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This study is designed to evaluate the immunogenicity and safety of GSK Biologicals' human papillomavirus (HPV) vaccine in adult female subjects aged 26-45 years. One group of subjects will receive the HPV vaccine and the other group will receive an active control (GSK Biologicals' hepatitis B vaccine). Immunogenicity data of the HPV group will be compared with those from the HPV group included in the NCT00779766 study (aged 18-25 years).
This Protocol Posting has been updated following Protocol Amendment 1, December 2010, leading to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervarix Group | Experimental | Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule. |
|
| Engerix Group | Active Comparator | Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK580299 (CervarixTM) | Biological | 3-dose schedule intramuscularly vaccination (Months 0, 1 and 6) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) and HPV-18 | A seroconverted subject was defined as a subject seronegative at baseline whose concentration for anti-HPV-16/18 antibodies, as measured by Enzyme-linked Immunosorbent assay (ELISA) , was higher than or equal to (≥) cut-off value. A seronegative subject was defined as a subject whose antibody concentration was below (<) cut-off value. Cut-off values were 8 ELISA units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies. | One month after third vaccination (Month 7) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Seropositive Against HPV-16 and HPV-18 | A seropositive subject was defined as a subject whose anti-HPV-16/18 antibody concentration, as measured by ELISA, was higher than or equal to (≥) cut-off value. Cut-off values were 8 ELISA units per milliliter (EL.U/mL) for anti-HPV-16 antibodies, and 7 EL.U/mL for anti-HPV-18 antibodies. | Before vaccination (Month 0) and one month after third vaccination (Month 7) |
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Inclusion Criteria:
Subjects must be of non-childbearing potential, i.e., have a current tubal ligation, hysterectomy, ovariectomy, be one year post-menopausal, or if of childbearing potential, they must be abstinent or have practiced adequate contraception for 30 days prior to vaccination, have a negative pregnancy test on the day of vaccination and agree to continue such precautions during the entire treatment period and for 2 months after completion of the vaccination series.
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 | Jintan | Jiangsu | 213200 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41276263 | Derived | Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2. | |
| 25424785 |
| 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 |
|---|---|---|---|
| 114590 | 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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The study comprised a Primary Vaccination Phase from Day 0 to Month 7, followed by a Long-Term Safety Follow-up Phase, up to Month 12.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cervarix Group | Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule. |
| FG001 | Engerix Group | Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cervarix Group | Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule. |
| BG001 | Engerix Group |
| 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 Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) and HPV-18 | A seroconverted subject was defined as a subject seronegative at baseline whose concentration for anti-HPV-16/18 antibodies, as measured by Enzyme-linked Immunosorbent assay (ELISA) , was higher than or equal to (≥) cut-off value. A seronegative subject was defined as a subject whose antibody concentration was below (<) cut-off value. Cut-off values were 8 ELISA units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies. | The analysis was based on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Count of Participants | Participants | One month after third vaccination (Month 7) |
|
Serious adverse events were assessed from Month 0 up to Month 12. Systematically assessed frequent adverse events were assessed during 7 days (Days 0-6) post vaccination period.
For the systematically assessed other (non-serious) adverse events the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
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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 a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aortic valve incompetence | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | 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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| Engerix-BTM | Biological | 3-dose schedule intramuscularly vaccination (Months 0, 1 and 6) |
|
| Concentrations for Anti-HPV-16 and Anti-HPV-18 Antibodies | Concentrations are given as geometric mean titers (GMTs), expressed in ELISA units per milliliter (EL.U/mL). Cut-off values were 8 EL.U/mL for anti-HPV-16 antibodies, and 7 EL.U/mL for anti-HPV-18 antibodies. | Before vaccination (Month 0) and one month after third vaccination (Month 7) |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Solicited local symptoms assessed were pain, redness and swelling. Grade 3 redness and swelling were redness and swelling above 50 millimeters (mm) and grade 3 pain was defined as pain that prevented normal activity. Any was defined as the incidence of a symptom regardless of intensity grade. | During the 7 days (Days 0 - 6) after any vaccination |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Solicited symptoms were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and temperature [axillary temperature above (>)37 degrees Celsius(°C)].Grade 3 temperature= temperature >39°C. Grade 3 utricaria= distributed on at least 4 body areas. Grade 3 symptom=prevented normal activity. Gastrointestinal symptoms=nausea, vomiting, diarrhoea and/or abdominal pain. Arthralgia (joint pain): in joints distal from injection site. Any=incidence of a symptom regardless of intensity grade or relationship to vaccination. Related = incidence of a symptom assessed by investigator as related to vaccination. | During the 7 days (Days 0 - 6) after any vaccination |
| Number of Subjects Reporting 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, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination, grade 3 was a SAE that prevented normal activities, and related was defined as a SAE assessed by the investigator to be causally related to the study vaccination. and related was an event assessed by the investigator as causally related to the study vaccination. | Throughout the study (from Month 0 up to Month 12) |
| Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | An unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination. | Within 30 days (Days 0 - 29) after any vaccination |
| Number of Subjects Reporting Medically Significant Conditions (MSCs) Including Potential Immune Mediated Diseases (pIMDs) | MSCs were AEs prompting emergency room or physician visits that were not related to common diseases (upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury), or not related to routine visits for physical examination or vaccination. It also included SAEs not related to common diseases. MSCs included pIMDs, a subset of MSCs that included autoimmune diseases and other inflammatory and/or neurological disorders of interest which might or might not have had an autoimmune etiology. | Throughout the study (from Month 0 up to Month 12) |
| Number of Subjects With Outcome of Pregnancies | The sole pregnancy outcome reported was elective termination with no apparent congenital anomaly. | Throughout the study (from Month 0 up to Month 12) |
| Derived |
| Zhu F, Li J, Hu Y, Zhang X, Yang X, Zhao H, Wang J, Yang J, Xia G, Dai Q, Tang H, Suryakiran P, Datta SK, Descamps D, Bi D, Struyf F. Immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine in healthy Chinese girls and women aged 9 to 45 years. Hum Vaccin Immunother. 2014;10(7):1795-806. doi: 10.4161/hv.28702. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 114590 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114590 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114590 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114590 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114590 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Withdrawal by Subject |
|
Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
| OG001 | Engerix Group | Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule. |
|
|
| Secondary | Number of Subjects Seropositive Against HPV-16 and HPV-18 | A seropositive subject was defined as a subject whose anti-HPV-16/18 antibody concentration, as measured by ELISA, was higher than or equal to (≥) cut-off value. Cut-off values were 8 ELISA units per milliliter (EL.U/mL) for anti-HPV-16 antibodies, and 7 EL.U/mL for anti-HPV-18 antibodies. | The analysis was based on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Count of Participants | Participants | Before vaccination (Month 0) and one month after third vaccination (Month 7) |
|
|
|
| Secondary | Concentrations for Anti-HPV-16 and Anti-HPV-18 Antibodies | Concentrations are given as geometric mean titers (GMTs), expressed in ELISA units per milliliter (EL.U/mL). Cut-off values were 8 EL.U/mL for anti-HPV-16 antibodies, and 7 EL.U/mL for anti-HPV-18 antibodies. | The analysis was based on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | Before vaccination (Month 0) and one month after third vaccination (Month 7) |
|
|
|
| Secondary | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Solicited local symptoms assessed were pain, redness and swelling. Grade 3 redness and swelling were redness and swelling above 50 millimeters (mm) and grade 3 pain was defined as pain that prevented normal activity. Any was defined as the incidence of a symptom regardless of intensity grade. | The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed. | Posted | Count of Participants | Participants | During the 7 days (Days 0 - 6) after any vaccination |
|
|
|
| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Solicited symptoms were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and temperature [axillary temperature above (>)37 degrees Celsius(°C)].Grade 3 temperature= temperature >39°C. Grade 3 utricaria= distributed on at least 4 body areas. Grade 3 symptom=prevented normal activity. Gastrointestinal symptoms=nausea, vomiting, diarrhoea and/or abdominal pain. Arthralgia (joint pain): in joints distal from injection site. Any=incidence of a symptom regardless of intensity grade or relationship to vaccination. Related = incidence of a symptom assessed by investigator as related to vaccination. | The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed. | Posted | Count of Participants | Participants | During the 7 days (Days 0 - 6) after any vaccination |
|
|
|
| Secondary | Number of Subjects Reporting 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, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination, grade 3 was a SAE that prevented normal activities, and related was defined as a SAE assessed by the investigator to be causally related to the study vaccination. and related was an event assessed by the investigator as causally related to the study vaccination. | The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | Throughout the study (from Month 0 up to Month 12) |
|
|
|
| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | An unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination. | The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | Within 30 days (Days 0 - 29) after any vaccination |
|
|
|
| Secondary | Number of Subjects Reporting Medically Significant Conditions (MSCs) Including Potential Immune Mediated Diseases (pIMDs) | MSCs were AEs prompting emergency room or physician visits that were not related to common diseases (upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury), or not related to routine visits for physical examination or vaccination. It also included SAEs not related to common diseases. MSCs included pIMDs, a subset of MSCs that included autoimmune diseases and other inflammatory and/or neurological disorders of interest which might or might not have had an autoimmune etiology. | The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | Throughout the study (from Month 0 up to Month 12) |
|
|
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| Secondary | Number of Subjects With Outcome of Pregnancies | The sole pregnancy outcome reported was elective termination with no apparent congenital anomaly. | The analysis was performed on Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented, solely on subjects with outcome of pregnancies. | Posted | Count of Participants | Participants | Throughout the study (from Month 0 up to Month 12) |
|
|
|
| 3 |
| 606 |
| 490 |
| 606 |
| EG001 | Engerix Group | Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule. | 3 | 606 | 318 | 606 |
| Atrial septal defect | Congenital, familial and genetic disorders | Non-systematic Assessment |
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| Mitral valve incompetence | Cardiac disorders | Non-systematic Assessment |
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| Tricuspid valve incompetence | Cardiac disorders | Non-systematic Assessment |
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| Gastroenteritis shigella | Infections and infestations | Non-systematic Assessment |
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| Fibroadenoma of breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Haemorrhage intracranial | Nervous system disorders | Non-systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | Non-systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | Non-systematic Assessment |
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| Redness | General disorders | Systematic Assessment |
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| Swelling | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Gastrointestinal | 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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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 |
| HPV-18, Day 0 |
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| HPV-18, Month 7 |
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| HPV-18, Day 0 |
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| HPV-18, Month 7 |
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| Any redness |
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| Grade 3 redness |
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| Any swelling |
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| Grade 3 swelling |
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| Related arthralgia |
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| Any fatigue |
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| Grade 3 fatigue |
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| Related fatigue |
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| Any gastrointestinal symptoms |
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| Grade 3 gastrointestinal symptoms |
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| Related gastrointestinal symptoms |
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| Any headache |
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| Grade 3 headache |
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| Related headache |
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| Any myalgia |
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| Grade 3 myalgia |
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| Related myalgia |
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| Any rash |
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| Grade 3 rash |
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| Related rash |
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| Temperature >37.0°C |
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| Temperature >39.0°C |
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| Related temperature |
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| Any urticaria |
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| Grade 3 urticaria |
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| Related urticaria |
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| Related SAE(s) |
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| Related AE(s) |
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