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Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. The infection of the cervix by certain oncogenic types of HPV, if not cleared, can lead to cervical cancer in women. This study will evaluate the immunogenicity and safety of the GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine (Cervarix TM) vaccine.
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 |
| |
| Placebo Group | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPV-16/18 VLP/AS04 vaccine (Cervarix TM) | 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 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 post Dose 3 (Month 7) |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HPV-16 and Anti-HPV-18 Antibody Titres | Titres are given as geometric mean titres (GMTs) calculated on all subjects. | Before vaccination (PRE) and one month post Dose 3 (Month 7) |
| Number of Subjects Reporting Solicited Local Symptoms |
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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 | Seoul | 110-744 | South Korea | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21860731 | Background | Kim SC, Song YS, Kim YT, Kim YT, Ryu KS, Gunapalaiah B, Bi D, Bock HL, Park JS. Human papillomavirus 16/18 AS04-adjuvanted cervical cancer vaccine: immunogenicity and safety in 15-25 years old healthy Korean women. J Gynecol Oncol. 2011 Jun 30;22(2):67-75. doi: 10.3802/jgo.2011.22.2.67. | |
| 18845199 | Background |
| 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 |
|---|---|---|---|
| 107291 | Statistical Analysis Plan | 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 HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule. |
| FG001 | Placebo Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Biological | Three doses of placebo administered intramuscularly according to a 0, 1, 6-month schedule. |
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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) | Unsolicited adverse event= Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. | During the 30-day (Days 0-29) period following each vaccination |
| Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions | NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. Medically significant AEs assessed include AEs prompting emergency room visits and physician office visits not related to common illnesses or Serious Adverse Events (SAEs) that are not related to common illnesses. | From Day 0 up to Month 7 |
| Number of Subjects Reporting Serious Adverse Events (SAE) | Serious adverse events assessed include medical occurrences that result in death, is 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. | From Day 0 up to Month 7 |
| Number of Subjects With Pregnancies and Their Outcome | Total: the total number of pregnancies in a group. The specific outcomes are also listed. | from Day 0 up to Month 7 |
| Seoul |
| 120-752 |
| South Korea |
| GSK Investigational Site | Seoul | 137-040 | South Korea |
| GSK Investigational Site | Seoul | 138-736 | South Korea |
| GSK Investigational Site | Seoul | 150-879 | South Korea |
| GSK Investigational Site | Seoul | 158-710 | South Korea |
| Verstraeten T, Descamps D, David MP, Zahaf T, Hardt K, Izurieta P, Dubin G, Breuer T. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 2008 Dec 2;26(51):6630-8. doi: 10.1016/j.vaccine.2008.09.049. |
| 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. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 107291 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107291 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107291 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107291 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107291 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107291 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cervarix Group | Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule. |
| BG001 | Placebo Group | Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule. |
| 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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| 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 immunogenicity. | Posted | Count of Participants | Participants | One month post Dose 3 (Month 7) |
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| Secondary | Anti-HPV-16 and Anti-HPV-18 Antibody Titres | Titres are given as geometric mean titres (GMTs) calculated on all subjects. | Analysis was performed on the ATP cohort for immunogenicity. | Posted | Geometric Mean | 95% Confidence Interval | titre | Before vaccination (PRE) and one month post Dose 3 (Month 7) |
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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 the 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 the 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) | Unsolicited adverse event= Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. | 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) and Medically Significant Conditions | NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. Medically significant AEs assessed include AEs prompting emergency room visits and physician office visits not related to common illnesses or Serious Adverse Events (SAEs) that are not related to common illnesses. | Posted | Count of Participants | Participants | From Day 0 up to Month 7 |
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| Secondary | Number of Subjects Reporting Serious Adverse Events (SAE) | Serious adverse events assessed include medical occurrences that result in death, is 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. | Posted | Count of Participants | Participants | From Day 0 up to Month 7 |
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| Secondary | Number of Subjects With Pregnancies and Their Outcome | Total: the total number of pregnancies in a group. The specific outcomes are also listed. | Analysis was performed on subjects with a pregnancy. | Posted | Count of Participants | Participants | from Day 0 up to Month 7 |
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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 HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule. | 2 | 149 | 144 | 149 | ||
| EG001 | Placebo Group | Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule. | 1 | 76 | 70 | 76 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis viral | Infections and infestations | Non-systematic Assessment |
| ||
| Ovarian cyst ruptured | Reproductive system and breast disorders | Non-systematic Assessment |
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| Pelvic inflammatory disease | Infections and infestations | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratoy tract infection | Infections and infestations | Non-systematic Assessment |
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| Dysmenorrhea | Reproductive system and breast disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Injection site pruritus | General disorders | Non-systematic Assessment |
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| Pain | General disorders | Systematic Assessment |
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| Redness | General disorders | Systematic Assessment |
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| Swelling | General disorders | Systematic Assessment |
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| Arthralgia | 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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| Urticaria | General disorders | Systematic Assessment |
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| Fatigue | 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 |
|---|---|
| C510352 | human papillomavirus vaccine, L1 type 16, 18 |
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| Male |
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| Anti-HPV-18 |
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