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This study will collect safety data of GlaxoSmithKline Biologicals' human papillomavirus (HPV) vaccine in healthy females of Chinese origin who are unable to receive all three doses of commercially available HPV vaccine before they are 25 years, and were placebo recipients in the primary study (NCT00306241).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervarix Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervarix | Biological | Subjects will receive three doses of the HPV vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Any Serious Adverse Event (SAE) and SAE(s) With a Causal Relationship to Vaccination as Assessed by the Investigator. | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. | During the entire study period (Day 0 up to the telephone contact at Month 12). |
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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 | Hong Kong | Hong Kong |
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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 |
|---|---|---|---|
| 111712 | Dataset Specification | 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 | Title | Description |
|---|---|---|
| FG000 | Cervarix Group | Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid of the non-dominant arm according to a 0, 1, 6-month schedule. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cervarix Group | Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid of the non-dominant arm according to a 0, 1, 6-month schedule. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Subjects Reporting Any Serious Adverse Event (SAE) and SAE(s) With a Causal Relationship to Vaccination as Assessed by the Investigator. | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. | Posted | Number | Subjects | During the entire study period (Day 0 up to the telephone contact at Month 12). |
|
Serious adverse events: Throughout the study period from Day 0 up to Month 12.
Only serious advers events have been assessed during the study and no other symptoms.
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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 received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid of the non-dominant arm according to a 0, 1, 6-month schedule. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abortion missed | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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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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| ID | Term |
|---|---|
| C510352 | human papillomavirus vaccine, L1 type 16, 18 |
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For additional information about this study please refer to the GSK Clinical Study Register |
| 111712 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111712 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111712 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111712 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111712 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111712 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 3 |
| 92 |
| 0 |
| 0 |
| Benign hydatidiform mole | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Hepatic enzyme increased | Investigations | Non-systematic Assessment |
|
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.
| 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 |