ID

34738

Beschrijving

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 form contains information about elimination criteria during the study and should be checked at each visit subsequent to the first visit. If any become applicable during the study, it will not require withdrawal of the subject from the study but may determine a subject’s evaluability in the according-to-protocol analysis.

Link

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

Trefwoorden

Versies (1)
  1. 25-01-19 25-01-19 -
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GlaxoSmithKline

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25 januari 2019

DOI

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Licentie

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

Engels

Elimination criteria

1 Formulieren  
  1. StudyEvent: ODM
    1. Elimination criteria
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beschrijving

Subject number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Visit number
Beschrijving

Visit number

Datatype

text

Alias
UMLS CUI [1]
C1549755
Date of visit
Beschrijving

Date of visit

Datatype

date

Alias
UMLS CUI [1]
C1320303
Elimination criteria during the study
Beschrijving

Elimination criteria during the study

Alias
UMLS CUI-1
C0680251
UMLS CUI-2
C2347804
Pregnancy
Beschrijving

Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
Use of any investigational or non-registered product (drug or vaccine) other than the study/control vaccine(s) during the study period
Beschrijving

Use of any investigational or non-registered product (drug or vaccine) other than the study/control vaccine(s)

Datatype

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2347804
UMLS CUI [2,1]
C0042210
UMLS CUI [2,2]
C1517586
UMLS CUI [2,3]
C0205394
UMLS CUI [2,4]
C2347804
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period.
Beschrijving

For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C1533734
UMLS CUI [1,3]
C0205191
UMLS CUI [2,1]
C0005525
UMLS CUI [2,2]
C1533734
UMLS CUI [2,3]
C0205191
Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study/control vaccine(s) and ending 30 days after (i.e. Days 0-29).
Beschrijving

Administration of routine meningococcal, hepatitis B, inactivated influenza, diphteria/tetanus and/or diphteria/tetanus-containing vaccine up to 8 days before each dose of study vaccine is allowed if the subject is outside of the 30 days follow-up period of the previous dose.

Datatype

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1444655
UMLS CUI [1,3]
C2348563
UMLS CUI [1,4]
C2347804
UMLS CUI [2,1]
C2368628
UMLS CUI [2,2]
C0205547
UMLS CUI [2,3]
C2347804
UMLS CUI [3]
C0700144
UMLS CUI [4]
C2240392
UMLS CUI [5]
C0021403
UMLS CUI [6]
C0058773
Administration of immunoglobulins and/or any blood product within three months preceding the first dose of study/ control vaccine or planned administration during the study period.
Beschrijving

Enrolment will be deferred until the subject is outside of specified window

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021027
UMLS CUI [1,2]
C1533734
UMLS CUI [1,3]
C0332185
UMLS CUI [2,1]
C0021027
UMLS CUI [2,2]
C1533734
UMLS CUI [2,3]
C1301732
UMLS CUI [3,1]
C0456388
UMLS CUI [3,2]
C1533734
UMLS CUI [3,3]
C0332185
UMLS CUI [4,1]
C0456388
UMLS CUI [4,2]
C1533734
UMLS CUI [4,3]
C1301732
Newly diagnosed immunosuppressive condition, including human immunodeficiency virus (HIV) infection.
Beschrijving

Newly diagnosed immunosuppressive condition

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021051
UMLS CUI [1,2]
C1518321
UMLS CUI [2,1]
C0019693
UMLS CUI [2,2]
C1518321
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Similar models

Elimination criteria

1 Formulieren
  1. StudyEvent: ODM
    1. Elimination criteria
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item
Visit number
text
C1549755 (UMLS CUI [1])
Visit number
Code List
Visit number
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)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Elimination criteria during the study
C0680251 (UMLS CUI-1)
C2347804 (UMLS CUI-2)
Pregnancy
Item
Pregnancy
boolean
C0032961 (UMLS CUI [1])
Use of any investigational or non-registered product (drug or vaccine) other than the study/control vaccine(s)
Item
Use of any investigational or non-registered product (drug or vaccine) other than the study/control vaccine(s) during the study period
boolean
C0304229 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0042210 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C2347804 (UMLS CUI [2,4])
Chronic administration of immunosuppressants or other immune-modifying drugs
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period.
boolean
C0021081 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0005525 (UMLS CUI [2,1])
C1533734 (UMLS CUI [2,2])
C0205191 (UMLS CUI [2,3])
Administration of a vaccine not foreseen by the study protocol
Item
Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study/control vaccine(s) and ending 30 days after (i.e. Days 0-29).
boolean
C2368628 (UMLS CUI [1,1])
C1444655 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
C2368628 (UMLS CUI [2,1])
C0205547 (UMLS CUI [2,2])
C2347804 (UMLS CUI [2,3])
C0700144 (UMLS CUI [3])
C2240392 (UMLS CUI [4])
C0021403 (UMLS CUI [5])
C0058773 (UMLS CUI [6])
Administration of immunoglobulins and/or any blood product
Item
Administration of immunoglobulins and/or any blood product within three months preceding the first dose of study/ control vaccine or planned administration during the study period.
boolean
C0021027 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0021027 (UMLS CUI [2,1])
C1533734 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
C0456388 (UMLS CUI [3,1])
C1533734 (UMLS CUI [3,2])
C0332185 (UMLS CUI [3,3])
C0456388 (UMLS CUI [4,1])
C1533734 (UMLS CUI [4,2])
C1301732 (UMLS CUI [4,3])
Newly diagnosed immunosuppressive condition
Item
Newly diagnosed immunosuppressive condition, including human immunodeficiency virus (HIV) infection.
boolean
C0021051 (UMLS CUI [1,1])
C1518321 (UMLS CUI [1,2])
C0019693 (UMLS CUI [2,1])
C1518321 (UMLS CUI [2,2])
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