ID

33989

Descripción

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

Palabras clave

  1. 10/1/19 10/1/19 -
Titular de derechos de autor

GSK group of companies

Subido en

10 de enero de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

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 3 (Primary)

Administrative data
Descripción

Administrative data

Dose Number
Descripción

Dose Number

Tipo de datos

text

Subject Number
Descripción

Subject Number

Tipo de datos

integer

Dose 3 - Local Symptoms - Vaccine 1
Descripción

Dose 3 - Local Symptoms - Vaccine 1

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

for Hib-MenC vaccine or MeningitecTM vaccine

Tipo de datos

text

Side of injection
Descripción

for investigator only

Tipo de datos

text

Site of injection
Descripción

for investigator only

Tipo de datos

text

Redness (Local Symptoms)
Descripción

Redness (Local Symptoms)

Day
Descripción

Day

Tipo de datos

integer

Size
Descripción

please measure the greatest diameter

Tipo de datos

float

Unidades de medida
  • mm
mm
Is the symptom ongoing after day 3?
Descripción

Ongoing after day 3?

Tipo de datos

boolean

If Yes, please record the last day of symptoms
Descripción

last day of symptoms

Tipo de datos

date

Was the visit medically attended?
Descripción

medically attended visit

Tipo de datos

boolean

Swelling (Local Symptoms)
Descripción

Swelling (Local Symptoms)

Day
Descripción

Day

Tipo de datos

text

Size
Descripción

please measure the greatest diameter

Tipo de datos

float

Unidades de medida
  • mm
mm
Is the symptom ongoing after day 3?
Descripción

Ongoing after day 3?

Tipo de datos

boolean

If Yes, please record the last day of symptoms
Descripción

last day of symptoms

Tipo de datos

date

Was the visit medically attended?
Descripción

medically attended visit?

Tipo de datos

boolean

Pain (Local Symptoms)
Descripción

Pain (Local Symptoms)

Day
Descripción

Day

Tipo de datos

integer

Intensity
Descripción

Intensity

Tipo de datos

integer

Is the symptom ongoing after day 3?
Descripción

Ongoing after day 3?

Tipo de datos

boolean

If Yes, please record the last day of symptom
Descripción

last day of symptom

Tipo de datos

date

Was the visit medically attended?
Descripción

medically attended visit?

Tipo de datos

boolean

Dose 3 - Local Symptoms - Vaccine 2
Descripción

Dose 3 - Local Symptoms - Vaccine 2

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

InfanrixTM-IPV vaccine or PediacelTM vaccine

Tipo de datos

text

Injection Side
Descripción

for investigator only

Tipo de datos

text

Injection Site
Descripción

for investigator only

Tipo de datos

text

Redness (Local Symptoms)
Descripción

Redness (Local Symptoms)

Day
Descripción

Day

Tipo de datos

integer

Size
Descripción

please measure the greatest diameter

Tipo de datos

float

Unidades de medida
  • mm
mm
Is the symptom ongoing after day 3?
Descripción

Ongoing after day 3?

Tipo de datos

boolean

If Yes, please record the last day of symptom
Descripción

the last day of symptom

Tipo de datos

date

Was the visit medically attended?
Descripción

medically attended visit

Tipo de datos

boolean

Swelling (Local Symptoms)
Descripción

Swelling (Local Symptoms)

Day
Descripción

Day

Tipo de datos

integer

Size
Descripción

please measure the greatest diameter

Tipo de datos

float

Unidades de medida
  • mm
mm
Is the symptom ongoing after day 3?
Descripción

Ongoing after day 3?

Tipo de datos

boolean

If Yes, please record the last day of symptom
Descripción

last day of symptom

Tipo de datos

date

Was the visit medically attended?
Descripción

medically attended visit?

Tipo de datos

boolean

Pain (Local Symptoms)
Descripción

Pain (Local Symptoms)

Day
Descripción

Day

Tipo de datos

integer

Intensity
Descripción

Intensity

Tipo de datos

integer

Is the symptom ongoing after day 3?
Descripción

Ongoing after day 3?

Tipo de datos

boolean

If Yes, please record the last day of symptom
Descripción

last day of symptom

Tipo de datos

date

Was the visit medically attended?
Descripción

medically attended visit

Tipo de datos

boolean

Dose 3 - Other Local Symptoms
Descripción

Dose 3 - Other Local Symptoms

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

Description

Tipo de datos

text

Please record the intensity of a symptom
Descripción

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).

Tipo de datos

integer

Start date
Descripción

Start date

Tipo de datos

date

End date
Descripción

End date

Tipo de datos

date

Is the symptom/event ongoing after day 3?
Descripción

Ongoing?

Tipo de datos

boolean

Was the visit medically attended?
Descripción

Medically attended visit?

Tipo de datos

boolean

Dose 3 - General Symptoms
Descripción

Dose 3 - General Symptoms

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

signs or symptoms at injection site

Tipo de datos

text

Temperature (General Symptoms)
Descripción

Temperature (General Symptoms)

Day
Descripción

Day

Tipo de datos

integer

Please record temperature
Descripción

Body Temperature

Tipo de datos

float

Unidades de medida
  • °C
°C
Type of temperature taking
Descripción

Type of temperature taking

Tipo de datos

text

Is the symptom ongoing after day 3?
Descripción

Ongoing after day 3?

Tipo de datos

boolean

If Yes, please record the last day of symptoms
Descripción

last day of symptoms

Tipo de datos

date

Was the visit medically attended?
Descripción

Medically attended visit?

Tipo de datos

boolean

Irritability / Fussiness (General Symptoms)
Descripción

Irritability / Fussiness (General Symptoms)

Day
Descripción

Day

Tipo de datos

integer

Intensity
Descripción

Intensity

Tipo de datos

integer

Is the symptom ongoing after day 3?
Descripción

Ongoing after day 3?

Tipo de datos

boolean

If Yes, please record the last day of symptoms
Descripción

last day of symptoms

Tipo de datos

date

Was the visit medically attended?
Descripción

medically attended visit?

Tipo de datos

boolean

Drowsiness (General Symptoms)
Descripción

Drowsiness (General Symptoms)

Day
Descripción

Day

Tipo de datos

integer

Intensity
Descripción

Intensity

Tipo de datos

integer

Is the symptom ongoing after day 3?
Descripción

Ongoing after day 3?

Tipo de datos

boolean

If Yes, please record the last day of symptoms
Descripción

last day of symptoms

Tipo de datos

date

Was the visit medically attended?
Descripción

medically attended visit?

Tipo de datos

boolean

Loss of Appetite (General Symptoms)
Descripción

Loss of Appetite (General Symptoms)

Day
Descripción

Day

Tipo de datos

text

Intensity
Descripción

Intensity

Tipo de datos

integer

Is the symptom ongoing after day 3?
Descripción

ongoing after day 3?

Tipo de datos

boolean

If Yes, please record the last day of symptoms
Descripción

last day of symptoms

Tipo de datos

date

Was the visit medically attended?
Descripción

Medically attended visit?

Tipo de datos

boolean

Dose 3 - Other General Symptoms
Descripción

Dose 3 - Other General Symptoms

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

Symptom description

Tipo de datos

text

Intensity
Descripción

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).

Tipo de datos

text

Start date
Descripción

Start date

Tipo de datos

date

End date
Descripción

End date

Tipo de datos

boolean

Is the symptom / event ongoing?
Descripción

ongoing

Tipo de datos

boolean

Was the visit medically attended?
Descripción

medically attended visit

Tipo de datos

boolean

Dose 3 - Medication
Descripción

Dose 3 - Medication

Trade / Generic Name
Descripción

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

Tipo de datos

text

Reason
Descripción

Reason

Tipo de datos

text

Total Daily Dose
Descripción

Total Daily Dose

Tipo de datos

text

Start Date
Descripción

Start Date

Tipo de datos

date

End Date
Descripción

End Date

Tipo de datos

date

Is the medication treatment ongoing?
Descripción

Ongoing?

Tipo de datos

boolean

Reminder
Descripción

Reminder

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

record date below

Tipo de datos

date

Similar models

Diary Cards for Dose 3 (Primary)

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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 3 - 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
Dose 3 - 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
Dose 3 - 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 3 - 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 3 - 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 3 - 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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