A phase IIIb, open, multi-centre gynaecological extension study for the follow-up of a subset of HPV-015 study subjects - HPV-062 EXT:015

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-017282-35-GB

Enrollment

1500

Registered

2010-06-04

Start date

2010-07-07

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine is indicated in females from 10 years of age onwards for the prevention of pre-malignant cervical lesions and cervical cancer causally related to Human Papillomavirus (HPV) types 16 and 18.

Interventions

Trade Name: Cervarix Pharmaceutical Form: Suspension for injection Other descriptive name: HPV-16 L1 antigen Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration n

Eligibility

Sex/Gender

All

Inclusion 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 HPV-015 and who fulfils either of the following criteria: -displayed normal cervical cytology but tested positive for oncogenic HPV infection at her concluding HPV-015 study visit -was pregnant so that no cervical sample could be collected at her concluding HPV-015 study visit Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: •A subject who at the HPV-015 concluding study visit displayed normal cervical cytology and who was negative for oncogenic HPV infection at that visit. •A subject who at the HPV-015 concluding study visit had a cervical lesion at that visit or who had a cervical lesion that required treatment at her HPV-015 exit colposcopy. •A subject for whom the cervical cytology results from the concluding HPV-015 study visit were unavailable for reasons other than pregnancy.

Design outcomes

Primary

Measure	Time frame
Main Objective: To provide clinical management and, if required, treatment to subjects who at their concluding HPV-015 study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or who were pregnant at their concluding visit of the HPV-015 study so that no cervical sample could be collected.;Secondary Objective: -;Primary end point(s): •Occurrence of positive oncogenic HPV DNA results in cervical samples by HPV DNA testing (Hybrid Capture ® 2 test [HC2]). •Occurrence of cervical cytological abnormalities in cervical samples by ThinPrep® PapTest. •Occurrence of referral to colposcopy. •Occurrence of referral to treatment.	—

Measure

Time frame

Main Objective: To provide clinical management and, if required, treatment to subjects who at their concluding HPV-015 study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or who were pregnant at their concluding visit of the HPV-015 study so that no cervical sample could be collected.;Secondary Objective: -;Primary end point(s): •Occurrence of positive oncogenic HPV DNA results in cervical samples by HPV DNA testing (Hybrid Capture ® 2 test [HC2]). •Occurrence of cervical cytological abnormalities in cervical samples by ThinPrep® PapTest. •Occurrence of referral to colposcopy. •Occurrence of referral to treatment.

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Countries

Netherlands, Portugal, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026