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This study is designed to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals' human papillomavirus (HPV) vaccine in pre-teen and adolescent female subjects aged 9 - 17 years. One group of subjects will receive the HPV vaccine and the other group will receive the control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervarix Group | Experimental | Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule. |
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| Placebo Group | Experimental | Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CervarixTM | Biological | Subjects will receive three doses of the Cervarix vaccine intramuscularly according to a 0, 1, 6-month schedule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) for Antibodies Against Human Papillomavirus (HPV)-16/18 Antigens | Titers were given as geometric mean titers and were measured by Enzyme-linked Immunosorbent Assay (ELISA) and expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL). | One month after the third dose (at Month 7) |
| 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 | Taizhou | Jiangsu | 225300 | 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 |
|---|---|---|---|
| 112022 | 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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| ID | Title | Description |
|---|---|---|
| FG000 | Cervarix Group | Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule. |
| FG001 | Placebo Group | Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle 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 into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule. |
| BG001 | Placebo 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 | Geometric Mean Titers (GMTs) for Antibodies Against Human Papillomavirus (HPV)-16/18 Antigens | Titers were given as geometric mean titers and were measured by Enzyme-linked Immunosorbent Assay (ELISA) and expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL). | Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included subjects who received 3 doses of the study vaccine or placebo and for whom data concerning immunogenicity measures were available. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | One month after the third dose (at Month 7) |
|
Serious adverse events were assessed from Day 0 up to Month 12. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 days and 30 days post vaccination period respectively.
For the systematically assessed other (non-serious) adverse events, the total participants at risk in Cervarix Group included those from Total Vaccinated cohort who had the symptom sheet completed and with at least one documented dose.
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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 into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal adhesions | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | 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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| Control | Other | Subjects will receive three doses of control intramuscularly according to a 0, 1, 6-month schedule. |
|
| At Month 7 |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeter (mm). | During the 7 days (Days 0 - 6) following each vaccination |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (= axillary temperature above 37.0 degrees Celsius (°C). Grade 3 fever = axillary temperature above 39.0°C. Grade 3 urticaria = urticaria distributed on at least 4 body areas. For other symptoms, any = occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 = a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination. | During the 7 days (Days 0 - 6) following each vaccination |
| Number of Subjects Reporting Medically Significant Conditions (MSCs) | Medically significant conditions (MSCs) are defined as: adverse events (AEs) prompting emergency room or physician visits that are not (1) related to common diseases or (2) 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, cervicovaginal yeast infections, menstrual cycle abnormalities and injury. MSCs were collected regardless of causal relationship to vaccination and intensity. | Throughout the study period (from Day 0 up to Month 12) |
| Number of Subjects Reporting Pregnancies and Pregnancy Outcomes | Throughout the study period (from Day 0 up to Month 12) |
| Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | 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 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 Any 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 and related was an event assessed by the investigator as causally related to the study vaccination. | Throughout the study period (from Day 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 |
| 112022 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112022 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112022 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112022 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112022 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Withdrawal by Subject |
|
Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle 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 |
|
| OG001 | Placebo Group | Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule. |
|
|
| 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 According-to-Protocol (ATP) cohort for immunogenicity on initially seronegative subjects for whom data concerning immunogenicity measures were available. | Posted | Count of Participants | Participants | At Month 7 |
|
|
|
| Secondary | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeter (mm). | The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed. | Posted | Count of Participants | Participants | During the 7 days (Days 0 - 6) following each vaccination |
|
|
|
| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (= axillary temperature above 37.0 degrees Celsius (°C). Grade 3 fever = axillary temperature above 39.0°C. Grade 3 urticaria = urticaria distributed on at least 4 body areas. For other symptoms, any = occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 = a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination. | The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed. | Posted | Count of Participants | Participants | During the 7 days (Days 0 - 6) following each vaccination |
|
|
|
| Secondary | Number of Subjects Reporting Medically Significant Conditions (MSCs) | Medically significant conditions (MSCs) are defined as: adverse events (AEs) prompting emergency room or physician visits that are not (1) related to common diseases or (2) 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, cervicovaginal yeast infections, menstrual cycle abnormalities and injury. MSCs were collected regardless of causal relationship to vaccination and intensity. | The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented. | Posted | Count of Participants | Participants | Throughout the study period (from Day 0 up to Month 12) |
|
|
|
| Secondary | Number of Subjects Reporting Pregnancies and Pregnancy Outcomes | The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented. | Posted | Count of Participants | Participants | Throughout the study period (from Day 0 up to Month 12) |
|
|
|
| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | 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 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 Total Vaccinated cohort which included all subjects with the vaccine administration documented. | Posted | Count of Participants | Participants | Within 30 days (Days 0 - 29) after any vaccination |
|
|
|
| Secondary | Number of Subjects Reporting Any 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 and related was an event assessed by the investigator as causally related to the study vaccination. | The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented. | Posted | Count of Participants | Participants | Throughout the study period (from Day 0 up to Month 12) |
|
|
|
| 5 |
| 374 |
| 360 |
| 374 |
| EG001 | Placebo Group | Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule. | 2 | 376 | 339 | 376 |
| Adnexa uteri cyst | Reproductive system and breast disorders | Non-systematic Assessment |
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| Bronchopneumonia | Infections and infestations | Non-systematic Assessment |
|
| Food poisoning | Gastrointestinal disorders | Non-systematic Assessment |
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| Hand fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Multiple fractures | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Ulna fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
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| Redness | General disorders | Systematic Assessment |
|
| Swelling | General disorders | Systematic Assessment |
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| Arthralgia | General disorders | Systematic Assessment |
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| Fatigue | 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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| Fever | General disorders | Systematic Assessment | Fever is defined as axillary temperate above 37.0 degrees Celsius. |
|
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 |
| Anti-HPV-18 |
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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 |
|
| 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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| Any fever |
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| Grade 3 fever |
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| Related fever |
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| Any urticaria |
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| Grade 3 urticaria |
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| Related urticaria |
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| Related AEs |
|