ID
35084
Beskrivning
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).
Nyckelord
Versioner (1)
- 2019-02-14 2019-02-14 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
14 februari 2019
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
Evaluation of immunogenicity and safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine in healthy females NCT00290277
Diary Card
- StudyEvent: ODM
Beskrivning
Local Symptoms
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0205276
Beskrivning
The itemgroup has to be completed for every symptom one after the other.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
Beskrivning
Day 0 = Day of vaccination. This item has to be filled in for every day for every symptom one after the other.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
Beskrivning
This item has to be filled in only for Redness and for Swelling for every day. Please measure the greatest diameter (in mm).
Datatyp
integer
Måttenheter
- 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
Beskrivning
This item has to be filled in only for pain for every day.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0522510
- UMLS CUI [1,3]
- C2700396
Beskrivning
This item has to be filled in for every symptom. If YES, please enter date of last day of symptoms below.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C0549178
Beskrivning
Date of last Day of Symptoms
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
Beskrivning
This item has to be filled in for every symptom.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C1457887
- UMLS CUI [1,4]
- C0205276
Beskrivning
Other local symptoms
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0205276
- UMLS CUI-3
- C0205394
Beskrivning
Other local symptoms Description
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C1521902
Beskrivning
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).
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C0518690
Beskrivning
This item has to be filled in for every 'other local symptom'.
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
Beskrivning
This item has to be filled in for every 'other local symptom'.
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
Beskrivning
This item has to be filled in for every 'other local symptom'.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C1457887
- UMLS CUI [1,4]
- C0205276
Beskrivning
Medication
Alias
- UMLS CUI-1
- C0013227
Beskrivning
Trade Generic name
Datatyp
text
Alias
- UMLS CUI [1]
- C0592502
Beskrivning
This item has to be filled in for every Medication.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Beskrivning
This item has to be filled in for every Medication.
Datatyp
text
Alias
- UMLS CUI [1]
- C0013153
Beskrivning
This item has to be filled in for every Medication.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0013227
Beskrivning
Start Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0013227
Beskrivning
Either 'End Date' or 'Continuing' has to be entered.
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0013227
Beskrivning
Either 'End Date' or 'Continuing' has to be entered.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1553904
- UMLS CUI [1,2]
- C0013227
Beskrivning
General Symptoms
Alias
- UMLS CUI-1
- C0159028
Beskrivning
The itemgroup has to be completed for every symptom one after the other.
Datatyp
text
Alias
- UMLS CUI [1]
- C0159028
Beskrivning
Day 0 = Day of vaccination. This item has to be filled in for every day for every symptom one after the other.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C0159028
Beskrivning
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.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0242485
- UMLS CUI [1,3]
- C0475264
Beskrivning
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
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0518690
Beskrivning
This item has to be filled in for every symptom. If YES, please enter date of last day of symptoms below.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0549178
Beskrivning
Date of last Day of Symptoms
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0159028
Beskrivning
This item has to be filled in for every symptom.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0159028
Beskrivning
Other general symptoms
Alias
- UMLS CUI-1
- C0159028
- UMLS CUI-2
- C0205394
Beskrivning
Other general symptoms Description
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C1521902
Beskrivning
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).
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0518690
Beskrivning
This item has to be filled in for every 'other general symptom'.
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0159028
Beskrivning
This item has to be filled in for every 'other general symptom'.
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0159028
Beskrivning
This item has to be filled in for every 'other general symptom'.
Datatyp
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])