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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000060-17 | EudraCT Number |
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Due to late study start, the possibility to enroll enough subjects dropped below the limit to provide scientifically acceptable data, hence study was cancelled.
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The purpose of this study is to establish the long-term persistence of the immune response and safety of the HPV vaccine in healthy females who were aged 9 to 25 years in the primary study (NCT00541970).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPV Group 1 | Experimental | Subjects who were aged 9-14 years at study entry and received two doses of the HPV-16/18 vaccine according to a 0,6-months schedule in the study HPV-048 PRI (NCT00541970). |
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| HPV Group 2 | Active Comparator | Subjects who were aged 15-25 years at study entry and received three doses of the HPV 16/18 vaccine according to a 0,1,6-months schedule in the study HPV-048 PRI (NCT00541970). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Procedure | Blood samples will be collected from all subjects at Year 6.5 |
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of immune persistence in terms of antibody titres | 6.5 years after first vaccination with HPV-16/18 administered in the study HPV-048 PRI (NCT00541970) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of immunogenicity in terms of seroconversion rates (SCRs) and antibody titres | 6.5 years after first vaccination with HPV-16/18 (20 µg of each antigen) administered in the study HPV-048 PRI (NCT00541970) | |
| Occurrence of SAEs | After primary study completion (Month 60) up to end of the study (Visit 1 at Year 6.5) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| C510352 | human papillomavirus vaccine, L1 type 16, 18 |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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