Gynaecological Follow-up of a Subset of 580299/008 (NCT00122681) Study Subjects
NCT ID: NCT00937950
Last Updated: 2019-10-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2022 participants
INTERVENTIONAL
2009-08-05
2014-01-20
Brief Summary
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This follow-up study will also be offered to subjects who were pregnant at their last NCT00122681 study visit (Visit 10, Month 48) so that no cervical sample could be collected at that visit.
The objectives \& outcome measures of the primary phase (study 008/580299) are presented in a separate protocol posting (NCT00122681).
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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HPV-052 study subjects Group
The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit.
Gynaecological follow-up
Subjects received a gynaecological follow-up with cytology and oncogenic HPV DNA testing every 12 months, for up to four years in this gynaecological follow-up study (HPV-052 EXT 008). No vaccine was administered in this extension study. Subjects received 3 doses of Cervarix/Havrix vaccine, administered intramuscularly, according to a 0, 1, 6-month vaccination schedule in the HPV-008 (NCT00122681) primary study.
Interventions
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Gynaecological follow-up
Subjects received a gynaecological follow-up with cytology and oncogenic HPV DNA testing every 12 months, for up to four years in this gynaecological follow-up study (HPV-052 EXT 008). No vaccine was administered in this extension study. Subjects received 3 doses of Cervarix/Havrix vaccine, administered intramuscularly, according to a 0, 1, 6-month vaccination schedule in the HPV-008 (NCT00122681) primary study.
Eligibility Criteria
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Inclusion Criteria
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
* A subject previously enrolled in the study NCT00122681 and who fulfils either of the following criteria:
* displayed normal cervical cytology but tested positive for oncogenic HPV infection at her last NCT00122681 study visit (Visit 10, Month 48).
or
\- was pregnant at her last visit of the NCT00122681 study (Visit 10, Month 48) so that no cervical sample could be collected at that visit.
Exclusion Criteria
* A subject who had a cervical lesion at her last NCT00122681 study visit (Visit 10, Month 48) or who had a cervical lesion that required treatment at the NCT00122681 exit colposcopy.
* A subject for whom the cervical cytology results from the last NCT00122681 study visit (Visit 10, Month 48) were unavailable for reasons other than pregnancy.
If at the time of enrolment the subject experiences heavy bleeding (menstruation or other) or heavy vaginal discharge, or is pregnant, the pelvic exam cannot be performed. The subject's first study visit will be deferred until condition is resolved according to investigator's medical judgment.
18 Years
FEMALE
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Clearwater, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Honolulu, Hawaii, United States
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Iowa City, Iowa, United States
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Wichita, Kansas, United States
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Bardstown, Kentucky, United States
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Omaha, Nebraska, United States
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Albuquerque, New Mexico, United States
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New York, New York, United States
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Chapel Hill, North Carolina, United States
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New Bern, North Carolina, United States
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Tulsa, Oklahoma, United States
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Portland, Oregon, United States
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Erie, Pennsylvania, United States
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Erie, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pleasant Hills, Pennsylvania, United States
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Wenatchee, Washington, United States
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Westmead, New South Wales, Australia
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Hobart, Tasmania, Australia
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Carlton, Victoria, Australia
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Parkville, Victoria, Australia
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Perth, Western Australia, Australia
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Brussels, , Belgium
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Edegem, , Belgium
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Leuven, , Belgium
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Porto Alegre, Rio Grande do Sul, Brazil
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Campinas, , Brazil
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Curitiba, , Brazil
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Edmonton, Alberta, Canada
GSK Investigational Site
Langley, British Columbia, Canada
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Truro, Nova Scotia, Canada
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Beauport, Quebec, Canada
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Montreal, Quebec, Canada
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Helsinki, , Finland
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Jyväskylä, , Finland
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Kotka, , Finland
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Kouvola, , Finland
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Kuopio, , Finland
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Lahti, , Finland
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Lappeenranta, , Finland
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Mikkeli, , Finland
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Oulu, , Finland
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Pori, , Finland
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Rauma, , Finland
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Seinäjoki, , Finland
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Tampere, , Finland
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Turku, , Finland
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Vaasa, , Finland
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Karlsruhe, Baden-Wurttemberg, Germany
GSK Investigational Site
Ravensburg, Baden-Wurttemberg, Germany
GSK Investigational Site
Rheinstetten, Baden-Wurttemberg, Germany
GSK Investigational Site
Munich, Bavaria, Germany
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Würzburg, Bavaria, Germany
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Frankfurt am Main, Hesse, Germany
GSK Investigational Site
Hanover, Lower Saxony, Germany
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Mainz, Rhineland-Palatinate, Germany
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Leipzig, Saxony, Germany
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Nordhausen, Thuringia, Germany
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Berlin, , Germany
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Berlin, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Modena, Emilia-Romagna, Italy
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Cavite, , Philippines
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Laguna, , Philippines
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Las Piñas, , Philippines
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Los Banos, Laguna, , Philippines
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Makati City, , Philippines
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Manila, , Philippines
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Barcelona, , Spain
GSK Investigational Site
L'Hospitalet de Llobregat, , Spain
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Madrid, , Spain
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Móstoles/Madrid, , Spain
GSK Investigational Site
Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Bangkok, , Thailand
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Bangkok, , Thailand
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Bangkok, , Thailand
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Aberdeen, , United Kingdom
GSK Investigational Site
London, , United Kingdom
GSK Investigational Site
Manchester, , United Kingdom
Countries
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Related Links
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IPD for this study will be made available via the Clinical Study Data Request site.
Other Identifiers
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2008-008124-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
112024
Identifier Type: -
Identifier Source: org_study_id
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