adverse Event (SAE) (1)
CL Item
Non-Serious Adverse Event (Non-SAE) (2)
CL Item
Other (e.g.withdrawal,protocol violation) (3)
If Other, please specify
Item
If Other, please specify
text
If SAE, record the SAE number
Item
If SAE, record the SAE number
integer
If non-SAE, please record the AE number
Item
If non-SAE, please record the AE number
integer
Item Group
Unsolicited Adverse Events
Item
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
text
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
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
Local Symptom
integer
Local Symptom
Code List
Local Symptom
CL Item
Redness (1)
CL Item
Swelling (2)
CL Item
Pain (3)
Item
Day
integer
Day
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
If Redness, record size
Item
If Redness, record size
float
If Swelling, record size
Item
If Swelling, record size
float
Item
If Pain, record Intensity
text
If Pain, record Intensity
Code List
If Pain, record Intensity
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Medically attended visit?
Item
Was the visit medically attended?
boolean
Item
If Yes, please record type
text
If Yes, please record type
Code List
If Yes, please record type
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item Group
Solicited Adverse Events - Local Symptoms - Vaccine 2
Item
Local Symptom
text
Local Symptom
Code List
Local Symptom
CL Item
Redness (1)
CL Item
Swelling (2)
CL Item
Pain (3)
Item
Day
text
Day
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
If Redness, record size
Item
If Redness, record size
float
If Swelling, record size
Item
If Swelling, record size
float
Item
If Pain, record Intensity
text
If Pain, record Intensity
Code List
If Pain, record Intensity
CL Item
none (1)
CL Item
mild (2)
CL Item
moderate (3)
CL Item
severe (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
medically attended visit?
Item
Was the visit medically attended?
boolean
Item
If Yes, please record type
text
If Yes, please record type
Code List
If Yes, please record type
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item Group
Solicited Adverse Events
Item
Has the subject experienced any of the following signs/symptoms during the solicited period?
text
Has the subject experienced any of the following signs/symptoms during the solicited period?
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 (4)
Item Group
General Symptoms
Item
Symptom
integer
Symptom
Code List
Symptom
CL Item
Fever (1)
CL Item
Irritability/Fussiness (2)
CL Item
Drowsiness (3)
CL Item
Loss of appetite (4)
Item
Day
integer
Day
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
If Fever, record t°
Item
If Fever, record t°
float
Item
If Irritability / Fussiness, record intensity
text
If Irritability / Fussiness, record intensity
Code List
If Irritability / Fussiness, record intensity
CL Item
none (1)
CL Item
mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item
If Drowsiness, record intensity
integer
If Drowsiness, record intensity
Code List
If Drowsiness, record intensity
CL Item
none (1)
CL Item
mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item
If Loss of appetite, record intensity
text
If Loss of appetite, record intensity
Code List
If Loss of appetite, record intensity
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Causality
Item
Causality
boolean
Medically attended visit?
Item
Medically attended visit?
boolean
Item
If Yes, record the type
text
If Yes, record the type
Code List
If Yes, record the type
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
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