Cervical cancer Human Papillomavirus infection
Conditions
Interventions
In the HPV-015 (104820) study the following groups were randomised:
One group randomised to HPV (HPV-16/18 L1/AS04) vaccination (0,5ml
intramuscular) in month 0, 1 en 6
One group randomised to conrol
Sponsors
GlaxoSmithKline
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - A subjects previously enrolled in the HPV-015 study - A subject with normal cervical cytology but positive test result for oncogenic HPV infection at concluding HPV-015 study visit - A subject that was pregnant so that no cervical sample could be collected at concluding HPV-015 study visit
Exclusion criteria
Exclusion criteria: - A subject with normal cervical cytology and negative test result for oncogenic HPV infection at concluding HPV-015 study visit - A subject with a cervical lesion or with a cervical lesion that required treatment at concluding HPV-015 study visit - A subject for whom the cervical cytology results were unavailable for reasons other than pregnancy at concluding HPV-015 study visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - 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 | — |
Countries
Netherlands
Outcome results
None listed