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).
Keywords
Versions (1)
- 2/14/19 2/14/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
February 14, 2019
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Evaluation of immunogenicity and safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine in healthy females NCT00290277
Diary Card
- StudyEvent: ODM
Description
Local Symptoms
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0205276
Description
The itemgroup has to be completed for every symptom one after the other.
Data type
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
Description
Day 0 = Day of vaccination. This item has to be filled in for every day for every symptom one after the other.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
Description
This item has to be filled in only for Redness and for Swelling for every day. Please measure the greatest diameter (in mm).
Data type
integer
Measurement units
- 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
Description
This item has to be filled in only for pain for every day.
Data type
text
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0522510
- UMLS CUI [1,3]
- C2700396
Description
This item has to be filled in for every symptom. If YES, please enter date of last day of symptoms below.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C0549178
Description
Date of last Day of Symptoms
Data type
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
Description
This item has to be filled in for every symptom.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C1457887
- UMLS CUI [1,4]
- C0205276
Description
Other local symptoms
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0205276
- UMLS CUI-3
- C0205394
Description
Other local symptoms Description
Data type
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C1521902
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).
Data type
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C0518690
Description
This item has to be filled in for every 'other local symptom'.
Data type
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
Description
This item has to be filled in for every 'other local symptom'.
Data type
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
Description
This item has to be filled in for every 'other local symptom'.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C1457887
- UMLS CUI [1,4]
- C0205276
Description
Medication
Alias
- UMLS CUI-1
- C0013227
Description
Trade Generic name
Data type
text
Alias
- UMLS CUI [1]
- C0592502
Description
This item has to be filled in for every Medication.
Data type
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Description
This item has to be filled in for every Medication.
Data type
text
Alias
- UMLS CUI [1]
- C0013153
Description
This item has to be filled in for every Medication.
Data type
text
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0013227
Description
Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0013227
Description
Either 'End Date' or 'Continuing' has to be entered.
Data type
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0013227
Description
Either 'End Date' or 'Continuing' has to be entered.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1553904
- UMLS CUI [1,2]
- C0013227
Description
General Symptoms
Alias
- UMLS CUI-1
- C0159028
Description
The itemgroup has to be completed for every symptom one after the other.
Data type
text
Alias
- UMLS CUI [1]
- C0159028
Description
Day 0 = Day of vaccination. This item has to be filled in for every day for every symptom one after the other.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C0159028
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.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0242485
- UMLS CUI [1,3]
- C0475264
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
Data type
integer
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0518690
Description
This item has to be filled in for every symptom. If YES, please enter date of last day of symptoms below.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0549178
Description
Date of last Day of Symptoms
Data type
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0159028
Description
This item has to be filled in for every symptom.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0159028
Description
Other general symptoms
Alias
- UMLS CUI-1
- C0159028
- UMLS CUI-2
- C0205394
Description
Other general symptoms Description
Data type
text
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C1521902
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).
Data type
integer
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0518690
Description
This item has to be filled in for every 'other general symptom'.
Data type
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0159028
Description
This item has to be filled in for every 'other general symptom'.
Data type
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0159028
Description
This item has to be filled in for every 'other general symptom'.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0159028
Similar models
Diary Card
- StudyEvent: ODM
C0011008 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0332156 (UMLS CUI [1,3])
C0019993 (UMLS CUI [1,2])
C0205276 (UMLS CUI-2)
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])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0205276 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
C0205276 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0242485 (UMLS CUI [1,2])
C0475264 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,3])
C0205394 (UMLS CUI-2)
C1521902 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,3])