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This phase 3b study is designed to assess the safety of GlaxoSmithKline Biological's HPV vaccine GSK580299 in female subjects who took part in study 008/580299 and received the control vaccine (Hepatitis A vaccine).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervarix Compliance Issue Centre Group | Experimental | Subjects from one centre where compliance issues were discovered, who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study |
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| Cervarix All Centres Group | Experimental | Subjects from all study centres who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK580299, GSK Biological's HPV vaccine | Biological | All subjects will receive 3 doses administered as an intramuscular injection, according to a 0, 1, 6-month schedule. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Note: Results from one center where compliance issues were discovered are presented also separately. | During the entire study period (up to Month 12) |
| Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs) | MSCs include adverse events prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury. | During the entire study period (up to Month 12) |
| Number of Subjects With Pregnancies and Pregnancy Outcomes | The pregnancy outcomes reported included elective termination, live birth and spontaneous abortion, all of which occurred with no apparent congenital (congenit.) anomalies (anom.) Note: Results from one non-compliant center (NCC) are also presented separately. | During the entire study period (up to 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 | Porto Alegre | Rio Grande do Sul | 90035-003 | Brazil | ||
| GSK Investigational Site |
Results from one study center where compliance issues were discovered were presented both separately from the entire study cohort, as well as included in it. Out of the 1239 subjects enrolled in this study, 2 did not receive vaccination and were hence eliminated from the study.
Subjects enrolled in this study were previously enrolled in the Control Group in the primary study (NCT00122681), where they had received Hepatitis A vaccination.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cervarix Group | Subjects who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Campinas |
| 13083-970 |
| Brazil |
| GSK Investigational Site | Curitiba | 80060-150 | Brazil |
| GSK Investigational Site | Taipei | 100 | Taiwan |
| GSK Investigational Site | Taipei | 112 | Taiwan |
| GSK Investigational Site | Taipei | 114 | Taiwan |
| GSK Investigational Site | Bangkok | 10330 | Thailand |
| GSK Investigational Site | Bangkok | 10400 | Thailand |
| GSK Investigational Site | Bangkok | 10700 | Thailand |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cervarix Group | Subjects who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study. |
| 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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| Age, Continuous | Non-compliant center population | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Gender | Non-compliant center population | Number | 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 Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Note: Results from one center where compliance issues were discovered are presented also separately. | Posted | Number | Subjects | During the entire study period (up to Month 12) |
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| Primary | Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs) | MSCs include adverse events prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury. | Posted | Number | Subjects | During the entire study period (up to Month 12) |
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| Primary | Number of Subjects With Pregnancies and Pregnancy Outcomes | The pregnancy outcomes reported included elective termination, live birth and spontaneous abortion, all of which occurred with no apparent congenital (congenit.) anomalies (anom.) Note: Results from one non-compliant center (NCC) are also presented separately. | The analysis was based on the subjects with positive pregnancy results in the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of Cervarix vaccine in this study and for whom data were available. | Posted | Number | Subjects | During the entire study period (up to Month 12) |
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SAEs were collected from study start until study end at Month 12.
Other adverse events were not assessed in this 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 the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study. | 11 | 1,237 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abortion spontaneous complete | Pregnancy, puerperium and perinatal conditions | MedDRA | Non-systematic Assessment |
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| Abortion spontaneous incomplete | Pregnancy, puerperium and perinatal conditions | MedDRA | Non-systematic Assessment |
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| Appendicitis | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
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| Chronic tonsillitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Haemangioma of liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
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| Ovarian germ cell teratoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
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| Thrombophlebitis | Vascular disorders | MedDRA | Non-systematic Assessment |
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| Thyroid cyst | Endocrine disorders | MedDRA | Non-systematic Assessment |
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| Calculus ureteric | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
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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 |
| D002583 | Uterine Cervical Neoplasms |
| 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 |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Title | Measurements |
|---|---|
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| Any SAEs non-compliant center (n=243) |
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| Grade 3 SAEs non-compliant center (n=243) |
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| Related SAEs non-compliant center (n=243) |
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