Phase 3 N=32 Prevention

Gynaecological Follow-up of a Subset of HPV-015 (NCT00294047) Study Subjects

Infections, Papillomavirus

Bottom Line

View on ClinicalTrials.gov: NCT01190176 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2018

Primary outcome: Primary: Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 12 — 2 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Gynaecological follow-up (Procedure); Cervarix (Biological); Placebo control (Biological)
Age: Adult, Older Adult · 28+ yrs
Sex: Female
Sponsor: GlaxoSmithKline
Primary completion: Sep 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 12	2	—
PRIMARY Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 24	3	—
PRIMARY Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 36	3	—
PRIMARY Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 48	1	—
PRIMARY Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 12	11; 2; 2	—
PRIMARY Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 24	11; 1; 0	—
PRIMARY Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 36	8; 1; 0	—
PRIMARY Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 48	6; 0; 0	—
PRIMARY Number of Subjects With Referral to Colposcopy at Month 12	4; 11; 4; 11; 4; 0	—
PRIMARY Number of Subjects With Referral to Colposcopy at Month 24	1; 11; 1; 11; 1; 0	—
PRIMARY Number of Subjects With Referral to Colposcopy at Month 36	3; 6; 3; 6; 3; 0	—
PRIMARY Number of Subjects With Referral to Colposcopy at Month 48	1; 5; 2; 4; 1; 1	—
PRIMARY Number of Subjects With Referral to Treatment at Month 12	0; 4; 0; 4	—
PRIMARY Number of Subjects With Referral to Treatment at Month 24	0; 1; 0; 1	—
PRIMARY Number of Subjects With Referral to Treatment at Month 36	1; 2; 1; 2; 1; 0	—
PRIMARY Number of Subjects With Referral to Treatment at Month 48	0; 2; 0; 2	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01190176). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.