| ID | Type | Description | Link |
|---|---|---|---|
| 105879 | Other Identifier | GSK | |
| 105880 | Other Identifier | GSK | |
| 105881 | Other Identifier | GSK | |
| 105882 | Other Identifier | GSK | |
| 2004-002083-18 | EudraCT Number |
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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 immunogenicity and safety of GSK Biologicals HPV-16/18 vaccine over 12 months, in women up to 55 years of age at study start. Approximately 660 study subjects will receive the HPV vaccine administered intramuscularly according to a 0-1-6 month schedule. The study will be extended to assess long-term safety and immunogenicity of the HPV-16/18 vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervarix (15-25 Years) Group | Experimental | Women aged 15 to 25 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule. |
|
| Cervarix (26-45 Years) Group | Experimental | Women aged 26 to 45 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule. |
|
| Cervarix (46-55 Years) Group | Experimental | Women aged 46 to 55 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervarix | Biological | Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Seroconverted Subjects for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies, in Women 15 to 25 Years of Age and Women 26 to 45 Years of Age | Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies [i.e. antibody titer greater than or equal to (≥) the cut-off value] in the sera of subjects seronegative before vaccination. Cut-off values were 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies. Data for the Cervarix (46-55 Years) Group are presented in the Secondary Outcomes as per Protocol. | At Month 7 |
| Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Months 18, 24, 36 and 48 | Anti-HPV 16/18 antibody titers were detected in sera samples and presented as Geometric Mean Titers (GMT), expressed in EL.U/mL. Data for pre-vaccination, Month 2, Month 7 and Month 12 are presented in the Secondary Outcomes as per Protocol. | At Months 18, 24, 36 and 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies, in Women 46 - 55 Years of Age | Seroconversion was 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 EL.U/mL for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies. Seroconversion results at Month 7 for the Cervarix (15-25 Years) Group and for the Cervarix (26-45 Years) Group are presented in the Primary Outcome Measure 1. |
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Inclusion criteria for primary study:
Inclusion criteria for extension studies
Exclusion criteria for primary study:
Exclusion criteria for extension studies
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Munich | Bavaria | 80799 | Germany | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19221517 | Background | Descamps D, Hardt K, Spiessens B, Izurieta P, Verstraeten T, Breuer T, Dubin G. Safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for cervical cancer prevention: a pooled analysis of 11 clinical trials. Hum Vaccin. 2009 May;5(5):332-40. doi: 10.4161/hv.5.5.7211. Epub 2009 May 20. | |
| 19022320 | 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 |
|---|---|---|---|
| 103514 | Annotated Case Report 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.
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Out of the 667 enrolled subjects, 1 subject was excluded for not receiving vaccination and the actual starting number was 666.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cervarix (15-25 Years) Group | Women aged 15 to 25 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule. |
| FG001 | Cervarix (26-45 Years) Group | Women aged 26 to 45 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule. |
| FG002 | Cervarix (46-55 Years) Group | Women aged 46 to 55 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Cervarix (15-25 Years) Group | Women aged 15 to 25 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule. |
| BG001 | Cervarix (26-45 Years) 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 for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies, in Women 15 to 25 Years of Age and Women 26 to 45 Years of Age | Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies [i.e. antibody titer greater than or equal to (≥) the cut-off value] in the sera of subjects seronegative before vaccination. Cut-off values were 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies. Data for the Cervarix (46-55 Years) Group are presented in the Secondary Outcomes as per Protocol. | The analysis was based the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis and who were seronegative before vaccination. | Posted | Count of Participants | Participants | At Month 7 |
|
Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
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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 (15-25 Years) Group | Women aged 15 to 25 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | MedDRA 8.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
Not provided
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C510352 | human papillomavirus vaccine, L1 type 16, 18 |
Not provided
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| At Month 7 |
| Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Pre-vaccination (PRE) and Months 2, 7 and 12 | Anti-HPV 16/18 antibody titers were detected in sera samples and presented as GMT, expressed in EL.U/mL. Data for Months 18, 24, 36 and 48 are presented in the Primary Outcome Measure 2 as per Protocol. | At PRE and Months 2, 7 and 12 |
| Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies at Month 2 and Month 12 | Seroconversion was 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 EL.U/mL for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies. Seroconversion results at Month 7 are presented in the Primary Outcome Measure 1 for Cervarix (15-25 Years) Group and Cervarix (26-45 Years) Group and in the Secondary Outcome Measure 3 for the Cervarix (46-55 Years) Group. | At Month 2 and Month 12 |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever above (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. | During the 7-day period (from the day of vaccination up to 6 subsequent days) following vaccination after each dose and across doses |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimetres (mm) of injection site. | During the 7-day period (from the day of vaccination up to 6 subsequent days) following vaccination after each dose and across doses |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. | During the 30-day (from the day of vaccination up to 29 subsequent days) post-vaccination period |
| Number of Subjects Reporting Serious Adverse Events (SAE) | An SAE is any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study subject, or may have evolved into one of the outcomes listed above. | During the entire study period (from Day 0 up to Month 48) |
| Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) | NOCDs assessed include chronic diseases such as autoimmune disorders, diabetes, allergies also asthma and pathognomic signs/symptoms of these diseases. | During the entire study period (from Day 0 up to Month 48) |
| Number of Subjects Reporting Medically Significant Conditions | Medically significant conditions are AEs prompting emergency room or physician visits that were not related to common diseases or routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. | During the entire study period (from Day 0 up to Month 48) |
| Anti-HPV-16/18 Antibody Titers Assessed by ELISA in a Subset of Subjects in Cervical Secretions (CVS) Samples | Anti-HPV 16/18 antibody titers were detected in CVS samples and presented as GMTs, expressed in EL.U/mL based on ELISA. | At Months 18 and 24 |
| Number of Subjects Seropositive for Total Immunoglobulin-G (IgG) in Blood (Serum) and in Cervical Samples (Secretion) in a Subset of Subjects | Seropositivity was defined as total IgG ≥ 0 microgram per milliliter (µg/mL) and was detected in sera and in CVS samples by ELISA. | At Months 18 and 24 |
| Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies | Outcomes of pregnancies were: Abnormal infant / Congenital anomaly, Elective termination, Missed abortion, Normal infant, Premature birth, Spontaneous abortion / Miscarriage and Outcome unknown. | During the entire study period (from Day 0 up to Month 48) |
| Würzburg |
| Bavaria |
| 97070 |
| Germany |
| GSK Investigational Site | Berlin | 12200 | Germany |
| GSK Investigational Site | Bydgoszcz | 85-021 | Poland |
| GSK Investigational Site | Poznan | 60-533 | Poland |
| GSK Investigational Site | Poznan | 61-709 | Poland |
| Schwarz TF, Spaczynski M, Schneider A, Wysocki J, Galaj A, Perona P, Poncelet S, Zahaf T, Hardt K, Descamps D, Dubin G; HPV Study Group for Adult Women. Immunogenicity and tolerability of an HPV-16/18 AS04-adjuvanted prophylactic cervical cancer vaccine in women aged 15-55 years. Vaccine. 2009 Jan 22;27(4):581-7. doi: 10.1016/j.vaccine.2008.10.088. Epub 2008 Nov 18. |
| 21892005 | Background | Schwarz TF, Spaczynski M, Schneider A, Wysocki J, Galaj A, Schulze K, Poncelet SM, Catteau G, Thomas F, Descamps D. Persistence of immune response to HPV-16/18 AS04-adjuvanted cervical cancer vaccine in women aged 15-55 years. Hum Vaccin. 2011 Sep;7(9):958-65. doi: 10.4161/hv.7.9.15999. Epub 2011 Sep 1. |
| 21157180 | Background | Schwarz TF, Kocken M, Petaja T, Einstein MH, Spaczynski M, Louwers JA, Pedersen C, Levin M, Zahaf T, Poncelet S, Hardt K, Descamps D, Dubin G. Correlation between levels of human papillomavirus (HPV)-16 and 18 antibodies in serum and cervicovaginal secretions in girls and women vaccinated with the HPV-16/18 AS04-adjuvanted vaccine. Hum Vaccin. 2010 Dec;6(12):1054-61. doi: 10.4161/hv.6.12.13399. Epub 2010 Dec 1. |
| 25208608 | Derived | Schwarz T, Spaczynski M, Kaufmann A, Wysocki J, Galaj A, Schulze K, Suryakiran P, Thomas F, Descamps D. Persistence of immune responses to the HPV-16/18 AS04-adjuvanted vaccine in women aged 15-55 years and first-time modelling of antibody responses in mature women: results from an open-label 6-year follow-up study. BJOG. 2015 Jan;122(1):107-18. doi: 10.1111/1471-0528.13070. Epub 2014 Sep 11. |
| 24731816 | Derived | Boxus M, Lockman L, Fochesato M, Lorin C, Thomas F, Giannini SL. Antibody avidity measurements in recipients of Cervarix vaccine following a two-dose schedule or a three-dose schedule. Vaccine. 2014 May 30;32(26):3232-6. doi: 10.1016/j.vaccine.2014.04.005. Epub 2014 Apr 13. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 103514 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 103514 are summarised with studies 105880 and 105881 on the GSK Clinical Study Register. |
| 103514 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 103514 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 103514 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 103514 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 103514 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Other |
|
Women aged 26 to 45 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
| BG002 | Cervarix (46-55 Years) Group | Women aged 46 to 55 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Cervarix (15-25 Years) Group |
Women aged 15 to 25 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule. |
| OG001 | Cervarix (26-45 Years) Group | Women aged 26 to 45 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule. |
|
|
|
| Primary | Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Months 18, 24, 36 and 48 | Anti-HPV 16/18 antibody titers were detected in sera samples and presented as Geometric Mean Titers (GMT), expressed in EL.U/mL. Data for pre-vaccination, Month 2, Month 7 and Month 12 are presented in the Secondary Outcomes as per Protocol. | The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis and who were seronegative before vaccination. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Months 18, 24, 36 and 48 |
|
|
|
| Secondary | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies, in Women 46 - 55 Years of Age | Seroconversion was 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 EL.U/mL for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies. Seroconversion results at Month 7 for the Cervarix (15-25 Years) Group and for the Cervarix (26-45 Years) Group are presented in the Primary Outcome Measure 1. | The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis and who were seronegative before vaccination. | Posted | Count of Participants | Participants | At Month 7 |
|
|
|
| Secondary | Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Pre-vaccination (PRE) and Months 2, 7 and 12 | Anti-HPV 16/18 antibody titers were detected in sera samples and presented as GMT, expressed in EL.U/mL. Data for Months 18, 24, 36 and 48 are presented in the Primary Outcome Measure 2 as per Protocol. | The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis and who were seronegative before vaccination. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At PRE and Months 2, 7 and 12 |
|
|
|
| Secondary | Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies at Month 2 and Month 12 | Seroconversion was 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 EL.U/mL for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies. Seroconversion results at Month 7 are presented in the Primary Outcome Measure 1 for Cervarix (15-25 Years) Group and Cervarix (26-45 Years) Group and in the Secondary Outcome Measure 3 for the Cervarix (46-55 Years) Group. | The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis and who were seronegative before vaccination. | Posted | Count of Participants | Participants | At Month 2 and Month 12 |
|
|
|
| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever above (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. | The analysis was based on the Total Vaccinated Cohort (TVC), which included all subjects with at least one study vaccine administered, on subjects with symptom sheets completed and for whom data were available. | Posted | Count of Participants | Participants | During the 7-day period (from the day of vaccination up to 6 subsequent days) following vaccination after each dose and across doses |
|
|
|
| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimetres (mm) of injection site. | The analysis was based on the TVC, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets completed and for whom data were available. | Posted | Count of Participants | Participants | During the 7-day period (from the day of vaccination up to 6 subsequent days) following vaccination after each dose and across doses |
|
|
|
| Secondary | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. | The analysis was based on the TVC, which included all subjects with at least one study vaccine administered and for whom data were available. | Posted | Count of Participants | Participants | During the 30-day (from the day of vaccination up to 29 subsequent days) post-vaccination period |
|
|
|
| Secondary | Number of Subjects Reporting Serious Adverse Events (SAE) | An SAE is any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study subject, or may have evolved into one of the outcomes listed above. | The analysis was based on the TVC (up to Month 7), which included all subjects with at least one study vaccine administered and on the Extended Follow-up (EFU) Vaccinated cohort (Month 7 to Month 48) which included subjects who received 3 doses of vaccine in the primary phase of the study and for whom data were available. | Posted | Count of Participants | Participants | During the entire study period (from Day 0 up to Month 48) |
|
|
|
| Secondary | Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) | NOCDs assessed include chronic diseases such as autoimmune disorders, diabetes, allergies also asthma and pathognomic signs/symptoms of these diseases. | The analysis was based on the TVC (data up to Month 7), which included all subjects with at least one study vaccine administered and on the EFU Vaccinated cohort (data from Month 7 to Month 48) which included subjects who received 3 doses of vaccine in the primary phase of the study and for whom data were available. | Posted | Count of Participants | Participants | During the entire study period (from Day 0 up to Month 48) |
|
|
|
| Secondary | Number of Subjects Reporting Medically Significant Conditions | Medically significant conditions are AEs prompting emergency room or physician visits that were not related to common diseases or routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. | The analysis was based on the TVC (data up to Month 7), which included all subjects with at least one study vaccine administered and on the EFU Vaccinated cohort (data from Month 7 to Month 48) which included subjects who received 3 doses of vaccine in the primary phase of the study and for whom data were available. | Posted | Count of Participants | Participants | During the entire study period (from Day 0 up to Month 48) |
|
|
|
| Secondary | Anti-HPV-16/18 Antibody Titers Assessed by ELISA in a Subset of Subjects in Cervical Secretions (CVS) Samples | Anti-HPV 16/18 antibody titers were detected in CVS samples and presented as GMTs, expressed in EL.U/mL based on ELISA. | The analysis was based on a subset of subjects from the TVC for whom CVS samples were available and who received at least one dose of vaccine in this study. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Months 18 and 24 |
|
|
|
| Secondary | Number of Subjects Seropositive for Total Immunoglobulin-G (IgG) in Blood (Serum) and in Cervical Samples (Secretion) in a Subset of Subjects | Seropositivity was defined as total IgG ≥ 0 microgram per milliliter (µg/mL) and was detected in sera and in CVS samples by ELISA. | The analysis was based on a subset of subjects from the TVC for whom CVS samples were available and who received at least one dose of vaccine in this study. | Posted | Count of Participants | Participants | At Months 18 and 24 |
|
|
|
| Secondary | Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies | Outcomes of pregnancies were: Abnormal infant / Congenital anomaly, Elective termination, Missed abortion, Normal infant, Premature birth, Spontaneous abortion / Miscarriage and Outcome unknown. | The analysis was based on the TVC, which included all subjects with at least one vaccine administration documented and for whom data were available. | Posted | Count of Participants | Participants | During the entire study period (from Day 0 up to Month 48) |
|
|
|
| 0 |
| 229 |
| 6 |
| 229 |
| 224 |
| 229 |
| EG001 | Cervarix (26-45 Years) Group | Women aged 26 to 45 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule. | 0 | 226 | 8 | 226 | 216 | 226 |
| EG002 | Cervarix (46-55 Years) Group | Women aged 46 to 55 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule. | 2 | 211 | 11 | 211 | 182 | 211 |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Multiple sclerosis | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Optic neuritis | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 8.0 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Vestibular neuronitis | Ear and labyrinth disorders | MedDRA 8.0 | Systematic Assessment |
|
| Abdominal hernia | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Carotid artery dissection | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Cervical polyp | Reproductive system and breast disorders | MedDRA 8.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
|
| Gastroduodenitis | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Uterine prolapse | Reproductive system and breast disorders | MedDRA 8.0 | Systematic Assessment |
|
| Venous thrombosis limb | Vascular disorders | MedDRA 8.0 | Systematic Assessment |
|
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
|
| Abortion spontaneous | Reproductive system and breast disorders | MedDRA 8.0 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.0 | Systematic Assessment |
|
| Premature labour | Reproductive system and breast disorders | MedDRA 8.0 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
|
| Abortion missed | Pregnancy, puerperium and perinatal conditions | MedDRA 8.0 | Systematic Assessment |
|
| Abortion spontaneous complete | Pregnancy, puerperium and perinatal conditions | MedDRA 8.0 | Systematic Assessment |
|
| Redness | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Swelling | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Arthralgia | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Fever | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Gastrointestinal symptoms | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Headache | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Myalgia | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Rash | General disorders | MedDRA 8.0 | 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.
| 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-16 (Month 24) |
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| Anti-HPV-16 (Month 36) |
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| Anti-HPV-16 (Month 48) |
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| Anti-HPV-18 (Month 18) |
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| Anti-HPV-18 (Month 24) |
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| Anti-HPV-18 (Month 36) |
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| Anti-HPV-18 (Month 48) |
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| Anti-HPV-16 (Month 2) |
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| Anti-HPV-16 (Month 7) |
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| Anti-HPV-16 (Month 12) |
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| Anti-HPV-18 (PRE) |
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| Anti-HPV-18 (Month 2) |
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| Anti-HPV-18 (Month 7) |
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| Anti-HPV-18 (Month 12) |
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| Anti-HPV-16 (Month 12) |
|
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| Anti-HPV-18 (Month 2) |
|
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| Anti-HPV-18 (Month 12) |
|
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| Any Arthralgia - Dose 2 |
|
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| Any Arthralgia - Dose 3 |
|
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| Any Arthralgia - Across doses |
|
|
| Grade 3 Arthralgia - Dose 1 |
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| Grade 3 Arthralgia - Dose 2 |
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| Grade 3 Arthralgia - Dose 3 |
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| Grade 3 Arthralgia - Across doses |
|
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| Related Arthralgia - Dose 1 |
|
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| Related Arthralgia - Dose 2 |
|
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| Related Arthralgia - Dose 3 |
|
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| Related Arthralgia - Across doses |
|
|
| Any Fatigue - Dose 1 |
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| Any Fatigue - Dose 2 |
|
|
| Any Fatigue - Dose 3 |
|
|
| Any Fatigue - Across doses |
|
|
| Grade 3 Fatigue - Dose 1 |
|
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| Grade 3 Fatigue - Dose 2 |
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| Grade 3 Fatigue - Dose 3 |
|
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| Grade 3 Fatigue - Across doses |
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| Related Fatigue - Dose 1 |
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| Related Fatigue - Dose 2 |
|
|
| Related Fatigue - Dose 3 |
|
|
| Related Fatigue - Across doses |
|
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| Any Fever - Dose 1 |
|
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| Any Fever - Dose 2 |
|
|
| Any Fever - Dose 3 |
|
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| Any Fever - Across doses |
|
|
| Grade 3 Fever - Dose 1 |
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| Grade 3 Fever - Dose 2 |
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| Grade 3 Fever - Dose 3 |
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| Grade 3 Fever - Across doses |
|
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| Related Fever - Dose 1 |
|
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| Related Fever - Dose 2 |
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| Related Fever - Dose 3 |
|
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| Related Fever - Across doses |
|
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| Any Gastrointestinal - Dose 1 |
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| Any Gastrointestinal - Dose 2 |
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| Any Gastrointestinal - Dose 3 |
|
|
| Any Gastrointestinal - Across doses |
|
|
| Grade 3 Gastrointestinal - Dose 1 |
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| Grade 3 Gastrointestinal - Dose 2 |
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|
| Grade 3 Gastrointestinal - Dose 3 |
|
|
| Grade 3 Gastrointestinal - Across doses |
|
|
| Related Gastrointestinal - Dose 1 |
|
|
| Related Gastrointestinal - Dose 2 |
|
|
| Related Gastrointestinal - Dose 3 |
|
|
| Related Gastrointestinal - Across doses |
|
|
| Any Headache - Dose 1 |
|
|
| Any Headache - Dose 2 |
|
|
| Any Headache - Dose 3 |
|
|
| Any Headache - Across doses |
|
|
| Grade 3 Headache - Dose 1 |
|
|
| Grade 3 Headache - Dose 2 |
|
|
| Grade 3 Headache - Dose 3 |
|
|
| Grade 3 Headache - Across doses |
|
|
| Related Headache - Dose 1 |
|
|
| Related Headache - Dose 2 |
|
|
| Related Headache - Dose 3 |
|
|
| Related Headache - Across doses |
|
|
| Any Myalgia - Dose 1 |
|
|
| Any Myalgia - Dose 2 |
|
|
| Any Myalgia - Dose 3 |
|
|
| Any Myalgia - Across doses |
|
|
| Grade 3 Myalgia - Dose 1 |
|
|
| Grade 3 Myalgia - Dose 2 |
|
|
| Grade 3 Myalgia - Dose 3 |
|
|
| Grade 3 Myalgia - Across doses |
|
|
| Related Myalgia - Dose 1 |
|
|
| Related Myalgia - Dose 2 |
|
|
| Related Myalgia - Dose 3 |
|
|
| Related Myalgia - Across doses |
|
|
| Any Rash - Dose 1 |
|
|
| Any Rash - Dose 2 |
|
|
| Any Rash - Dose 3 |
|
|
| Any Rash - Across doses |
|
|
| Grade 3 Rash - Dose 1 |
|
|
| Grade 3 Rash - Dose 2 |
|
|
| Grade 3 Rash - Dose 3 |
|
|
| Grade 3 Rash - Across doses |
|
|
| Related Rash - Dose 1 |
|
|
| Related Rash - Dose 2 |
|
|
| Related Rash - Dose 3 |
|
|
| Related Rash - Across doses |
|
|
| Any Urticaria - Dose 1 |
|
|
| Any Urticaria - Dose 2 |
|
|
| Any Urticaria - Dose 3 |
|
|
| Any Urticaria - Across doses |
|
|
| Grade 3 Urticaria - Dose 1 |
|
|
| Grade 3 Urticaria - Dose 2 |
|
|
| Grade 3 Urticaria - Dose 3 |
|
|
| Grade 3 Urticaria - Across doses |
|
|
| Related Urticaria - Dose 1 |
|
|
| Related Urticaria - Dose 2 |
|
|
| Related Urticaria - Dose 3 |
|
|
| Related Urticaria - Across doss |
|
|
| Any Pain - Dose 2 |
|
|
| Any Pain - Dose 3 |
|
|
| Any Pain - Across doses |
|
|
| Grade 3 Pain - Dose 1 |
|
|
| Grade 3 Pain - Dose 2 |
|
|
| Grade 3 Pain - Dose 3 |
|
|
| Grade 3 Pain - Across doses |
|
|
| Any Redness - Dose 1 |
|
|
| Any Redness - Dose 2 |
|
|
| Any Redness - Dose 3 |
|
|
| Any Redness - Across doses |
|
|
| Grade 3 Redness - Dose 1 |
|
|
| Grade 3 Redness - Dose 2 |
|
|
| Grade 3 Redness - Dose 3 |
|
|
| Grade 3 Redness - Across doses |
|
|
| Any Swelling - Dose 1 |
|
|
| Any Swelling - Dose 2 |
|
|
| Any Swelling - Dose 3 |
|
|
| Any Swelling - Across doses |
|
|
| Grade 3 Swelling - Dose 1 |
|
|
| Grade 3 Swelling - Dose 2 |
|
|
| Grade 3 Swelling - Dose 3 |
|
|
| Grade 3 Swelling - Across doses |
|
|
|
| Subjects with any Related AE(s) |
|
| Month 7 to Month 12 |
|
|
| Month 12 to Month 18 |
|
|
| Month 18 to Month 24 |
|
|
| Month 24 to Month 36 |
|
|
| Month 36 to Month 48 |
|
|
| Month 7 to Month 12 |
|
|
| Month 12 to Month 18 |
|
|
| Month 18 to Month 24 |
|
|
| Month 24 to Month 36 |
|
|
| Month 36 to Month 48 |
|
|
| Day 30 to Month 7 |
|
|
| Month 7 to Month 12 |
|
|
| Month 12 to Month 18 |
|
|
| Month 18 to Month 24 |
|
|
| Month 24 to Month 36 |
|
|
| Month 36 to Month 48 |
|
|
| Anti-HPV-16 (Month 24) |
|
|
| Anti-HPV-18 (Month 18) |
|
|
| Anti-HPV-18 (Month 24) |
|
|
| IgG serum (Month 24) |
|
|
| IgG secretion (Month 18) |
|
|
| IgG secretion (Month 24) |
|
|
|
| Missed abortion |
|
| Normal infant |
|
| Premature birth |
|
| Spontaneous abortion / Miscarriage |
|
| Outcome unknown |
|