Follow-up Study of GSK Biologicals' Human Papilloma Virus (HPV) Vaccine to Prevent Cervical Infection in Young Adults

Study Overview
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Brief Summary
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Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This is an observer blind follow up study of the study HPV-001, which evaluated the ability of the HPV vaccine to prevent HPV infection. The current study invites all of the 1113 subjects in the HPV-001 study that received all three doses of vaccine/placebo to be enrolled and followed-up for several additional years to see if the HPV vaccine prevents HPV-16 and HPV-18 infections and to evaluate the safety of the vaccine. Subjects will remain in the same study group as in the primary study. No vaccine or placebo will be administered in this study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Official Title
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Study of the Efficacy of Candidate HPV 16/18 VLP Vaccine in the Prevention of HPV-16 and/or HPV-18 Cervical Infection in Adolescent & Young Adult Women in North America and Brazil Vaccinated in Primary Study 580299/001

Conditions
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Infections, Papillomavirus

Intervention / Treatment
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* Biological: HPV 16/18 VLP AS04


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participated in study 580299/001 and received all three doses of vaccine/placebo. Written informed consent obtained from the subject prior to enrollment Exclusion Criteria: Decoding of the subject's treatment allocation to either the subject or the investigator in study 580299/001.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: HPV 16/18 VLP AS04|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incident cervical infection with HPV-16 and/or HPV-18 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persistent cervical infection (6-month definition) with HPV 16 and/or HPV 18. |  |  | 
| Persistent cervical infection (6-month definition) with oncogenic HPV types. |  |  | 
| Incident cervical infection with oncogenic HPV types. |  |  | 
| Histopathologically-confirmed CIN 1+ or CIN 2+ associated with HPV 16 and/or HPV 18 detected within the lesional component of the cervical tissue specimen. |  |  | 
| Histopathologically-confirmed CIN 1+ or CIN 2+ associated with oncogenic HPV types detected within the lesional component of the cervical tissue specimen. |  |  | 
| Abnormal cytology associated with an HPV-16 and/or HPV-18 cervical infection. |  |  | 
| Abnormal cytology associated with oncogenic HPV type cervical infection. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV vaccine efficacy, Prophylaxis HPV 16/18 infections