ID

33995

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2019-01-10 2019-01-10 -
Rättsinnehavare

GSK group of companies

Uppladdad den

10 januari 2019

DOI

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Licens

Creative Commons BY-NC 3.0
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Primary & Booster Immunogenicity of Hib-MenC vs a Licensed Men-C Vaccine - 104056

Engelsk

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

1 Formulär  
Administrative data
Beskrivning

Administrative data

Previous Study Number
Beskrivning

Previous Study Number

Datatyp

text

Subject Number
Beskrivning

Subject Number

Datatyp

integer

Temperature
Beskrivning

Temperature

Record the type of temperature measurement
Beskrivning

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)

Datatyp

text

Temperature Log
Beskrivning

Temperature Log

Day number
Beskrivning

Please record the information every day within 42-day period

Datatyp

integer

Temperature
Beskrivning

Temperature

Datatyp

float

Måttenheter
  • °C
°C
Medically attended visit?
Beskrivning

Medically attended visit?

Datatyp

boolean

Rash / Exanthem
Beskrivning

Rash / Exanthem

Has any rash / exanthem event occurred?
Beskrivning

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

Datatyp

boolean

Rash Event Log
Beskrivning

Rash Event Log

Rash Episode Number
Beskrivning

Rash Episode Number

Datatyp

integer

Description
Beskrivning

Description

Datatyp

text

Administration Site
Beskrivning

Administration Site

Datatyp

integer

Date started
Beskrivning

Date started

Datatyp

date

Date stopped
Beskrivning

Date stopped

Datatyp

date

Did the subject seek medical advice?
Beskrivning

medical advice

Datatyp

boolean

Record the intensity
Beskrivning

Rash intensity

Datatyp

integer

Was the visit medically attended?
Beskrivning

medically attended visit?

Datatyp

boolean

Temperature
Beskrivning

Temperature

Datatyp

float

Måttenheter
  • °C
°C
Parotid / Salivary Gland Swelling
Beskrivning

Parotid / Salivary Gland Swelling

Has any parotid/salivary gland swelling occurred?
Beskrivning

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

Datatyp

boolean

Parotid/Salivary Gland Swelling Events
Beskrivning

Parotid/Salivary Gland Swelling Events

Episode Number
Beskrivning

Episode Number

Datatyp

integer

Description
Beskrivning

Description

Datatyp

text

Date started
Beskrivning

Date started

Datatyp

date

Date stopped
Beskrivning

Date stopped

Datatyp

date

Intensity
Beskrivning

Intensity

Datatyp

integer

Was the visit medically attended?
Beskrivning

medically attended visit

Datatyp

boolean

Temperature
Beskrivning

Temperature

Datatyp

float

Måttenheter
  • °C
°C
Febrile Convulsions - Suspected Signs of Meningism
Beskrivning

Febrile Convulsions - Suspected Signs of Meningism

Has any case of febrile convulsions occurred?
Beskrivning

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

Datatyp

boolean

Febrile Convulsions Log
Beskrivning

Febrile Convulsions Log

Episode Number
Beskrivning

Episode Number

Datatyp

integer

Descriptions
Beskrivning

Descriptions

Datatyp

text

Date started
Beskrivning

Date started

Datatyp

date

Date stopped
Beskrivning

Date stopped

Datatyp

date

Was the visit medically attended?
Beskrivning

medically attended visit?

Datatyp

boolean

Temperature
Beskrivning

Temperature

Datatyp

float

Måttenheter
  • °C
°C
Reminder
Beskrivning

Reminder

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

Record the date below

Datatyp

date

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Similar models

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

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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