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Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go 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. GlaxoSmithKline Biologicals has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the AS04 adjuvant (control vaccine) and is also evaluating novel HPV vaccines formulations. This study will evaluate a novel GSK Biologicals' HPV vaccine (GSK1674330A) in terms of safety and immunogenicity compared to the control vaccine. There will be different levels of blinding in the study.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
| |
| Group B | Experimental |
| |
| Group C | Experimental |
| |
| Group D | Experimental |
| |
| Group E | Experimental |
| |
| Group F | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK Biologicals' HPV vaccine (GSK1674330A) | Biological | Intramuscular administration, 5 different formulations |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence, intensity and relationship to vaccination of any solicited local or general symptoms | Within 7 days after each vaccine dose |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of serious adverse events | Up to one month after the last dose of vaccine | |
| Occurrence, intensity and relationship to vaccination of any unsolicited symptom | Within 30 days after each vaccine dose |
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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 | Brussels | 1070 | Belgium | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24674663 | Derived | Van Damme P, Leroux-Roels G, Simon P, Foidart JM, Donders G, Hoppenbrouwers K, Levin M, Tibaldi F, Poncelet S, Moris P, Dessy F, Giannini SL, Descamps D, Dubin G. Effects of varying antigens and adjuvant systems on the immunogenicity and safety of investigational tetravalent human oncogenic papillomavirus vaccines: results from two randomized trials. Vaccine. 2014 Jun 17;32(29):3694-705. doi: 10.1016/j.vaccine.2014.03.040. Epub 2014 Mar 25. |
| Label | URL |
|---|---|
| Results for study 109836 can be found on the GSK Clinical Study Register | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 109836 | Study Protocol | 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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| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| Cervarix TM | Biological | Intramuscular administration |
|
|
| Occurrence of clinically relevant abnormalities in biochemical and hematological parameters | Assessed at Month 0, one month and six months after the last dose of vaccine |
| Occurrence of serious adverse events during the extended safety follow-up | Up to six months after the last dose of vaccine |
| Occurrence of pregnancy and pregnancy outcomes, new onset chronic diseases or medically significant conditions, regardless of causal relationship to vaccination | Throughout the study period (Month 0 up to six months after the last dose of vaccine) |
| HPV-16 and HPV-18 seropositivity rates and GMTs before the second dose of vaccine | One month after the second dose of vaccine, and six months after the last dose of vaccine |
| Seropositivity rates to other defined HPV types and GMTs before the second dose of vaccine | One month after the second dose of vaccine and at one month and six months after the last dose of vaccine |
| HPV-16 and -18 seropositivity rates and GMTs | One month after the last dose of vaccine |
| Ghent |
| 9000 |
| Belgium |
| GSK Investigational Site | Wilrijk | 2610 | Belgium |
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
For additional information about this study please refer to the GSK Clinical Study Register |
| 109836 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109836 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109836 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109836 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109836 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 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 |