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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-002546-20 | EudraCT Number |
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This is a multicentre study in which women were planned to receive either the Human Papillomavirus Vaccine (HPV) vaccine or control. Under Protocol Amendment 3, study participation will last approximately 48 months and involves a total of eleven scheduled visits. Under Protocol Amendment 4, study participation will last up to 84 months and involves a maximum of seventeen scheduled visits.
The Protocol Posting has been updated due to protocol amendment 5 and in order to comply with the FDA Amendment Act, Sep 2007.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervarix Group | Experimental | Subjects received 3 doses of Cervarixâ„¢ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule. |
|
| Aluminium Hydroxide Group | Placebo Comparator | Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervarix | Biological | Subjects were planned to receive three doses of the study vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | CIN1+ = CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Persistent HPV infection = detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.
| Up to Month 48 |
| Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | CIN1+ = CIN grades 1, 2 and 3, AIS and invasive cervical cancer. Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.
| Up to Month 48 |
| Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | CIN1+ = CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Persistent HPV infection = detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. - DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and 6 and seronegative/positive (sero-/+) at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) - Overall: subjects DNA- at Month 0 and 6 for the corresponding HPV-type, regardless of initial serostatus |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Detection was done in:
|
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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 | Fountain Valley | California | 92708 | United States | ||
| 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. | |
| 25189358 | 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 |
|---|---|---|---|
| 104820 | Informed Consent Form | View IPD |
IPD is available via the Clinical Study Data Request site (click on the link provided below)
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.
Enrolment was stratified by (1) age, with the majority of subjects in age strata 26 - 35 years and 36 - 45 years (about 45% each) and about 10% in the age stratum 46+ years, and (2) previous HPV history (in each age stratum, the number of women with a history of HPV infection/treatment was limited to approximately 15%).
Some subjects completed the study at Months 36 and 48 as they did not want to participate to the extensions up to Month 84, but they were included in the safety analysis for these subsequent timepoints.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cervarix Group | Subjects received 3 doses of Cervarixâ„¢ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule. |
| FG001 | Aluminium Hydroxide Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Month 48 |
|
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| Placebo control | Biological | Subjects were planned to receive three doses of the control vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule. |
|
| Up to Month 84 |
| Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | CIN1+ = CIN grades 1, 2 and 3, AIS and invasive cervical cancer. Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. - DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. | Up to Month 84 |
| Up to Month 48 |
| Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | Persistent cervical HPV infection (12-month definition) was defined as the detection of the same HPV type(s) PCR in cervical samples at all available time points over approximately a 12-month interval (evaluations are planned at approximately 6-month intervals).
| Up to Month 48 |
| Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Detection was done in subjects HPV DNA- for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus. HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18. HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. | Up to Month 48 |
| Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | Persistent HPV infection (12-month definition) = detection of the same HPV type(s) by PCR in cervical samples at available time points over approximately a 12-month interval (evaluations are planned at approximately 6-month intervals). Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. subjects HPV DNA- for the corresponding HPV type at Month 0 6, regardless of initial serostatus. HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 , 68 | Up to Month 48 |
| Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | CIN2+ was defined as CIN grades 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in:
Note: Results for seropositive status were not analysed. | Up to Month 48 |
| Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in:
| Up to Month 48 |
| Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus. | Up to Month 48 |
| Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Irrespective of HPV Cervical Infection and Irrespective of Baseline HPV DNA Status | CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on all subjects irrespective of their baseline HPV DNA status. | Up to Month 48 |
| Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection | Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US). Detection was done in:
Results for seropositive status were not analysed. | Up to Month 48 |
| Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Detection was done in subjects who were HPV DNA negative for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus. HRW-HPV= All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR= High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 | Up to Month 48 |
| Number of Subjects With Histopathologically Confirmed Reduction of Local Cervical Therapy | Detection was done on all subjects irrespective of their baseline HPV DNA status. | Up to Month 48 |
| Number of Subjects With First Colposcopy | Detection was done on all subjects irrespective of their baseline HPV DNA status. | Up to Month 48 |
| Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection | Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus. | Up to Month 48 |
| Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus. The lesion was assigned to an HPV type found in the lesion if (1) the same HPV type was found in at least 1 of the 2 (closest) preceding cytology samples, or (2) none of the HPV types found in the lesion were found in any of the 2 preceding cytology samples (isolate HPV types) | Up to Month 48 |
| Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | Seroconversion was defined as the appearance of antibodies (i.e.; titre greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. HPV-16 assay cut-off value was defined as greater than or equal to 8 ELISA units per millilitre (EL.U/mL). Seronegative (Sero-) subjects are subjects who had an antibody concentration below 8 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 8 EL.U/mL prior to vaccination. Immuno subset=subjects from selected sites N≥1000, at least 250 per region | At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84 |
| Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | Seroconversion was defined as the appearance of antibodies (i.e.; titre greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. HPV-18 assay cut-off value was defined as greater than or equal to 7 ELISA units per millilitre (EL.U/mL). Seronegative (Sero-) subjects are subjects who had an antibody concentration below 7 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 7 EL.U/mL prior to vaccination. Immuno subset=subjects from selected sites N≥1000, at least 250 per region | At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84 |
| Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | GMCs were expressed in ELISA units per milliliter (EL.U/mL). Seronegative (Sero-) subjects are subjects who had an antibody concentration below 8 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 8 EL.U/mL prior to vaccination. Immuno subset=subjects from selected sites (N≥1000, at least 250 per region) | At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84 |
| Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | GMCs were expressed in ELISA units per milliliter (EL.U/mL). Seronegative (Sero-) subjects are subjects who had an antibody concentration below 7 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 7 EL.U/mL prior to vaccination. Immuno subset=subjects from selected sites (N≥1000, at least 250 per region) | At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84 |
| Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | Seroconversion was defined as the appearance of antibodies (i.e.; titre greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. HPV-16/18 assay cut-off value was defined as greater than or equal to 40 Estimated dose 50% (ED50). Sero- subjects are subjects who had an antibody concentration below 40 ED50 prior to vaccination. Sero+ subjects are subjects who had an antibody concentration equal to or above 50 ED50 prior to vaccination. ED50 = the estimated serum dilution reducing the signal generated by viral infection by 50% | Prior to vaccination and at Months 7, 12, 18, 24, 48 and 84. |
| Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | Titers are expressed as geometric mean antibody titers (GMTs). Seronegative (Sero-) subjects are subjects who had an antibody titer below 40 ED50 prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody titer equal to or above 40 ED50 prior to vaccination. ED50 = Estimated dose 50%, the estimated serum dilution reducing the signal generated by viral infection by 50% | Prior to vaccination and at Months 7, 12, 18, 24, 48 and 84. |
| 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 was defined as redness/swelling above 50 millimeter (mm). | Within 7 days (Days 0-6) after 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 (Fever = axillary temperature above 37.5 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = axillary temperature above 39.0°C. | Within 7 days (Days 0-6) after vaccination |
| Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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. Grade 3 unsolicited AE = an event that prevented normal activity. A related AE = event assessed by the investigator as causally related to the study vaccination. | Within 30 days (Days 0 - 29) post-vaccination period. |
| Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs). | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. A related SAE was defined as an event assessed by the investigator as causally related to the study vaccination. | Up to Month 48 and up to Month 84 |
| Number of Subjects Reporting Related or Fatal Serious Adverse Event. | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | Up to Month 84 |
| Number of Subjects Reporting Any AE/SAE Leading to Premature Discontinuation of the Study. | 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. Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | Up to Month 84 |
| Number of Subjects Reporting New Onset of Chronic Disease (NOCDs). | NOCDs include autoimmune disorders, asthma and type I diabetes. | Up to Month 48 |
| Number of Subjects Reporting New Onset of Autoimmune Disease (NOADs). | Up to Month 48 |
| Number of Subjects Reporting Medically Significant Conditions (MAEs). | Medically significant conditions were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury. | Up to Month 48 |
| Number of Subjects With Pregnancies and Their Outcomes. | Pregnancy outcomes are live infant, premature live infant, elective termination, ectopic pregnancy, spontaneous abortion, lost to follow-up and pregnancy ongoing. For each category it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA). | Up to Month 48 |
| Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the Type Assignment Algorithm (TAA) | CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. TAA: Type assignment algorithm. The lesion was assigned to an HPV type found in the lesion if
| Up to Month 48 |
| Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Detection was done in: - DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. | Up to Month 84 |
| Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | Persistent cervical HPV infection (12-month definition) was defined as the detection of the same HPV type(s) PCR in cervical samples at all available time points over approximately a 12-month interval (evaluations are planned at approximately 6-month intervals). - DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. | Up to Month 84 |
| Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Detection was done in subjects HPV DNA- for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus. HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18. HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. | Up to Month 84 |
| Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. subjects HPV DNA- for the corresponding HPV type at Month 0 6, regardless of initial serostatus. HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 , 68 | Up to Month 84 |
| Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | CIN2+ was defined as CIN grades 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in: - DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. Note: Results for seropositive status were not analysed. | Up to Month 84 |
| Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in: - DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. | Up to Month 84 |
| Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | Up to Month 84 |
| Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Irrespective of HPV Cervical Infection and Irrespective of Baseline HPV DNA Status | CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on all subjects irrespective of their baseline HPV DNA status. | Up to Month 84 |
| Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection | Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US). Detection was done in: - DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. Results for seropositive status were not analysed. | Up to Month 84 |
| Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Detection was done in subjects who were HPV DNA negative for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus. HRW-HPV= All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR= High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 | Up to Month 48 |
| Number of Subjects With Histopathologically Confirmed Reduction of Local Cervical Therapy | Detection was done on all subjects irrespective of their baseline HPV DNA status. | Up to Month 84 |
| Number of Subjects With First Colposcopy | Detection was done on all subjects irrespective of their baseline HPV DNA status. | Up to Month 84 |
| Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection | Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus. | Up to Month 84 |
| Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus. The lesion was assigned to an HPV type found in the lesion if (1) the same HPV type was found in at least 1 of the 2 (closest) preceding cytology samples, or (2) none of the HPV types found in the lesion were found in any of the 2 preceding cytology samples (isolate HPV types) | Up to Month 84 |
| Aurora |
| Colorado |
| 80045 |
| United States |
| GSK Investigational Site | Golden | Colorado | 80401 | United States |
| GSK Investigational Site | Coral Gables | Florida | 33134 | United States |
| GSK Investigational Site | Miami | Florida | 33136 | United States |
| GSK Investigational Site | Augusta | Georgia | 30912 | United States |
| GSK Investigational Site | Iowa City | Iowa | 52242 | United States |
| GSK Investigational Site | Wichita | Kansas | 67207 | United States |
| GSK Investigational Site | Bardstown | Kentucky | 40004 | United States |
| GSK Investigational Site | Louisville | Kentucky | 40202 | United States |
| GSK Investigational Site | Chaska | Minnesota | 55318 | United States |
| GSK Investigational Site | Omaha | Nebraska | 68131 | United States |
| GSK Investigational Site | Lebanon | New Hampshire | 03756 | United States |
| GSK Investigational Site | Albuquerque | New Mexico | 87131 | United States |
| GSK Investigational Site | Syracuse | New York | 13057 | United States |
| GSK Investigational Site | Chapel Hill | North Carolina | 27514 | United States |
| GSK Investigational Site | New Bern | North Carolina | 28562 | United States |
| GSK Investigational Site | Akron | Ohio | 44311 | United States |
| GSK Investigational Site | Cleveland | Ohio | 44122 | United States |
| GSK Investigational Site | Tulsa | Oklahoma | 74105 | United States |
| GSK Investigational Site | Portland | Oregon | 97210 | United States |
| GSK Investigational Site | Carnegie | Pennsylvania | 15106 | United States |
| GSK Investigational Site | Erie | Pennsylvania | 16507 | United States |
| GSK Investigational Site | Erie | Pennsylvania | 16508 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19107 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15213 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15236 | United States |
| GSK Investigational Site | Wexford | Pennsylvania | 15090 | United States |
| GSK Investigational Site | Austin | Texas | 78705 | United States |
| GSK Investigational Site | Houston | Texas | 77004 | United States |
| GSK Investigational Site | Houston | Texas | 77030 | United States |
| GSK Investigational Site | Salt Lake City | Utah | 84109 | United States |
| GSK Investigational Site | Salt Lake City | Utah | 84121 | United States |
| GSK Investigational Site | South Jordan | Utah | 84095 | United States |
| GSK Investigational Site | Wenatchee | Washington | 98801 | United States |
| GSK Investigational Site | La Crosse | Wisconsin | 54601 | United States |
| GSK Investigational Site | Parkville | Victoria | 3052 | Australia |
| GSK Investigational Site | Perth | Western Australia | Australia |
| GSK Investigational Site | Edmonton | Alberta | T6G 2C8 | Canada |
| GSK Investigational Site | Vancouver | British Columbia | V6H 3N1 | Canada |
| GSK Investigational Site | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| GSK Investigational Site | Truro | Nova Scotia | B2N 1L2 | Canada |
| GSK Investigational Site | Waterloo | Ontario | N2L 6H6 | Canada |
| GSK Investigational Site | Québec | Quebec | G1S 2L6 | Canada |
| GSK Investigational Site | Sherbrooke | Quebec | J1H 1Z1 | Canada |
| GSK Investigational Site | Cuenavaca | Morelos | 62430 | Mexico |
| GSK Investigational Site | Jojutla / Morelos | Mexico |
| GSK Investigational Site | Amsterdam | 1007 MB | Netherlands |
| GSK Investigational Site | Delft | 2625 AD | Netherlands |
| GSK Investigational Site | Rotterdam | 3015 CE | Netherlands |
| GSK Investigational Site | Lima | Peru |
| GSK Investigational Site | Laguna | Philippines |
| GSK Investigational Site | San Pablo | Philippines |
| GSK Investigational Site | Taft Avenue, Manila | 1700 | Philippines |
| GSK Investigational Site | Almada | 2805-267 Almada | Portugal |
| GSK Investigational Site | Coimbra | 3000-075 Coimbra | Portugal |
| GSK Investigational Site | Lisbon | 1200-831 Lisboa | Portugal |
| GSK Investigational Site | Porto | 4200-023 Porto | Portugal |
| GSK Investigational Site | Setúbal | 2910-446 Setúbal | Portugal |
| GSK Investigational Site | Moscow | 109263 | Russia |
| GSK Investigational Site | Moscow | 115 478 | Russia |
| GSK Investigational Site | Moscow | 117997 | Russia |
| GSK Investigational Site | Saint Petersburg | 190020 | Russia |
| GSK Investigational Site | Saint Petersburg | 199034 | Russia |
| GSK Investigational Site | Yekaterinburg | 620073 | Russia |
| GSK Investigational Site | Singapore | 119074 | Singapore |
| GSK Investigational Site | Singapore | 229899 | Singapore |
| GSK Investigational Site | Bangkok | 10400 | Thailand |
| GSK Investigational Site | Bangkok | 10700 | Thailand |
| GSK Investigational Site | Northwood | Middlesex | HA6 2RN | United Kingdom |
| GSK Investigational Site | Aberdeen | AB25 7ZD | United Kingdom |
| GSK Investigational Site | Cardiff | CF14 4XN | United Kingdom |
| GSK Investigational Site | Gateshead | NE9 6SX | United Kingdom |
| GSK Investigational Site | London | EC1M 6BQ | United Kingdom |
| GSK Investigational Site | Manchester | M13 9WL | United Kingdom |
| Skinner SR, Szarewski A, Romanowski B, Garland SM, Lazcano-Ponce E, Salmeron J, Del Rosario-Raymundo MR, Verheijen RH, Quek SC, da Silva DP, Kitchener H, Fong KL, Bouchard C, Money DM, Ilancheran A, Cruickshank ME, Levin MJ, Chatterjee A, Stapleton JT, Martens M, Quint W, David MP, Meric D, Hardt K, Descamps D, Geeraerts B, Struyf F, Dubin G; VIVIANE Study Group. Efficacy, safety, and immunogenicity of the human papillomavirus 16/18 AS04-adjuvanted vaccine in women older than 25 years: 4-year interim follow-up of the phase 3, double-blind, randomised controlled VIVIANE study. Lancet. 2014 Dec 20;384(9961):2213-27. doi: 10.1016/S0140-6736(14)60920-X. Epub 2014 Sep 1. |
| 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. |
| 27373900 | Background | Wheeler CM, Skinner SR, Del Rosario-Raymundo MR, Garland SM, Chatterjee A, Lazcano-Ponce E, Salmeron J, McNeil S, Stapleton JT, Bouchard C, Martens MG, Money DM, Quek SC, Romanowski B, Vallejos CS, Ter Harmsel B, Prilepskaya V, Fong KL, Kitchener H, Minkina G, Lim YKT, Stoney T, Chakhtoura N, Cruickshank ME, Savicheva A, da Silva DP, Ferguson M, Molijn AC, Quint WGV, Hardt K, Descamps D, Suryakiran PV, Karkada N, Geeraerts B, Dubin G, Struyf F; VIVIANE Study Group. Efficacy, safety, and immunogenicity of the human papillomavirus 16/18 AS04-adjuvanted vaccine in women older than 25 years: 7-year follow-up of the phase 3, double-blind, randomised controlled VIVIANE study. Lancet Infect Dis. 2016 Oct;16(10):1154-1168. doi: 10.1016/S1473-3099(16)30120-7. Epub 2016 Jun 28. |
| 27998562 | Background | Wheeler CM, Struyf F; HPV-015 study group. The safety of Cervarix? - Authors' reply. Lancet Infect Dis. 2017 Jan;17(1):20-21. doi: 10.1016/S1473-3099(16)30540-0. No abstract available. |
| 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. |
| 31273942 | Derived | Rosillon D, Baril L, Del Rosario-Raymundo MR, Wheeler CM, Skinner SR, Garland SM, Salmeron J, Lazcano-Ponce E, Vallejos CS, Stoney T, Ter Harmsel B, Lim TYK, Quek SC, Minkina G, McNeil SA, Bouchard C, Fong KL, Money D, Ilancheran A, Savicheva A, Cruickshank M, Chatterjee A, Fiander A, Martens M, Bozonnat MC, Struyf F, Dubin G, Castellsague X. Risk of newly detected infections and cervical abnormalities in adult women seropositive or seronegative for naturally acquired HPV-16/18 antibodies. Cancer Med. 2019 Aug;8(10):4938-4953. doi: 10.1002/cam4.1879. Epub 2019 Jul 5. |
| 26685704 | Derived | Skinner SR, Wheeler CM, Romanowski B, Castellsague X, Lazcano-Ponce E, Del Rosario-Raymundo MR, Vallejos C, Minkina G, Pereira Da Silva D, McNeil S, Prilepskaya V, Gogotadze I, Money D, Garland SM, Romanenko V, Harper DM, Levin MJ, Chatterjee A, Geeraerts B, Struyf F, Dubin G, Bozonnat MC, Rosillon D, Baril L; VIVIANE Study Group. Progression of HPV infection to detectable cervical lesions or clearance in adult women: Analysis of the control arm of the VIVIANE study. Int J Cancer. 2016 May 15;138(10):2428-38. doi: 10.1002/ijc.29971. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 104820 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104820 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104820 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104820 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104820 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule. |
| Participated up to Month 48 |
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| COMPLETED |
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| NOT COMPLETED |
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| Month 84 |
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|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cervarix Group | Subjects received 3 doses of Cervarixâ„¢ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule. |
| BG001 | Aluminium Hydroxide Group | Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | CIN1+ = CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Persistent HPV infection = detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.
| The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded. | Posted | Count of Participants | Participants | Up to Month 48 |
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| Primary | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | CIN1+ = CIN grades 1, 2 and 3, AIS and invasive cervical cancer. Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.
| The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded. | Posted | Count of Participants | Participants | Up to Month 48 |
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| Primary | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | CIN1+ = CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Persistent HPV infection = detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. - DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and 6 and seronegative/positive (sero-/+) at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) - Overall: subjects DNA- at Month 0 and 6 for the corresponding HPV-type, regardless of initial serostatus | The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded. | Posted | Count of Participants | Participants | Up to Month 84 |
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| Primary | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | CIN1+ = CIN grades 1, 2 and 3, AIS and invasive cervical cancer. Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. - DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. | The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded. | Posted | Count of Participants | Participants | Up to Month 84 |
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| Secondary | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Detection was done in:
| The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded. | Posted | Count of Participants | Participants | Up to Month 48 |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | Persistent cervical HPV infection (12-month definition) was defined as the detection of the same HPV type(s) PCR in cervical samples at all available time points over approximately a 12-month interval (evaluations are planned at approximately 6-month intervals).
| The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded. | Posted | Count of Participants | Participants | Up to Month 48 |
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| Secondary | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Detection was done in subjects HPV DNA- for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus. HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18. HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. | The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded. | Posted | Count of Participants | Participants | Up to Month 48 |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | Persistent HPV infection (12-month definition) = detection of the same HPV type(s) by PCR in cervical samples at available time points over approximately a 12-month interval (evaluations are planned at approximately 6-month intervals). Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. subjects HPV DNA- for the corresponding HPV type at Month 0 6, regardless of initial serostatus. HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 , 68 | The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded. | Posted | Count of Participants | Participants | Up to Month 48 |
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| Secondary | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | CIN2+ was defined as CIN grades 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in:
Note: Results for seropositive status were not analysed. | The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded. | Posted | Count of Participants | Participants | Up to Month 48 |
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| Secondary | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in:
| The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded. | Posted | Count of Participants | Participants | Up to Month 48 |
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| Secondary | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus. | The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | Up to Month 48 |
|
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| Secondary | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Irrespective of HPV Cervical Infection and Irrespective of Baseline HPV DNA Status | CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on all subjects irrespective of their baseline HPV DNA status. | The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | Up to Month 48 |
|
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| Secondary | Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection | Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US). Detection was done in:
Results for seropositive status were not analysed. | The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded. | Posted | Count of Participants | Participants | Up to Month 48 |
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| Secondary | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Detection was done in subjects who were HPV DNA negative for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus. HRW-HPV= All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR= High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 | The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded. | Posted | Count of Participants | Participants | Up to Month 48 |
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| Secondary | Number of Subjects With Histopathologically Confirmed Reduction of Local Cervical Therapy | Detection was done on all subjects irrespective of their baseline HPV DNA status. | The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | Up to Month 48 |
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| Secondary | Number of Subjects With First Colposcopy | Detection was done on all subjects irrespective of their baseline HPV DNA status. | The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | Up to Month 48 |
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| Secondary | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection | Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus. | The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | Up to Month 48 |
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| Secondary | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus. The lesion was assigned to an HPV type found in the lesion if (1) the same HPV type was found in at least 1 of the 2 (closest) preceding cytology samples, or (2) none of the HPV types found in the lesion were found in any of the 2 preceding cytology samples (isolate HPV types) | The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | Up to Month 48 |
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| Secondary | Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | Seroconversion was defined as the appearance of antibodies (i.e.; titre greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. HPV-16 assay cut-off value was defined as greater than or equal to 8 ELISA units per millilitre (EL.U/mL). Seronegative (Sero-) subjects are subjects who had an antibody concentration below 8 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 8 EL.U/mL prior to vaccination. Immuno subset=subjects from selected sites N≥1000, at least 250 per region | The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included. | Posted | Count of Participants | Participants | At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84 |
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| Secondary | Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | Seroconversion was defined as the appearance of antibodies (i.e.; titre greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. HPV-18 assay cut-off value was defined as greater than or equal to 7 ELISA units per millilitre (EL.U/mL). Seronegative (Sero-) subjects are subjects who had an antibody concentration below 7 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 7 EL.U/mL prior to vaccination. Immuno subset=subjects from selected sites N≥1000, at least 250 per region | The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included. | Posted | Count of Participants | Participants | At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84 |
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| Secondary | Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | GMCs were expressed in ELISA units per milliliter (EL.U/mL). Seronegative (Sero-) subjects are subjects who had an antibody concentration below 8 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 8 EL.U/mL prior to vaccination. Immuno subset=subjects from selected sites (N≥1000, at least 250 per region) | The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84 |
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| Secondary | Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | GMCs were expressed in ELISA units per milliliter (EL.U/mL). Seronegative (Sero-) subjects are subjects who had an antibody concentration below 7 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 7 EL.U/mL prior to vaccination. Immuno subset=subjects from selected sites (N≥1000, at least 250 per region) | The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84 |
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| Secondary | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | Seroconversion was defined as the appearance of antibodies (i.e.; titre greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. HPV-16/18 assay cut-off value was defined as greater than or equal to 40 Estimated dose 50% (ED50). Sero- subjects are subjects who had an antibody concentration below 40 ED50 prior to vaccination. Sero+ subjects are subjects who had an antibody concentration equal to or above 50 ED50 prior to vaccination. ED50 = the estimated serum dilution reducing the signal generated by viral infection by 50% | The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included. | Posted | Count of Participants | Participants | Prior to vaccination and at Months 7, 12, 18, 24, 48 and 84. |
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| Secondary | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | Titers are expressed as geometric mean antibody titers (GMTs). Seronegative (Sero-) subjects are subjects who had an antibody titer below 40 ED50 prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody titer equal to or above 40 ED50 prior to vaccination. ED50 = Estimated dose 50%, the estimated serum dilution reducing the signal generated by viral infection by 50% | The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Prior to vaccination and at Months 7, 12, 18, 24, 48 and 84. |
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| 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 was defined as redness/swelling above 50 millimeter (mm). | The Total Vaccinated cohort included all subjects with at least one vaccine administration documented and symptom sheets completed. | Posted | Count of Participants | Participants | Within 7 days (Days 0-6) after vaccination |
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| 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 (Fever = axillary temperature above 37.5 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = axillary temperature above 39.0°C. | The Total Vaccinated cohort included all subjects with at least one vaccine administration documented and symptom sheets completed. | Posted | Count of Participants | Participants | Within 7 days (Days 0-6) after vaccination |
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| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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. Grade 3 unsolicited AE = an event that prevented normal activity. A related AE = event assessed by the investigator as causally related to the study vaccination. | The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | Within 30 days (Days 0 - 29) post-vaccination period. |
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| Secondary | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs). | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. A related SAE was defined as an event assessed by the investigator as causally related to the study vaccination. | The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | Up to Month 48 and up to Month 84 |
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| Secondary | Number of Subjects Reporting Related or Fatal Serious Adverse Event. | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | Up to Month 84 |
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| Secondary | Number of Subjects Reporting Any AE/SAE Leading to Premature Discontinuation of the Study. | 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. Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | Up to Month 84 |
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| Secondary | Number of Subjects Reporting New Onset of Chronic Disease (NOCDs). | NOCDs include autoimmune disorders, asthma and type I diabetes. | The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | Up to Month 48 |
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| Secondary | Number of Subjects Reporting New Onset of Autoimmune Disease (NOADs). | The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | Up to Month 48 |
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| Secondary | Number of Subjects Reporting Medically Significant Conditions (MAEs). | Medically significant conditions were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury. | The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | Up to Month 48 |
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| Secondary | Number of Subjects With Pregnancies and Their Outcomes. | Pregnancy outcomes are live infant, premature live infant, elective termination, ectopic pregnancy, spontaneous abortion, lost to follow-up and pregnancy ongoing. For each category it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA). | The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | Up to Month 48 |
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| Secondary | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the Type Assignment Algorithm (TAA) | CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. TAA: Type assignment algorithm. The lesion was assigned to an HPV type found in the lesion if
| The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded. | Posted | Count of Participants | Participants | Up to Month 48 |
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| Secondary | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Detection was done in: - DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. | The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded. | Posted | Count of Participants | Participants | Up to Month 84 |
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| Secondary | Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | Persistent cervical HPV infection (12-month definition) was defined as the detection of the same HPV type(s) PCR in cervical samples at all available time points over approximately a 12-month interval (evaluations are planned at approximately 6-month intervals). - DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. | The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded. | Posted | Count of Participants | Participants | Up to Month 84 |
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| Secondary | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Detection was done in subjects HPV DNA- for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus. HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18. HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. | The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded. | Posted | Count of Participants | Participants | Up to Month 84 |
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| Secondary | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. subjects HPV DNA- for the corresponding HPV type at Month 0 6, regardless of initial serostatus. HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 , 68 | The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded. | Posted | Count of Participants | Participants | Up to Month 84 |
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| Secondary | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | CIN2+ was defined as CIN grades 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in: - DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. Note: Results for seropositive status were not analysed. | The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded. | Posted | Count of Participants | Participants | Up to Month 84 |
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| Secondary | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in: - DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. | The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded. | Posted | Count of Participants | Participants | Up to Month 84 |
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| Secondary | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | Up to Month 84 |
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| Secondary | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Irrespective of HPV Cervical Infection and Irrespective of Baseline HPV DNA Status | CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on all subjects irrespective of their baseline HPV DNA status. | The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | Up to Month 84 |
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| Secondary | Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection | Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US). Detection was done in: - DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. Results for seropositive status were not analysed. | The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded. | Posted | Count of Participants | Participants | Up to Month 84 |
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| Secondary | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Detection was done in subjects who were HPV DNA negative for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus. HRW-HPV= All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR= High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 | The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded. | Posted | Count of Participants | Participants | Up to Month 48 |
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| Secondary | Number of Subjects With Histopathologically Confirmed Reduction of Local Cervical Therapy | Detection was done on all subjects irrespective of their baseline HPV DNA status. | The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | Up to Month 84 |
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| Secondary | Number of Subjects With First Colposcopy | Detection was done on all subjects irrespective of their baseline HPV DNA status. | The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | Up to Month 84 |
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| Secondary | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection | Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus. | The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | Up to Month 84 |
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| Secondary | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus. The lesion was assigned to an HPV type found in the lesion if (1) the same HPV type was found in at least 1 of the 2 (closest) preceding cytology samples, or (2) none of the HPV types found in the lesion were found in any of the 2 preceding cytology samples (isolate HPV types) | The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | Up to Month 84 |
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SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
Not provided
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 Cervarixâ„¢ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule. | 291 | 2,881 | 2,543 | 2,881 | ||
| EG001 | Aluminium Hydroxide Group | Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule. | 269 | 2,871 | 2,236 | 2,871 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abortion spontaneous complete | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Abortion spontaneous incomplete | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Appendicitis | Infections and infestations | Non-systematic Assessment |
| ||
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Abortion missed | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Cholelithiasis | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Blighted ovum | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Abortion threatened | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Ovarian cyst | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Dengue fever | Infections and infestations | Non-systematic Assessment |
| ||
| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Pyelonephritis | Infections and infestations | Non-systematic Assessment |
| ||
| Hypertension | Vascular disorders | Non-systematic Assessment |
| ||
| Suicide attempt | Psychiatric disorders | Non-systematic Assessment |
| ||
| Uterine polyp | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Cholecystitis | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Nephrolithiasis | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Cholecystitis chronic | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Menorrhagia | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Post procedural haemorrhage | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Premature labour | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pyelonephritis acute | Infections and infestations | Non-systematic Assessment |
| ||
| Ankle fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Calculus ureteric | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Depression | Psychiatric disorders | Non-systematic Assessment |
| ||
| Drug hypersensitivity | Immune system disorders | Non-systematic Assessment |
| ||
| Dysfunctional uterine bleeding | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Endometriosis | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Gastritis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastrooesophageal reflux disease | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Ligament rupture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Ovarian adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Road traffic accident | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Ruptured ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Vertigo | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Abdominal pain lower | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Angina unstable | Cardiac disorders | Non-systematic Assessment |
| ||
| Arrested labour | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Bartholin's cyst | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Bronchitis | Infections and infestations | Non-systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Diarrhoea infectious | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Foot fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Gestational hypertension | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Goitre | Endocrine disorders | Non-systematic Assessment |
| ||
| Haemorrhoids | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Lower respiratory tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Salpingitis | Infections and infestations | Non-systematic Assessment |
| ||
| Sinus bradycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Migraine | Nervous system disorders | Non-systematic Assessment |
| ||
| Convulsion | Nervous system disorders | Non-systematic Assessment |
| ||
| Osteoarthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Cholecystitis acute | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Completed suicide | Psychiatric disorders | Non-systematic Assessment |
| ||
| Obesity | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Anaphylactic reaction | Immune system disorders | Non-systematic Assessment |
| ||
| Asthmatic crisis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Bipolar disorder | Psychiatric disorders | Non-systematic Assessment |
| ||
| Bronchopneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Hiatus hernia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Ileus | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Intestinal obstruction | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Major depression | Psychiatric disorders | Non-systematic Assessment |
| ||
| Meniscus injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Ovarian cyst torsion | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Premature delivery | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Non-systematic Assessment |
| ||
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Abortion complete | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Abortion induced | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Abscess | Infections and infestations | Non-systematic Assessment |
| ||
| Acute myocardial infarction | Cardiac disorders | Non-systematic Assessment |
| ||
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Addison's disease | Endocrine disorders | Non-systematic Assessment |
| ||
| Adenocarcinoma of the cervix | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Adenoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Adenomyosis | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Adnexal torsion | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Alcohol poisoning | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Altered state of consciousness | Nervous system disorders | Non-systematic Assessment |
| ||
| Amniotic cavity infection | Infections and infestations | Non-systematic Assessment |
| ||
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Anaesthetic complication pulmonary | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Anaplastic astrocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Angina pectoris | Cardiac disorders | Non-systematic Assessment |
| ||
| Angle closure glaucoma | Eye disorders | Non-systematic Assessment |
| ||
| Anorexia nervosa | Psychiatric disorders | Non-systematic Assessment |
| ||
| Arteriosclerosis | Vascular disorders | Non-systematic Assessment |
| ||
| Arthritis reactive | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Arthropod sting | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Atypical pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Autoimmune thyroiditis | Endocrine disorders | Non-systematic Assessment |
| ||
| Bartholinitis | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Basal ganglia haemorrhage | Nervous system disorders | Non-systematic Assessment |
| ||
| Basedow's disease | Endocrine disorders | Non-systematic Assessment |
| ||
| Bone fissure | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Brain contusion | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Breast cancer female | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Breast cancer stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Bronchogenic cyst | Congenital, familial and genetic disorders | Non-systematic Assessment |
| ||
| Burn infection | Infections and infestations | Non-systematic Assessment |
| ||
| Calculus bladder | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Cardiac arrest | Cardiac disorders | Non-systematic Assessment |
| ||
| Cardiac valve disease | Cardiac disorders | Non-systematic Assessment |
| ||
| Cardio-respiratory arrest | Cardiac disorders | Non-systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Non-systematic Assessment |
| ||
| Cerebral cyst | Nervous system disorders | Non-systematic Assessment |
| ||
| Cerebral ischaemia | Nervous system disorders | Non-systematic Assessment |
| ||
| Cerebrovascular accident | Nervous system disorders | Non-systematic Assessment |
| ||
| Cervix cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Chest pain | General disorders | Non-systematic Assessment |
| ||
| Chlamydial infection | Infections and infestations | Non-systematic Assessment |
| ||
| Cholesterosis | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Chronic gastritis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Chronic myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Chronic tonsillitis | Infections and infestations | Non-systematic Assessment |
| ||
| Clostridium difficile colitis | Infections and infestations | Non-systematic Assessment |
| ||
| Colitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Colitis ulcerative | Immune system disorders | Non-systematic Assessment |
| ||
| Colpocele | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Concussion | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Contusion | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Conversion disorder | Psychiatric disorders | Non-systematic Assessment |
| ||
| Costochondritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Cyst | General disorders | Non-systematic Assessment |
| ||
| Cystitis klebsiella | Infections and infestations | Non-systematic Assessment |
| ||
| Depression suicidal | Psychiatric disorders | Non-systematic Assessment |
| ||
| Diabetic coma | Nervous system disorders | Non-systematic Assessment |
| ||
| Diverticulitis | Infections and infestations | Non-systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Non-systematic Assessment |
| ||
| Duodenal ulcer | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dysmenorrhoea | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Endometrial hyperplasia | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Endosalpingiosis | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Enteritis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Enterocolitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Epiploic appendagitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Escherichia urinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Fibroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Fibula fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Foetal death | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Foot deformity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Gastric ulcer | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastric ulcer perforation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastritis erosive | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Genital prolapse | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Genitourinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Glioblastoma multiforme | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Haematemesis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Haematochezia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Haemorrhage in pregnancy | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Haemorrhoids thrombosed | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Head injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Hepatitis C | Infections and infestations | Non-systematic Assessment |
| ||
| Herpes virus infection | Infections and infestations | Non-systematic Assessment |
| ||
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Homicide | Social circumstances | Non-systematic Assessment |
| ||
| Hydronephrosis | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Hyperemesis gravidarum | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Hypersensitivity | Immune system disorders | Non-systematic Assessment |
| ||
| Hypertensive crisis | Vascular disorders | Non-systematic Assessment |
| ||
| Hypertensive heart disease | Cardiac disorders | Non-systematic Assessment |
| ||
| Ileus paralytic | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Ill-defined disorder | General disorders | Non-systematic Assessment |
| ||
| Impaired gastric emptying | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Incarcerated hernia | General disorders | Non-systematic Assessment |
| ||
| Incisional hernia | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Inguinal hernia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Intracranial aneurysm | Nervous system disorders | Non-systematic Assessment |
| ||
| Intracranial haematoma | Nervous system disorders | Non-systematic Assessment |
| ||
| Irritable bowel syndrome | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Ischaemic stroke | Nervous system disorders | Non-systematic Assessment |
| ||
| Jaundice | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Joint dislocation | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Joint instability | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Liposarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Liver disorder | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Lupus-like syndrome | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Lyme disease | Infections and infestations | Non-systematic Assessment |
| ||
| Macular oedema | Eye disorders | Non-systematic Assessment |
| ||
| Mediastinum neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Menometrorrhagia | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Metrorrhagia | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Microcytic anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Monoparesis | Nervous system disorders | Non-systematic Assessment |
| ||
| Multiple fractures | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Nasal cyst | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Nasal disorder | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Nasopharyngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
| ||
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Oedema | General disorders | Non-systematic Assessment |
| ||
| Oedema peripheral | General disorders | Non-systematic Assessment |
| ||
| Oedematous pancreatitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Opisthorchiasis | Infections and infestations | Non-systematic Assessment |
| ||
| Ovarian germ cell teratoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Ovarian neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Overdose | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Pancreatitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Pancreatitis acute | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Paronychia | Infections and infestations | Non-systematic Assessment |
| ||
| Pasteurella infection | Infections and infestations | Non-systematic Assessment |
| ||
| Patella fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Pelvic abscess | Infections and infestations | Non-systematic Assessment |
| ||
| Pelvic inflammatory disease | Infections and infestations | Non-systematic Assessment |
| ||
| Pelvic prolapse | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Periostitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Peritonsillar abscess | Infections and infestations | Non-systematic Assessment |
| ||
| Pharyngitis | Infections and infestations | Non-systematic Assessment |
| ||
| Pilonidal cyst | Infections and infestations | Non-systematic Assessment |
| ||
| Pituitary tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Placenta accreta | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Placental transfusion syndrome | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pneumonia bacterial | Infections and infestations | Non-systematic Assessment |
| ||
| Pneumonia mycoplasmal | Infections and infestations | Non-systematic Assessment |
| ||
| Pneumonia streptococcal | Infections and infestations | Non-systematic Assessment |
| ||
| Polycystic ovaries | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Polymyalgia rheumatica | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Post lumbar puncture syndrome | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Post procedural haematoma | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Post procedural infection | Infections and infestations | Non-systematic Assessment |
| ||
| Postpartum haemorrhage | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Premature rupture of membranes | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Psychotic disorder | Psychiatric disorders | Non-systematic Assessment |
| ||
| Pulmonary tuberculosis | Infections and infestations | Non-systematic Assessment |
| ||
| Pyloric stenosis | Congenital, familial and genetic disorders | Non-systematic Assessment |
| ||
| Pyonephrosis | Infections and infestations | Non-systematic Assessment |
| ||
| Pyrexia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Radius fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Renal abscess | Infections and infestations | Non-systematic Assessment |
| ||
| Renal colic | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Renal failure acute | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Renal oncocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Retained products of conception | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Retinal vein thrombosis | Eye disorders | Non-systematic Assessment |
| ||
| Rib fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Sarcoidosis | Immune system disorders | Non-systematic Assessment |
| ||
| Sedation | Nervous system disorders | Non-systematic Assessment |
| ||
| Sepsis | Infections and infestations | Non-systematic Assessment |
| ||
| Sinus disorder | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Skull fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Small intestinal obstruction | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Spinal compression fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Splenic infarction | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Stillbirth | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Stress cardiomyopathy | Cardiac disorders | Non-systematic Assessment |
| ||
| Suicidal ideation | Psychiatric disorders | Non-systematic Assessment |
| ||
| Supraventricular tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Synovial cyst | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Synovitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Tendon injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Tendon rupture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Tenosynovitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Tension headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Teratoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Thermal burn | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Threatened labour | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Thyroid cyst | Endocrine disorders | Non-systematic Assessment |
| ||
| Tibia fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Tonsillitis | Infections and infestations | Non-systematic Assessment |
| ||
| Tooth abscess | Infections and infestations | Non-systematic Assessment |
| ||
| Tooth impacted | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Toxicity to various agents | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Trigeminal neuralgia | Nervous system disorders | Non-systematic Assessment |
| ||
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Typhoid fever | Infections and infestations | Non-systematic Assessment |
| ||
| Ulnar nerve injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Umbilical hernia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Ureteric obstruction | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Ureteric stenosis | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Urinary retention | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Urinary retention postoperative | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Uterine atony | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Uterine cyst | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Uterine prolapse | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Uterovaginal prolapse | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Vaginal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Vaginal haemorrhage | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Vaginal prolapse | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Vertebral artery dissection | Nervous system disorders | Non-systematic Assessment |
| ||
| Vertigo positional | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Vestibular neuronitis | Infections and infestations | Non-systematic Assessment |
| ||
| Wound | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Pharyngotonsillitis | Infections and infestations | Non-systematic Assessment |
| ||
| Postoperative abscess | Infections and infestations | Non-systematic Assessment |
| ||
| Prolonged labour | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Ligament sprain | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Viral infection | Infections and infestations | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Redness | General disorders | Systematic Assessment |
| ||
| Swelling | General disorders | Systematic Assessment |
| ||
| Arthralgia | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Fever | General disorders | Systematic Assessment |
| ||
| Gastrointestinal | General disorders | Systematic Assessment |
| ||
| Headache | General disorders | Systematic Assessment |
| ||
| Myalgia | General disorders | Systematic Assessment |
| ||
| Rash | General disorders | Systematic Assessment |
| ||
| Urticaria | General disorders | 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 |
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| C510352 | human papillomavirus vaccine, L1 type 16, 18 |
Not provided
Not provided
Not provided
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Absent Cervix |
|
| Work related reasons |
|
| Center closed, subject did not transfer |
|
| Family problems |
|
| Lack of time |
|
| Personal reason |
|
| Subject does not want male physician |
|
| Transport reimbursement delayed |
|
| Unable to reach study site |
|
| Under investigation locally |
|
| Visit missed |
|
| No consent for Month 84 Follow-up |
|
| Male |
|
| HPV-16, DNA- and sero- subjects |
|
|
| HPV-18, DNA- and sero- subjects |
|
|
| HPV-16/18, DNA- and sero+ subjects |
|
|
| HPV-16, DNA- and sero+ subjects |
|
|
| HPV-18, DNA- and sero+ subjects |
|
|
| HPV-16/18, overall |
|
|
| HPV-16, overall |
|
|
| HPV-18, overall |
|
|
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule. |
|
|
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|
|
|
|
|
|
|
|
|
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
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