ID
25019
Description
Study ID: 100571 (M138) Clinical Study ID: 100571 Study Title: Double-blind randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine containing 1440 EL.U of antigen per mL and injected according to a 0, 12 month schedule in healthy adult volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00291876 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: Hepatitis A Vaccine, Inactivated Trade Name: Havrix Study Indication: Hepatitis A https://clinicaltrials.gov/ct2/show/NCT00291876
Lien
https://clinicaltrials.gov/ct2/show/NCT00291876
Mots-clés
Versions (3)
- 24/08/2017 24/08/2017 -
- 24/08/2017 24/08/2017 -
- 24/08/2017 24/08/2017 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
24 août 2017
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
Modèle Commentaires :
Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.
Groupe Item commentaires pour :
Item commentaires pour :
Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.
GSK Hepatitis A Vaccine ADDITIONAL VACCINATION Diary Card NCT00291876
GSK Hepatitis A Vaccine ADDITIONAL VACCINATION Diary Card NCT00291876
Description
LOCAL SYMPTOMS
Description
Redness
Type de données
integer
Unités de mesure
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Description
Redness size day 0
Type de données
integer
Unités de mesure
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Description
Redness size day 1
Type de données
integer
Unités de mesure
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Description
Redness size day 2
Type de données
integer
Unités de mesure
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Description
Redness size day 3
Type de données
integer
Unités de mesure
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Description
Ongoing after day 3?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0549178
Description
Date of last day of symptoms
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0332575
- UMLS CUI [1,3]
- C2700396
Description
Size Swelling
Type de données
integer
Unités de mesure
- dd/mm/yy
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0038999
- UMLS CUI [1,3]
- C2700396
Description
Size Swelling Day 0
Type de données
integer
Unités de mesure
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0038999
- UMLS CUI [1,3]
- C2700396
Description
Size Swelling Day 1
Type de données
integer
Unités de mesure
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0038999
- UMLS CUI [1,3]
- C2700396
Description
Size Swelling Day 2
Type de données
integer
Unités de mesure
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0038999
- UMLS CUI [1,3]
- C2700396
Description
Size Swelling Day 3
Type de données
integer
Unités de mesure
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0038999
- UMLS CUI [1,3]
- C2700396
Description
Ongoing after day 3?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0549178
Description
Date of last day of symptoms
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0038999
- UMLS CUI [1,3]
- C2700396
Description
Pain (at injection site): 0 : Absent 1 : Painful on touch 2 : Painful when limb is moved 3 : Spontaneously painful
Type de données
integer
Alias
- UMLS CUI [1,1]
- C3840282
- UMLS CUI [1,2]
- C2700396
Description
Pain intensity day 0
Type de données
integer
Alias
- UMLS CUI [1]
- C3840282
Description
Pain intensity day 1
Type de données
integer
Alias
- UMLS CUI [1]
- C3840282
Description
Pain intensity day 2
Type de données
integer
Alias
- UMLS CUI [1]
- C3840282
Description
Pain intensity day 3
Type de données
integer
Alias
- UMLS CUI [1]
- C3840282
Description
Ongoing after day 3?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0549178
- UMLS CUI [1,2]
- C0030193
Description
Date of last day of symptoms
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0030193
Description
Other Local Symptoms
Description
Description - please specify side(s) and site(s)
Type de données
text
Alias
- UMLS CUI [1]
- C0441987
- UMLS CUI [2]
- C1515974
Description
Intensity
Type de données
integer
Alias
- UMLS CUI [1]
- C0522510
Description
Start date
Type de données
date
Unités de mesure
- day month year
Alias
- UMLS CUI [1]
- C0808070
Description
End date
Type de données
date
Unités de mesure
- day month year
Alias
- UMLS CUI [1]
- C0806020
Description
Ongoing
Type de données
boolean
Alias
- UMLS CUI [1]
- C0549178
Description
MEDICATION
Alias
- UMLS CUI-1
- C0013227
Description
Trade / Generic Name
Type de données
text
Alias
- UMLS CUI [1,1]
- C0027365
- UMLS CUI [1,2]
- C0013227
Description
Medical Indication
Type de données
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C0013227
Description
Total Daily Dose
Type de données
text
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0013227
Description
Start date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Description
End date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Description
pharmacotherapy ongoing
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0013216
- UMLS CUI [1,2]
- C0549178
Description
SOLICITED ADVERSE EVENTS – GENERAL SYMPTOMS
Description
Adverse Events General Symptoms
Type de données
text
Alias
- UMLS CUI [1]
- C1556354
Description
Fever
Type de données
boolean
Alias
- UMLS CUI [1]
- C0015967
Description
body temperature site
Type de données
integer
Alias
- UMLS CUI [1]
- C0489453
Description
Fever Day 0
Type de données
float
Unités de mesure
- °C
Alias
- UMLS CUI [1]
- C0015967
Description
Fever Day 1
Type de données
float
Unités de mesure
- dd/mm/yy
Alias
- UMLS CUI [1]
- C0015967
Description
Fever Day 2
Type de données
float
Unités de mesure
- dd/mm/yy
Alias
- UMLS CUI [1]
- C0015967
Description
Fever Day 3
Type de données
float
Unités de mesure
- dd/mm/yy
Alias
- UMLS CUI [1]
- C0015967
Description
symptom ongoing
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C3174772
Description
date last symptoms
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C1457887
Description
Fatigue
Type de données
boolean
Alias
- UMLS CUI [1]
- C0015672
Description
Fatigue Day 0
Type de données
integer
Alias
- UMLS CUI [1]
- C0015672
Description
Fatigue Day 1
Type de données
integer
Alias
- UMLS CUI [1]
- C0015672
Description
Fatigue Day 2
Type de données
integer
Alias
- UMLS CUI [1]
- C0015672
Description
Fatigue Day 3
Type de données
integer
Alias
- UMLS CUI [1]
- C0015672
Description
Fatigue ongoing after day 3
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0015672
- UMLS CUI [1,2]
- C3174772
Description
Date of last day of symptoms
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0015672
- UMLS CUI [1,3]
- C2700396
Description
Headache
Type de données
boolean
Alias
- UMLS CUI [1]
- C0018681
Description
If Yes, please specify
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C0522510
Description
Headache on Day 0
Type de données
integer
Alias
- UMLS CUI [1]
- C0018681
Description
Headache on Day 1
Type de données
integer
Alias
- UMLS CUI [1]
- C0018681
Description
Headache on Day 2
Type de données
integer
Alias
- UMLS CUI [1]
- C0018681
Description
Headache on Day 3
Type de données
integer
Alias
- UMLS CUI [1]
- C0018681
Description
Headache ongoing after day 3
Type de données
boolean
Alias
- UMLS CUI [1]
- C0018681
Description
Headache ongoing after day 3? If Yes, please specify
Type de données
date
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C0011008
Description
Gastrointestinal symptoms
Type de données
boolean
Alias
- UMLS CUI [1]
- C0426576
Description
If Yes, please specify
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0426576
- UMLS CUI [1,2]
- C0522510
Description
Gastrointestinal symptoms on Day 0
Type de données
integer
Alias
- UMLS CUI [1]
- C0426576
Description
Gastrointestinal symptoms on Day 1
Type de données
integer
Alias
- UMLS CUI [1]
- C0426576
Description
Gastrointestinal symptoms on Day 2
Type de données
integer
Alias
- UMLS CUI [1]
- C0426576
Description
Gastrointestinal symptoms on Day 3
Type de données
integer
Alias
- UMLS CUI [1]
- C0426576
Description
Gastrointestinal symptoms ongoing after day 3
Type de données
boolean
Alias
- UMLS CUI [1]
- C0426576
Description
Gastrointestinal symptoms ongoing after day 3? If Yes, please specify
Type de données
date
Alias
- UMLS CUI [1,1]
- C0426576
- UMLS CUI [1,2]
- C0011008
Description
visit date
Type de données
date
Alias
- UMLS CUI [1]
- C1320303
Description
telephone number
Type de données
text
Alias
- UMLS CUI [1]
- C1515258
Description
Other General Symptoms
Alias
- UMLS CUI-1
- C1457887
Description
symptom
Type de données
text
Alias
- UMLS CUI [1]
- C1457887
Description
Intensity
Type de données
integer
Alias
- UMLS CUI [1]
- C0518690
Description
symptom Start Date
Type de données
date
Alias
- UMLS CUI [1]
- C0808070
Description
End date
Type de données
date
Alias
- UMLS CUI [1]
- C0806020
Description
ongoing
Type de données
date
Alias
- UMLS CUI [1]
- C0549178
Similar models
GSK Hepatitis A Vaccine ADDITIONAL VACCINATION Diary Card NCT00291876
C0600091 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C2700396 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,2])
C1515974 (UMLS CUI [2])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C3174772 (UMLS CUI [1,2])
C0015672 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])