Trial Outcomes & Findings for Gynaecological Follow-up of a Subset of 580299/008 (NCT00122681) Study Subjects (NCT NCT00937950)
NCT ID: NCT00937950
Last Updated: 2019-10-29
Results Overview
Subjects who presented oncogenic HPV DNA in cervical samples by HPV DNA testing. The presence of oncogenic HPV infection was determined by the Hybrid Capture 2 (HCII) test, which detects HPV DNA types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68. Missing = For some of the subjects whose result was indicated as quantity not sufficient (QNS).
COMPLETED
PHASE3
2022 participants
At Months 12, 24, 36, 48
2019-10-29
Participant Flow
Out of the 2022 subjects enrolled in this study, 19 were excluded for reasons of non-eligibility, hence only 2003 started the study.
Participant milestones
| Measure |
HPV-052 Study Subjects Group
The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit.
|
|---|---|
|
Overall Study
STARTED
|
2003
|
|
Overall Study
COMPLETED
|
1787
|
|
Overall Study
NOT COMPLETED
|
216
|
Reasons for withdrawal
| Measure |
HPV-052 Study Subjects Group
The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
23
|
|
Overall Study
Migrated/moved from study area
|
27
|
|
Overall Study
Lost to Follow-up
|
144
|
|
Overall Study
Missing confirmed
|
4
|
|
Overall Study
Other
|
18
|
Baseline Characteristics
Gynaecological Follow-up of a Subset of 580299/008 (NCT00122681) Study Subjects
Baseline characteristics by cohort
| Measure |
HPV-052 Study Subjects Group
n=2003 Participants
The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit.
|
|---|---|
|
Age, Continuous
|
24.3 Years
STANDARD_DEVIATION 3.06 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2003 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
58 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White/Caucasian
|
1211 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Arabic/north African
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · East & south east Asian
|
549 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · South Asian
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Hispanic
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Chinese
|
106 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Indian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Not specified
|
50 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Months 12, 24, 36, 48Population: The analysis was based on the Total HPV-052 cohort, which included subjects with available data at the considered time points and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.
Subjects who presented oncogenic HPV DNA in cervical samples by HPV DNA testing. The presence of oncogenic HPV infection was determined by the Hybrid Capture 2 (HCII) test, which detects HPV DNA types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68. Missing = For some of the subjects whose result was indicated as quantity not sufficient (QNS).
Outcome measures
| Measure |
HPV-052 Study Subjects Group
n=1467 Participants
The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit.
|
|---|---|
|
Number of Subjects With HPV DNA in Cervical Samples by Hybrid Capture 2 Test (HCII)
Positive DNA (Month 12 Post HPV-008)
|
615 Participants
|
|
Number of Subjects With HPV DNA in Cervical Samples by Hybrid Capture 2 Test (HCII)
Negative DNA (Month 12 Post HPV-008)
|
828 Participants
|
|
Number of Subjects With HPV DNA in Cervical Samples by Hybrid Capture 2 Test (HCII)
Missing DNA (Month 12 Post HPV-008)
|
24 Participants
|
|
Number of Subjects With HPV DNA in Cervical Samples by Hybrid Capture 2 Test (HCII)
Positive DNA (Month 24 Post HPV-008)
|
418 Participants
|
|
Number of Subjects With HPV DNA in Cervical Samples by Hybrid Capture 2 Test (HCII)
Negative DNA (Month 24 Post HPV-008)
|
444 Participants
|
|
Number of Subjects With HPV DNA in Cervical Samples by Hybrid Capture 2 Test (HCII)
Missing DNA (Month 24 Post HPV-008)
|
7 Participants
|
|
Number of Subjects With HPV DNA in Cervical Samples by Hybrid Capture 2 Test (HCII)
Positive DNA (Month 36 Post HPV-008)
|
255 Participants
|
|
Number of Subjects With HPV DNA in Cervical Samples by Hybrid Capture 2 Test (HCII)
Negative DNA (Month 36 Post HPV-008)
|
236 Participants
|
|
Number of Subjects With HPV DNA in Cervical Samples by Hybrid Capture 2 Test (HCII)
Missing DNA (Month 36 Post HPV-008)
|
4 Participants
|
|
Number of Subjects With HPV DNA in Cervical Samples by Hybrid Capture 2 Test (HCII)
Positive DNA (Month 48 Post HPV-008)
|
144 Participants
|
|
Number of Subjects With HPV DNA in Cervical Samples by Hybrid Capture 2 Test (HCII)
Negative DNA (Month 48 Post HPV-008)
|
107 Participants
|
|
Number of Subjects With HPV DNA in Cervical Samples by Hybrid Capture 2 Test (HCII)
Missing DNA (Month 48 Post HPV-008)
|
7 Participants
|
PRIMARY outcome
Timeframe: At Months 12, 24, 36, 48Population: The analysis was based on the Total HPV-052 cohort, which included subjects with available data at the considered time points and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.
Subjects with normal cervical cytology, who were found to be oncogenic HPV DNA positive in two subsequent tests, were referred to colposcopy. The result of the subjects' last HPV-008 study visit was taken into account at Visit 1. Subjects with a single cervical cytology reading of ≥ atypical squamous cells of undetermined significance (ASC-US) positive for oncogenic HPV DNA were referred for colposcopy. Subjects with a single cervical cytology reading of ≥ low grade squamous intraepithelial lesion (LSIL) were referred to colposcopy, irrespective of their oncogenic HPV DNA test result.
Outcome measures
| Measure |
HPV-052 Study Subjects Group
n=2003 Participants
The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit.
|
|---|---|
|
Number of Subjects With Colposcopy Referral and Colposcopy Adequacy
Colposcopy referral (Month 12) Yes
|
572 Participants
|
|
Number of Subjects With Colposcopy Referral and Colposcopy Adequacy
Colposcopy referral (Month 12) No
|
1429 Participants
|
|
Number of Subjects With Colposcopy Referral and Colposcopy Adequacy
Colposcopy referral (Month 12) Missing
|
2 Participants
|
|
Number of Subjects With Colposcopy Referral and Colposcopy Adequacy
Algorithm respected (Month 12) Yes
|
371 Participants
|
|
Number of Subjects With Colposcopy Referral and Colposcopy Adequacy
Algorithm respected (Month 12) No
|
21 Participants
|
|
Number of Subjects With Colposcopy Referral and Colposcopy Adequacy
Colposcopy adequacy (Month12),Satisfactory
|
370 Participants
|
|
Number of Subjects With Colposcopy Referral and Colposcopy Adequacy
Colposcopy adequacy (Month12), Unsatisfactory
|
18 Participants
|
|
Number of Subjects With Colposcopy Referral and Colposcopy Adequacy
Colposcopy adequacy (Month 12), Missing
|
4 Participants
|
|
Number of Subjects With Colposcopy Referral and Colposcopy Adequacy
Colposcopy referral (Month 24) Yes
|
385 Participants
|
|
Number of Subjects With Colposcopy Referral and Colposcopy Adequacy
Colposcopy referral (Month 24) No
|
1615 Participants
|
|
Number of Subjects With Colposcopy Referral and Colposcopy Adequacy
Colposcopy referral (Month 24) Missing
|
3 Participants
|
|
Number of Subjects With Colposcopy Referral and Colposcopy Adequacy
Algorithm respected (Month 24) Yes
|
254 Participants
|
|
Number of Subjects With Colposcopy Referral and Colposcopy Adequacy
Algorithm respected (Month 24) No
|
8 Participants
|
|
Number of Subjects With Colposcopy Referral and Colposcopy Adequacy
Algorithm respected (Month 24) Missing
|
1 Participants
|
|
Number of Subjects With Colposcopy Referral and Colposcopy Adequacy
Colposcopy adequacy (Month24), Satisfactory
|
245 Participants
|
|
Number of Subjects With Colposcopy Referral and Colposcopy Adequacy
Colposcopy adequacy(Month24),Unsatisfactory
|
14 Participants
|
|
Number of Subjects With Colposcopy Referral and Colposcopy Adequacy
Colposcopy adequacy (Month 24), Missing
|
4 Participants
|
|
Number of Subjects With Colposcopy Referral and Colposcopy Adequacy
Colposcopy referral (Month 36) Yes
|
224 Participants
|
|
Number of Subjects With Colposcopy Referral and Colposcopy Adequacy
Colposcopy referral (Month 36) No
|
1776 Participants
|
|
Number of Subjects With Colposcopy Referral and Colposcopy Adequacy
Colposcopy referral (Month 36) Missing
|
3 Participants
|
|
Number of Subjects With Colposcopy Referral and Colposcopy Adequacy
Algorithm respected (Month 36) Yes
|
154 Participants
|
|
Number of Subjects With Colposcopy Referral and Colposcopy Adequacy
Algorithm respected (Month 36) No
|
4 Participants
|
|
Number of Subjects With Colposcopy Referral and Colposcopy Adequacy
Colposcopy adequacy (Month36), Satisfactory
|
150 Participants
|
|
Number of Subjects With Colposcopy Referral and Colposcopy Adequacy
Colposcopy adequacy(Month36), Unsatisfactory
|
7 Participants
|
|
Number of Subjects With Colposcopy Referral and Colposcopy Adequacy
Colposcopy adequacy (Month 36), Missing
|
1 Participants
|
|
Number of Subjects With Colposcopy Referral and Colposcopy Adequacy
Colposcopy referral (Month 48) Yes
|
133 Participants
|
|
Number of Subjects With Colposcopy Referral and Colposcopy Adequacy
Colposcopy referral (Month 48) No
|
1867 Participants
|
|
Number of Subjects With Colposcopy Referral and Colposcopy Adequacy
Colposcopy referral (Month 48) Missing
|
3 Participants
|
|
Number of Subjects With Colposcopy Referral and Colposcopy Adequacy
Algorithm respected (Month 48) Yes
|
96 Participants
|
|
Number of Subjects With Colposcopy Referral and Colposcopy Adequacy
Algorithm respected (Month 48) No
|
0 Participants
|
|
Number of Subjects With Colposcopy Referral and Colposcopy Adequacy
Colposcopy adequacy (Month48), Satisfactory
|
92 Participants
|
|
Number of Subjects With Colposcopy Referral and Colposcopy Adequacy
Colposcopy adequacy (Month48), Unsatisfactory
|
3 Participants
|
|
Number of Subjects With Colposcopy Referral and Colposcopy Adequacy
Colposcopy adequacy (Month 48), Missing
|
1 Participants
|
PRIMARY outcome
Timeframe: At Months 12, 24, 36, 48Population: The analysis was based on the Total HPV-052 cohort, which included subjects with available data at the considered time points and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.
Subjects who presented normal, ASC-US (Atypical Squamous Cell of Undetermined Significance), LSIL (Low-grade Squamous Intraepithelial Lesions), HSIL (High-grade Squamous Intraepithelial Lesions), AGC (Atypical Glandular Cells), ASC-H (Atypical Squamous Cells cannot exclude HSIL) cervical cytology. Cervical cytology examination was performed using the ThinPrep PapTest. Note: One subject may have presented with different cytology results at the yearly visit throughout the maximum 4-year follow-up period and therefore may be counted in more than one result category in the analysis.
Outcome measures
| Measure |
HPV-052 Study Subjects Group
n=1467 Participants
The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit.
|
|---|---|
|
Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest
Normal, Month 12
|
1193 Participants
|
|
Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest
ASC-US, Month 12
|
154 Participants
|
|
Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest
ASC-H, Month 12
|
8 Participants
|
|
Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest
LSIL, Month 12
|
100 Participants
|
|
Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest
HSIL, Month 12
|
8 Participants
|
|
Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest
AGC, Month 12
|
4 Participants
|
|
Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest
Normal, Month 24
|
662 Participants
|
|
Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest
ASC-US, Month 24
|
117 Participants
|
|
Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest
ASC-H, Month 24
|
11 Participants
|
|
Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest
LSIL, Month 24
|
68 Participants
|
|
Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest
HSIL, Month 24
|
7 Participants
|
|
Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest
AGC, Month 24
|
2 Participants
|
|
Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest
Normal, Month 36
|
390 Participants
|
|
Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest
ASC-US, Month 36
|
58 Participants
|
|
Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest
ASC-H, Month 36
|
4 Participants
|
|
Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest
LSIL, Month 36
|
34 Participants
|
|
Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest
HSIL, Month 36
|
5 Participants
|
|
Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest
AGC, Month 36
|
3 Participants
|
|
Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest
Normal, Month 48
|
206 Participants
|
|
Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest
ASC-US, Month 48
|
28 Participants
|
|
Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest
ASC-H, Month 48
|
0 Participants
|
|
Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest
LSIL, Month 48
|
16 Participants
|
|
Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest
HSIL, Month 48
|
6 Participants
|
|
Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest
AGC, Month 48
|
2 Participants
|
PRIMARY outcome
Timeframe: At Month 12Population: The analysis was based on the Total HPV-052 cohort, which included subjects for whom data were available at the considered time point and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.
Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other. CIN = Cervical intraepithelial neoplasia. CIN1/CIN2/CIN3 = Cervical intraepithelial neoplasia grade 1/grade 2/grade 3. Note: Only CIN1/Only CIN2/Only CIN3 categories contain the subject who has only CIN1/CIN2/CIN3, but not the combinations.
Outcome measures
| Measure |
HPV-052 Study Subjects Group
n=199 Participants
The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit.
|
|---|---|
|
Number of Subjects With Cervical Biopsy Results at Month 12
Negative
|
76 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 12
Only CIN1(positive)
|
41 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 12
Only CIN1(negative)
|
158 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 12
Only CIN2 (positive)
|
18 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 12
Only CIN2 (negative)
|
181 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 12
Only CIN3 (positive)
|
8 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 12
Only CIN3 (negative)
|
191 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 12
CIN1 and CIN2 (positive)
|
3 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 12
CIN1 and CIN2(negative)
|
196 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 12
CIN1 and CIN3(positive)
|
1 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 12
CIN1 and CIN3 (negative)
|
198 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 12
CIN2 and CIN3 (positive)
|
1 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 12
CIN2 and CIN3 (negative)
|
198 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 12
CIN1 and CIN2 and CIN3 (positive)
|
0 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 12
CIN1 and CIN2 and CIN3 (negative)
|
199 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 12
AIS (positive)
|
0 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 12
AIS (negative)
|
199 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 12
Invasive malignancy (positive)
|
0 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 12
Invasive malignancy (negative)
|
199 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 12
Other
|
85 Participants
|
PRIMARY outcome
Timeframe: At Month 24Population: The analysis was based on the Total HPV-052 cohort, which included subjects for whom data were available at the considered time point and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.
Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other. CIN = Cervical intraepithelial neoplasia. CIN1/CIN2/CIN3 = Cervical intraepithelial neoplasia grade 1/grade 2/grade 3. Note: Only CIN1/Only CIN2/Only CIN3 categories contain the subject who has only CIN1/CIN2/CIN3, but not the combinations.
Outcome measures
| Measure |
HPV-052 Study Subjects Group
n=147 Participants
The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit.
|
|---|---|
|
Number of Subjects With Cervical Biopsy Results at Month 24
Negative
|
38 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 24
Only CIN1(positive)
|
47 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 24
Only CIN1(negative)
|
100 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 24
Only CIN2 (positive)
|
8 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 24
Only CIN2 (negative)
|
139 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 24
Only CIN3 (positive)
|
8 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 24
Only CIN3 (negative)
|
139 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 24
CIN1 and CIN2 (positive)
|
2 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 24
CIN1 and CIN2(negative)
|
145 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 24
CIN1 and CIN3(positive)
|
0 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 24
CIN1 and CIN3 (negative)
|
147 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 24
CIN2 and CIN3 (positive)
|
1 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 24
CIN2 and CIN3 (negative)
|
146 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 24
CIN1 and CIN2 and CIN3 (positive)
|
0 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 24
CIN1 and CIN2 and CIN3 (negative)
|
147 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 24
AIS (positive)
|
1 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 24
AIS (negative)
|
146 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 24
Invasive malignancy (positive)
|
0 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 24
Invasive malignancy (negative)
|
147 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 24
Other
|
56 Participants
|
PRIMARY outcome
Timeframe: At Month 36Population: The analysis was based on the Total HPV-052 cohort, which included subjects for whom data were available at the considered time point and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.
Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other. CIN = Cervical intraepithelial neoplasia. CIN1/CIN2/CIN3 = Cervical intraepithelial neoplasia grade 1/grade 2/grade 3. Note: Only CIN1/Only CIN2/Only CIN3 categories contain the subject who has only CIN1/CIN2/CIN3, but not the combinations.
Outcome measures
| Measure |
HPV-052 Study Subjects Group
n=88 Participants
The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit.
|
|---|---|
|
Number of Subjects With Cervical Biopsy Results at Month 36
Negative
|
31 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 36
Only CIN1(positive)
|
31 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 36
Only CIN1(negative)
|
57 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 36
Only CIN2 (positive)
|
6 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 36
Only CIN2 (negative)
|
82 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 36
Only CIN3 (positive)
|
3 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 36
Only CIN3 (negative)
|
85 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 36
CIN1 and CIN2 (positive)
|
0 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 36
CIN1 and CIN2(negative)
|
88 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 36
CIN1 and CIN3(positive)
|
0 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 36
CIN1 and CIN3 (negative)
|
88 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 36
CIN2 and CIN3 (positive)
|
0 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 36
CIN2 and CIN3 (negative)
|
88 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 36
CIN1 and CIN2 and CIN3 (positive)
|
0 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 36
CIN1 and CIN2 and CIN3 (negative)
|
88 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 36
AIS (positive)
|
0 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 36
AIS (negative)
|
88 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 36
Invasive malignancy (positive)
|
0 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 36
Invasive malignancy (negative)
|
88 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 36
Other
|
25 Participants
|
PRIMARY outcome
Timeframe: At Month 48Population: The analysis was based on the Total HPV-052 cohort, which included subjects for whom data were available at the considered time point and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.
Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other. CIN = Cervical intraepithelial neoplasia. CIN1/CIN2/CIN3 = Cervical intraepithelial neoplasia grade 1/grade 2/grade 3. Note: Only CIN1/Only CIN2/Only CIN3 categories contain the subject who has only CIN1/CIN2/CIN3, but not the combinations.
Outcome measures
| Measure |
HPV-052 Study Subjects Group
n=54 Participants
The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit.
|
|---|---|
|
Number of Subjects With Cervical Biopsy Results at Month 48
Negative
|
21 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 48
Only CIN1(positive)
|
15 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 48
Only CIN1(negative)
|
39 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 48
Only CIN2 (positive)
|
5 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 48
Only CIN2 (negative)
|
49 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 48
Only CIN3 (positive)
|
2 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 48
Only CIN3 (negative)
|
52 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 48
CIN1 and CIN2 (positive)
|
1 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 48
CIN1 and CIN2(negative)
|
53 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 48
CIN1 and CIN3(positive)
|
0 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 48
CIN1 and CIN3 (negative)
|
54 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 48
CIN2 and CIN3 (positive)
|
0 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 48
CIN2 and CIN3 (negative)
|
54 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 48
CIN1 and CIN2 and CIN3 (positive)
|
0 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 48
CIN1 and CIN2 and CIN3 (negative)
|
54 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 48
AIS (positive)
|
0 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 48
AIS (negative)
|
54 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 48
Invasive malignancy (positive)
|
0 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 48
Invasive malignancy (negative)
|
54 Participants
|
|
Number of Subjects With Cervical Biopsy Results at Month 48
Other
|
11 Participants
|
PRIMARY outcome
Timeframe: At Month 12Population: The analysis was based on the Total HPV-052 cohort, which included subjects for whom data were available at the considered time point and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.
If a high-grade lesion was detected, the subject was to be referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was to be handled according to local medical practice within the local health care system. The subject's participation in the study concluded after treatment. The treatment types included the following: Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.
Outcome measures
| Measure |
HPV-052 Study Subjects Group
n=392 Participants
The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit.
|
|---|---|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 12
Treatment referral, Yes
|
33 Participants
|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 12
Treatment referral, No
|
359 Participants
|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 12
Loop excision of cervix, Yes
|
14 Participants
|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 12
Loop excision of cervix, No
|
18 Participants
|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 12
Loop cone of cervix, Yes
|
15 Participants
|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 12
Loop cone of cervix, No
|
17 Participants
|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 12
Cold knife cone of cervix, Yes
|
0 Participants
|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 12
Cold knife cone of cervix, No
|
32 Participants
|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 12
Laser excision, Yes
|
1 Participants
|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 12
Laser excision, No
|
31 Participants
|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 12
Other
|
4 Participants
|
PRIMARY outcome
Timeframe: At Month 24Population: The analysis was based on the Total HPV-052 cohort, which included subjects for whom data were available at the considered time point and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.
If a high-grade lesion was detected, the subject was to be referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was to be handled according to local medical practice within the local health care system. The subject's participation in the study concluded after treatment. The treatment types included the following: Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.
Outcome measures
| Measure |
HPV-052 Study Subjects Group
n=263 Participants
The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit.
|
|---|---|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 24
Treatment referral, Yes
|
19 Participants
|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 24
Treatment referral, No
|
243 Participants
|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 24
Treatment referral, Missing
|
1 Participants
|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 24
Loop excision of cervix, Yes
|
9 Participants
|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 24
Loop excision of cervix, No
|
8 Participants
|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 24
Loop cone of cervix, Yes
|
4 Participants
|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 24
Loop cone of cervix, No
|
13 Participants
|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 24
Cold knife cone of cervix, Yes
|
1 Participants
|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 24
Cold knife cone of cervix, No
|
16 Participants
|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 24
Laser excision, Yes
|
0 Participants
|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 24
Laser excision, No
|
17 Participants
|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 24
Other
|
4 Participants
|
PRIMARY outcome
Timeframe: At Month 36Population: The analysis was based on the Total HPV-052 cohort, which included subjects for whom data were available at the considered time point and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.
If a high-grade lesion was detected, the subject was to be referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was to be handled according to local medical practice within the local health care system. The subject's participation in the study concluded after treatment. The treatment types included the following: Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.
Outcome measures
| Measure |
HPV-052 Study Subjects Group
n=158 Participants
The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit.
|
|---|---|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 36
Treatment referral, Yes
|
13 Participants
|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 36
Treatment referral, No
|
145 Participants
|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 36
Loop excision of cervix, Yes
|
4 Participants
|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 36
Loop excision of cervix, No
|
6 Participants
|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 36
Loop cone of cervix, Yes
|
4 Participants
|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 36
Loop cone of cervix, No
|
6 Participants
|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 36
Cold knife cone of cervix, Yes
|
0 Participants
|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 36
Cold knife cone of cervix, No
|
10 Participants
|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 36
Laser excision, Yes
|
0 Participants
|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 36
Laser excision, No
|
10 Participants
|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 36
Other
|
2 Participants
|
PRIMARY outcome
Timeframe: At Month 48Population: The analysis was based on the Total HPV-052 cohort, which included subjects for whom data were available at the considered time point and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.
If a high-grade lesion was detected, the subject was to be referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was to be handled according to local medical practice within the local health care system. The subject's participation in the study concluded after treatment. The treatment types included the following: Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.
Outcome measures
| Measure |
HPV-052 Study Subjects Group
n=96 Participants
The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit.
|
|---|---|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 48
Treatment referral, Yes
|
9 Participants
|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 48
Treatment referral, No \
|
87 Participants
|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 48
Loop excision of cervix, Yes
|
1 Participants
|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 48
Loop excision of cervix, No
|
7 Participants
|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 48
Loop cone of cervix, Yes
|
5 Participants
|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 48
Loop cone of cervix, No
|
3 Participants
|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 48
Cold knife cone of cervix, Yes
|
0 Participants
|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 48
Cold knife cone of cervix, No
|
8 Participants
|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 48
Laser excision, Yes
|
1 Participants
|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 48
Laser excision, No
|
7 Participants
|
|
Number of Subjects With Treatment Referrals by Treatment Type at Month 48
Other
|
1 Participants
|
PRIMARY outcome
Timeframe: From Month 12 [i.e. 12 months after the last visit in HPV-008 (NCT00122681) primary study) up to Month 48 [i.e. 48 months after the last visit in HPV-008 (NCT00122681) primary study]Population: The analysis was based on the Total HPV-052 cohort, which included subjects who had their symptom sheet completed and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
HPV-052 Study Subjects Group
n=2003 Participants
The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit.
|
|---|---|
|
Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs) Leading to Withdrawal
|
216 Participants
|
PRIMARY outcome
Timeframe: From Month 12 [i.e. 12 months after the last visit in HPV-008 (NCT00122681) primary study) up to Month 48 [i.e. 48 months after the last visit in HPV-008 (NCT00122681) primary study]Population: The analysis was based on the Total HPV-052 cohort, which included subjects who had their symptom sheet completed and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
Outcome measures
| Measure |
HPV-052 Study Subjects Group
n=2003 Participants
The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit.
|
|---|---|
|
Number of Subjects With Any Fatal SAEs, With Any SAEs Assessed as Possibly Related to Study Participation or to a Concurrent GSK Medication.
Subjects with fatal SAEs
|
0 Participants
|
|
Number of Subjects With Any Fatal SAEs, With Any SAEs Assessed as Possibly Related to Study Participation or to a Concurrent GSK Medication.
Subjects with any related SAEs
|
0 Participants
|
|
Number of Subjects With Any Fatal SAEs, With Any SAEs Assessed as Possibly Related to Study Participation or to a Concurrent GSK Medication.
Subjects with any SAEs due to concurrent GSK medic
|
0 Participants
|
Adverse Events
HPV-052 Study Subjects Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER