ID

35084

Description

Study ID: 100478 Clinical Study ID: 100478 Study Title: Study to show non-inferiority of Tritanrix™-HepB/Hib-MenAC (+/- hepatitis B vaccine at birth) versus Tritanrix™-HepB/Hiberix™ without hepatitis B vacc. at birth for antibody response to all vaccine antigens given in healthy infants Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00290303 Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis This form contains the Diary Card and has to be filled in for every dose of vaccination (1-3).

Mots-clés

Versions (1)
  1. 14/02/2019 14/02/2019 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

14 février 2019

DOI

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Licence

Creative Commons BY-NC 3.0
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Evaluation of immunogenicity and safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine in healthy females NCT00290277

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Diary Card

1 Formulaires  
  1. StudyEvent: ODM
    1. Diary Card
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Protocol Number
Description

Protocol Number

Type de données

text

Alias
UMLS CUI [1]
C2348563
Subject number
Description

Subject number

Type de données

text

Alias
UMLS CUI [1]
C2348585
Day 0 = Date of vaccination
Description

Day 0 = Date of vaccination

Type de données

date

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0011008
Dose of vaccination
Description

The form has to be filled in once for each vaccination dose.

Type de données

text

Alias
UMLS CUI [1,1]
C1115464
UMLS CUI [1,2]
C0042210
Please do not forget to bring back the diary card on:
Description

Return of diary card

Type de données

date

Alias
UMLS CUI [1,1]
C3890583
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0332156
In case of hospitalisation, please inform:
Description

In case of hospitalisation, please inform

Type de données

text

Alias
UMLS CUI [1,1]
C1880174
UMLS CUI [1,2]
C0019993
Local Symptoms
Description

Local Symptoms

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
Local symptom
Description

The itemgroup has to be completed for every symptom one after the other.

Type de données

integer

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
Day
Description

Day 0 = Day of vaccination. This item has to be filled in for every day for every symptom one after the other.

Type de données

integer

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
Size
Description

This item has to be filled in only for Redness and for Swelling for every day. Please measure the greatest diameter (in mm).

Type de données

integer

Unités de mesure
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
UMLS CUI [1,3]
C2700396
UMLS CUI [2,1]
C0456389
UMLS CUI [2,2]
C0038999
UMLS CUI [2,3]
C2700396
mm
Intensity
Description

This item has to be filled in only for pain for every day.

Type de données

text

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Ongoing after Day 6?
Description

This item has to be filled in for every symptom. If YES, please enter date of last day of symptoms below.

Type de données

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C0549178
Date of last Day of Symptoms
Description

Date of last Day of Symptoms

Type de données

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
Medically attended visit?
Description

This item has to be filled in for every symptom.

Type de données

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Other local symptoms
Description

Other local symptoms

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
UMLS CUI-3
C0205394
Please describe other local symptom and specify side(s) and site(s):
Description

Other local symptoms Description

Type de données

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C1521902
Other local symptoms Intensity
Description

This item has to be filled in for every 'other local symptom'. Mild = easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate = sufficiently discomforting to interfere with normal everyday activities. Severe = prevents normal, everyday activities. (In adults/ adolescents, such an adverse event would, forexample, prevent attendance at work/ school and would necessitate the administration ofcorrective therapy).

Type de données

integer

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C0518690
Start date
Description

This item has to be filled in for every 'other local symptom'.

Type de données

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
End date
Description

This item has to be filled in for every 'other local symptom'.

Type de données

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
Medically attended visit?
Description

This item has to be filled in for every 'other local symptom'.

Type de données

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Medication
Description

Medication

Alias
UMLS CUI-1
C0013227
Trade Generic name
Description

Trade Generic name

Type de données

text

Alias
UMLS CUI [1]
C0592502
Medication Reason
Description

This item has to be filled in for every Medication.

Type de données

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Route of medication
Description

This item has to be filled in for every Medication.

Type de données

text

Alias
UMLS CUI [1]
C0013153
Total Daily Dose
Description

This item has to be filled in for every Medication.

Type de données

text

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0013227
Start Date
Description

Start Date

Type de données

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0013227
End Date
Description

Either 'End Date' or 'Continuing' has to be entered.

Type de données

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0013227
Continuing
Description

Either 'End Date' or 'Continuing' has to be entered.

Type de données

boolean

Alias
UMLS CUI [1,1]
C1553904
UMLS CUI [1,2]
C0013227
General Symptoms
Description

General Symptoms

Alias
UMLS CUI-1
C0159028
General symptom
Description

The itemgroup has to be completed for every symptom one after the other.

Type de données

text

Alias
UMLS CUI [1]
C0159028
Day
Description

Day 0 = Day of vaccination. This item has to be filled in for every day for every symptom one after the other.

Type de données

integer

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0159028
Temperature Measurement Localisation
Description

This item has to be completed only for general symptom 'temperature'. Rectal measurement is not recommended. Please record the temperature every day in the evening. If temperature has been taken more than once a day, please reportthe highest value for the day.

Type de données

integer

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0242485
UMLS CUI [1,3]
C0475264
Intensity of general symptom
Description

This item has to be completed for every general symptom (except temperature) one after the other. Please note the different meanings of intensity 0-3 depending on the symptom. Fatigue - Headache - Gastrointestinal symptoms (including nausea,vomiting, diarrhea and / or abdominal pain) - Arthralgia (joint pain: only in joints which are distalfrom the injection site) - Rash - Myalgia: 0 = Normal. 1 = Symptoms that are easily tolerated. 2 = Symptoms that interfere with normal activity. 3 = Symptoms that prevent normal activity. Urticaria: 0 = Normal. 1 = Urticaria distributed on a single body areaonly. 2 = Urticaria distributed on 2 or 3 body areas butnot more. 3 = Urticaria distributed on at least 4 bodyareas

Type de données

integer

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C0518690
Ongoing after Day 6?
Description

This item has to be filled in for every symptom. If YES, please enter date of last day of symptoms below.

Type de données

boolean

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C0549178
Date of last Day of Symptoms
Description

Date of last Day of Symptoms

Type de données

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0159028
Medically attended visit?
Description

This item has to be filled in for every symptom.

Type de données

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0159028
Other general symptoms
Description

Other general symptoms

Alias
UMLS CUI-1
C0159028
UMLS CUI-2
C0205394
Please describe other general symptom and give details below:
Description

Other general symptoms Description

Type de données

text

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C1521902
Other general symptoms Intensity
Description

This item has to be filled in for every 'other general symptom'. Mild = easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate = sufficiently discomforting to interfere with normal everyday activities. Severe = prevents normal, everyday activities. (In adults/ adolescents, such an adverse event would, forexample, prevent attendance at work/ school and would necessitate the administration ofcorrective therapy).

Type de données

integer

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C0518690
Start date
Description

This item has to be filled in for every 'other general symptom'.

Type de données

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0159028
End date
Description

This item has to be filled in for every 'other general symptom'.

Type de données

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0159028
Medically attended visit?
Description

This item has to be filled in for every 'other general symptom'.

Type de données

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0159028
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Similar models

Diary Card

1 Formulaires
  1. StudyEvent: ODM
    1. Diary Card
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Protocol Number
Item
Protocol Number
text
C2348563 (UMLS CUI [1])
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Day 0 = Date of vaccination
Item
Day 0 = Date of vaccination
date
C0042196 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Dose of vaccination
text
C1115464 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Dose of vaccination
Code List
Dose of vaccination
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Return of diary card
Item
Please do not forget to bring back the diary card on:
date
C3890583 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0332156 (UMLS CUI [1,3])
In case of hospitalisation, please inform
Item
In case of hospitalisation, please inform:
text
C1880174 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
Item Group
Local Symptoms
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
Item
Local symptom
integer
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
Local symptom
Code List
Local symptom
CL Item
Redness (1)
CL Item
Swelling (2)
CL Item
Pain (3)
Item
Day
integer
C0439228 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Day
Code List
Day
CL Item
Day 0 (0)
CL Item
Day 1 (1)
CL Item
Day 2 (2)
CL Item
Day 3 (3)
CL Item
Day 4 (4)
CL Item
Day 5 (5)
CL Item
Day 6 (6)
Size
Item
Size
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [2,1])
C0038999 (UMLS CUI [2,2])
C2700396 (UMLS CUI [2,3])
Item
Intensity
text
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Intensity
Code List
Intensity
CL Item
Absent (0)
CL Item
Pain on touch (1)
CL Item
Pain when limb is moved (2)
CL Item
Pain that prevents normal activity (3)
Ongoing after Day 6?
Item
Ongoing after Day 6?
boolean
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
C0806020 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Medically attended visit
Item
Medically attended visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Item Group
Other local symptoms
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
Other local symptoms Description
Item
Please describe other local symptom and specify side(s) and site(s):
text
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Other local symptoms Intensity
integer
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
Other local symptoms Description
Code List
Other local symptoms Intensity
CL Item
Mild (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Start date
Item
Start date
date
C0808070 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
End date
Item
End date
date
C0806020 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Medically attended visit
Item
Medically attended visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Item Group
Medication
C0013227 (UMLS CUI-1)
Trade Generic name
Item
Trade Generic name
text
C0592502 (UMLS CUI [1])
Medication Reason
Item
Medication Reason
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Route of medication
Item
Route of medication
text
C0013153 (UMLS CUI [1])
Total Daily Dose
Item
Total Daily Dose
text
C2348070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Continuing
Item
Continuing
boolean
C1553904 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item Group
General Symptoms
C0159028 (UMLS CUI-1)
Item
General symptom
text
C0159028 (UMLS CUI [1])
General symptom
Code List
General symptom
CL Item
Temeperature (1)
CL Item
Fatigue (2)
CL Item
Headache (3)
CL Item
Gastrointestinal Symptoms (4)
CL Item
Athralgia(s) (5)
CL Item
Myalgia (6)
CL Item
Rash (7)
CL Item
Urticaria (8)
Item
Day
integer
C0439228 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Day
Code List
Day
CL Item
Day 0 (0)
CL Item
Day 1 (1)
CL Item
Day 2 (2)
CL Item
Day 3 (3)
CL Item
Day 4 (4)
CL Item
Day 5 (5)
CL Item
Day 6 (6)
Item
Temperature Measurement Localisation
integer
C0005903 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
C0475264 (UMLS CUI [1,3])
Temperature Measurement Localisation
Code List
Temperature Measurement Localisation
CL Item
Axillary (1)
CL Item
Oral (2)
CL Item
Rectal (3)
Item
Intensity of general symptom
integer
C0159028 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Intensity of general symptom
Code List
Intensity of general symptom
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Ongoing after Day 6?
Item
Ongoing after Day 6?
boolean
C0159028 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
C0806020 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Medically attended visit
Item
Medically attended visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,3])
Item Group
Other general symptoms
C0159028 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Other general symptoms Description
Item
Please describe other general symptom and give details below:
text
C0159028 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item
Other general symptoms Intensity
integer
C0159028 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Other local symptoms Description
Code List
Other general symptoms Intensity
CL Item
Mild (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Start date
Item
Start date
date
C0808070 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
End date
Item
End date
date
C0806020 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Medically attended visit
Item
Medically attended visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,3])
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