Clinical trial NCT01190176: Gynaecological Follow-up of a Subset of HPV-015 (NCT00294047) Study Subjects
Official title: Gynaecological Follow-up of a Subset of HPV-015 Study Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Papillomavirus
Keywords: HPV
HPV vaccine
Cervical neoplasia
Human papillomavirus
Papillomavirus
Cervical cancer
Human papillomavirus (HPV) type 16/18 infections
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-08-27
Enrollment: 34
Sex: FEMALE
Minimum age (years): 28
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study is intended to provide up to a maximum of four years of annual oncogenic human papillomavirus (HPV) DNA testing and cervical cytology examination for NCT00294047 study subjects who displayed normal cervical cytology but tested positive for oncogenic HPV infection at their concluding NCT00294047 study visit.

Women who were pregnant at their concluding NCT00294047 study visit may also be included in this study, as no cervical sample could be collected at that visit.

The objectives and outcome measures of the primary phase (NCT00294047) are presented in a separate protocol posting.

Detailed description: Cervarix or Control \[Al(OH)3\] has been administered in the primary study NCT00294047.

Eligibility criteria: Inclusion Criteria:

* Written informed consent obtained from the subject prior to enrolment.
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
* A subject previously enrolled in the study NCT00294047 and who fulfils either of the following criteria:

  * displayed normal cervical cytology but tested positive for oncogenic HPV infection at her concluding NCT00294047 study visit
  * was pregnant so that no cervical sample could be collected at her concluding NCT00294047 study visit

Exclusion Criteria:

* A subject who at the NCT00294047 concluding study visit displayed normal cervical cytology and who was negative for oncogenic HPV infection at that visit.
* A subject who at the NCT00294047 concluding study visit had a cervical lesion at that visit or who had a cervical lesion that required treatment at her NCT00294047 exit colposcopy.
* A subject for whom the cervical cytology results from the concluding NCT00294047 study visit were unavailable for reasons other than pregnancy.

Primary outcomes:
measure: Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 12
timeFrame: At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
measure: Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 24
timeFrame: At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
measure: Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 36
timeFrame: At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
measure: Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 48
timeFrame: At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
measure: Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 12
timeFrame: At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
measure: Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 24
timeFrame: At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
measure: Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 36
timeFrame: At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
measure: Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 48
timeFrame: At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
measure: Number of Subjects With Referral to Colposcopy at Month 12
timeFrame: At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
measure: Number of Subjects With Referral to Colposcopy at Month 24
timeFrame: At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
measure: Number of Subjects With Referral to Colposcopy at Month 36
timeFrame: At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
measure: Number of Subjects With Referral to Colposcopy at Month 48
timeFrame: At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
measure: Number of Subjects With Referral to Treatment at Month 12
timeFrame: At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
measure: Number of Subjects With Referral to Treatment at Month 24
timeFrame: At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
measure: Number of Subjects With Referral to Treatment at Month 36
timeFrame: At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
measure: Number of Subjects With Referral to Treatment at Month 48
timeFrame: At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: GSK Investigational Site
state: Iowa
city: Wichita
country: United States
facility: GSK Investigational Site
state: Kansas
city: Wenatchee
country: United States
facility: GSK Investigational Site
state: Washington
city: Edmonton
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Vancouver
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Halifax
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Truro
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Sherbrooke
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Amsterdam
country: Netherlands
facility: GSK Investigational Site
city: Rotterdam
country: Netherlands
facility: GSK Investigational Site
city: Almada
country: Portugal
facility: GSK Investigational Site
city: Coimbra
country: Portugal
facility: GSK Investigational Site
city: Lisboa
country: Portugal
facility: GSK Investigational Site
city: Setúbal
country: Portugal
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Sankt-Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Singapore
country: Singapore
facility: GSK Investigational Site
city: Singapore
country: Singapore
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: