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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-12

Study Completion Date

2017-09-20

Brief Summary

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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.

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Detailed Description

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

Conditions

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Infections, Papillomavirus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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HPV-062 study subjects Group

HPV-015 (NCT00294047) study subjects who had normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 (NCT00294047) study visit or were pregnant, so that no cervical sample could be collected at their concluding HPV-015 (NCT00294047) study visit.

Group Type EXPERIMENTAL

Gynaecological follow-up

Intervention Type PROCEDURE

Subjects will receive a gynaecological follow-up with cytology and oncogenic HPV DNA testing every 12 months, for up to a maximum of four years.

Cervarix

Intervention Type BIOLOGICAL

Subjects received 3 doses of the HPV vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule in the primary study HPV-015.

Placebo control

Intervention Type BIOLOGICAL

Subjects received 3 doses of the control \[Al(OH)3\] administered intramuscularly according to a 0, 1, 6 month vaccination schedule in the primary study HPV-015.

Interventions

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Gynaecological follow-up

Subjects will receive a gynaecological follow-up with cytology and oncogenic HPV DNA testing every 12 months, for up to a maximum of four years.

Intervention Type PROCEDURE

Cervarix

Subjects received 3 doses of the HPV vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule in the primary study HPV-015.

Intervention Type BIOLOGICAL

Placebo control

Subjects received 3 doses of the control \[Al(OH)3\] administered intramuscularly according to a 0, 1, 6 month vaccination schedule in the primary study HPV-015.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

28 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes