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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. This study will supplement an ongoing study evaluating the safety, efficacy and immunogenicity of the vaccine in women aged 26 years and above. This study will therefore assess additional immunogenicity parameters of the vaccine in women from selected investigative sites.
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 |
|---|---|---|---|
| Cervarix Group | Experimental | Subjects who received 3 doses of Cervarix during the primary study (NCT00294047). |
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| Placebo Group | Placebo Comparator | Subjects who received 3 doses of placebo during the primary study (NCT00294047). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Biological | Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Cytokine-positive CD4/CD8 Cells Per Million in Tests Producing at Least 2 Different Cytokines | The geometric mean and 95% confidence interval of the number of Human Papilloma Virus type 16 (HPV-16) and HPV-18 specific CD4 and CD8 cells producing at least 2 different cytokines is reported per million of CD4 or CD8 T-cells, respectively. | At Month 12 and Month 18 after first vaccination |
| Number of B-cells Per Million Showing a Specific Memory Response for HPV-16 and HPV-18 | The geometric mean and 95% confidence interval of the number of HPV-16 and HPV-18 specific memory B-cells is reported per million of B-cells. An arbitrary value of 0 was given for subjects with antibody concentration below the limit of quantification. | At Month 12 and Month 18 after first vaccination |
| Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations Above Pre-defined Cut-off Values | Cut-off values assessed include 8 enzyme-linked immunosorbent assay units Per Milliliter (EL.U/mL)for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies. | At Month 12 and Month 18 after first vaccination |
| Titers of Anti-HPV-16 and Anti-HPV-18 Antibodies | Titers are presented as Geometric Mean Titers (GMTs). | At Month 12 and Month 18 after first vaccination |
| Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) Immunoglobulin G (IgG) Antibodies | Titers given as Geometric Mean Titers (GMTs). An arbitrary value of 0 was given for subjects with antibody concentration below the limit of quantification. | At Month 12 and Month 18 after first vaccination |
| Correlation of Anti-HPV-16 and Anti-HPV-18 Antibodies in Serum and in Cervical Secretion (CVS) Samples |
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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 | Amsterdam | 1007 MB | Netherlands | |||
| GSK Investigational Site |
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| Label | URL |
|---|---|
| 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 |
| ID | Type | URL | Comment |
|---|---|---|---|
| 109801 | Individual Participant Data Set | 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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This ancillary study will consist of supplemental testing of serological and cervical samples obtained at Visit 5 (Month 12) and Visit 6 (Month 18) of the primary study HPV-015 (NCT00294047) from pre-selected sites.
Subjects enrolled at pre-selected sites in the primary study HPV-015 (NCT00294047) who were in the immunogenicity subset and have received all three doses of vaccine/control were asked to participate in the present ancillary study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cervarix Group | Subjects who received 3 doses of Cervarix during the primary study (NCT00294047). |
| FG001 | Placebo Group | Subjects who received 3 doses of placebo during the primary study (NCT00294047). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Cervarix TM | Biological | Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule. |
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Pearson coefficients of correlation between serum and CVS for anti-HPV-16 and anti-HPV-18 titers standardized for total IgG were calculated. |
| At Month 12 and Month 18 after first vaccination |
| Delft |
| 2625 AD |
| Netherlands |
For additional information about this study please refer to the GSK Clinical Study Register |
| 109801 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109801 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109801 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109801 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109801 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cervarix Group | Subjects who received 3 doses of Cervarix during the primary study (NCT00294047). |
| BG001 | Placebo Group | Subjects who received 3 doses of placebo during the primary study (NCT00294047). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Gender | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Cytokine-positive CD4/CD8 Cells Per Million in Tests Producing at Least 2 Different Cytokines | The geometric mean and 95% confidence interval of the number of Human Papilloma Virus type 16 (HPV-16) and HPV-18 specific CD4 and CD8 cells producing at least 2 different cytokines is reported per million of CD4 or CD8 T-cells, respectively. | Analysis was performed on subjects from the Total Vaccinated Cohort with available results. | Posted | Geometric Mean | 95% Confidence Interval | cells per million CD4/CD8 T-cells | At Month 12 and Month 18 after first vaccination |
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| Primary | Number of B-cells Per Million Showing a Specific Memory Response for HPV-16 and HPV-18 | The geometric mean and 95% confidence interval of the number of HPV-16 and HPV-18 specific memory B-cells is reported per million of B-cells. An arbitrary value of 0 was given for subjects with antibody concentration below the limit of quantification. | Analysis was performed on subjects from the Total Vaccinated Cohort with available results. | Posted | Geometric Mean | 95% Confidence Interval | cells per million B-cells | At Month 12 and Month 18 after first vaccination |
|
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| Primary | Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations Above Pre-defined Cut-off Values | Cut-off values assessed include 8 enzyme-linked immunosorbent assay units Per Milliliter (EL.U/mL)for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies. | Analysis was performed on subjects from the Total Vaccinated Cohort with available results. | Posted | Number | Subjects | At Month 12 and Month 18 after first vaccination |
|
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| Primary | Titers of Anti-HPV-16 and Anti-HPV-18 Antibodies | Titers are presented as Geometric Mean Titers (GMTs). | Analysis was performed on subjects from the Total Vaccinated Cohort with available results. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Month 12 and Month 18 after first vaccination |
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| Primary | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) Immunoglobulin G (IgG) Antibodies | Titers given as Geometric Mean Titers (GMTs). An arbitrary value of 0 was given for subjects with antibody concentration below the limit of quantification. | Analysis was performed on the Total Vaccinated Cohort, on subjects with available data. None of the subjects in the Placebo Group had detectable antibodies against HPV-16 at Months 12 and 18 and against HPV-18 at Month 12. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Month 12 and Month 18 after first vaccination |
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| Primary | Correlation of Anti-HPV-16 and Anti-HPV-18 Antibodies in Serum and in Cervical Secretion (CVS) Samples | Pearson coefficients of correlation between serum and CVS for anti-HPV-16 and anti-HPV-18 titers standardized for total IgG were calculated. | Analysis was performed on the Total Vaccinated Cohort, only on those subjects from the Cervarix group with CVS sample results available. | Posted | Number | correlation coefficient | At Month 12 and Month 18 after first vaccination |
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No safety data were collected in the framework of this ancillary study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cervarix Group | Subjects who received 3 doses of Cervarix during the primary study (NCT00294047). | 0 | 0 | 0 | 0 | ||
| EG001 | Placebo Group | Subjects who received 3 doses of placebo during the primary study (NCT00294047). | 0 | 0 | 0 | 0 |
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No safety data were collected in the framework of this ancillary study.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| 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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| Male |
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| HPV-16 specific CD8 [Month 12] (n=52,46) |
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| HPV-16 specific CD8 [Month 18] (n=50,47) |
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| HPV-18 specific CD4 [Month 12] (n=52,46) |
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| HPV-18 specific CD4 [Month 18] (n=52,47) |
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| HPV-18 specific CD8 [Month 12] (n=52,46) |
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| HPV-18 specific CD8 [Month 18] (n=50,47) |
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