ID
34736
Description
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
Keywords
Versions (1)
- 1/25/19 1/25/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
January 25, 2019
DOI
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License
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
Demography
- StudyEvent: ODM
Description
Administrative data
Alias
- UMLS CUI-1
- C1320722
Description
Centre number
Data type
text
Alias
- UMLS CUI [1,1]
- C2825181
- UMLS CUI [1,2]
- C1300638
Description
Subject number
Data type
text
Alias
- UMLS CUI [1]
- C2348585
Description
Treatment number
Data type
text
Alias
- UMLS CUI [1,1]
- C1522541
- UMLS CUI [1,2]
- C0600091
Description
Protocol number
Data type
text
Alias
- UMLS CUI [1,1]
- C0008971
- UMLS CUI [1,2]
- C0600091
Description
Date of visit
Data type
date
Alias
- UMLS CUI [1]
- C1320303
Description
Demography
Alias
- UMLS CUI-1
- C0011298
Description
Date of birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
In this study, only female participants were allowed.
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
Ethnicity
Data type
integer
Alias
- UMLS CUI [1]
- C0015031
Description
Race: African American / African Heritage
Data type
boolean
Alias
- UMLS CUI [1]
- C0027567
- UMLS CUI [2,1]
- C0085756
- UMLS CUI [2,2]
- C0034510
Description
Race: American Indian or Alaskan Native
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1515945
- UMLS CUI [1,2]
- C0034510
Description
Race: Asian - Central/South Asian Heritage
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0238696
- UMLS CUI [1,2]
- C0034510
- UMLS CUI [2,1]
- C1519427
- UMLS CUI [2,2]
- C0034510
Description
Race: Asian - East Asian Heritage
Data type
boolean
Alias
- UMLS CUI [1]
- C4540996
Description
Race: Asian - Japanese Heritage
Data type
boolean
Alias
- UMLS CUI [1]
- C1556094
Description
Race: Asian - South East Asian Heritage
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0238697
- UMLS CUI [1,2]
- C0034510
Description
Race: Native Hawaiian or Other Pacific Islander
Data type
boolean
Alias
- UMLS CUI [1]
- C1513907
Description
Race: White - Arabic/North African Heritage
Data type
boolean
Alias
- UMLS CUI [1]
- C0238604
- UMLS CUI [2,1]
- C2698217
- UMLS CUI [2,2]
- C0034510
Description
Race: White - White/Caucasian/European Heritage
Data type
boolean
Alias
- UMLS CUI [1]
- C0043157
Description
Other Race, specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C3845569
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Demography
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