ID

33987

Beschrijving

Study ID: 103974 (primary study) Clinical Study ID: 103974 Study Title: Demonstrate non-inferiority of Men-C immune response of Hib-MenC with Infanrix™-IPV versus a licensed Men-C vaccine with Pediacel™ when given at 2, 3, 4 months and the immunogenicity of Hib-MenC when given as a booster dose at 12-15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00258700 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENC-TT; Menitorix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

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  1. 10-01-19 10-01-19 -
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GSK group of companies

Geüploaded op

10 januari 2019

DOI

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Licentie

Creative Commons BY-NC 3.0

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Primary & Booster Immunogenicity of Hib-MenC vs a Licensed Men-C Vaccine - 103974

Diary Cards for Dose 1 (Primary)

Administrative data
Beschrijving

Administrative data

Dose Number
Beschrijving

Dose Number

Datatype

text

Subject Number
Beschrijving

Subject Number

Datatype

integer

Dose 1 - Local Symptoms - Vaccine 1
Beschrijving

Dose 1 - Local Symptoms - Vaccine 1

Please fill in the section below and assess the occurrence of any signs or symptoms at injection site
Beschrijving

for Hib-MenC vaccine or MeningitecTM vaccine

Datatype

text

Side of injection
Beschrijving

for investigator only

Datatype

text

Site of injection
Beschrijving

for investigator only

Datatype

text

Redness (Local Symptoms)
Beschrijving

Redness (Local Symptoms)

Day
Beschrijving

Day

Datatype

integer

Size
Beschrijving

please measure the greatest diameter

Datatype

float

Maateenheden
  • mm
mm
Is the symptom ongoing after day 3?
Beschrijving

Ongoing after day 3?

Datatype

boolean

If Yes, please record the last day of symptoms
Beschrijving

last day of symptoms

Datatype

date

Was the visit medically attended?
Beschrijving

medically attended visit

Datatype

boolean

Swelling (Local Symptoms)
Beschrijving

Swelling (Local Symptoms)

Day
Beschrijving

Day

Datatype

text

Size
Beschrijving

please measure the greatest diameter

Datatype

float

Maateenheden
  • mm
mm
Is the symptom ongoing after day 3?
Beschrijving

Ongoing after day 3?

Datatype

boolean

If Yes, please record the last day of symptoms
Beschrijving

last day of symptoms

Datatype

date

Was the visit medically attended?
Beschrijving

medically attended visit?

Datatype

boolean

Pain (Local Symptoms)
Beschrijving

Pain (Local Symptoms)

Day
Beschrijving

Day

Datatype

integer

Intensity
Beschrijving

Intensity

Datatype

integer

Is the symptom ongoing after day 3?
Beschrijving

Ongoing after day 3?

Datatype

boolean

If Yes, please record the last day of symptom
Beschrijving

last day of symptom

Datatype

date

Was the visit medically attended?
Beschrijving

medically attended visit?

Datatype

boolean

Dose 1 - Local Symptoms - Vaccine 2
Beschrijving

Dose 1 - Local Symptoms - Vaccine 2

Please fill in the section below and assess the occurrence of any signs or symptoms at injection site
Beschrijving

InfanrixTM-IPV vaccine or PediacelTM vaccine

Datatype

text

Injection Side
Beschrijving

for investigator only

Datatype

text

Injection Site
Beschrijving

for investigator only

Datatype

text

Redness (Local Symptoms)
Beschrijving

Redness (Local Symptoms)

Day
Beschrijving

Day

Datatype

integer

Size
Beschrijving

please measure the greatest diameter

Datatype

float

Maateenheden
  • mm
mm
Is the symptom ongoing after day 3?
Beschrijving

Ongoing after day 3?

Datatype

boolean

If Yes, please record the last day of symptom
Beschrijving

the last day of symptom

Datatype

date

Was the visit medically attended?
Beschrijving

medically attended visit

Datatype

boolean

Swelling (Local Symptoms)
Beschrijving

Swelling (Local Symptoms)

Day
Beschrijving

Day

Datatype

integer

Size
Beschrijving

please measure the greatest diameter

Datatype

float

Maateenheden
  • mm
mm
Is the symptom ongoing after day 3?
Beschrijving

Ongoing after day 3?

Datatype

boolean

If Yes, please record the last day of symptom
Beschrijving

last day of symptom

Datatype

date

Was the visit medically attended?
Beschrijving

medically attended visit?

Datatype

boolean

Pain (Local Symptoms)
Beschrijving

Pain (Local Symptoms)

Day
Beschrijving

Day

Datatype

integer

Intensity
Beschrijving

Intensity

Datatype

integer

Is the symptom ongoing after day 3?
Beschrijving

Ongoing after day 3?

Datatype

boolean

If Yes, please record the last day of symptom
Beschrijving

last day of symptom

Datatype

date

Was the visit medically attended?
Beschrijving

medically attended visit

Datatype

boolean

Dose 1 - Other Local Symptoms
Beschrijving

Dose 1 - Other Local Symptoms

Describe the side(s), site(s), and other details
Beschrijving

Description

Datatype

text

Please record the intensity of a symptom
Beschrijving

Mild (an adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities). Moderate (an adverse event which is sufficiently discomforting to interfere with normal everyday activities). Severe (an adverse event which prevents normal, everyday activities; in a young child, such an adverse event would, for example, prevent attendance at school/kindergarten/a day-care center and would cause the parents/guardians to seek medical advice).

Datatype

integer

Start date
Beschrijving

Start date

Datatype

date

End date
Beschrijving

End date

Datatype

date

Is the symptom/event ongoing after day 3?
Beschrijving

Ongoing?

Datatype

boolean

Was the visit medically attended?
Beschrijving

Medically attended visit?

Datatype

boolean

Dose 1 - General Symptoms
Beschrijving

Dose 1 - General Symptoms

Please fill in the section below and assess the occurrence of any signs or symptoms at injection site
Beschrijving

signs or symptoms at injection site

Datatype

text

Temperature (General Symptoms)
Beschrijving

Temperature (General Symptoms)

Day
Beschrijving

Day

Datatype

integer

Please record temperature
Beschrijving

Body Temperature

Datatype

float

Maateenheden
  • °C
°C
Type of temperature taking
Beschrijving

Type of temperature taking

Datatype

text

Is the symptom ongoing after day 3?
Beschrijving

Ongoing after day 3?

Datatype

boolean

If Yes, please record the last day of symptoms
Beschrijving

last day of symptoms

Datatype

date

Was the visit medically attended?
Beschrijving

Medically attended visit?

Datatype

boolean

Irritability / Fussiness (General Symptoms)
Beschrijving

Irritability / Fussiness (General Symptoms)

Day
Beschrijving

Day

Datatype

integer

Intensity
Beschrijving

Intensity

Datatype

integer

Is the symptom ongoing after day 3?
Beschrijving

Ongoing after day 3?

Datatype

boolean

If Yes, please record the last day of symptoms
Beschrijving

last day of symptoms

Datatype

date

Was the visit medically attended?
Beschrijving

medically attended visit?

Datatype

boolean

Drowsiness (General Symptoms)
Beschrijving

Drowsiness (General Symptoms)

Day
Beschrijving

Day

Datatype

integer

Intensity
Beschrijving

Intensity

Datatype

integer

Is the symptom ongoing after day 3?
Beschrijving

Ongoing after day 3?

Datatype

boolean

If Yes, please record the last day of symptoms
Beschrijving

last day of symptoms

Datatype

date

Was the visit medically attended?
Beschrijving

medically attended visit?

Datatype

boolean

Loss of Appetite (General Symptoms)
Beschrijving

Loss of Appetite (General Symptoms)

Day
Beschrijving

Day

Datatype

text

Intensity
Beschrijving

Intensity

Datatype

integer

Is the symptom ongoing after day 3?
Beschrijving

ongoing after day 3?

Datatype

boolean

If Yes, please record the last day of symptoms
Beschrijving

last day of symptoms

Datatype

date

Was the visit medically attended?
Beschrijving

Medically attended visit?

Datatype

boolean

Dose 1 - Other General Symptoms
Beschrijving

Dose 1 - Other General Symptoms

Describe the side(s), site(s), and other details below
Beschrijving

Symptom description

Datatype

text

Intensity
Beschrijving

Mild (an adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities). Moderate (an adverse event which is sufficiently discomforting to interfere with normal everyday activities). Severe (an adverse event which prevents normal, everyday activities; in a young child, such an adverse event would, for example, prevent attendance at school/kindergarten/a day-care center and would cause the parents/guardians to seek medical advice).

Datatype

text

Start date
Beschrijving

Start date

Datatype

date

End date
Beschrijving

End date

Datatype

boolean

Is the symptom / event ongoing?
Beschrijving

ongoing

Datatype

boolean

Was the visit medically attended?
Beschrijving

medically attended visit

Datatype

boolean

Dose 1 - Medication
Beschrijving

Dose 1 - Medication

Trade / Generic Name
Beschrijving

Please fill in if any medication has been taken since the vaccination

Datatype

text

Reason
Beschrijving

Reason

Datatype

text

Total Daily Dose
Beschrijving

Total Daily Dose

Datatype

text

Start Date
Beschrijving

Start Date

Datatype

date

End Date
Beschrijving

End Date

Datatype

date

Is the medication treatment ongoing?
Beschrijving

Ongoing?

Datatype

boolean

Reminder
Beschrijving

Reminder

Please do not forget to bring back the diary card on
Beschrijving

record date below

Datatype

date

Similar models

Diary Cards for Dose 1 (Primary)

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
Item
Dose Number
text
Code List
Dose Number
CL Item
Dose 1 (1)
CL Item
Dose 2 (2)
CL Item
Dose 3 (3)
Subject Number
Item
Subject Number
integer
Item Group
Dose 1 - Local Symptoms - Vaccine 1
signs or symptoms at injection site
Item
Please fill in the section below and assess the occurrence of any signs or symptoms at injection site
text
Item
Side of injection
text
Code List
Side of injection
CL Item
Left (1)
CL Item
Right (2)
Item
Site of injection
text
Code List
Site of injection
CL Item
Arm (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item Group
Redness (Local Symptoms)
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)
Size
Item
Size
float
Ongoing after day 3?
Item
Is the symptom ongoing after day 3?
boolean
last day of symptoms
Item
If Yes, please record the last day of symptoms
date
medically attended visit
Item
Was the visit medically attended?
boolean
Item Group
Swelling (Local Symptoms)
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)
Size
Item
Size
float
Ongoing after day 3?
Item
Is the symptom ongoing after day 3?
boolean
last day of symptoms
Item
If Yes, please record the last day of symptoms
date
medically attended visit?
Item
Was the visit medically attended?
boolean
Item Group
Pain (Local Symptoms)
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)
Item
Intensity
integer
Code List
Intensity
CL Item
absent (1)
CL Item
minor reaction to touch (2)
CL Item
cries /protests on touch (3)
CL Item
cries when limb is moved / spontaneously painful (4)
Ongoing after day 3?
Item
Is the symptom ongoing after day 3?
boolean
last day of symptom
Item
If Yes, please record the last day of symptom
date
medically attended visit?
Item
Was the visit medically attended?
boolean
signs or symptoms at injection site
Item
Please fill in the section below and assess the occurrence of any signs or symptoms at injection site
text
Item
Injection Side
text
Code List
Injection Side
CL Item
Left (1)
CL Item
Right (2)
Item
Injection Site
text
Code List
Injection Site
CL Item
Arm (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item Group
Redness (Local Symptoms)
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)
Size
Item
Size
float
Ongoing after day 3?
Item
Is the symptom ongoing after day 3?
boolean
the last day of symptom
Item
If Yes, please record the last day of symptom
date
medically attended visit
Item
Was the visit medically attended?
boolean
Item Group
Swelling (Local Symptoms)
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)
Size
Item
Size
float
Ongoing after day 3?
Item
Is the symptom ongoing after day 3?
boolean
last day of symptom
Item
If Yes, please record the last day of symptom
date
medically attended visit?
Item
Was the visit medically attended?
boolean
Item Group
Pain (Local Symptoms)
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)
Item
Intensity
integer
Code List
Intensity
CL Item
absent (1)
CL Item
minor reaction to touch (2)
CL Item
cries /protests on touch (3)
CL Item
cries when limb is moved / spontaneously painful (4)
Ongoing after day 3?
Item
Is the symptom ongoing after day 3?
boolean
last day of symptom
Item
If Yes, please record the last day of symptom
date
medically attended visit
Item
Was the visit medically attended?
boolean
Item Group
Dose 1 - Other Local Symptoms
Description
Item
Describe the side(s), site(s), and other details
text
Item
Please record the intensity of a symptom
integer
Code List
Please record the intensity of a symptom
CL Item
mild  (1)
CL Item
moderate  (2)
CL Item
severe (3)
Start date
Item
Start date
date
End date
Item
End date
date
Ongoing?
Item
Is the symptom/event ongoing after day 3?
boolean
Medically attended visit?
Item
Was the visit medically attended?
boolean
Item Group
Dose 1 - General Symptoms
signs or symptoms at injection site
Item
Please fill in the section below and assess the occurrence of any signs or symptoms at injection site
text
Item Group
Temperature (General Symptoms)
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)
Body Temperature
Item
Please record temperature
float
Item
Type of temperature taking
text
Code List
Type of temperature taking
CL Item
Axillary (1)
CL Item
Rectal (2)
Ongoing after day 3?
Item
Is the symptom ongoing after day 3?
boolean
last day of symptoms
Item
If Yes, please record the last day of symptoms
date
Medically attended visit?
Item
Was the visit medically attended?
boolean
Item Group
Irritability / Fussiness (General Symptoms)
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)
Item
Intensity
integer
Code List
Intensity
CL Item
Behavior as usual (1)
CL Item
Crying more than usual / no effect on normal activity (2)
CL Item
Crying more than usual / interferes with normal activity (3)
CL Item
Crying that cannot be comforted / prevents normal activity (4)
Ongoing after day 3?
Item
Is the symptom ongoing after day 3?
boolean
last day of symptoms
Item
If Yes, please record the last day of symptoms
date
medically attended visit?
Item
Was the visit medically attended?
boolean
Item Group
Drowsiness (General Symptoms)
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)
Item
Intensity
integer
Code List
Intensity
CL Item
Behavior as usual (1)
CL Item
Drowsiness easily tolerated (2)
CL Item
Drowsiness that interferes with normal activity (3)
CL Item
Drowsiness that prevents normal activity (4)
Ongoing after day 3?
Item
Is the symptom ongoing after day 3?
boolean
last day of symptoms
Item
If Yes, please record the last day of symptoms
date
medically attended visit?
Item
Was the visit medically attended?
boolean
Item Group
Loss of Appetite (General Symptoms)
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
integer
Code List
Intensity
CL Item
Appetite as usual (1)
CL Item
Eating less than usual / no effect on normal activity (2)
CL Item
Eating less than usual / interferes with normal activity (3)
CL Item
Not eating at all (4)
ongoing after day 3?
Item
Is the symptom ongoing after day 3?
boolean
last day of symptoms
Item
If Yes, please record the last day of symptoms
date
Medically attended visit?
Item
Was the visit medically attended?
boolean
Item Group
Dose 1 - Other General Symptoms
Symptom description
Item
Describe the side(s), site(s), and other details below
text
Item
Intensity
text
Code List
Intensity
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
Start date
Item
Start date
date
End date
Item
End date
boolean
ongoing
Item
Is the symptom / event ongoing?
boolean
medically attended visit
Item
Was the visit medically attended?
boolean
Item Group
Dose 1 - Medication
Trade / Generic Name
Item
Trade / Generic Name
text
Reason
Item
Reason
text
Total Daily Dose
Item
Total Daily Dose
text
Start Date
Item
Start Date
date
End Date
Item
End Date
date
Ongoing?
Item
Is the medication treatment ongoing?
boolean
Item Group
Reminder
diary card date reminder
Item
Please do not forget to bring back the diary card on
date

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