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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 study will evaluate the consistency of consecutive vaccine lots and the non-inferiority of modified manufacturing processes of GSK Biologicals HPV-16/18 vaccine and the vaccine safety, over 12 months, in young adolescents and women of 10-25 years of age at study start. Approximately 750 study subjects will receive different lots of the HPV vaccine administered intramuscularly according to a 0-1-6 month schedule.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPV-16/18 L1/AS04 | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Demonstration of lot-to-lot consistency in terms of immunogenicity of 3 lots of HPV-16/18 vaccine. | ||
| Demonstration of non-inferiority in terms of immunogenicity of the HPV vaccine produced with a revised manufacturing process compared to the HPV vaccine produced with a previous manufacturing process |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of HPV vaccine in entire study period. Immunogenicity bridge between pre-adolescent and adolescent population. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Koebenhavn NV | 2400 | Denmark | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35149535 | Derived | Lehtinen M, Lagheden C, Luostarinen T, Eriksson T, Apter D, Bly A, Gray P, Harjula K, Heikkila K, Hokkanen M, Karttunen H, Kuortti M, Nieminen P, Nummela M, Paavonen J, Palmroth J, Petaja T, Pukkala E, Soderlund-Strand A, Veivo U, Dillner J. Human papillomavirus vaccine efficacy against invasive, HPV-positive cancers: population-based follow-up of a cluster-randomised trial. BMJ Open. 2021 Dec 30;11(12):e050669. doi: 10.1136/bmjopen-2021-050669. |
| Label | URL |
|---|---|
| Month 18 FU | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 580299/012 | Informed Consent Form | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| Odense C |
| 5000 |
| Denmark |
| GSK Investigational Site | Tallinn | 1162 | Estonia |
| GSK Investigational Site | Tartu | 50417 | Estonia |
| GSK Investigational Site | Seinäjoki | 60100 | Finland |
| GSK Investigational Site | Tampere | 33200 | Finland |
| GSK Investigational Site | Athens | 11527 | Greece |
| GSK Investigational Site | Athens | 11528 | Greece |
| GSK Investigational Site | Heraklion, Crete | 71110 | Greece |
| GSK Investigational Site | Thessaloniki | 54642 | Greece |
| GSK Investigational Site | Rotterdam | 3011 EN | Netherlands |
| GSK Investigational Site | Rotterdam | 3015 GE | Netherlands |
| GSK Investigational Site | Kazan' | 420015 | Russia |
| GSK Investigational Site | Moscow | 115 478 | Russia |
| GSK Investigational Site | Moscow | 119991 | Russia |
| GSK Investigational Site | Smolensk | 214018 | Russia |
| GSK Investigational Site | Volgograd | 400130 | Russia |
| Month 24 FU | View source |
| Month 36 FU | View source |
| Month 48 FU | View source |
For additional information about this study please refer to the GSK Clinical Study Register |
| 580299/012 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 580299/012 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 580299/012 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 580299/012 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 580299/012 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 580299/012 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 580299/012 are summarised with studies 107476 (M18), 107477 (M24), and 107479 (M36) on the GSK Clinical Study Register. |
| 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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