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Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. This study will evaluate the efficacy in prevention of persistent HPV-16 or HPV-18 cervical infection lasting at least 6 months, the immunogenicity and safety of GSK Biologicals HPV-16/18 vaccine (Cervarix TM ) over 24 months in Japanese adult women aged 20 - 25 years of age at study start. Approximately 1000 study subjects will either receive the HPV vaccine or a control vaccine (Hepatitis A vaccine) administered intramuscularly according to a 0-1-6 month schedule.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
The Protocol Posting has been updated to reflect changes as a consequence of an amendment to the protocol. Sections impacted are Official Title of the study and Intervention name.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervarix Group | Experimental | Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule. |
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| Aimmugen Group | Active Comparator | Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPV-16/18 vaccine (Cervarix™) | Biological | Intramuscular injection, 3 doses |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Persistent Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18) | Persistent HPV-16 or HPV-18 infection is defined as at least 2 positive Human Papillomavirus (HPV) deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an approximate interval of 6 months (> 150 days) [as assessed in women who were, for the corresponding HPV type, seronegative at Month 0 and HPV DNA negative (by PCR) at Month 0 and Month 6]. | Throughout the study period (up to Month 24) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Incident Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18) | HPV-16 or HPV-18 incident infection is defined as at least one positive HPV-16 or HPV-18 deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assay in women who were, for the corresponding HPV type, seronegative at Month 0 and HPV DNA negative (by PCR) at Month 0 and Month 6. |
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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 | Kagoshima | 892-0824 | Japan | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19574783 | Background | Konno R, Dobbelaere KO, Godeaux OO, Tamura S, Yoshikawa H. Immunogenicity, reactogenicity, and safety of human papillomavirus 16/18 AS04-adjuvanted vaccine in Japanese women: interim analysis of a phase II, double-blind, randomized controlled trial at month 7. Int J Gynecol Cancer. 2009 Jul;19(5):905-11. doi: 10.1111/IGC.0b013e3181a23c0e. | |
| 20375805 |
| 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 |
|---|---|---|---|
| 104798 | Informed Consent Form | 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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Six subjects enrolled in this study were not vaccinated and hence not reported as started in the participant flow table below.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cervarix Group | Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule. |
| FG001 | Aimmugen Group | Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Aimmugen™ |
| Biological |
Intramuscular injection, 3 doses |
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| Up to Month 24 |
| Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Human Papillomavirus 16 (HPV-16) and/or Human Papillomavirus 18 (HPV-18) Cervical Infection | Cytologically-confirmed abnormalities assessed include atypical squamous cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), atypical squamous cells-can not exclude HSIL (ASC-H) and atypical glandular cells (AGC). These cytological abnormalities were assessed in women who were, for the corresponding Human Papillomavirus (HPV) type, seronegative at Month 0 and HPV deoxyribonucleic acid (DNA) negative (by polymerase chain reaction) at Month 0 and Month 6. | Up to Month 24 |
| Number of Subjects With Histopathologically-confirmed Lesions Concurrently Associated With Human Papillomavirus 16 (HPV-16) and/or Human Papillomavirus (HPV-18) Cervical Infection | Histopathologically-confirmed lesions assessed include cervical intraepithelial neoplasia of grade 1 (CIN1), grade 2 (CIN2), grade 3 (CIN3) and adenocarcinoma. These lesions were assessed in women who were, for the corresponding Human Papillomavirus (HPV) type, seronegative at Month 0 and HPV deoxyribonucleic acid (DNA) negative (by polymerase chain reaction) at Month 0 and Month 6. | Up to Month 24 |
| Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | Incident infection for oncogenic HPV types is defined as at least one positive oncogenic HPV type deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assay in women who were, for the corresponding HPV type, HPV DNA negative (by PCR) at Month 0 and Month 6. Oncogenic (high risk [HR]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68. | Up to Month 24 |
| Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | Persistent infection for oncogenic HPV types is defined as at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an approximate interval of 6 months (> 150 days) [as assessed in women who were, for the corresponding HPV type, HPV DNA negative (by PCR) at Month 0 and Month 6]. Oncogenic (high risk [HR]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68. | Up to Month 24 |
| Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | Cytologically-confirmed abnormalities assessed include ASC-US, LSIL, HSIL, ASC-H and AGC. These cytological abnormalities were assessed in women who were, for the corresponding HPV type (determined by PCR), HPV DNA negative (by PCR) at Month 0 and Month 6. Oncogenic (high risk [HR]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68. | Up to Month 24 |
| Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | Histopathologically-confirmed lesions assessed include cervical intraepithelial neoplasia of grade 1 (CIN1), grade 2 (CIN2), grade 3 (CIN3) and adenocarcinoma. These lesions were assessed in women who were, for the corresponding HPV type (determined by polymerase chain reaction)), HPV deoxyribonucleic acid (DNA) negative at Month 0 and Month 6. Oncogenic (high risk [HR]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68. | Up to Month 24 |
| Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value | Anti-HPV-16 antibody cut-off value assessed include 8 ELISA units per milliliter (EL.U/mL) and anti-HPV-18 antibody cut-off value assessed include 7 EL.U/mL. | At Months 0 (pre-vaccination), 6, 7, 12, 18 and 24 |
| Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL). | At Months 0, 6, 7, 12, 18 and 24 |
| Number of Subjects Reporting Solicited Local and General Symptoms | Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include arthralgia, fatigue, fever (above 37.5 degree Celsius), gastrointestinal symptoms, headache, myalgia, rash and urticaria. | Within 7 days after each and any vaccination |
| Number of Subjects Reporting Unsolicited Adverse Events (AE) | 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. | Within 30 days after any vaccination |
| Number of Subjects Reporting Serious Adverse Events (SAE) | 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. | Throughout the study period (up to Month 24) |
| Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs) | NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include adverse events (AEs) 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. | Throughout the study period (up to Month 24) |
| Outcome of Any Reported Pregnancies | Information on any subject who became pregnant while participating in this study was collected. The outcomes of the pregnancies are reported below. | Throughout the study period (up to Month 24) |
| Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Hematological parameters assessed in blood samples include hemoglobin, haematocrit, mean corpuscular (MC) hemoglobin, mean corpuscular (MC) hemoglobin concentration, mean corpuscular (MC) volume, platelet count, red blood cell count, white blood cell count. Abnormalities reported include values outside the normal ranges: values higher than normal are designated as "Above" and values lower than normal as "Below" while "Unknown" stands for values not determined. | At Month 0 and Month 7 |
| Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Biochemical parameters were assessed in blood samples. Abnormalities reported include values outside the normal ranges: values higher than normal are designated as "Above" and values lower than normal as "Below" while "Unknown" stands for values not determined. Abbreviations: aminotransferase (ALT), aspartate aminotransferase (ASP), C reactive protein (CRP), gamma-glutamyl-transferase (GGT) and lactate dehydrogenase (LDH). | At Month 0 and Month 7 |
| Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Abnormalities in concentrations (expressed as milligrams per deciliter [mg/dL]) are presented categorical as follows: Protein: <10 (-)*; 10-25 (+-)*; 25-85 (+); 85-250 (2+); 250-800 (3+). Glucose: <30 (-)*; 30-60 (+-)*; 60-125 (+); 125-250 (2+); 250-750 (3+). Urobilinogen: <1.5 (+-)*; 1.5-3.5 (+); 3.5-7 (2+); 7-14 (3+). Bilirubin: <0.35 (-)*; 0.35-1.5 (+); 1.5-5 (2+); 5-12 (3+). Occult blood: <0.015 (-)*; 0.015-0.045 (+-); 0.045-015 (+); 0.15-0.75 (2+); >0.75 (3+). Ketone body: <2.5 (-)*; 2.5-7.5 (+-); 7.5-30 (+); 30-70 (2+); 70-125 (3+). Normal ranges indicated by asterix*. | At Month 0 and Month 7 |
| Tokyo |
| 160-0017 |
| Japan |
| GSK Investigational Site | Tokyo | 183-0056 | Japan |
| GSK Investigational Site |
| Konno R, Tamura S, Dobbelaere K, Yoshikawa H. Efficacy of human papillomavirus 16/18 AS04-adjuvanted vaccine in Japanese women aged 20 to 25 years: interim analysis of a phase 2 double-blind, randomized, controlled trial. Int J Gynecol Cancer. 2010 Apr;20(3):404-10. doi: 10.1111/IGC.0b013e3181d373a5. |
| 21251162 | Background | Konno R, Tamura S, Dobbelaere K, Yoshikawa H. Prevalence and type distribution of human papillomavirus in healthy Japanese women aged 20 to 25 years old enrolled in a clinical study. Cancer Sci. 2011 Apr;102(4):877-82. doi: 10.1111/j.1349-7006.2011.01878.x. Epub 2011 Feb 17. |
| Background | Konno R et al. Efficacy, immunogenicity and safety of HPV 16/18 AS04-adjuvanted vaccine in Japanese women. Abstract presented at European Research Organization on Genital Infection and Neoplasia 2010 (EUROGIN). Monte Carlo, Monaco, 17-20 February 2010. |
| Background | Konno R et al. Interim analysis of clinical trial of HPV-16/18-AS04 vaccine in Japan. Abstract presented at the 25th International Papillomavirus Conference, Malmö, Sweden, 8-14 May 2009. |
| 18845199 | Background | 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. |
| 31824976 | Derived | Chen J, Gopala K, Akarsh PK, Struyf F, Rosillon D. Prevalence and Incidence of Human Papillomavirus (HPV) Infection Before and After Pregnancy: Pooled Analysis of the Control Arms of Efficacy Trials of HPV-16/18 AS04-Adjuvanted Vaccine. Open Forum Infect Dis. 2019 Dec 4;6(12):ofz486. doi: 10.1093/ofid/ofz486. eCollection 2019 Dec. |
| 25424783 | Derived | Konno R, Yoshikawa H, Okutani M, Quint W, V Suryakiran P, Lin L, Struyf F. Efficacy of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical intraepithelial neoplasia and cervical infection in young Japanese women. Hum Vaccin Immunother. 2014;10(7):1781-94. doi: 10.4161/hv.28712. |
| 20606533 | Derived | Konno R, Tamura S, Dobbelaere K, Yoshikawa H. Efficacy of human papillomavirus type 16/18 AS04-adjuvanted vaccine in Japanese women aged 20 to 25 years: final analysis of a phase 2 double-blind, randomized controlled trial. Int J Gynecol Cancer. 2010 Jul;20(5):847-55. doi: 10.1111/IGC.0b013e3181da2128. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 104798 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104798 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104798 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104798 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104798 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cervarix Group | Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule. |
| BG001 | Aimmugen Group | Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | 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 With Persistent Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18) | Persistent HPV-16 or HPV-18 infection is defined as at least 2 positive Human Papillomavirus (HPV) deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an approximate interval of 6 months (> 150 days) [as assessed in women who were, for the corresponding HPV type, seronegative at Month 0 and HPV DNA negative (by PCR) at Month 0 and Month 6]. | Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data. | Posted | Count of Participants | Participants | Throughout the study period (up to Month 24) |
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| Secondary | Number of Subjects With Incident Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18) | HPV-16 or HPV-18 incident infection is defined as at least one positive HPV-16 or HPV-18 deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assay in women who were, for the corresponding HPV type, seronegative at Month 0 and HPV DNA negative (by PCR) at Month 0 and Month 6. | Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data. | Posted | Count of Participants | Participants | Up to Month 24 |
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| Secondary | Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Human Papillomavirus 16 (HPV-16) and/or Human Papillomavirus 18 (HPV-18) Cervical Infection | Cytologically-confirmed abnormalities assessed include atypical squamous cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), atypical squamous cells-can not exclude HSIL (ASC-H) and atypical glandular cells (AGC). These cytological abnormalities were assessed in women who were, for the corresponding Human Papillomavirus (HPV) type, seronegative at Month 0 and HPV deoxyribonucleic acid (DNA) negative (by polymerase chain reaction) at Month 0 and Month 6. | Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data. | Posted | Count of Participants | Participants | Up to Month 24 |
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| Secondary | Number of Subjects With Histopathologically-confirmed Lesions Concurrently Associated With Human Papillomavirus 16 (HPV-16) and/or Human Papillomavirus (HPV-18) Cervical Infection | Histopathologically-confirmed lesions assessed include cervical intraepithelial neoplasia of grade 1 (CIN1), grade 2 (CIN2), grade 3 (CIN3) and adenocarcinoma. These lesions were assessed in women who were, for the corresponding Human Papillomavirus (HPV) type, seronegative at Month 0 and HPV deoxyribonucleic acid (DNA) negative (by polymerase chain reaction) at Month 0 and Month 6. | Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data. | Posted | Count of Participants | Participants | Up to Month 24 |
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| Secondary | Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | Incident infection for oncogenic HPV types is defined as at least one positive oncogenic HPV type deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assay in women who were, for the corresponding HPV type, HPV DNA negative (by PCR) at Month 0 and Month 6. Oncogenic (high risk [HR]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68. | Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data. | Posted | Count of Participants | Participants | Up to Month 24 |
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| Secondary | Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | Persistent infection for oncogenic HPV types is defined as at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an approximate interval of 6 months (> 150 days) [as assessed in women who were, for the corresponding HPV type, HPV DNA negative (by PCR) at Month 0 and Month 6]. Oncogenic (high risk [HR]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68. | Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data. | Posted | Count of Participants | Participants | Up to Month 24 |
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| Secondary | Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | Cytologically-confirmed abnormalities assessed include ASC-US, LSIL, HSIL, ASC-H and AGC. These cytological abnormalities were assessed in women who were, for the corresponding HPV type (determined by PCR), HPV DNA negative (by PCR) at Month 0 and Month 6. Oncogenic (high risk [HR]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68. | Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data. | Posted | Count of Participants | Participants | Up to Month 24 |
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| Secondary | Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | Histopathologically-confirmed lesions assessed include cervical intraepithelial neoplasia of grade 1 (CIN1), grade 2 (CIN2), grade 3 (CIN3) and adenocarcinoma. These lesions were assessed in women who were, for the corresponding HPV type (determined by polymerase chain reaction)), HPV deoxyribonucleic acid (DNA) negative at Month 0 and Month 6. Oncogenic (high risk [HR]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68. | Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data. | Posted | Count of Participants | Participants | Up to Month 24 |
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| Secondary | Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value | Anti-HPV-16 antibody cut-off value assessed include 8 ELISA units per milliliter (EL.U/mL) and anti-HPV-18 antibody cut-off value assessed include 7 EL.U/mL. | Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity. | Posted | Count of Participants | Participants | At Months 0 (pre-vaccination), 6, 7, 12, 18 and 24 |
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| Secondary | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL). | Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Months 0, 6, 7, 12, 18 and 24 |
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| Secondary | Number of Subjects Reporting Solicited Local and General Symptoms | Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include arthralgia, fatigue, fever (above 37.5 degree Celsius), 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 | Within 7 days after each and any vaccination |
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| Secondary | Number of Subjects Reporting Unsolicited Adverse Events (AE) | 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. | Analysis was performed on the Total Vaccinated Cohort. | Posted | Count of Participants | Participants | Within 30 days after any vaccination |
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| Secondary | Number of Subjects Reporting Serious Adverse Events (SAE) | 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. | Analysis was performed on the Total Vaccinated Cohort. | Posted | Count of Participants | Participants | Throughout the study period (up to Month 24) |
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| Secondary | Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs) | NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include adverse events (AEs) 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. | Analysis was performed on the Total Vaccinated Cohort. | Posted | Count of Participants | Participants | Throughout the study period (up to Month 24) |
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| Secondary | Outcome of Any Reported Pregnancies | Information on any subject who became pregnant while participating in this study was collected. The outcomes of the pregnancies are reported below. | Analysis was performed on those subjects reporting pregnancy during the study period. | Posted | Count of Participants | Participants | Throughout the study period (up to Month 24) |
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| Secondary | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Hematological parameters assessed in blood samples include hemoglobin, haematocrit, mean corpuscular (MC) hemoglobin, mean corpuscular (MC) hemoglobin concentration, mean corpuscular (MC) volume, platelet count, red blood cell count, white blood cell count. Abnormalities reported include values outside the normal ranges: values higher than normal are designated as "Above" and values lower than normal as "Below" while "Unknown" stands for values not determined. | Analysis was performed on the Total Vaccinated Cohort. | Posted | Count of Participants | Participants | At Month 0 and Month 7 |
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| Secondary | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Biochemical parameters were assessed in blood samples. Abnormalities reported include values outside the normal ranges: values higher than normal are designated as "Above" and values lower than normal as "Below" while "Unknown" stands for values not determined. Abbreviations: aminotransferase (ALT), aspartate aminotransferase (ASP), C reactive protein (CRP), gamma-glutamyl-transferase (GGT) and lactate dehydrogenase (LDH). | Analysis was performed on the Total Vaccinated Cohort. | Posted | Count of Participants | Participants | At Month 0 and Month 7 |
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| Secondary | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Abnormalities in concentrations (expressed as milligrams per deciliter [mg/dL]) are presented categorical as follows: Protein: <10 (-)*; 10-25 (+-)*; 25-85 (+); 85-250 (2+); 250-800 (3+). Glucose: <30 (-)*; 30-60 (+-)*; 60-125 (+); 125-250 (2+); 250-750 (3+). Urobilinogen: <1.5 (+-)*; 1.5-3.5 (+); 3.5-7 (2+); 7-14 (3+). Bilirubin: <0.35 (-)*; 0.35-1.5 (+); 1.5-5 (2+); 5-12 (3+). Occult blood: <0.015 (-)*; 0.015-0.045 (+-); 0.045-015 (+); 0.15-0.75 (2+); >0.75 (3+). Ketone body: <2.5 (-)*; 2.5-7.5 (+-); 7.5-30 (+); 30-70 (2+); 70-125 (3+). Normal ranges indicated by asterix*. | Analysis was performed on the Total Vaccinated cohort. | Posted | Count of Participants | Participants | At Month 0 and Month 7 |
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Total number of subjects at risk corresponds to
Not provided
| 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 GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule. | 1 | 519 | 18 | 519 | 512 | 519 |
| EG001 | Aimmugen Group | Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule. | 0 | 521 | 19 | 521 | 459 | 521 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Abortion threatened | Pregnancy, puerperium and perinatal conditions | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Acute tonsillitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Threatened labour | Pregnancy, puerperium and perinatal conditions | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Abortion missed | Pregnancy, puerperium and perinatal conditions | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Abortion spontaneous incomplete | Pregnancy, puerperium and perinatal conditions | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Acute abdomen | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Allergic granulomatous angiitis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Avulsion fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Borderline personality disorder | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Brain contusion | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Eyeball rupture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Ligament injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Mastitis postpartum | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Moyamoya disease | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Ovarian haemorrhage | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Panic disorder | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Polycystic ovaries | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | MedDRA | Systematic Assessment |
| |
| Redness | General disorders | MedDRA | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA | Systematic Assessment |
| |
| Arthralgia | General disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Fever | General disorders | MedDRA | Systematic Assessment |
| |
| Gastrointestinal symptoms | General disorders | MedDRA | Systematic Assessment |
| |
| Headache | General disorders | MedDRA | Systematic Assessment |
| |
| Myalgia | General disorders | MedDRA | Systematic Assessment |
| |
| Rash | General disorders | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Injection site warmth | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
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 |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C510352 | human papillomavirus vaccine, L1 type 16, 18 |
Not provided
Not provided
Not provided
| Male |
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| HPV-18 |
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