ID

35161

Beschreibung

Study ID: 107495 Clinical Study ID: 107495 Study Title: A phase II, open, randomized study in adults aged between 18 and 60 years designed to evaluate the reactogenicity and immunogenicity of a 1- and 2-dose prime-boost concept of pandemic monovalent (H5N1) influenza vaccine (split virus formulation) adjuvanted with AS03, administered according to different vaccination schedules. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00430521 https://clinicaltrials.gov/ct2/show/NCT00430521 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Pandemic influenza vaccine (GSK1119711A)-formulation 1, Pandemic influenza vaccine (GSK1119711A)-formulation 2 Trade Name: N/A Study Indication: Influenza There are 4 workbooks (WB): WB 1: Protocol 107495, (H5N1-012), Groups: VT/VT/6Mo, VT/IN/6Mo WB 2: Protocol 107495, (H5N1-012), Groups: VT/VT/12Mo, VT/IN/12Mo WB 3: Protocol 107495 (H5N1-012) GROUPS: 2VT/VT/6MO, 2VT/IN/6MO WB 4: Protocol 107495 (H5N1-012) Groups: 2VT/VT/12Mo, 2VT/IN/12Mo Every Workbook has the following visits: Visit Day 0 (Screening, Dose 1), Visit Day 21, Visit Month 6, Visit Month 12 and Visit Month 18. After Month 6 (+30 days, if applicable) and Month 12 (+30 days, if applicable) there is a Core Analysis section, followed by a final study conclusion after Month 18. Workbook 1 schedules a vaccination at screening and Month 6 each, Workbook 2 at Screening and Month 12. 30 days after the first vaccination there is an additional telephone contact. After the second vaccination additional visits/contacts are necessary in both workbooks: a visit at Month 6/12 + 7 and 21 days and a telephone contact on Month 6/12 + 30 days. Workbook 3 schedules a vaccination at screening, Day 21 and Month 6 and Workbook 4 at screening, Day 21 and Month 12. After the second vaccination there is an additional visit on Day 42 and a telephone contact on day 51. After the third vaccination there are additional visits/contacts: visits at Month 6/12 + 7 and 21 days and a telephone contact at Month 6/12 + 30 days. After Month 6 (+30 days, if applicable) and Month 12 (+30 days, if applicable) there is a Core Analysis section. This document contains the Solicited adverse events - local and general symptoms and Unsolicited AE form. It has to be filled in for screening for all workbooks (WB1-4). It also has to be filled in for: WB 1: Visit Month 6 WB 2: Visit Month 12 WB 3: Visit Day 21 and Visit Month 6 WB 4: Visit Day 21 and Visit Month 12

Link

https://clinicaltrials.gov/ct2/show/NCT00430521

Stichworte

Versionen (2)
  1. 18.02.19 18.02.19 -
  2. 20.02.19 20.02.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

20. Februar 2019

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Evaluation of reactogenicity and immunogenicity of pandemic monovalent (H5N1) influenza vaccine in adults, NCT00430521

Englisch

Solicited adverse events - local and general symptoms, Unsolicited AE

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Workbook number
Beschreibung

Workbook number

Datentyp

integer

Alias
UMLS CUI [1]
C2986015
Visit type
Beschreibung

Visit type

Datentyp

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C0545082
Solicited adverse events - local symptoms
Beschreibung

Solicited adverse events - local symptoms

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
UMLS CUI-3
C0042196
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Beschreibung

Signs/symptoms after vaccination

Datentyp

text

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0042196
Local Symptoms
Beschreibung

Local Symptoms

Datentyp

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
Presence of symptom
Beschreibung

Please tick No/Yes for each symptom

Datentyp

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0150312
Day of symptom
Beschreibung

Day of symptom

Datentyp

integer

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C1457887
Size of symptom
Beschreibung

Note for: Redness, Swelling, Ecchymosis and Induration

Datentyp

integer

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0518690
mm
Intensity of symptom
Beschreibung

Intensity of symptom

Datentyp

integer

Alias
UMLS CUI [1]
C0518690
Ongoing after Day 6?
Beschreibung

Symptom's ongoing

Datentyp

text

Alias
UMLS CUI [1,1]
C0549178
UMLS CUI [1,2]
C1457887
Date of last day of symptom
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1457887
Medically attended visit
Beschreibung

Medically attended visit

Datentyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
Type of medically attended visit
Beschreibung

Type of medically attended visit

Datentyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1386497
Solicited adverse events - general symptoms
Beschreibung

Solicited adverse events - general symptoms

Alias
UMLS CUI-1
C0159028
UMLS CUI-2
C0042196
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Beschreibung

Signs/symptoms after vaccination

Datentyp

text

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0042196
General symptoms
Beschreibung

General symptoms

Datentyp

text

Alias
UMLS CUI [1]
C0159028
Presence of symptom
Beschreibung

Please tick No/Yes for each symptom

Datentyp

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0150312
Day of symptom
Beschreibung

Day of symptom

Datentyp

integer

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C1457887
Measurement of body temperature
Beschreibung

Measurement of body temperature

Datentyp

text

Alias
UMLS CUI [1,1]
C0886414
UMLS CUI [1,2]
C0449444
If fever, note body temperature
Beschreibung

Definition of Fever: Axillary >= 37.5°C, Oral >= 37.5°C, Rectal >= 38° C

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Body temperature not taken
Beschreibung

Body temperature not taken

Datentyp

boolean

Alias
UMLS CUI [1]
C0437722
Intensity of symptom
Beschreibung

For Fatigue, Headache, Myalgia, Shivering, Arthralgia, Sweating increase

Datentyp

integer

Alias
UMLS CUI [1]
C0518690
Ongoing after Day 6?
Beschreibung

Symptom's ongoing

Datentyp

text

Alias
UMLS CUI [1,1]
C0549178
UMLS CUI [1,2]
C1457887
Date of last day of symptom
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1457887
Causality?
Beschreibung

Causality of symptoms

Datentyp

text

Alias
UMLS CUI [1]
C0015127
Medically attended visit
Beschreibung

Medically attended visit

Datentyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
Type of medically attended visit
Beschreibung

Type of medically attended visit

Datentyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1386497
Unsolicited Adverse events
Beschreibung

Unsolicited Adverse events

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0042196
Has the subject experienced any serious or non-serious unsolicited adverse events between the vaccination and the following visit?
Beschreibung

If you tick yes, please fill in the Non-Serious Adverse Event section or Serious Adverse Event report, as appropriate. Time specification: For WB1: 1) between Visit Day 0 and Telephone contact Day 30, 2) between Visit Month 6 and Telephone contact Month 6 + 30 days. For WB2: 1) between Visit Day 0 and Telephone contact Day 30, 2) between Visit Month 12 and Telephone contact Month 12 + 30 days. For WB3: 1) between Visit Day 0 and Visit Day 21, 2) between Visit Day 21 and Telephone contact Day 51, 3) between Visit Month 6 and Telephone contact Month 6 + 30 days. For WB4: 1) between Visit Day 0 and Visit Day 21, 2) between Visit Day 21 and Telephone contact Day 51, 3) between Visit Month 12 and Telephone contact Month 12 + 30 days.

Datentyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C4055646
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Solicited adverse events - local and general symptoms, Unsolicited AE

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item
Workbook number
integer
C2986015 (UMLS CUI [1])
Workbook number
Code List
Workbook number
CL Item
WB 1 (1)
CL Item
WB 2 (2)
CL Item
WB 3 (3)
CL Item
WB 4 (4)
Item
Visit type
integer
C0332307 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
Screening (all WB's) (1)
CL Item
Visit Month 6 (WB1+3) (2)
CL Item
Visit Month 12 (WB2+4) (3)
CL Item
Visit Day 21 (WB3+4) (4)
Item Group
Solicited adverse events - local symptoms
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
Item
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
text
C0037088 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Signs/symptoms after vaccination
Code List
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
CL Item
Information not available (U)
CL Item
No Vaccine administered  (NA)
CL Item
No (N)
CL Item
Yes (Y)
Item
Local Symptoms
text
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
Local Symptoms
Code List
Local Symptoms
CL Item
Redness (RE)
CL Item
Swelling (SW)
CL Item
Ecchymosis (EC)
CL Item
Induration (IN)
CL Item
Pain (PA)
Item
Presence of symptom
text
C1457887 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
Present of symptom
Code List
Presence of symptom
CL Item
No (N)
CL Item
Yes (Y)
Item
Day of symptom
integer
C0439228 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Day of symptom
Code List
Day of symptom
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Day 4 (5)
CL Item
Day 5 (6)
CL Item
Day 6 (7)
Size of symptom
Item
Size of symptom
integer
C0456389 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Item
Intensity of symptom
integer
C0518690 (UMLS CUI [1])
Intensity of symptom
Code List
Intensity of symptom
CL Item
Absent (0)
CL Item
Painful on touch  (1)
CL Item
Painful when limb is moved  (2)
CL Item
Pain that prevents normal activity (3)
Item
Ongoing after Day 6?
text
C0549178 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Symptom's ongoing
Code List
Ongoing after Day 6?
CL Item
No (N)
CL Item
Yes (Y)
Date of last day of symptom
Item
Date of last day of symptom
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Item
Medically attended visit
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Medically attended visit
Code List
Medically attended visit
CL Item
No (N)
CL Item
Yes (Y)
Item
Type of medically attended visit
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
Medically attended visit
Code List
Type of medically attended visit
CL Item
Hospitalization (HO)
CL Item
Emergency Room (ER)
CL Item
Medical Personnel (MD)
Item Group
Solicited adverse events - general symptoms
C0159028 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
Item
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
text
C0037088 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Signs/symptoms after vaccination
Code List
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
CL Item
Information not available (U)
CL Item
No Vaccine administered  (NA)
CL Item
No (N)
CL Item
Yes (Y)
Item
General symptoms
text
C0159028 (UMLS CUI [1])
General symptoms
Code List
General symptoms
CL Item
Fever (FE)
CL Item
Fatigue (FA)
CL Item
Headache (HE)
CL Item
Myalgia (MY)
CL Item
Shivering (SH)
CL Item
Arthralgia (AR)
CL Item
Sweating increase (SE)
Item
Presence of symptom
text
C1457887 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
Present of symptom
Code List
Presence of symptom
CL Item
No (N)
CL Item
Yes (Y)
Item
Day of symptom
integer
C0439228 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Day of symptom
Code List
Day of symptom
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Day 4 (5)
CL Item
Day 5 (6)
CL Item
Day 6 (7)
Item
Measurement of body temperature
text
C0886414 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
Measurement of body temperature
Code List
Measurement of body temperature
CL Item
Axillary (preferable) (A)
CL Item
Oral (O)
CL Item
Rectal (R)
Body temperature
Item
If fever, note body temperature
float
C0005903 (UMLS CUI [1])
Body temperature not taken
Item
Body temperature not taken
boolean
C0437722 (UMLS CUI [1])
Item
Intensity of symptom
integer
C0518690 (UMLS CUI [1])
Intensity of symptom
Code List
Intensity of symptom
CL Item
Normal (0)
CL Item
Symptoms that are easily tolerated (1)
CL Item
Symptoms that interfere with normal activity (2)
CL Item
Symptoms that prevent normal activity (3)
Item
Ongoing after Day 6?
text
C0549178 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Symptom's ongoing
Code List
Ongoing after Day 6?
CL Item
No (N)
CL Item
Yes (Y)
Date of last day of symptom
Item
Date of last day of symptom
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Item
Causality?
text
C0015127 (UMLS CUI [1])
Causality of symptoms
Code List
Causality?
CL Item
No (N)
CL Item
Yes (Y)
Item
Medically attended visit
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Medically attended visit
Code List
Medically attended visit
CL Item
No (N)
CL Item
Yes (Y)
Item
Type of medically attended visit
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
Medically attended visit
Code List
Type of medically attended visit
CL Item
Hospitalization (HO)
CL Item
Emergency Room (ER)
CL Item
Medical Personnel (MD)
Item Group
Unsolicited Adverse events
C0877248 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
Item
Has the subject experienced any serious or non-serious unsolicited adverse events between the vaccination and the following visit?
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C4055646 (UMLS CUI [1,3])
SAE/Non-serious AE unsolicited adverse events
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events between the vaccination and the following visit?
CL Item
Information not available (U)
CL Item
No vaccine administered (NA)
CL Item
No (N)
CL Item
Yes (Y)
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video