ID

33993

Description

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

Keywords

  1. 1/10/19 1/10/19 -
  2. 1/10/19 1/10/19 -
Copyright Holder

GSK group of companies

Uploaded on

January 10, 2019

DOI

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License

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 Booster Dose (Local and General Symptoms)

Administrative data
Description

Administrative data

Subject Number
Description

Subject Number

Data type

integer

Booster Dose - Local Symptoms - Vaccine 1
Description

Booster Dose - Local Symptoms - Vaccine 1

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

for Hib-MenC vaccine

Data type

text

Side of injection
Description

for investigator only

Data type

text

Site of injection
Description

for investigator only

Data type

text

Redness (Local Symptoms)
Description

Redness (Local Symptoms)

Day
Description

Day

Data type

integer

Size
Description

please measure the greatest diameter

Data type

float

Measurement units
  • mm
mm
Is the symptom ongoing after day 3?
Description

Ongoing after day 3?

Data type

boolean

If Yes, please record the last day of symptoms
Description

last day of symptoms

Data type

date

Was the visit medically attended?
Description

medically attended visit

Data type

boolean

Swelling (Local Symptoms)
Description

Swelling (Local Symptoms)

Day
Description

Day

Data type

text

Size
Description

please measure the greatest diameter

Data type

float

Measurement units
  • mm
mm
Is the symptom ongoing after day 3?
Description

Ongoing after day 3?

Data type

boolean

If Yes, please record the last day of symptoms
Description

last day of symptoms

Data type

date

Was the visit medically attended?
Description

medically attended visit?

Data type

boolean

Pain (Local Symptoms)
Description

Pain (Local Symptoms)

Day
Description

Day

Data type

integer

Intensity
Description

Intensity

Data type

integer

Is the symptom ongoing after day 3?
Description

Ongoing after day 3?

Data type

boolean

If Yes, please record the last day of symptom
Description

last day of symptom

Data type

date

Was the visit medically attended?
Description

medically attended visit?

Data type

boolean

Booster Dose - Local Symptoms - Vaccine 2
Description

Booster Dose - Local Symptoms - Vaccine 2

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

PriorixTM vaccine

Data type

text

Injection Side
Description

for investigator only

Data type

text

Injection Site
Description

for investigator only

Data type

text

Redness (Local Symptoms)
Description

Redness (Local Symptoms)

Day
Description

Day

Data type

integer

Size
Description

please measure the greatest diameter

Data type

float

Measurement units
  • mm
mm
Is the symptom ongoing after day 3?
Description

Ongoing after day 3?

Data type

boolean

If Yes, please record the last day of symptom
Description

the last day of symptom

Data type

date

Was the visit medically attended?
Description

medically attended visit

Data type

boolean

Swelling (Local Symptoms)
Description

Swelling (Local Symptoms)

Day
Description

Day

Data type

integer

Size
Description

please measure the greatest diameter

Data type

float

Measurement units
  • mm
mm
Is the symptom ongoing after day 3?
Description

Ongoing after day 3?

Data type

boolean

If Yes, please record the last day of symptom
Description

last day of symptom

Data type

date

Was the visit medically attended?
Description

medically attended visit?

Data type

boolean

Pain (Local Symptoms)
Description

Pain (Local Symptoms)

Day
Description

Day

Data type

integer

Intensity
Description

Intensity

Data type

integer

Is the symptom ongoing after day 3?
Description

Ongoing after day 3?

Data type

boolean

If Yes, please record the last day of symptom
Description

last day of symptom

Data type

date

Was the visit medically attended?
Description

medically attended visit

Data type

boolean

Booster Dose - Other Local Symptoms
Description

Booster Dose - Other Local Symptoms

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

Description

Data type

text

Please record the intensity of a symptom
Description

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).

Data type

integer

Start date
Description

Start date

Data type

date

End date
Description

End date

Data type

date

Is the symptom/event ongoing after day 3?
Description

Ongoing?

Data type

boolean

Was the visit medically attended?
Description

Medically attended visit?

Data type

boolean

Booster Dose - General Symptoms
Description

Booster Dose - General Symptoms

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

signs or symptoms at injection site

Data type

text

Temperature (General Symptoms)
Description

Temperature (General Symptoms)

Day
Description

Day

Data type

integer

Please record temperature
Description

Body Temperature

Data type

float

Measurement units
  • °C
°C
Type of temperature taking
Description

Type of temperature taking

Data type

text

Is the symptom ongoing after day 3?
Description

Ongoing after day 3?

Data type

boolean

If Yes, please record the last day of symptoms
Description

last day of symptoms

Data type

date

Was the visit medically attended?
Description

Medically attended visit?

Data type

boolean

Irritability / Fussiness (General Symptoms)
Description

Irritability / Fussiness (General Symptoms)

Day
Description

Day

Data type

integer

Intensity
Description

Intensity

Data type

integer

Is the symptom ongoing after day 3?
Description

Ongoing after day 3?

Data type

boolean

If Yes, please record the last day of symptoms
Description

last day of symptoms

Data type

date

Was the visit medically attended?
Description

medically attended visit?

Data type

boolean

Drowsiness (General Symptoms)
Description

Drowsiness (General Symptoms)

Day
Description

Day

Data type

integer

Intensity
Description

Intensity

Data type

integer

Is the symptom ongoing after day 3?
Description

Ongoing after day 3?

Data type

boolean

If Yes, please record the last day of symptoms
Description

last day of symptoms

Data type

date

Was the visit medically attended?
Description

medically attended visit?

Data type

boolean

Loss of Appetite (General Symptoms)
Description

Loss of Appetite (General Symptoms)

Day
Description

Day

Data type

text

Intensity
Description

Intensity

Data type

integer

Is the symptom ongoing after day 3?
Description

ongoing after day 3?

Data type

boolean

If Yes, please record the last day of symptoms
Description

last day of symptoms

Data type

date

Was the visit medically attended?
Description

Medically attended visit?

Data type

boolean

Booster Dose - Other General Symptoms
Description

Booster Dose - Other General Symptoms

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

Symptom description

Data type

text

Intensity
Description

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).

Data type

text

Start date
Description

Start date

Data type

date

End date
Description

End date

Data type

boolean

Is the symptom / event ongoing?
Description

ongoing

Data type

boolean

Was the visit medically attended?
Description

medically attended visit

Data type

boolean

Booster Dose - Medication
Description

Booster Dose - Medication

Trade / Generic Name
Description

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

Data type

text

Reason
Description

Reason

Data type

text

Total Daily Dose
Description

Total Daily Dose

Data type

text

Start Date
Description

Start Date

Data type

date

End Date
Description

End Date

Data type

date

Is the medication treatment ongoing?
Description

Ongoing?

Data type

boolean

Reminder
Description

Reminder

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

record date below

Data type

date

Similar models

Diary Cards for Booster Dose (Local and General Symptoms)

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item Group
Booster Dose - 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
Item Group
Booster Dose - Local Symptoms - Vaccine 2
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
Booster Dose - 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
Booster Dose - 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
Booster Dose - 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
Booster Dose - 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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