ID

34736

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 form contains information about informed consent and demographics and should be filled in at visit 1 (month 0, pre-vacc).

Link

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

Stichworte

Versionen (1)
  1. 25.01.19 25.01.19 -
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GlaxoSmithKline

Hochgeladen am

25. Januar 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

Demography

1 Formulare  
  1. StudyEvent: ODM
    1. Demography
Informed consent
Beschreibung

Informed consent

Alias
UMLS CUI-1
C0021430
Informed consent Date
Beschreibung

I certify, that Informed Consent has been obtained prior to any study procedure.

Datentyp

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0184661
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0011008
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Centre number
Beschreibung

Centre number

Datentyp

text

Alias
UMLS CUI [1,1]
C2825181
UMLS CUI [1,2]
C1300638
Subject number
Beschreibung

Subject number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Treatment number
Beschreibung

Treatment number

Datentyp

text

Alias
UMLS CUI [1,1]
C1522541
UMLS CUI [1,2]
C0600091
Protocol number
Beschreibung

Protocol number

Datentyp

text

Alias
UMLS CUI [1,1]
C0008971
UMLS CUI [1,2]
C0600091
Date of visit
Beschreibung

Date of visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Demography
Beschreibung

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Beschreibung

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschreibung

In this study, only female participants were allowed.

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Ethnicity, tick one:
Beschreibung

Ethnicity

Datentyp

integer

Alias
UMLS CUI [1]
C0015031
Race: African American / African Heritage
Beschreibung

Race: African American / African Heritage

Datentyp

boolean

Alias
UMLS CUI [1]
C0027567
UMLS CUI [2,1]
C0085756
UMLS CUI [2,2]
C0034510
Race: American Indian or Alaskan Native
Beschreibung

Race: American Indian or Alaskan Native

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1515945
UMLS CUI [1,2]
C0034510
Race: Asian - Central/South Asian Heritage
Beschreibung

Race: Asian - Central/South Asian Heritage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0238696
UMLS CUI [1,2]
C0034510
UMLS CUI [2,1]
C1519427
UMLS CUI [2,2]
C0034510
Race: Asian - East Asian Heritage
Beschreibung

Race: Asian - East Asian Heritage

Datentyp

boolean

Alias
UMLS CUI [1]
C4540996
Race: Asian - Japanese Heritage
Beschreibung

Race: Asian - Japanese Heritage

Datentyp

boolean

Alias
UMLS CUI [1]
C1556094
Race: Asian - South East Asian Heritage
Beschreibung

Race: Asian - South East Asian Heritage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0238697
UMLS CUI [1,2]
C0034510
Race: Native Hawaiian or Other Pacific Islander
Beschreibung

Race: Native Hawaiian or Other Pacific Islander

Datentyp

boolean

Alias
UMLS CUI [1]
C1513907
Race: White - Arabic/North African Heritage
Beschreibung

Race: White - Arabic/North African Heritage

Datentyp

boolean

Alias
UMLS CUI [1]
C0238604
UMLS CUI [2,1]
C2698217
UMLS CUI [2,2]
C0034510
Race: White - White/Caucasian/European Heritage
Beschreibung

Race: White - White/Caucasian/European Heritage

Datentyp

boolean

Alias
UMLS CUI [1]
C0043157
Other Race, specify
Beschreibung

Other Race, specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0034510
UMLS CUI [1,2]
C3845569
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Ähnliche Modelle

Demography

1 Formulare
  1. StudyEvent: ODM
    1. Demography
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Informed consent
C0021430 (UMLS CUI-1)
Informed Consent Date
Item
Informed consent Date
date
C0021430 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])
C0021430 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Centre number
Item
Centre number
text
C2825181 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Treatment number
Item
Treatment number
text
C1522541 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Protocol number
Item
Protocol number
text
C0008971 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Item
Ethnicity, tick one:
integer
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity, tick one:
CL Item
American Hispanic or Latino (1)
CL Item
Not American Hispanic or Latino (2)
Race: African American / African Heritage
Item
Race: African American / African Heritage
boolean
C0027567 (UMLS CUI [1])
C0085756 (UMLS CUI [2,1])
C0034510 (UMLS CUI [2,2])
Race: American Indian or Alaskan Native
Item
Race: American Indian or Alaskan Native
boolean
C1515945 (UMLS CUI [1,1])
C0034510 (UMLS CUI [1,2])
Race: Asian - Central/South Asian Heritage
Item
Race: Asian - Central/South Asian Heritage
boolean
C0238696 (UMLS CUI [1,1])
C0034510 (UMLS CUI [1,2])
C1519427 (UMLS CUI [2,1])
C0034510 (UMLS CUI [2,2])
Race: Asian - East Asian Heritage
Item
Race: Asian - East Asian Heritage
boolean
C4540996 (UMLS CUI [1])
Race: Asian - Japanese Heritage
Item
Race: Asian - Japanese Heritage
boolean
C1556094 (UMLS CUI [1])
Race: Asian - South East Asian Heritage
Item
Race: Asian - South East Asian Heritage
boolean
C0238697 (UMLS CUI [1,1])
C0034510 (UMLS CUI [1,2])
Race: Native Hawaiian or Other Pacific Islander
Item
Race: Native Hawaiian or Other Pacific Islander
boolean
C1513907 (UMLS CUI [1])
Race: White - Arabic/North African Heritage
Item
Race: White - Arabic/North African Heritage
boolean
C0238604 (UMLS CUI [1])
C2698217 (UMLS CUI [2,1])
C0034510 (UMLS CUI [2,2])
Race: White - White/Caucasian/European Heritage
Item
Race: White - White/Caucasian/European Heritage
boolean
C0043157 (UMLS CUI [1])
Other Race, specify
Item
Other Race, specify
text
C0034510 (UMLS CUI [1,1])
C3845569 (UMLS CUI [1,2])
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