Trial Outcomes & Findings for Follow-up Study to Evaluate the Long-term Efficacy of the HPV Vaccine (580299) in Healthy Young Adult Women in Brazil (NCT NCT00518336)
NCT ID: NCT00518336
Last Updated: 2016-12-09
Results Overview
Cervical HPV infection was defined as the first detection of an HPV type in a subject previously negative for that HPV type.
COMPLETED
PHASE2
433 participants
Up to year 8
2016-12-09
Participant Flow
Out of the five subjects withdraw at Year 7, three subjects came back during Year 8 and are therefore not longer considered as withdraw subjects. At Year 9, one subject, who did not participate to Year 7 and Year 8 visits, came back for one of the visits and was added to Total cohort.
Participant milestones
| Measure |
Cervarix Group
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Year 7
STARTED
|
222
|
211
|
|
Year 7
COMPLETED
|
220
|
208
|
|
Year 7
NOT COMPLETED
|
2
|
3
|
|
Year 8
STARTED
|
223
|
213
|
|
Year 8
COMPLETED
|
222
|
211
|
|
Year 8
NOT COMPLETED
|
1
|
2
|
|
Year 9
STARTED
|
224
|
213
|
|
Year 9
COMPLETED
|
219
|
212
|
|
Year 9
NOT COMPLETED
|
5
|
1
|
Reasons for withdrawal
| Measure |
Cervarix Group
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Year 7
Lost to Follow-up
|
2
|
0
|
|
Year 7
Could not attend in time
|
0
|
3
|
|
Year 8
Lost to Follow-up
|
1
|
1
|
|
Year 8
Could not attend in time
|
0
|
1
|
|
Year 9
Migrated/moved from study area
|
1
|
1
|
|
Year 9
Lost to Follow-up
|
3
|
0
|
|
Year 9
Personal reasons
|
1
|
0
|
Baseline Characteristics
Follow-up Study to Evaluate the Long-term Efficacy of the HPV Vaccine (580299) in Healthy Young Adult Women in Brazil
Baseline characteristics by cohort
| Measure |
Cervarix Group
n=222 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=211 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Total
n=433 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.5 years
STANDARD_DEVIATION 3.2 • n=5 Participants
|
26.4 years
STANDARD_DEVIATION 2.9 • n=7 Participants
|
26.5 years
STANDARD_DEVIATION 3.05 • n=5 Participants
|
|
Gender
Female
|
222 Participants
n=5 Participants
|
211 Participants
n=7 Participants
|
433 Participants
n=5 Participants
|
|
Gender
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to year 8Population: According-To-Protocol (ATP) cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
Cervical HPV infection was defined as the first detection of an HPV type in a subject previously negative for that HPV type.
Outcome measures
| Measure |
Cervarix Group
n=178 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=139 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18
HPV-16 (N=176;122)
|
0 subjects
|
5 subjects
|
|
Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18
HPV-18 (N=178;133)
|
0 subjects
|
4 subjects
|
|
Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18
HPV-16/18 (N=176;139)
|
0 subjects
|
5 subjects
|
PRIMARY outcome
Timeframe: Up to year 9Population: The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
Cervical HPV infection was defined as the first detection of an HPV type in a subject previously negative for that HPV type
Outcome measures
| Measure |
Cervarix Group
n=179 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=140 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18
HPV-16 (N=179;133)
|
0 Subjects
|
9 Subjects
|
|
Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18
HPV-18 (N=177;140)
|
0 Subjects
|
6 Subjects
|
|
Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18
HPV-16/18 (N=177;122)
|
0 Subjects
|
9 Subjects
|
PRIMARY outcome
Timeframe: Up to year 7Population: The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
Cervical HPV infection was defined as the first detection of an HPV type in a subject previously negative for that HPV type.
Outcome measures
| Measure |
Cervarix Group
n=171 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=133 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and /or HPV-18
HPV-16 (N=171;128)
|
0 Subjects
|
2 Subjects
|
|
Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and /or HPV-18
HPV-18 (N=169;133)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and /or HPV-18
HPV-16/18 (N=169;117)
|
0 Subjects
|
2 Subjects
|
SECONDARY outcome
Timeframe: Up to year 8Population: The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=154 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=135 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type
Including HPV-16 or 18 (N=154; 133)
|
32 subjects
|
39 subjects
|
|
Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type
Without HPV-16 or 18 (N=154; 135)
|
32 subjects
|
36 subjects
|
SECONDARY outcome
Timeframe: Up to year 8Population: The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
Oncogenic types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=201 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=180 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type
HPV-31 (N=195; 168)
|
1 subjects
|
5 subjects
|
|
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type
HPV-33 (N=195; 175)
|
0 subjects
|
1 subjects
|
|
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type
HPV-35 (N=195; 177)
|
4 subjects
|
5 subjects
|
|
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type
HPV-39 (N=189; 162)
|
4 subjects
|
2 subjects
|
|
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type
HPV-45 (N=201; 174)
|
3 subjects
|
5 subjects
|
|
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type
HPV-51 (N=166; 152)
|
4 subjects
|
10 subjects
|
|
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type
HPV-52 (N=170; 152)
|
15 subjects
|
9 subjects
|
|
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type
HPV-56 (N=181; 168)
|
2 subjects
|
4 subjects
|
|
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type
HPV-58 (N=189; 173)
|
4 subjects
|
2 subjects
|
|
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type
HPV-59 (N=193; 180)
|
2 subjects
|
1 subjects
|
|
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type
HPV-66 (N= 176; 164)
|
3 subjects
|
8 subjects
|
|
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type
HPV-68 (N= 186; 166)
|
6 subjects
|
6 subjects
|
SECONDARY outcome
Timeframe: Up to year 8Population: The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=178 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=151 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18
HPV-16/18 (N=178; 144)
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18
HPV-16 (N=178; 149)
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18
HPV-18 (N=178;151)
|
0 subjects
|
0 subjects
|
SECONDARY outcome
Timeframe: Up to year 8Population: The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=162 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=143 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Types
Including HPV-16 or 18 (N=162; 142)
|
15 subjects
|
17 subjects
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Types
Without HPV-16 or 18 (N=162; 143)
|
15 subjects
|
17 subjects
|
SECONDARY outcome
Timeframe: Up to year 8Population: The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
Oncogenic HPV types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months. Subjects with an event did not report the same event during the earlier studies. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=203 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=184 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-35 (N= 200; 180)
|
2 Subjects
|
3 Subjects
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-39 (N= 199; 174)
|
2 Subjects
|
2 Subjects
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-45 (N= 203; 184)
|
4 Subjects
|
1 Subjects
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-31 (N= 201; 180)
|
1 Subjects
|
4 Subjects
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-33 (N= 199; 182)
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-51 (N= 191; 174)
|
3 Subjects
|
3 Subjects
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-52 (N= 185; 166)
|
4 Subjects
|
4 Subjects
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-56 (N= 196; 182)
|
1 Subjects
|
2 Subjects
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-58 (N= 195; 181)
|
3 Subjects
|
3 Subjects
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-59 (N=202; 184)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-66 (N= 191; 171)
|
1 Subjects
|
2 Subjects
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-68 (N= 199; 181)
|
2 Subjects
|
2 Subjects
|
SECONDARY outcome
Timeframe: Up to year 8Population: The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=178 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=156 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18
HPV-16/18 (N= 178; 152)
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18
HPV-16 (N= 178; 154)
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18
HPV-18 (N= 178; 156)
|
0 subjects
|
0 subjects
|
SECONDARY outcome
Timeframe: Up to year 8Population: The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=163 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=143 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Types
Including HPV-16 or 18 (N= 163; 142)
|
8 subjects
|
3 subjects
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Types
Without HPV-16 or 18 (N= 163; 143)
|
8 subjects
|
3 subjects
|
SECONDARY outcome
Timeframe: Up to year 8Population: The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
Individual oncogenic non-vaccine HPV types include HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months. Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=204 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=186 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-31 (N= 202; 181)
|
1 subjects
|
2 subjects
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-33 (N= 202; 184)
|
1 subjects
|
0 subjects
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-35 (N= 200; 185)
|
0 subjects
|
1 subjects
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV- 39 (N= 200; 179)
|
2 subjects
|
1 subjects
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-45 (N= 204; 186)
|
3 subjects
|
1 subjects
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV- 51 (N= 198; 182)
|
1 subjects
|
1 subjects
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-52 (N= 191; 172)
|
3 subjects
|
1 subjects
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-56 (N= 200; 185)
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-58 (N= 199; 183)
|
0 subjects
|
1 subjects
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-59 (N= 203; 186)
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-66 (N= 195; 177)
|
0 subjects
|
1 subjects
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-68 (N= 200; 184)
|
1 subjects
|
0 subjects
|
SECONDARY outcome
Timeframe: Up to year 8Population: The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)
CIN1+ was defined as CIN (Cervical Intraepithelial Neoplasia) grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=199 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=186 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-18 (N= 199; 186)
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-16/18 (N= 199; 182)
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-16 (N= 199; 183)
|
0 subjects
|
0 subjects
|
SECONDARY outcome
Timeframe: Up to year 8Population: The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)
CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=199 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=187 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
Including HRV-16 or 18
|
0 subjects
|
1 subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
Without HRV-16 or 18
|
0 subjects
|
1 subjects
|
SECONDARY outcome
Timeframe: Up to year 8Population: The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)
CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=222 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=209 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-52 (N= 218; 204)
|
0 subjects
|
1 subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-56 (N= 219; 209)
|
0 subjects
|
1 subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-58 (N=221; 206)
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-31 (N= 221; 207)
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-33 (N= 220; 207)
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-35 (N= 219; 206)
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-39 (N= 222; 209)
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-45 (N= 221; 208)
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-51 (N= 215; 206)
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-59 (N=220; 208)
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-66 (N= 219; 203)
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-68 (N= 221; 209)
|
0 subjects
|
0 subjects
|
SECONDARY outcome
Timeframe: Up to year 8Population: The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)
CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=199 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=186 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-16/18 (N= 199; 184)
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-16 (N= 199; 185)
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-18 (N= 199; 186)
|
0 subjects
|
0 subjects
|
SECONDARY outcome
Timeframe: Up to year 8Population: The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)
CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer. Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=199 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=187 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
Including HPV-16 or 18
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
Without HPV-16 or 18
|
0 subjects
|
0 subjects
|
SECONDARY outcome
Timeframe: Up to year 8Population: The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)
CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer. Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies. and were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=222 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=209 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-31 (N= 221; 208)
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-33 (N= 220; 208)
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-35 (N= 220; 206)
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-39 (N= 222; 209)
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-45 (N= 221; 208)
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-51 (N= 217; 207)
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-52 (N= 218; 206)
|
0 subjects
|
1 subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-56 (N= 219; 209)
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-58 (N= 221; 207)
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-59 (N= 220; 208)
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-66 (N= 220; 205)
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-68 (N= 221; 209)
|
0 subjects
|
0 subjects
|
SECONDARY outcome
Timeframe: Up to year 8Population: The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)
Abnormal cytology included atypical squamus cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), atypical glandular cells (AGC), atypical squamus cells and cannot exclude HSIL (ASC-H). Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=199 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=177 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection
HPV-16/18 (N= 198; 165)
|
0 subjects
|
1 subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection
HPV-16 (N= 198; 171)
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection
HPV-18 (N= 199; 177)
|
0 subjects
|
1 subjects
|
SECONDARY outcome
Timeframe: Up to year 8Population: The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)
Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H. Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=196 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=184 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Oncogenic HPV Types Cervical Infection
Including HPV-16 or 18 (N= 196; 183)
|
10 subjects
|
15 subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Oncogenic HPV Types Cervical Infection
Without HPV-16 or 18 (N= 196; 184)
|
10 subjects
|
15 subjects
|
SECONDARY outcome
Timeframe: Up to year 8Population: The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)
Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H. Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=220 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=206 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-58 (N= 213; 199)
|
0 subjects
|
3 subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-59 (N= 216; 206)
|
0 subjects
|
1 subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-31 (N= 217; 200)
|
0 subjects
|
5 subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-33 (N= 218; 202)
|
0 subjects
|
1 subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-35 (N= 217; 202)
|
1 subjects
|
1 subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-39 (N= 217; 197)
|
1 subjects
|
1 subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-45 (N= 220; 204)
|
2 subjects
|
0 subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-51 (N= 202; 194)
|
1 subjects
|
3 subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-52 (N= 205; 183)
|
3 subjects
|
3 subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-56 (N= 207; 202)
|
1 subjects
|
1 subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-66 (N= 214; 194)
|
2 subjects
|
1 subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-68 (N= 217; 202)
|
2 subjects
|
1 subjects
|
SECONDARY outcome
Timeframe: Up to year 8Population: The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)
Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=199 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=183 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection
HPV-16/18 (N= 198; 174)
|
0 subjects
|
1 subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection
HPV-16 (N= 198; 177)
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection
HPV-18 (N= 199; 183)
|
0 subjects
|
1 subjects
|
SECONDARY outcome
Timeframe: Up to year 8Population: The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)
Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H. Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=197 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=186 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Oncogenic HPV Types Cervical Infection
Including HPV-16 or 18
|
7 subjects
|
12 subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Oncogenic HPV Types Cervical Infection
Without HPV-16 or 18
|
7 subjects
|
12 subjects
|
SECONDARY outcome
Timeframe: Up to year 8Population: The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)
Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H. Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=220 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=207 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-31 (N= 218; 202)
|
0 subjects
|
4 subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-33 (N= 219; 205)
|
0 subjects
|
1 subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-35 (N= 217; 204)
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-39 (N= 219; 200)
|
1 subjects
|
1 subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-45 (N= 220; 205)
|
2 subjects
|
0 subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-51 (N= 211; 197)
|
1 subjects
|
3 subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-52 (N= 210; 191)
|
2 subjects
|
3 subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-56 (N= 211; 202)
|
1 subjects
|
0 subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-58 (N= 216; 203)
|
0 subjects
|
2 subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-59 (N= 219; 207)
|
0 subjects
|
1 subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-66 (N= 217; 195)
|
0 subjects
|
1 subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-68 (N= 219; 206)
|
2 subjects
|
1 subjects
|
SECONDARY outcome
Timeframe: At Months 77-101Population: The analyses were performed on the ATP cohort for immunogenicity, which included evaluable subjects for whom immunogenicity data were available.
Titers are given as Geometric Mean Titers (GMTs) expressed as ELISA Units per milliliter (EL.U/mL).
Outcome measures
| Measure |
Cervarix Group
n=111 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=68 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort
Anti-HPV-16 Month 83-88 (N= 111; 68)
|
383.4 EL.U/mL
Interval 312.9 to 469.9
|
5.1 EL.U/mL
Interval 4.4 to 6.0
|
|
Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort
Anti-HPV-16 Month 89-94 (N= 94; 67)
|
346.3 EL.U/mL
Interval 270.3 to 443.6
|
5.4 EL.U/mL
Interval 4.4 to 6.7
|
|
Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort
Anti-HPV-18 Month 95-101 (N= 87; 56)
|
246.5 EL.U/mL
Interval 197.6 to 307.5
|
4.6 EL.U/mL
Interval 3.7 to 5.6
|
|
Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort
Anti-HPV-16 Month 77-82 (N= 69; 54)
|
374.9 EL.U/mL
Interval 291.8 to 481.8
|
5.4 EL.U/mL
Interval 4.4 to 6.6
|
|
Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort
Anti-HPV-16 Month 95-101 (N= 87; 56)
|
435.1 EL.U/mL
Interval 347.5 to 544.9
|
5.4 EL.U/mL
Interval 4.4 to 6.6
|
|
Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort
Anti-HPV-18 Month 77-82 (N= 69; 54)
|
252.8 EL.U/mL
Interval 196.9 to 324.7
|
4.3 EL.U/mL
Interval 3.7 to 5.1
|
|
Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort
Anti-HPV-18 Month 83-88 (N= 111; 68)
|
251.0 EL.U/mL
Interval 208.7 to 301.8
|
5.0 EL.U/mL
Interval 4.1 to 6.1
|
|
Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort
Anti-HPV-18 Month 89-94 (N= 94; 67)
|
234.6 EL.U/mL
Interval 188.8 to 291.5
|
4.4 EL.U/mL
Interval 3.7 to 5.2
|
SECONDARY outcome
Timeframe: At Months 77-101Population: The analyses were performed on a subset of the ATP cohort for immunogenicity, which included evaluable subjects for whom immunogenicity data were available.
Data are expressed as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum
Outcome measures
| Measure |
Cervarix Group
n=30 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=8 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset
Anti-HPV-16 Month 77-82 (N= 15; 4)
|
1616.1 titer
Interval 592.7 to 4407.0
|
20.0 titer
Interval 20.0 to 20.0
|
|
Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset
Anti-HPV-16 Month 83-88 (N= 30; 8)
|
1990.7 titer
Interval 1228.5 to 3225.8
|
20.0 titer
Interval 20.0 to 20.0
|
|
Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset
Anti-HPV-16 Month 89-94 (N= 18; 6)
|
1385.0 titer
Interval 740.6 to 2590.0
|
20.0 titer
Interval 20.0 to 20.0
|
|
Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset
Anti-HPV-16 Month 95-101 (N= 27; 6)
|
1611.6 titer
Interval 934.1 to 2780.3
|
20.0 titer
Interval 20.0 to 20.0
|
|
Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset
Anti-HPV-18 Month 77-82 (N= 15; 4)
|
845.4 titer
Interval 361.6 to 1976.7
|
20.0 titer
Interval 20.0 to 20.0
|
|
Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset
Anti-HPV-18 Month 83-88 (N= 30; 8)
|
751.6 titer
Interval 466.3 to 1211.5
|
20.0 titer
Interval 20.0 to 20.0
|
|
Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset
Anti-HPV-18 Month 89-94 (N= 18; 6)
|
1185.3 titer
Interval 656.1 to 2141.1
|
20.0 titer
Interval 20.0 to 20.0
|
|
Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset
Anti-HPV-18 Month 95-101 (N= 27; 6)
|
578.2 titer
Interval 352.9 to 947.1
|
20.0 titer
Interval 20.0 to 20.0
|
SECONDARY outcome
Timeframe: Up to year 7Population: The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)
NOCDs include for example asthma, type I diabetes, allergies, ...
Outcome measures
| Measure |
Cervarix Group
n=222 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=211 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 7
|
0 subjects
|
0 subjects
|
SECONDARY outcome
Timeframe: Up to year 8Population: The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)
NOCDs included for example asthma, type I diabetes, allergies, ... NOCDs which were not unblinded at the subject level at the time of the analysis are not presented and will be disclosed as soon as they become available.
Outcome measures
| Measure |
Cervarix Group
n=223 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=213 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With NOCD up to Year 8
|
5 subjects
|
2 subjects
|
SECONDARY outcome
Timeframe: Up to year 7Population: The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)
Outcome measures
| Measure |
Cervarix Group
n=222 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=211 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With New Onset Autoimmune Disease (NOAD) up to Year 7
|
0 subjects
|
0 subjects
|
SECONDARY outcome
Timeframe: Up to year 8Population: The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)
The values of NOADs are not yet corresponding to the values in each group. The cases are still blinded. They will be disclosed as soon as the results will be available.
Outcome measures
| Measure |
Cervarix Group
n=223 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=213 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With NOAD up to Year 8
|
2 subjects
|
2 subjects
|
SECONDARY outcome
Timeframe: Up to year 7Population: The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)
Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury. Medically significant conditions which were not unblinded at the time of the analysis are not presented yet.
Outcome measures
| Measure |
Cervarix Group
n=222 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=211 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Medically Significant Conditions up to Year 7
|
18 subjects
|
13 subjects
|
SECONDARY outcome
Timeframe: up to year 8Population: The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)
Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury. Medically significant conditions which were not unblinded at the time of the analysis are not presented yet.
Outcome measures
| Measure |
Cervarix Group
n=223 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=213 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Medically Significant Conditions up to Year 8
|
40 subjects
|
24 subjects
|
SECONDARY outcome
Timeframe: Up to year 7Population: The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)
SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject
Outcome measures
| Measure |
Cervarix Group
n=222 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=211 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs) up to Year 7
|
4 subjects
|
5 subjects
|
SECONDARY outcome
Timeframe: up to year 8Population: The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)
SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject
Outcome measures
| Measure |
Cervarix Group
n=223 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=213 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With SAEs up to Year 8
|
10 subjects
|
7 subjects
|
SECONDARY outcome
Timeframe: Up to year 9Population: The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=155 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=136 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type.
Including HPV-16 or 18 (N=155;135)
|
38 Subjects
|
49 Subjects
|
|
Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type.
Without HPV-16 or 18 (N=155;136)
|
38 Subjects
|
45 Subjects
|
SECONDARY outcome
Timeframe: Up to year 9Population: The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
Oncogenic types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=203 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=182 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type
HPV-31 (N=197;170)
|
4 Subjects
|
5 Subjects
|
|
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type
HPV-33 (N=197;177)
|
2 Subjects
|
4 Subjects
|
|
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type
HPV-35 (N=197;179)
|
4 Subjects
|
9 Subjects
|
|
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type
HPV-39 (N=191;163)
|
5 Subjects
|
3 Subjects
|
|
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type
HPV-45 (N=203;176)
|
3 Subjects
|
5 Subjects
|
|
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type
HPV-51 (N=167;154)
|
11 Subjects
|
15 Subjects
|
|
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type
HPV-52 (N=172;153)
|
18 Subjects
|
10 Subjects
|
|
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type
HPV-56 (N=182;170)
|
3 Subjects
|
4 Subjects
|
|
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type
HPV-58 (N=191;175)
|
7 Subjects
|
3 Subjects
|
|
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type
HPV-59 (N=195;182)
|
2 Subjects
|
2 Subjects
|
|
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type
HPV-66 (N=176;165)
|
4 Subjects
|
10 Subjects
|
|
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type
HPV-68 (N=188;166)
|
8 Subjects
|
9 Subjects
|
SECONDARY outcome
Timeframe: Up to year 9Population: The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study, who complied with the protocol and for whom efficacy data were available.
Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study
Outcome measures
| Measure |
Cervarix Group
n=179 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=152 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18
HPV-16/18 (N=179;144)
|
0 Subjects
|
4 Subjects
|
|
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18
HPV-16 (N=179;149)
|
0 Subjects
|
3 Subjects
|
|
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18
HPV-18 (N=179;152)
|
0 Subjects
|
3 Subjects
|
SECONDARY outcome
Timeframe: Up to year 9Population: The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=163 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=144 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Type
Including HPV-16 or 18 (N=163;143)
|
20 Subjects
|
25 Subjects
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Type
Without HPV-16 or 18 (N=163;144)
|
20 Subjects
|
24 Subjects
|
SECONDARY outcome
Timeframe: Up to year 9Population: The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
Oncogenic HPV types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months. Subjects with an event did not report the same event during the earlier studies. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=205 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=186 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-35 (N=202;182)
|
4 Subjects
|
4 Subjects
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-39 (N=201;176)
|
3 Subjects
|
2 Subjects
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-31 (N=203;182)
|
1 Subjects
|
4 Subjects
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-33 (N=201;184)
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-45 (N=205;186)
|
4 Subjects
|
1 Subjects
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-51 (N=193;176)
|
4 Subjects
|
4 Subjects
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-52 (N=187;167)
|
6 Subjects
|
7 Subjects
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-56 (N=198;184)
|
1 Subjects
|
3 Subjects
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-58 (N=197;183)
|
5 Subjects
|
3 Subjects
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-59 (N=204;186)
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-66 (N=192;172)
|
1 Subjects
|
5 Subjects
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-68 (N=201;182)
|
4 Subjects
|
2 Subjects
|
SECONDARY outcome
Timeframe: Up to year 9Population: The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study
Outcome measures
| Measure |
Cervarix Group
n=179 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=157 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18
HPV-16 (N=179;155)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18
HPV-16/18 (N=179;153)
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18
HPV-18 (N=179;157)
|
0 Subjects
|
2 Subjects
|
SECONDARY outcome
Timeframe: Up to year 9Population: The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=164 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=144 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Types
Including HPV-16 or 18 (N=164;143)
|
13 Subjects
|
10 Subjects
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Types
Without HPV-16 or 18 (N=164;144)
|
13 Subjects
|
8 Subjects
|
SECONDARY outcome
Timeframe: Up to year 9Population: The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
Individual oncogenic non-vaccine HPV types include HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months. Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study
Outcome measures
| Measure |
Cervarix Group
n=206 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=188 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-68 (N=202;185)
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-31 (N=204,183)
|
1 Subjects
|
4 Subjects
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-33 (N=204;186)
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-35 (N=202;187)
|
2 Subjects
|
2 Subjects
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-39 (N=202;181)
|
2 Subjects
|
1 Subjects
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-45 (N=206;188)
|
4 Subjects
|
1 Subjects
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-51 (N=200;184)
|
2 Subjects
|
2 Subjects
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-52 (N=193;174)
|
3 Subjects
|
3 Subjects
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-56 (N=202;187)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-58 (N=201;185)
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-59 (N=205;188)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-66 (N=196;179)
|
0 Subjects
|
1 Subjects
|
SECONDARY outcome
Timeframe: Up to year 9Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
Cervical Intraepithelial Neoplasia (CIN1)+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=200 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=187 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-16/18 (N=200;183)
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-16 (N=200;184)
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-18 (N=200;187)
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: Up to year 9Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=200 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=188 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
Including HPV-16 or 18 (N=200;188)
|
3 Subjects
|
4 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
Without HPV-16 or 18 (N=200;188)
|
3 Subjects
|
4 Subjects
|
SECONDARY outcome
Timeframe: Up to year 9Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=224 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=211 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-31 (N=223;209)
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-33 (N=222;209)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-35 (N=221;208)
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-39 (N=224;211)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-45 (N=223;210)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-51 (N=217;208)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-52 (N=220;206)
|
2 Subjects
|
2 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-56 (N=221;211)
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-58 (N=223;208)
|
0 Subjects
|
2 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-59 (N=222;210)
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-66 (N=220;205)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-68 (N=223;210)
|
2 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: Up to year 9Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=200 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=187 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-16/18 (N=200;185)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-16 (N=200;186)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-18 (N=200;187)
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: Up to year 9Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer. Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=200 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=188 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
Including HPV-16 or 18 (N=200;188)
|
0 Subjects
|
2 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
Without HPV-16 or 18 (N=200;188)
|
0 Subjects
|
2 Subjects
|
SECONDARY outcome
Timeframe: Up to year 9Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer. Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=224 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=211 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-33 (N=222;210)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-31 (N=223;210)
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-35 (N=222;208)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-39 (N=224;211)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-45 (N=223;210)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-51 (N=219;209)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-52 (N=220;208)
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-56 (N=221;211)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-58 (N=223;209)
|
0 Subjects
|
2 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-59 (N=222;210)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-66 (N=221;207)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-68 (N=223;210)
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: Up to year 9Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
Abnormal cytology included atypical squamus cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), atypical glandular cells (AGC), atypical squamus cells and cannot exclude HSIL (ASC-H). Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study
Outcome measures
| Measure |
Cervarix Group
n=200 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=178 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection
HPV-16/18 (N=199;165)
|
0 Subjects
|
3 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection
HPV-16 (N=199;171)
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection
HPV-18 (N=200;178)
|
0 Subjects
|
2 Subjects
|
SECONDARY outcome
Timeframe: Up to year 9Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H. Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=197 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=185 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Oncogenic HPV Types Cervical Infection
Including HPV-16 or 18 (N=197;184)
|
15 Subjects
|
25 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Oncogenic HPV Types Cervical Infection
Without HPV-16 or 18 (N=197;185)
|
15 Subjects
|
25 Subjects
|
SECONDARY outcome
Timeframe: Up to year 9Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H. Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study
Outcome measures
| Measure |
Cervarix Group
n=222 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=208 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-31 (N=219;202)
|
1 Subjects
|
5 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-33 (N=220;204)
|
0 Subjects
|
2 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-35 (N=219;204)
|
1 Subjects
|
3 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-39 (N=219;198)
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-45 (N=222;206)
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-51 (N=203;196)
|
3 Subjects
|
7 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-52 (N=207;184)
|
5 Subjects
|
5 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-56 (N=208;204)
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-58 (N=215;201)
|
3 Subjects
|
4 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-59 (N=218;208)
|
0 Subjects
|
2 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-66 (N=214;195)
|
2 Subjects
|
2 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-68 (N=219;202)
|
2 Subjects
|
2 Subjects
|
SECONDARY outcome
Timeframe: Up to year 9Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=200 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=184 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection
HPV-18 (N=200;184)
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection
HPV-16/18 (N=199;174)
|
0 Subjects
|
2 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection
HPV-16 (N=199;177)
|
0 Subjects
|
1 Subjects
|
SECONDARY outcome
Timeframe: Up to year 9Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H. Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=198 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=187 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Oncogenic HPV Types Cervical Infection
Without HPV-16 or 18 (N=198;187)
|
12 Subjects
|
19 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Oncogenic HPV Types Cervical Infection
Including HPV-16 or 18 (N=198;187)
|
12 Subjects
|
19 Subjects
|
SECONDARY outcome
Timeframe: Up to year 9Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H. Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=222 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=209 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-031 (N=220;204)
|
1 Subjects
|
5 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-33 (N=221;207)
|
0 Subjects
|
2 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-35 (N=219;206)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-39 (N=221;201)
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-45 (N=222;207)
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-51 (N=212;199)
|
2 Subjects
|
5 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-52 (N=212;192)
|
4 Subjects
|
5 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-56 (N=212;204)
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-58 (N=218;205)
|
2 Subjects
|
3 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-59 (N=221;209)
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-66 (N=217;196)
|
0 Subjects
|
2 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-68 (N=221;206)
|
2 Subjects
|
1 Subjects
|
SECONDARY outcome
Timeframe: At Month 77 until year 9 (Month 113)Population: The analyses were performed on the ATP cohort for immunogenicity, which included evaluable subjects for whom immunogenicity data were available.
Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked immunosorbent assay (ELISA) Units per milliliter (EL.U/mL). The cut-off-vales assessed were \>= 8 or 7 EL. U/mL for anti-HPV-16 and 18, respectively.
Outcome measures
| Measure |
Cervarix Group
n=111 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=65 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort
Anti-HPV-16 Month 77-82 (N=69;52)
|
374.9 EL. U/mL
Interval 291.8 to 481.8
|
5.2 EL. U/mL
Interval 4.3 to 6.2
|
|
Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort
Anti-HPV-16 Month 83-88 (N=111;65)
|
383.4 EL. U/mL
Interval 312.9 to 469.9
|
5.2 EL. U/mL
Interval 4.4 to 6.1
|
|
Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort
Anti-HPV-16 Month 89-94 (N=94;65)
|
346.3 EL. U/mL
Interval 270.3 to 443.6
|
5.4 EL. U/mL
Interval 4.4 to 6.7
|
|
Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort
Anti-HPV-16 Month 95-100 (N=87;53)
|
435.1 EL. U/mL
Interval 347.5 to 544.9
|
5.4 EL. U/mL
Interval 4.4 to 6.7
|
|
Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort
Anti-HPV-16 Month 101-106 (N=87;63)
|
322.8 EL. U/mL
Interval 249.4 to 417.6
|
5.2 EL. U/mL
Interval 4.3 to 6.3
|
|
Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort
Anti-HPV-16 Month 107-113 (N=92;60)
|
418.3 EL. U/mL
Interval 344.0 to 508.6
|
6.1 EL. U/mL
Interval 4.9 to 7.8
|
|
Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort
Anti-HPV-18 Month 77-82 (N=69;52)
|
252.8 EL. U/mL
Interval 196.9 to 324.7
|
4.2 EL. U/mL
Interval 3.6 to 4.9
|
|
Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort
Anti-HPV-18 Month 83-88 (N=111;65)
|
251.0 EL. U/mL
Interval 208.7 to 301.8
|
5.0 EL. U/mL
Interval 4.1 to 6.1
|
|
Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort
Anti-HPV-18 Month 89-94 (N=94;65)
|
234.6 EL. U/mL
Interval 188.8 to 291.5
|
4.4 EL. U/mL
Interval 3.7 to 5.2
|
|
Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort
Anti-HPV-18 Month 95-100 (N=87;53)
|
246.5 EL. U/mL
Interval 197.6 to 307.5
|
4.6 EL. U/mL
Interval 3.7 to 5.8
|
|
Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort
Anto-HPV-18 Month 101-106 (N=87;63)
|
225.0 EL. U/mL
Interval 177.1 to 285.8
|
4.1 EL. U/mL
Interval 3.6 to 4.6
|
|
Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort
Anti-HPV-18 Month 107-113 (N=92;60)
|
242.6 EL. U/mL
Interval 199.3 to 295.2
|
4.8 EL. U/mL
Interval 3.9 to 6.0
|
SECONDARY outcome
Timeframe: At Month 77 until year 9 (Month 113)Population: The analyses were performed on the ATP cohort for immunogenicity, which included evaluable subjects for whom immunogenicity data were available.
Data are expressed as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum
Outcome measures
| Measure |
Cervarix Group
n=30 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=8 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset
Anti-HPV-18 Month 89-94 (N=18;6)
|
1185.3 Titer
Interval 656.1 to 2141.1
|
20.0 Titer
Interval 20.0 to 20.0
|
|
Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset
Anti-HPV-18 Month 101-106 (N=16;7)
|
860.1 Titer
Interval 441.0 to 1677.3
|
20.0 Titer
Interval 20.0 to 20.0
|
|
Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset
Anti-HPV-18 Month 107-113 (N=30;5)
|
552.0 Titer
Interval 358.5 to 850.1
|
20.0 Titer
Interval 20.0 to 20.0
|
|
Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset
Anti-HPV-16 Month 77-82 (N=15;4)
|
1616.1 Titer
Interval 592.7 to 4407.0
|
20.0 Titer
Interval 20.0 to 20.0
|
|
Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset
Anti-HPV-16 Month 83-88 (N=30;8)
|
1990.7 Titer
Interval 1228.5 to 3225.8
|
20.0 Titer
Interval 20.0 to 20.0
|
|
Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset
Anti-HPV-16 Month 89-94 (N=18;6)
|
1385.0 Titer
Interval 740.6 to 2590.0
|
20.0 Titer
Interval 20.0 to 20.0
|
|
Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset
Anti-HPV-16 Month 95-101 (N=27;6)
|
1611.6 Titer
Interval 934.1 to 2780.3
|
20.0 Titer
Interval 20.0 to 20.0
|
|
Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset
Anti-HPV-16 Month 101-106 (N=16;7)
|
1380.7 Titer
Interval 667.5 to 2855.8
|
20.0 Titer
Interval 20.0 to 20.0
|
|
Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset
Anti-HPV-16 Month 107-113 (N=30;5)
|
1549.8 Titer
Interval 1027.9 to 2336.8
|
20.0 Titer
Interval 20.0 to 20.0
|
|
Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset
Anti-HPV-18 Month 77-82 (N=15;4)
|
845.4 Titer
Interval 361.6 to 1976.7
|
20.0 Titer
Interval 20.0 to 20.0
|
|
Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset
Anti-HPV-18 Month 83-88 (N=30;8)
|
751.6 Titer
Interval 466.3 to 1211.5
|
20.0 Titer
Interval 20.0 to 20.0
|
|
Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset
Anti-HPV-18 Month 95-101 (N=27;6)
|
578.2 Titer
Interval 352.9 to 947.1
|
20.0 Titer
Interval 20.0 to 20.0
|
SECONDARY outcome
Timeframe: Up to year 9Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo).
NOCDs include for example asthma, type I diabetes, allergies, ...
Outcome measures
| Measure |
Cervarix Group
n=224 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=213 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 9
Type 2 diabetes mellitus
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 9
Rheumatoid arthritis
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 9
Dermatitis allergic
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 9
Number of Subjects With NOCD up to Year 9
|
6 Subjects
|
3 Subjects
|
|
Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 9
Hypothyroidism
|
2 Subjects
|
1 Subjects
|
|
Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 9
Drug hypersensitivity
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 9
Rhinitis allergic
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 9
Skin reaction
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 9
Vitiligo
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 9
Hypertension
|
1 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: Up to year 9Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
Outcome measures
| Measure |
Cervarix Group
n=224 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=213 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With New Onset Autoimmune Disease (NOAD) up to Year 9.
Number of Subjects With NOAD up to Year 9
|
4 Subjects
|
1 Subjects
|
|
Number of Subjects With New Onset Autoimmune Disease (NOAD) up to Year 9.
Hypothyroidism
|
2 Subjects
|
1 Subjects
|
|
Number of Subjects With New Onset Autoimmune Disease (NOAD) up to Year 9.
Rheumatoid arthritis
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects With New Onset Autoimmune Disease (NOAD) up to Year 9.
Vitiligo
|
1 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: Up to year 9Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Outcome measures
| Measure |
Cervarix Group
n=224 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=213 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Peptic ulcer
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Dengue fever
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Rhinitis allergic
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Dermatitis allergic
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Haematoma
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Medically Signifant Conditions up to Year 9
|
60 Subjects
|
38 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Gastritis
|
5 Subjects
|
2 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Hypertension
|
5 Subjects
|
2 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Abortion spontaneous incomplete
|
5 Subjects
|
1 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Depression
|
5 Subjects
|
1 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Nephrolithiasis
|
3 Subjects
|
0 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Abortion missed
|
2 Subjects
|
2 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Hypothyroidism
|
2 Subjects
|
1 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Panic disorder
|
2 Subjects
|
1 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Bursitis
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Ovarian cyst
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Ovarian disorder
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Anaemia
|
0 Subjects
|
2 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Gynaecological chlamydia infection
|
0 Subjects
|
2 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Pneumonia
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Pyelonephritis
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Blood pressure increased
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Bipolar disorder
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Genital herpes
|
0 Subjects
|
3 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Haemorrhoids
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Vomiting
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Chest pain
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Cholelithiasis
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Breast infection
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Erysipelas
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Gingival abscess
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Pelvic inflammatory disease
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Staphylococcal infection
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Toxoplasmosis
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Abnormal loss of weight
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Metabolic syndrome
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Cervical spinal stenosis
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Synovial cyst
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Tendonitis
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Benign breast neoplasm
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Benign hydatidiform mole
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Ovarian cancer
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Headache
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Blighted ovum
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Intra-uterine death
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Oligohydramnios
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Pre-eclampsia
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Medically Signifant Conditions up to Year 9
Sexual abuse
|
0 Subjects
|
1 Subjects
|
SECONDARY outcome
Timeframe: up to year 9Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject
Outcome measures
| Measure |
Cervarix Group
n=224 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=213 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs) up to Year 9.
|
20 Subjects
|
11 Subjects
|
SECONDARY outcome
Timeframe: Up to year 7Population: The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=148 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=126 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type.
Including HPV-16 or 18 (N=148;122)
|
22 Subjects
|
16 Subjects
|
|
Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type.
Without HPV-16 or 18 (N=148;126)
|
22 Subjects
|
14 Subjects
|
SECONDARY outcome
Timeframe: Up to year 7Population: The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
Oncogenic types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=193 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=174 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type.
HPV-68 (N=179;159)
|
4 Subjects
|
2 Subjects
|
|
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type.
HPV-31 (N=187;162)
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type.
HPV-33 (N=187;168)
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type.
HPV-35 (N=187;170)
|
3 Subjects
|
3 Subjects
|
|
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type.
HPV-39 (N=181;156)
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type.
HPV-45 (N=193;167)
|
2 Subjects
|
3 Subjects
|
|
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type.
HPV-51 (N=158;146)
|
2 Subjects
|
3 Subjects
|
|
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type.
HPV-52 (N=162;147)
|
10 Subjects
|
3 Subjects
|
|
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type.
HPV-56 (N=174;162)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type.
HPV-58 (N=182;166)
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type.
HPV-59 (N=186;174)
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type.
HPV-66 (N=169;157)
|
3 Subjects
|
3 Subjects
|
SECONDARY outcome
Timeframe: Up to year 7Population: The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study
Outcome measures
| Measure |
Cervarix Group
n=171 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=145 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18
HPV-16/18 (N=171;139)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18
HPV-16 (N=171;144)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18
HPV-18 (N=171;145)
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: Up to year 7Population: The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=157 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=138 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Type
Including HPV-16 or 18 (N=157;137)
|
5 Subjects
|
4 Subjects
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Type
Without HPV-16 or 18 (N=157;138)
|
5 Subjects
|
4 Subjects
|
SECONDARY outcome
Timeframe: Up to year 7Population: The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
Oncogenic HPV types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months. Subjects with an event did not report the same event during the earlier studies. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=195 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=177 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-56 (N=189; 175)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-59 (N=195; 177)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-31 (N= 193; 173)
|
0 Subjects
|
2 Subjects
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-33 (N=191; 175)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-35 (N=192; 173)
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-39 (N=191; 168)
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-45 (N=195; 177)
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-51 (N=183; 167)
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-52 (N=177; 160)
|
2 Subjects
|
1 Subjects
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-58 (N=188; 174)
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-66 (N=183; 164)
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-68 (N=191; 174)
|
1 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: Up to year 7Population: The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=171 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=150 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18
HPV-16/18 (N=171;146)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18
HPV-16 (N=171;148)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18
HPV-18 (N=171;150)
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: Up to year 7Population: The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=158 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=138 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Type
Including HPV-16 or 18 (N=158;138)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Type
Without HPV-16 or 18 (N=158;138)
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: Up to year 7Population: The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
Individual oncogenic non-vaccine HPV types include HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months. Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=196 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=179 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-39 (N=192;173)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-66 (N=187;170)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-31 (N=194;174)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-33 (N=194;177)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-35 (N=192;178)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-45 (N=196;179)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-51 (N=190;175)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-52 (N=183;166)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-56 (N=193;178)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-58 (N=193;178)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-59 (N=196;179)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
HPV-68 (N=192;177)
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: Up to year 7Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=191 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=178 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-16/18 (N=191;175)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-16 (N=191;176)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-18 (N=191;178)
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: Up to year 7Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=191 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=179 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
Including HPV-16 or 18 (N=191;179)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
Without HPV-16 or 18 (N=191;179)
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: Up to year 7Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=214 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=201 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-35 (N=211;198)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-51 (N=207;198)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-52 (N=210;196)
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-59 (N=212;200)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-68 (N=213;201)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-31 (N=213;199)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-33 (N=212;199)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-39 (N=214;201)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-45 (N=213;200)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-56 (N=211;201)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-58 (N=213;198)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-66 (N=211;195)
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: Up to year 7Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=191 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=178 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-18 (N=191;178)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen
HVP-16/18 (N=191;176)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-16 (N=191;177)
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: Up to year 7Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer. Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=191 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=179 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
Including HPV-16 or 18 (N=191;179)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
Without HPV-16 or 18 (N=191;179)
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: Up to year 7Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer. Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=214 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=201 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-31 (N=213;200)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-33 (N=212;200)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-35 (N=212;198)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-39 (N=214;201)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-45 (N=213;200)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-51 (N=209;199)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-52 (N=210;198)
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-56 (N=211;201)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-58 (N=213;199)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-59 (N=212;200)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-66 (N=212;197)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-68 (N=213;201)
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: Up to year 7Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
Abnormal cytology included atypical squamus cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), atypical glandular cells (AGC), atypical squamus cells and cannot exclude HSIL (ASC-H). Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=191 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=169 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection
HPV-16/18 (N=190;158)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection
HPV-16 (N=190;164)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection
HPV-18 (N=191;169)
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: Up to year 7Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H. Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=188 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=176 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Oncogenic HPV Types Cervical Infection
Including HPV-16 or 18 (N=188;175)
|
3 Subjects
|
8 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Oncogenic HPV Types Cervical Infection
Without HPV-16 or 18 (N=188;176)
|
3 Subjects
|
8 Subjects
|
SECONDARY outcome
Timeframe: Up to year 7Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H. Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=212 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=198 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-51 (N=194;187)
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-31 (N=209;192)
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-33 (N=210;194)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-35 (N=209;194)
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-39 (N=209;189)
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-45 (N=212;196)
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-52 (N=197;176)
|
1 Subjects
|
2 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-56 (N=200;194)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-58 (N=206;191)
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-59 (N=209;198)
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-66 (N=206;186)
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-68 (N=210;194)
|
1 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: Up to year 7Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=191 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=175 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection
HPV-16/18 (N=190;167)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection
HPV-16 (N=190;170)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection
HPV-18 (N=191;175)
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: Up to year 7Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H. Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=189 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=178 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Oncogenic HPV Types Cervical Infection
Without HPV-16 or 18 (N=189;178)
|
2 Subjects
|
6 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Oncogenic HPV Types Cervical Infection
Including HPV-16 or 18 (N=189;178)
|
2 Subjects
|
6 Subjects
|
SECONDARY outcome
Timeframe: Up to year 7Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H. Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study.
Outcome measures
| Measure |
Cervarix Group
n=212 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=199 Participants
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-68 (N=211;198)
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-56 (204;194)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-58 (N=209;195)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-59 (N=212;199)
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-66 (N=209;187)
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-33 (N=211;197)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-35 (N=209;196)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-39 (N=211;192)
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-45 (N=212;197)
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-51 (N=203;190)
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-52 (N=202;184)
|
0 Subjects
|
2 Subjects
|
|
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
HPV-31 (N=210;194)
|
0 Subjects
|
1 Subjects
|
Adverse Events
Cervarix Group
Placebo Group
Serious adverse events
| Measure |
Cervarix Group
n=224 participants at risk
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
Placebo Group
n=213 participants at risk
Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous incomplete
|
2.2%
5/224 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
0.47%
1/213 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.89%
2/224 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
0.94%
2/213 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
|
Infections and infestations
Appendicitis
|
0.89%
2/224 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
0.00%
0/213 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
|
Psychiatric disorders
Bipolar disorder
|
0.45%
1/224 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
0.47%
1/213 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.45%
1/224 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
0.00%
0/213 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.45%
1/224 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
0.00%
0/213 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
|
Infections and infestations
Bacterial pyelonephritis
|
0.45%
1/224 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
0.00%
0/213 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign hydatidiform mole
|
0.00%
0/224 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
0.47%
1/213 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
|
Pregnancy, puerperium and perinatal conditions
Blighted ovum
|
0.00%
0/224 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
0.47%
1/213 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
|
Infections and infestations
Bronchiectasis
|
0.45%
1/224 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
0.00%
0/213 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
|
Psychiatric disorders
Depression suicidal
|
0.45%
1/224 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
0.00%
0/213 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.45%
1/224 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
0.00%
0/213 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/224 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
0.47%
1/213 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
|
Metabolism and nutrition disorders
Gestational diabetes
|
0.45%
1/224 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
0.00%
0/213 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
|
Pregnancy, puerperium and perinatal conditions
Intra-uterine death
|
0.00%
0/224 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
0.47%
1/213 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.45%
1/224 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
0.00%
0/213 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
|
Nervous system disorders
Myelitis
|
0.45%
1/224 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
0.00%
0/213 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.45%
1/224 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
0.00%
0/213 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
|
Pregnancy, puerperium and perinatal conditions
Oligohydramnios
|
0.00%
0/224 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
0.47%
1/213 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/224 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
0.47%
1/213 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/224 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
0.47%
1/213 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
|
Infections and infestations
Pneumonia primary atypical
|
0.45%
1/224 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
0.00%
0/213 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
0.00%
0/224 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
0.47%
1/213 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/224 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
0.47%
1/213 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
|
Renal and urinary disorders
Renal artery thrombosis
|
0.45%
1/224 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
0.00%
0/213 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
|
Psychiatric disorders
Suicide attempt
|
0.45%
1/224 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
0.00%
0/213 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
|
Vascular disorders
Varicose vein
|
0.45%
1/224 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
0.00%
0/213 • Serious adverse events: during the follow-up period up to Year 9.
Only serious adverse events were assessed in the study and no other symptoms.
|
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
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