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Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. The current phase 3b study is designed to assess the immunogenicity and safety of GlaxoSmithKline Biologicals' HPV vaccine GSK580299 administered according to an alternative dosing schedule as compared to the standard dosing schedule in young female subjects aged 15 - 25 years. 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-12 Group | Experimental | Women received 3 doses of Cervarix TM (human papillomavirus (HPV) vaccine) administered according to a 0, 1, 12-month schedule |
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| Cervarix-6 Group | Active Comparator | Women received 3 doses of Cervarix TM (HPV vaccine) administered according to a 0, 1, 6-month schedule. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervarix TM | Biological | Intramuscular administration into the deltoid region of the non-dominant arm according to a 0, 1, 12-month schedule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination. Cut-off values were 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. | One month after the third vaccine dose |
| Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies | Titer given as geometric mean titer (GMT). | One month after the third vaccine dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies | Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination. Cut-off values were 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. |
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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 | Brescia | Lombardy | 25123 | Italy | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21273939 | Derived | Esposito S, Birlutiu V, Jarcuska P, Perino A, Man SC, Vladareanu R, Meric D, Dobbelaere K, Thomas F, Descamps D. Immunogenicity and safety of human papillomavirus-16/18 AS04-adjuvanted vaccine administered according to an alternative dosing schedule compared with the standard dosing schedule in healthy women aged 15 to 25 years: results from a randomized study. Pediatr Infect Dis J. 2011 Mar;30(3):e49-55. doi: 10.1097/INF.0b013e318206c26e. |
| 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 |
|---|---|---|---|
| 109179 | 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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A total of 805 subjects were enrolled and 804 subjects were vaccinated and included in the analyses.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cervarix-12 Group | Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule. |
| FG001 | Cervarix-6 Group | Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Cervarix TM | Biological | Intramuscular administration into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule. |
|
| One month after the second vaccine dose |
| Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies | Titer given as GMT. | One month after the second vaccine dose |
| Number of Subjects Reporting Solicited Local Symptoms | Solicited local symptoms assessed include pain, redness and swelling at the injection site. | During the 7-day (Days 0-6) period following each vaccination |
| Number of Subjects Reporting Solicited General Symptoms | Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria. | During the 7-day (Days 0-6) period following each vaccination |
| Number of Subjects Reporting Unsolicited Adverse Events (AE) | An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | During the 30-day (Days 0-29) period following each vaccination |
| Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs), New Onset Autoimmune Diseases (NOADs), Serious Adverse Events (SAEs), and Medically Significant Conditions (MSCs) | Entire study period = up to Month 18 Cervarix-12 & Month 12 Cervarix-6. NOCDs assessed include eg. autoimmune disorders (NOADs), asthma, type I diabetes. MSCs assessed include AEs prompting emergency room visits and physician office visits not related to common illnesses. An SAE is any untoward medical occurrence that: results in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. | During the entire study period (up to Month 18 or up to Month 12) |
| Number of Subjects With Pregnancies and Their Outcomes | Entire study period = up to Month 18 Cervarix-12 & Month 12 Cervarix-6 Number of pregnancies and pregnancy outcomes. | During the entire study period (up to Month 18 or Month 12) |
| Number of Subjects Completing the 3-dose Vaccination Schedule | After the third vaccine dose |
| Lodi |
| Lombardy |
| 26900 |
| Italy |
| GSK Investigational Site | Milan | Lombardy | 20122 | Italy |
| GSK Investigational Site | Cagliari | Sardinia | 09127 | Italy |
| GSK Investigational Site | Sassari | Sardinia | 07100 | Italy |
| GSK Investigational Site | Palermo | Sicily | 90127 | Italy |
| GSK Investigational Site | Ragusa | Sicily | 97100 | Italy |
| GSK Investigational Site | Bucharest | 010507 | Romania |
| GSK Investigational Site | Bucharest | 077190 | Romania |
| GSK Investigational Site | Bucharest | 22102 | Romania |
| GSK Investigational Site | Cluj-Napoca | 400217 | Romania |
| GSK Investigational Site | Sibiu | 550245 | Romania |
| GSK Investigational Site | Sibiu | Romania |
| GSK Investigational Site | Dolný Kubín | 026 01 | Slovakia |
| GSK Investigational Site | Nová Dubnica | 018 51 | Slovakia |
| GSK Investigational Site | Trenčín | 911 01 | Slovakia |
For additional information about this study please refer to the GSK Clinical Study Register |
| 109179 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109179 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109179 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109179 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109179 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109179 | Dataset Specification | 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-12 Group | Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule. |
| BG001 | Cervarix-6 Group | Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | 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 Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination. Cut-off values were 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 initially seronegative subjects from the According-to-Protocol (ATP) cohort for analysis of immunogenicity | Posted | Count of Participants | Participants | One month after the third vaccine dose |
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| Primary | Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies | Titer given as geometric mean titer (GMT). | Analysis was performed on initially seronegative subjects from the ATP cohort for analysis of immunogenicity | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | One month after the third vaccine dose |
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| Secondary | Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies | Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination. Cut-off values were 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 initially seronegative subjects from the ATP cohort for analysis of immunogenicity | Posted | Count of Participants | Participants | One month after the second vaccine dose |
|
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| Secondary | Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies | Titer given as GMT. | Analysis was performed on initially seronegative subjects from the ATP cohort for analysis of immunogenicity | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | One month after the second vaccine dose |
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| Secondary | Number of Subjects Reporting Solicited Local Symptoms | Solicited local symptoms assessed include pain, redness and swelling at the injection site. | Analysis was performed on the Total Vaccinated Cohort, on subjects with available data. | Posted | Count of Participants | Participants | During the 7-day (Days 0-6) period following each vaccination |
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| Secondary | Number of Subjects Reporting Solicited General Symptoms | Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria. | Analysis was performed on the Total Vaccinated Cohort, on subjects with available data. | Posted | Count of Participants | Participants | During the 7-day (Days 0-6) period following each vaccination |
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| Secondary | Number of Subjects Reporting Unsolicited Adverse Events (AE) | An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | Analysis was performed on the Total Vaccinated Cohort, on subjects with available data. | Posted | Count of Participants | Participants | During the 30-day (Days 0-29) period following each vaccination |
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| Secondary | Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs), New Onset Autoimmune Diseases (NOADs), Serious Adverse Events (SAEs), and Medically Significant Conditions (MSCs) | Entire study period = up to Month 18 Cervarix-12 & Month 12 Cervarix-6. NOCDs assessed include eg. autoimmune disorders (NOADs), asthma, type I diabetes. MSCs assessed include AEs prompting emergency room visits and physician office visits not related to common illnesses. An SAE is any untoward medical occurrence that: results in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. | Posted | Count of Participants | Participants | During the entire study period (up to Month 18 or up to Month 12) |
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| Secondary | Number of Subjects With Pregnancies and Their Outcomes | Entire study period = up to Month 18 Cervarix-12 & Month 12 Cervarix-6 Number of pregnancies and pregnancy outcomes. | Analysis was performed on the Total vaccinated cohort, on pregnant subjects | Posted | Count of Participants | Participants | During the entire study period (up to Month 18 or Month 12) |
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| Secondary | Number of Subjects Completing the 3-dose Vaccination Schedule | Posted | Count of Participants | Participants | After the third vaccine dose |
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Analysis for other adverse events were performed on the Total vaccinated cohort, on subjects with available data.
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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-12 Group | Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule. | 12 | 403 | 388 | 403 | ||
| EG001 | Cervarix-6 Group | Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule. | 9 | 401 | 389 | 401 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | Non-systematic Assessment |
| ||
| Breast cancer female | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Chondropathy | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Cyst | General disorders | Non-systematic Assessment |
| ||
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
| ||
| Hypertension | Vascular disorders | Non-systematic Assessment |
| ||
| Ovarian cyst ruptured | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Pharyngitis | Infections and infestations | Non-systematic Assessment |
| ||
| Road traffic accident | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Non-systematic Assessment |
| ||
| Tendon injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Thyroiditis | Endocrine disorders | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Tracheitis | Infections and infestations | Non-systematic Assessment |
| ||
| Vertigo | Ear and labyrinth disorders | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Abortion threatened | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Brain hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Cephalhaematoma | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Convulsion | Nervous system disorders | Non-systematic Assessment |
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| Foetal distress syndrome | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Multiple injuries | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | Systematic Assessment |
| ||
| Redness | General disorders | Systematic Assessment |
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| Swelling | General disorders | Systematic Assessment |
| ||
| Arthralgia | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Temperature ≥ 37.5°C | General disorders | Systematic Assessment |
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| Gastrointestinal symptoms | General disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Myalgia | General disorders | Systematic Assessment |
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| Rash | General disorders | 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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| ID | Term |
|---|---|
| D053918 | Papillomavirus Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Male |
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| Anti-HPV-18 |
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| Participants |
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