ID

34924

Beschreibung

Study ID: 104951 Clinical Study ID: 104951 Study Title: A Phase III, double-blind, randomized, controlled study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals' HPV-16/18 L1 VLP AS04 vaccine administered intramuscularly according to a 0_ 1_ 6 month schedule in healthy female subjects aged 10 - 14 years. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00290277 https://clinicaltrials.gov/ct2/show/NCT00290277 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: HPV-16/18 L1/AS04 Vaccine Trade Name: N/A Study Indication: Infections, Papillomavirus This forms contains information about concomitant medication/vaccination. Record any concomitant medication/vaccination, including any medication administered prophylactically in anticipation of reaction to the vaccination (analgesic, antipyretic). This section about concomitant medication/vaccination must be checked for final assessment at the end of the study.

Link

https://clinicaltrials.gov/ct2/show/NCT00290277

Stichworte

Versionen (1)
  1. 04.02.19 04.02.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

4. Februar 2019

DOI

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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

Englisch

Concomitant medication/vaccination

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beschreibung

Subject number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Date of visit
Beschreibung

Date of visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Visit number
Beschreibung

The items have to be filled in at every visit.

Datentyp

text

Alias
UMLS CUI [1]
C1549755
Have any medications/treatments been administered during study period?
Beschreibung

If YES, please specify below.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0013227
UMLS CUI [2]
C1707479
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
Beschreibung

Any vaccine not foreseen in the study protocol administered in the period beginning 30 days preceding each dose ofstudy/ control vaccine and ending one month (minimum 30 days) after each dose of study vaccine is to be recorded. If YES, specify below.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0042210
Concomitant Medication
Beschreibung

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Trade / generic name
Beschreibung

Trade / generic name

Datentyp

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C2347852
Medical Indication: prophylactic?
Beschreibung

A prophylactic medication is a medication administered in the absence of ANY symptom and in anticipation of a reaction to the vaccination.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C3146298
UMLS CUI [1,3]
C0199176
Total daily dose
Beschreibung

Total daily dose

Datentyp

text

Alias
UMLS CUI [1]
C2826638
Route of administration
Beschreibung

Route of administration

Datentyp

text

Alias
UMLS CUI [1]
C2826730
Start date
Beschreibung

Start date

Datentyp

date

Alias
UMLS CUI [1]
C2826734
End date
Beschreibung

If continuing at end of study, tick below.

Datentyp

date

Alias
UMLS CUI [1]
C2826744
Medication continuing at end of study
Beschreibung

Medication continuing at end of study

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2826666
UMLS CUI [1,2]
C0444496
Concomitant Vaccination
Beschreibung

Concomitant Vaccination

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
Trade / (Generic) Name
Beschreibung

Trade / (Generic) Name

Datentyp

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C0042210
Route of Administration
Beschreibung

Route of Administration

Datentyp

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Administration Date
Beschreibung

Administration Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0042210
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Ähnliche Modelle

Concomitant medication/vaccination

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item
Visit number
text
C1549755 (UMLS CUI [1])
Visit number
Code List
Visit number
CL Item
Visit 1 (month 0, pre-vacc) (Visit 1)
CL Item
Visit 2 (month 1) (Visit 2)
CL Item
Visit 3 (month 6) (Visit 3)
CL Item
Visit 4 (month 7, post vacc III) (Visit 4)
Have any medications/treatments been administered during study period?
Item
Have any medications/treatments been administered during study period?
boolean
C2347852 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1707479 (UMLS CUI [2])
Administration of vaccine(s) other than the study vaccine
Item
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
boolean
C2347852 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Trade / generic name
Item
Trade / generic name
text
C2360065 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Medical Indication: prophylactic?
Item
Medical Indication: prophylactic?
boolean
C0013227 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C0199176 (UMLS CUI [1,3])
Total daily dose
Item
Total daily dose
text
C2826638 (UMLS CUI [1])
Item
Route of administration
text
C2826730 (UMLS CUI [1])
Route of administration
Code List
Route of administration
CL Item
External (EXT)
CL Item
Intradermal (ID)
CL Item
Inhalation (IH)
CL Item
Intramuscular (IM)
CL Item
Intraarticular (IR)
CL Item
Intrathekal (IT)
CL Item
Intravenous (IV)
CL Item
Intranasal (NA)
CL Item
Parenteral (PE)
CL Item
Oral (PO)
CL Item
Rectal (PR)
CL Item
Subcutaneous (SC)
CL Item
Sublingual (SL)
CL Item
Transdermal (TD)
CL Item
Topical (TO)
CL Item
Vaginal (VA)
CL Item
Other (OTH)
CL Item
Unknown (UKN)
Start date
Item
Start date
date
C2826734 (UMLS CUI [1])
End date
Item
End date
date
C2826744 (UMLS CUI [1])
Medication continuing at end of study
Item
Medication continuing at end of study
boolean
C2826666 (UMLS CUI [1,1])
C0444496 (UMLS CUI [1,2])
Item Group
Concomitant Vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Trade / (Generic) Name
Item
Trade / (Generic) Name
text
C2360065 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Item
Route of Administration
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Route of Administration
Code List
Route of Administration
CL Item
External (EXT)
CL Item
Intradermal (ID)
CL Item
Inhalation (IH)
CL Item
Intramuscular (IM)
CL Item
Intraarticular (IR)
CL Item
Intrathekal (IT)
CL Item
Intravenous (IV)
CL Item
Intranasal (NA)
CL Item
Parenteral (PE)
CL Item
Oral (PO)
CL Item
Rectal (PR)
CL Item
Subcutaneous (SC)
CL Item
Sublingual (SL)
CL Item
Transdermal (TD)
CL Item
Topical (TO)
CL Item
Vaginal (VA)
CL Item
Other (OTH)
CL Item
Unknown (UKN)
Administration Date
Item
Administration Date
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
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