ID

33995

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

Versions (1)
  1. 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 - 104056

English

Diary Card - Booster Dose (day 0-day 42)

1 forms  
Administrative data
Description

Administrative data

Previous Study Number
Description

Previous Study Number

Data type

text

Subject Number
Description

Subject Number

Data type

integer

Temperature
Description

Temperature

Record the type of temperature measurement
Description

preferably rectal measurement; please record temperature daily from day 0 to day 14 after vaccination at bedtime; if temperature has been taken more than once a day, please report the highest value for the day; if multiple measures a day, please report the highest value for the day. Fever definition: Rectal (≥ 38°C), Axillary (≥ 37.5°C)

Data type

text

Temperature Log
Description

Temperature Log

Day number
Description

Please record the information every day within 42-day period

Data type

integer

Temperature
Description

Temperature

Data type

float

Measurement units
  • °C
°C
Medically attended visit?
Description

Medically attended visit?

Data type

boolean

Rash / Exanthem
Description

Rash / Exanthem

Has any rash / exanthem event occurred?
Description

In case rash/exanthem is (are) observed, the parents/guardians are instructed to bring the child for a visit to investigator for complete clinical examination, further assessments and/or appropriate treatment

Data type

boolean

Rash Event Log
Description

Rash Event Log

Rash Episode Number
Description

Rash Episode Number

Data type

integer

Description
Description

Description

Data type

text

Administration Site
Description

Administration Site

Data type

integer

Date started
Description

Date started

Data type

date

Date stopped
Description

Date stopped

Data type

date

Did the subject seek medical advice?
Description

medical advice

Data type

boolean

Record the intensity
Description

Rash intensity

Data type

integer

Was the visit medically attended?
Description

medically attended visit?

Data type

boolean

Temperature
Description

Temperature

Data type

float

Measurement units
  • °C
°C
Parotid / Salivary Gland Swelling
Description

Parotid / Salivary Gland Swelling

Has any parotid/salivary gland swelling occurred?
Description

In case rash/exanthem is (are) observed, the parents/guardians are instructed to bring the child for a visit to investigator for complete clinical examination, further assessments and/or appropriate treatment

Data type

boolean

Parotid/Salivary Gland Swelling Events
Description

Parotid/Salivary Gland Swelling Events

Episode Number
Description

Episode Number

Data type

integer

Description
Description

Description

Data type

text

Date started
Description

Date started

Data type

date

Date stopped
Description

Date stopped

Data type

date

Intensity
Description

Intensity

Data type

integer

Was the visit medically attended?
Description

medically attended visit

Data type

boolean

Temperature
Description

Temperature

Data type

float

Measurement units
  • °C
°C
Febrile Convulsions - Suspected Signs of Meningism
Description

Febrile Convulsions - Suspected Signs of Meningism

Has any case of febrile convulsions occurred?
Description

In case rash/exanthem is (are) observed, the parents/guardians are instructed to bring the child for a visit to investigator for complete clinical examination, further assessments and/or appropriate treatment

Data type

boolean

Febrile Convulsions Log
Description

Febrile Convulsions Log

Episode Number
Description

Episode Number

Data type

integer

Descriptions
Description

Descriptions

Data type

text

Date started
Description

Date started

Data type

date

Date stopped
Description

Date stopped

Data type

date

Was the visit medically attended?
Description

medically attended visit?

Data type

boolean

Temperature
Description

Temperature

Data type

float

Measurement units
  • °C
°C
Reminder
Description

Reminder

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

Record the date below

Data type

date

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Similar models

Diary Card - Booster Dose (day 0-day 42)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Item
Previous Study Number
text
Previous Study Number
Code List
Previous Study Number
CL Item
103974 (1)
Subject Number
Item
Subject Number
integer
Item Group
Temperature
Item
Record the type of temperature measurement
text
Fever
Code List
Record the type of temperature measurement
CL Item
Rectal  (1)
CL Item
Axillary  (2)
Item Group
Temperature Log
Day number
Item
Day number
integer
Temperature
Item
Temperature
float
Medically attended visit?
Item
Medically attended visit?
boolean
Item Group
Rash / Exanthem
Rash
Item
Has any rash / exanthem event occurred?
boolean
Item Group
Rash Event Log
Rash Episode Number
Item
Rash Episode Number
integer
Description
Item
Description
text
Item
Administration Site
integer
Administration Site
Code List
Administration Site
CL Item
Right deltoid (1)
CL Item
Non-administration site (2)
Date started
Item
Date started
date
Date stopped
Item
Date stopped
date
medical advice
Item
Did the subject seek medical advice?
boolean
Item
Record the intensity
integer
Rash intensity
Code List
Record the intensity
CL Item
1-50 lesions (1)
CL Item
51 - 150 lesions (2)
CL Item
> 150 lesions (3)
medically attended visit?
Item
Was the visit medically attended?
boolean
Temperature
Item
Temperature
float
Item Group
Parotid / Salivary Gland Swelling
parotid / salivary gland swelling
Item
Has any parotid/salivary gland swelling occurred?
boolean
Item Group
Parotid/Salivary Gland Swelling Events
Episode Number
Item
Episode Number
integer
Description
Item
Description
text
Date started
Item
Date started
date
Date stopped
Item
Date stopped
date
Item
Intensity
integer
Intensity
Code List
Intensity
CL Item
Swelling without difficulties to move the jaw (1)
CL Item
Swelling with difficulties to move the jaw (2)
CL Item
Swelling and additional general symptoms (3)
medically attended visit
Item
Was the visit medically attended?
boolean
Temperature
Item
Temperature
float
Item Group
Febrile Convulsions - Suspected Signs of Meningism
Febrile Convulsions
Item
Has any case of febrile convulsions occurred?
boolean
Item Group
Febrile Convulsions Log
Episode Number
Item
Episode Number
integer
Descriptions
Item
Descriptions
text
Date started
Item
Date started
date
Date stopped
Item
Date stopped
date
medically attended visit?
Item
Was the visit medically attended?
boolean
Temperature
Item
Temperature
float
Item Group
Reminder
Please do not forget to bring back the diary card on
Item
Please do not forget to bring back the diary card on
date
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