ID

33987

Descrizione

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. 10/01/19 10/01/19 -
Titolare del copyright

GSK group of companies

Caricato su

10 gennaio 2019

DOI

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Licenza

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
Descrizione

Administrative data

Dose Number
Descrizione

Dose Number

Tipo di dati

text

Subject Number
Descrizione

Subject Number

Tipo di dati

integer

Dose 1 - Local Symptoms - Vaccine 1
Descrizione

Dose 1 - Local Symptoms - Vaccine 1

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

for Hib-MenC vaccine or MeningitecTM vaccine

Tipo di dati

text

Side of injection
Descrizione

for investigator only

Tipo di dati

text

Site of injection
Descrizione

for investigator only

Tipo di dati

text

Redness (Local Symptoms)
Descrizione

Redness (Local Symptoms)

Day
Descrizione

Day

Tipo di dati

integer

Size
Descrizione

please measure the greatest diameter

Tipo di dati

float

Unità di misura
  • mm
mm
Is the symptom ongoing after day 3?
Descrizione

Ongoing after day 3?

Tipo di dati

boolean

If Yes, please record the last day of symptoms
Descrizione

last day of symptoms

Tipo di dati

date

Was the visit medically attended?
Descrizione

medically attended visit

Tipo di dati

boolean

Swelling (Local Symptoms)
Descrizione

Swelling (Local Symptoms)

Day
Descrizione

Day

Tipo di dati

text

Size
Descrizione

please measure the greatest diameter

Tipo di dati

float

Unità di misura
  • mm
mm
Is the symptom ongoing after day 3?
Descrizione

Ongoing after day 3?

Tipo di dati

boolean

If Yes, please record the last day of symptoms
Descrizione

last day of symptoms

Tipo di dati

date

Was the visit medically attended?
Descrizione

medically attended visit?

Tipo di dati

boolean

Pain (Local Symptoms)
Descrizione

Pain (Local Symptoms)

Day
Descrizione

Day

Tipo di dati

integer

Intensity
Descrizione

Intensity

Tipo di dati

integer

Is the symptom ongoing after day 3?
Descrizione

Ongoing after day 3?

Tipo di dati

boolean

If Yes, please record the last day of symptom
Descrizione

last day of symptom

Tipo di dati

date

Was the visit medically attended?
Descrizione

medically attended visit?

Tipo di dati

boolean

Dose 1 - Local Symptoms - Vaccine 2
Descrizione

Dose 1 - Local Symptoms - Vaccine 2

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

InfanrixTM-IPV vaccine or PediacelTM vaccine

Tipo di dati

text

Injection Side
Descrizione

for investigator only

Tipo di dati

text

Injection Site
Descrizione

for investigator only

Tipo di dati

text

Redness (Local Symptoms)
Descrizione

Redness (Local Symptoms)

Day
Descrizione

Day

Tipo di dati

integer

Size
Descrizione

please measure the greatest diameter

Tipo di dati

float

Unità di misura
  • mm
mm
Is the symptom ongoing after day 3?
Descrizione

Ongoing after day 3?

Tipo di dati

boolean

If Yes, please record the last day of symptom
Descrizione

the last day of symptom

Tipo di dati

date

Was the visit medically attended?
Descrizione

medically attended visit

Tipo di dati

boolean

Swelling (Local Symptoms)
Descrizione

Swelling (Local Symptoms)

Day
Descrizione

Day

Tipo di dati

integer

Size
Descrizione

please measure the greatest diameter

Tipo di dati

float

Unità di misura
  • mm
mm
Is the symptom ongoing after day 3?
Descrizione

Ongoing after day 3?

Tipo di dati

boolean

If Yes, please record the last day of symptom
Descrizione

last day of symptom

Tipo di dati

date

Was the visit medically attended?
Descrizione

medically attended visit?

Tipo di dati

boolean

Pain (Local Symptoms)
Descrizione

Pain (Local Symptoms)

Day
Descrizione

Day

Tipo di dati

integer

Intensity
Descrizione

Intensity

Tipo di dati

integer

Is the symptom ongoing after day 3?
Descrizione

Ongoing after day 3?

Tipo di dati

boolean

If Yes, please record the last day of symptom
Descrizione

last day of symptom

Tipo di dati

date

Was the visit medically attended?
Descrizione

medically attended visit

Tipo di dati

boolean

Dose 1 - Other Local Symptoms
Descrizione

Dose 1 - Other Local Symptoms

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

Description

Tipo di dati

text

Please record the intensity of a symptom
Descrizione

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 di dati

integer

Start date
Descrizione

Start date

Tipo di dati

date

End date
Descrizione

End date

Tipo di dati

date

Is the symptom/event ongoing after day 3?
Descrizione

Ongoing?

Tipo di dati

boolean

Was the visit medically attended?
Descrizione

Medically attended visit?

Tipo di dati

boolean

Dose 1 - General Symptoms
Descrizione

Dose 1 - General Symptoms

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

signs or symptoms at injection site

Tipo di dati

text

Temperature (General Symptoms)
Descrizione

Temperature (General Symptoms)

Day
Descrizione

Day

Tipo di dati

integer

Please record temperature
Descrizione

Body Temperature

Tipo di dati

float

Unità di misura
  • °C
°C
Type of temperature taking
Descrizione

Type of temperature taking

Tipo di dati

text

Is the symptom ongoing after day 3?
Descrizione

Ongoing after day 3?

Tipo di dati

boolean

If Yes, please record the last day of symptoms
Descrizione

last day of symptoms

Tipo di dati

date

Was the visit medically attended?
Descrizione

Medically attended visit?

Tipo di dati

boolean

Irritability / Fussiness (General Symptoms)
Descrizione

Irritability / Fussiness (General Symptoms)

Day
Descrizione

Day

Tipo di dati

integer

Intensity
Descrizione

Intensity

Tipo di dati

integer

Is the symptom ongoing after day 3?
Descrizione

Ongoing after day 3?

Tipo di dati

boolean

If Yes, please record the last day of symptoms
Descrizione

last day of symptoms

Tipo di dati

date

Was the visit medically attended?
Descrizione

medically attended visit?

Tipo di dati

boolean

Drowsiness (General Symptoms)
Descrizione

Drowsiness (General Symptoms)

Day
Descrizione

Day

Tipo di dati

integer

Intensity
Descrizione

Intensity

Tipo di dati

integer

Is the symptom ongoing after day 3?
Descrizione

Ongoing after day 3?

Tipo di dati

boolean

If Yes, please record the last day of symptoms
Descrizione

last day of symptoms

Tipo di dati

date

Was the visit medically attended?
Descrizione

medically attended visit?

Tipo di dati

boolean

Loss of Appetite (General Symptoms)
Descrizione

Loss of Appetite (General Symptoms)

Day
Descrizione

Day

Tipo di dati

text

Intensity
Descrizione

Intensity

Tipo di dati

integer

Is the symptom ongoing after day 3?
Descrizione

ongoing after day 3?

Tipo di dati

boolean

If Yes, please record the last day of symptoms
Descrizione

last day of symptoms

Tipo di dati

date

Was the visit medically attended?
Descrizione

Medically attended visit?

Tipo di dati

boolean

Dose 1 - Other General Symptoms
Descrizione

Dose 1 - Other General Symptoms

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

Symptom description

Tipo di dati

text

Intensity
Descrizione

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 di dati

text

Start date
Descrizione

Start date

Tipo di dati

date

End date
Descrizione

End date

Tipo di dati

boolean

Is the symptom / event ongoing?
Descrizione

ongoing

Tipo di dati

boolean

Was the visit medically attended?
Descrizione

medically attended visit

Tipo di dati

boolean

Dose 1 - Medication
Descrizione

Dose 1 - Medication

Trade / Generic Name
Descrizione

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

Tipo di dati

text

Reason
Descrizione

Reason

Tipo di dati

text

Total Daily Dose
Descrizione

Total Daily Dose

Tipo di dati

text

Start Date
Descrizione

Start Date

Tipo di dati

date

End Date
Descrizione

End Date

Tipo di dati

date

Is the medication treatment ongoing?
Descrizione

Ongoing?

Tipo di dati

boolean

Reminder
Descrizione

Reminder

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

record date below

Tipo di dati

date

Similar models

Diary Cards for Dose 1 (Primary)

Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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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