Trial Outcomes & Findings for Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects (NCT NCT00947115)
NCT ID: NCT00947115
Last Updated: 2020-10-30
Results Overview
Anti-HPV-16/18 antibody titers are presented as Geometric Mean Titers (GMTs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The immune response of the HPV-16/18 vaccine (as determined by anti-HPV-16/18 antibodies assessed by ELISA) in the HPV-060 study population was compared with the immune response obtained in study HPV-001 and its long-term follow-up studies HPV-007/HPV-023 at equivalent timepoints and with the immune response obtained after natural infection in subjects from study HPV-008. The immune response data for the efficacy studies HPV-001/HPV-007/HPV-023 can be found under the NCT record NCT00518336. The immune response data for the HPV-008 study can be found under the NCT record NCT00122681.
COMPLETED
PHASE3
525 participants
At Years 5, 6 and 7
2020-10-30
Participant Flow
This study was conducted at six centers in Germany and Poland.
Out of the 525 enrolled subjects, 1 subject was excluded for not receiving vaccination and the actual starting number was 524.
Participant milestones
| Measure |
Cervarix 15-25 Years Group
Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 26-45 Years Group
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 46-55 Years Group
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
|---|---|---|---|
|
Overall Study
STARTED
|
159
|
194
|
171
|
|
Overall Study
COMPLETED
|
142
|
172
|
156
|
|
Overall Study
NOT COMPLETED
|
17
|
22
|
15
|
Reasons for withdrawal
| Measure |
Cervarix 15-25 Years Group
Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 26-45 Years Group
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 46-55 Years Group
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
|---|---|---|---|
|
Overall Study
Missed reporting interval
|
3
|
4
|
2
|
|
Overall Study
Physician Decision
|
0
|
2
|
0
|
|
Overall Study
Death
|
0
|
1
|
1
|
|
Overall Study
Migrated from study area
|
2
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
4
|
|
Overall Study
Lost to Follow-up
|
11
|
12
|
8
|
Baseline Characteristics
Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects
Baseline characteristics by cohort
| Measure |
Cervarix 15-25 Years Group
n=159 Participants
Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 26-45 Years Group
n=194 Participants
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 46-55 Years Group
n=171 Participants
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Total
n=524 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
25.7 Years
STANDARD_DEVIATION 2.82 • n=5 Participants
|
41.0 Years
STANDARD_DEVIATION 6.02 • n=7 Participants
|
54.4 Years
STANDARD_DEVIATION 3.15 • n=5 Participants
|
40.9 Years
STANDARD_DEVIATION 12.22 • n=4 Participants
|
|
Sex: Female, Male
Female
|
159 Participants
n=5 Participants
|
194 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
524 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
159 Participants
n=5 Participants
|
193 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
523 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At Years 5, 6 and 7Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Years 5, 6 and 7, which included all evaluable subjects from the ATP cohort for immunogenicity of the primary study HPV-014 (NCT00196937), who were seronegative before vaccination and for whom immunogenicity data at Years 5, 6 and 7 were available.
Anti-HPV-16/18 antibody titers are presented as Geometric Mean Titers (GMTs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The immune response of the HPV-16/18 vaccine (as determined by anti-HPV-16/18 antibodies assessed by ELISA) in the HPV-060 study population was compared with the immune response obtained in study HPV-001 and its long-term follow-up studies HPV-007/HPV-023 at equivalent timepoints and with the immune response obtained after natural infection in subjects from study HPV-008. The immune response data for the efficacy studies HPV-001/HPV-007/HPV-023 can be found under the NCT record NCT00518336. The immune response data for the HPV-008 study can be found under the NCT record NCT00122681.
Outcome measures
| Measure |
Cervarix 15-25 Years Group
n=134 Participants
Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 26-45 Years Group
n=146 Participants
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 46-55 Years Group
n=146 Participants
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
|---|---|---|---|
|
Anti-Human Papillomavirus (Anti-HPV)-16/18 Antibody Titers in Serum at Years 5, 6 and 7
Anti-HPV-16 [Year 5]
|
1495.7 EL.U/mL
Interval 1249.2 to 1790.9
|
518.7 EL.U/mL
Interval 423.2 to 635.6
|
282.4 EL.U/mL
Interval 234.3 to 340.5
|
|
Anti-Human Papillomavirus (Anti-HPV)-16/18 Antibody Titers in Serum at Years 5, 6 and 7
Anti-HPV-16 [Year 6]
|
1344.6 EL.U/mL
Interval 1130.2 to 1599.6
|
526.0 EL.U/mL
Interval 434.7 to 636.4
|
277.7 EL.U/mL
Interval 228.0 to 338.2
|
|
Anti-Human Papillomavirus (Anti-HPV)-16/18 Antibody Titers in Serum at Years 5, 6 and 7
Anti-HPV-16 [Year 7]
|
1014.0 EL.U/mL
Interval 847.0 to 1214.0
|
369.5 EL.U/mL
Interval 295.7 to 461.7
|
201.4 EL.U/mL
Interval 163.6 to 247.9
|
|
Anti-Human Papillomavirus (Anti-HPV)-16/18 Antibody Titers in Serum at Years 5, 6 and 7
Anti-HPV-18 [Year 5]
|
440.4 EL.U/mL
Interval 367.8 to 527.2
|
168.8 EL.U/mL
Interval 140.7 to 202.4
|
104.6 EL.U/mL
Interval 86.0 to 127.2
|
|
Anti-Human Papillomavirus (Anti-HPV)-16/18 Antibody Titers in Serum at Years 5, 6 and 7
Anti-HPV-18 [Year 6]
|
438.2 EL.U/mL
Interval 366.6 to 523.7
|
167.5 EL.U/mL
Interval 138.1 to 203.1
|
97.6 EL.U/mL
Interval 79.2 to 120.3
|
|
Anti-Human Papillomavirus (Anti-HPV)-16/18 Antibody Titers in Serum at Years 5, 6 and 7
Anti-HPV-18 [Year 7]
|
307.8 EL.U/mL
Interval 256.2 to 369.7
|
119.8 EL.U/mL
Interval 98.4 to 145.9
|
81.7 EL.U/mL
Interval 65.7 to 101.5
|
PRIMARY outcome
Timeframe: At Years 8, 9 and 10Population: The analysis was performed on the ATP cohort for immunogenicity at Years 8, 9 and 10, which included all evaluable subjects from the ATP cohort for immunogenicity of the primary study HPV-014 (NCT00196937), who were seronegative before vaccination and for whom immunogenicity data at Years 8, 9 and 10 were available.
Anti-HPV-16/18 antibody titers are presented as Geometric Mean Titers (GMTs) and expressed in EL.U/mL. The immune response of the HPV-16/18 vaccine (as determined by anti-HPV-16/18 antibodies assessed by ELISA) in the HPV-060 study population was compared with the immune response obtained in study HPV-001 and its long-term follow-up studies HPV-007/HPV-023 at equivalent timepoints and with the immune response obtained after natural infection in subjects from study HPV-008. The immune response data for the efficacy studies HPV-001/HPV-007/HPV-023 can be found under the NCT number NCT00518336. The immune response data for the HPV-008 study can be found under the NCT number NCT00122681.
Outcome measures
| Measure |
Cervarix 15-25 Years Group
n=132 Participants
Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 26-45 Years Group
n=148 Participants
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 46-55 Years Group
n=132 Participants
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
|---|---|---|---|
|
Anti-HPV-16/18 Antibody Titers in Serum at Years 8, 9 and 10
Anti-HPV-18 [Year 10]
|
321.1 EL.U/mL
Interval 265.0 to 389.1
|
115.4 EL.U/mL
Interval 93.9 to 142.0
|
69.7 EL.U/mL
Interval 56.0 to 86.8
|
|
Anti-HPV-16/18 Antibody Titers in Serum at Years 8, 9 and 10
Anti-HPV-16 [Year 8]
|
1123.3 EL.U/mL
Interval 930.2 to 1356.5
|
392.1 EL.U/mL
Interval 315.3 to 487.7
|
189.1 EL.U/mL
Interval 153.0 to 233.7
|
|
Anti-HPV-16/18 Antibody Titers in Serum at Years 8, 9 and 10
Anti-HPV-16 [Year 9]
|
980.9 EL.U/mL
Interval 825.5 to 1165.6
|
366.5 EL.U/mL
Interval 303.5 to 442.6
|
180.2 EL.U/mL
Interval 148.4 to 218.7
|
|
Anti-HPV-16/18 Antibody Titers in Serum at Years 8, 9 and 10
Anti-HPV-16 [Year 10]
|
965.4 EL.U/mL
Interval 802.2 to 1161.8
|
334.4 EL.U/mL
Interval 270.5 to 413.5
|
157.4 EL.U/mL
Interval 128.4 to 193.1
|
|
Anti-HPV-16/18 Antibody Titers in Serum at Years 8, 9 and 10
Anti-HPV-18 [Year 8]
|
375.1 EL.U/mL
Interval 310.6 to 453.0
|
134.1 EL.U/mL
Interval 107.5 to 167.4
|
82.6 EL.U/mL
Interval 65.9 to 103.6
|
|
Anti-HPV-16/18 Antibody Titers in Serum at Years 8, 9 and 10
Anti-HPV-18 [Year 9]
|
327.4 EL.U/mL
Interval 273.4 to 392.1
|
122.5 EL.U/mL
Interval 101.1 to 148.4
|
75.6 EL.U/mL
Interval 60.9 to 94.0
|
PRIMARY outcome
Timeframe: At Years 5, 6 and 7Population: The analysis was performed on the ATP cohort for immunogenicity at Years 5, 6 and 7, which included all evaluable subjects from the ATP cohort for immunogenicity of the primary study HPV-014 (NCT00196937), who were seronegative before vaccination and for whom immunogenicity data at Years 5, 6 and 7 were available.
Seroconversion was defined as the appearance of anti-HPV-16 and anti- HPV-18 antibodies \[i.e. antibody titer greater than or equal to (≥) the cut-off value\] in the serum of subjects seronegative before vaccination in the primary study HPV-014 (NCT00196937). Cut-off values were 8 EL.U/mL for anti-HPV-16 antibody titers and 7 EL.U/mL for anti-HPV-18 antibody titers.
Outcome measures
| Measure |
Cervarix 15-25 Years Group
n=134 Participants
Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 26-45 Years Group
n=146 Participants
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 46-55 Years Group
n=146 Participants
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
|---|---|---|---|
|
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 5, 6 and 7
anti-HPV-16 [Year 6]
|
128 Participants
|
130 Participants
|
116 Participants
|
|
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 5, 6 and 7
anti-HPV-16 [Year 5]
|
128 Participants
|
127 Participants
|
118 Participants
|
|
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 5, 6 and 7
anti-HPV-16 [Year 7]
|
125 Participants
|
119 Participants
|
111 Participants
|
|
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 5, 6 and 7
anti-HPV-18 [Year 5]
|
134 Participants
|
144 Participants
|
143 Participants
|
|
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 5, 6 and 7
anti-HPV-18 [Year 6]
|
133 Participants
|
146 Participants
|
138 Participants
|
|
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 5, 6 and 7
anti-HPV-18 [Year 7]
|
130 Participants
|
135 Participants
|
131 Participants
|
PRIMARY outcome
Timeframe: At Years 8, 9 and 10Population: The analysis was performed on the ATP cohort for immunogenicity at Years 8, 9 and 10, which included all evaluable subjects from the ATP cohort for immunogenicity of the primary study HPV-014 (NCT00196937), who were seronegative before vaccination and for whom immunogenicity data at Years 8, 9 and 10 were available.
Seroconversion was defined as the appearance of anti-HPV-16 and anti-HPV-18 antibodies (i.e. antibody titer ≥ the cut-off value) in the serum of subjects seronegative before vaccination in the primary study HPV-014 (NCT00196937). Cut-off values were 19 EL.U/mL for anti-HPV-16 antibody titers and 18 EL.U/mL for anti-HPV-18 antibody titers.
Outcome measures
| Measure |
Cervarix 15-25 Years Group
n=132 Participants
Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 26-45 Years Group
n=148 Participants
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 46-55 Years Group
n=132 Participants
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
|---|---|---|---|
|
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 8, 9 and 10
anti-HPV-18 [Year 8]
|
120 Participants
|
118 Participants
|
104 Participants
|
|
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 8, 9 and 10
anti-HPV-16 [Year 8]
|
116 Participants
|
106 Participants
|
95 Participants
|
|
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 8, 9 and 10
anti-HPV-16 [Year 9]
|
127 Participants
|
132 Participants
|
106 Participants
|
|
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 8, 9 and 10
anti-HPV-16 [Year 10]
|
123 Participants
|
120 Participants
|
103 Participants
|
|
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 8, 9 and 10
anti-HPV-18 [Year 9]
|
132 Participants
|
141 Participants
|
113 Participants
|
|
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 8, 9 and 10
anti-HPV-18 [Year 10]
|
126 Participants
|
133 Participants
|
109 Participants
|
SECONDARY outcome
Timeframe: At Year 5 and Year 6Population: Analysis was performed on a subset of subjects from the Total Vaccinated Cohort (TVC), who volunteered for CVS sample collection at Years 5 and 6 and for whom the collected CVS sample contained less than 200 erythrocytes per microliter.
Anti-HPV-16/18 titers in CVS samples are presented as GMTs and expressed in EL.U/mL.
Outcome measures
| Measure |
Cervarix 15-25 Years Group
n=39 Participants
Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 26-45 Years Group
n=39 Participants
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 46-55 Years Group
n=28 Participants
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
|---|---|---|---|
|
Anti-HPV-16/18 Secretion Antibody Titers in Cervico-vaginal Secretion (CVS) Samples at Years 5 and 6 in a Subset of Subjects
Anti-HPV-18 [Year 5]
|
30.9 EL.U/mL
Interval 20.9 to 45.6
|
24.6 EL.U/mL
Interval 14.8 to 41.0
|
33.3 EL.U/mL
Interval 15.8 to 70.0
|
|
Anti-HPV-16/18 Secretion Antibody Titers in Cervico-vaginal Secretion (CVS) Samples at Years 5 and 6 in a Subset of Subjects
Anti-HPV-16 [Year 5]
|
90.2 EL.U/mL
Interval 61.9 to 131.3
|
47.2 EL.U/mL
Interval 32.2 to 69.2
|
56.8 EL.U/mL
Interval 28.7 to 112.4
|
|
Anti-HPV-16/18 Secretion Antibody Titers in Cervico-vaginal Secretion (CVS) Samples at Years 5 and 6 in a Subset of Subjects
Anti-HPV-16 [Year 6]
|
80.3 EL.U/mL
Interval 46.8 to 137.8
|
43.8 EL.U/mL
Interval 26.0 to 73.9
|
37.1 EL.U/mL
Interval 20.8 to 66.0
|
|
Anti-HPV-16/18 Secretion Antibody Titers in Cervico-vaginal Secretion (CVS) Samples at Years 5 and 6 in a Subset of Subjects
Anti-HPV-18 [Year 6]
|
22.9 EL.U/mL
Interval 13.8 to 37.9
|
19.9 EL.U/mL
Interval 11.4 to 34.9
|
19.2 EL.U/mL
Interval 11.7 to 31.8
|
SECONDARY outcome
Timeframe: At Years 7, 8, 9 and 10Population: Analysis was performed on a subset of subjects from the TVC, who volunteered for CVS sample collection at Years 7, 8, 9 and 10 and for whom the collected CVS sample contained less than 200 erythrocytes per microliter.
Anti-HPV-16/18 titers in CVS samples are presented as GMTs and expressed in EL.U/mL.
Outcome measures
| Measure |
Cervarix 15-25 Years Group
n=41 Participants
Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 26-45 Years Group
n=40 Participants
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 46-55 Years Group
n=32 Participants
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
|---|---|---|---|
|
Anti-HPV-16/18 Secretion Antibody Titers in CVS Samples at Years 7, 8, 9 and 10 in a Subset of Subjects
Anti-HPV-16 [Year 7]
|
63.0 EL.U/mL
Interval 38.6 to 102.9
|
33.3 EL.U/mL
Interval 21.6 to 51.2
|
42.3 EL.U/mL
Interval 25.0 to 71.5
|
|
Anti-HPV-16/18 Secretion Antibody Titers in CVS Samples at Years 7, 8, 9 and 10 in a Subset of Subjects
Anti-HPV-18 [Year 7]
|
33.5 EL.U/mL
Interval 19.8 to 56.6
|
17.5 EL.U/mL
Interval 10.2 to 30.1
|
49.0 EL.U/mL
Interval 22.4 to 107.3
|
|
Anti-HPV-16/18 Secretion Antibody Titers in CVS Samples at Years 7, 8, 9 and 10 in a Subset of Subjects
Anti-HPV-16 [Year 8]
|
45.6 EL.U/mL
Interval 29.6 to 70.1
|
43.9 EL.U/mL
Interval 24.8 to 77.7
|
54.6 EL.U/mL
Interval 34.3 to 86.8
|
|
Anti-HPV-16/18 Secretion Antibody Titers in CVS Samples at Years 7, 8, 9 and 10 in a Subset of Subjects
Anti-HPV-18 [Year 8]
|
17.8 EL.U/mL
Interval 11.2 to 28.4
|
26.2 EL.U/mL
Interval 14.7 to 46.8
|
31.9 EL.U/mL
Interval 14.7 to 69.2
|
|
Anti-HPV-16/18 Secretion Antibody Titers in CVS Samples at Years 7, 8, 9 and 10 in a Subset of Subjects
Anti-HPV-16 [Year 9]
|
67.7 EL.U/mL
Interval 45.4 to 101.0
|
42.6 EL.U/mL
Interval 23.6 to 76.8
|
62.6 EL.U/mL
Interval 36.7 to 106.5
|
|
Anti-HPV-16/18 Secretion Antibody Titers in CVS Samples at Years 7, 8, 9 and 10 in a Subset of Subjects
Anti-HPV-18 [Year 9]
|
28.1 EL.U/mL
Interval 18.5 to 42.8
|
23.9 EL.U/mL
Interval 15.8 to 36.1
|
50.4 EL.U/mL
Interval 25.1 to 101.3
|
|
Anti-HPV-16/18 Secretion Antibody Titers in CVS Samples at Years 7, 8, 9 and 10 in a Subset of Subjects
Anti-HPV-16 [Year 10]
|
43.4 EL.U/mL
Interval 28.1 to 67.1
|
34.3 EL.U/mL
Interval 24.1 to 48.7
|
56.0 EL.U/mL
Interval 31.5 to 99.7
|
|
Anti-HPV-16/18 Secretion Antibody Titers in CVS Samples at Years 7, 8, 9 and 10 in a Subset of Subjects
Anti-HPV-18 [Year 10]
|
29.4 EL.U/mL
Interval 17.6 to 49.4
|
22.7 EL.U/mL
Interval 13.8 to 37.3
|
45.1 EL.U/mL
Interval 22.9 to 88.6
|
SECONDARY outcome
Timeframe: At Year 5 and Year 6Population: Analysis was performed on a subset of subjects from the TVC, who volunteered for CVS sample collection at Year 5 and Year 6 and for whom the collected CVS sample contained less than 200 erythrocytes per microliter.
IgG antibody titers in CVS samples are presented as GMTs and expressed in microgram per milliliter (µg/mL).
Outcome measures
| Measure |
Cervarix 15-25 Years Group
n=39 Participants
Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 26-45 Years Group
n=39 Participants
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 46-55 Years Group
n=28 Participants
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
|---|---|---|---|
|
Total Immunoglobulin G (IgG) Secretion Antibody Titers in CVS Samples at Years 5 and 6 in a Subset of Subjects
IgG secretion antibodies [Year 6]
|
546.5 µg/mL
Interval 352.2 to 848.2
|
499.8 µg/mL
Interval 327.7 to 762.2
|
1012.9 µg/mL
Interval 696.7 to 1472.6
|
|
Total Immunoglobulin G (IgG) Secretion Antibody Titers in CVS Samples at Years 5 and 6 in a Subset of Subjects
IgG secretion antibodies [Year 5]
|
577.8 µg/mL
Interval 411.3 to 811.6
|
550.5 µg/mL
Interval 373.7 to 811.0
|
990.6 µg/mL
Interval 540.2 to 1816.4
|
SECONDARY outcome
Timeframe: At Years 7, 8, 9 and 10Population: Analysis was performed on a subset of subjects from the TVC, who volunteered for CVS sample collection at Years 7, 8, 9, 10 and for whom the collected CVS sample contained less than 200 erythrocytes per microliter.
Total IgG antibody titers in CVS samples are presented as GMTs and expressed in microgram per milliliter (µg/mL).
Outcome measures
| Measure |
Cervarix 15-25 Years Group
n=39 Participants
Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 26-45 Years Group
n=37 Participants
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 46-55 Years Group
n=32 Participants
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
|---|---|---|---|
|
Total IgG Secretion Antibody Titers in CVS Samples at Years 7, 8, 9, and 10 in a Subset of Subjects
IgG secretion antibodies [Year 7]
|
517.5 µg/mL
Interval 348.1 to 769.4
|
372.2 µg/mL
Interval 236.7 to 585.4
|
1263.2 µg/mL
Interval 793.8 to 2010.2
|
|
Total IgG Secretion Antibody Titers in CVS Samples at Years 7, 8, 9, and 10 in a Subset of Subjects
IgG secretion antibodies [Year 8]
|
304.8 µg/mL
Interval 211.1 to 440.1
|
457.2 µg/mL
Interval 308.2 to 678.2
|
928.2 µg/mL
Interval 578.0 to 1490.6
|
|
Total IgG Secretion Antibody Titers in CVS Samples at Years 7, 8, 9, and 10 in a Subset of Subjects
IgG secretion antibodies [Year 9]
|
435.1 µg/mL
Interval 293.2 to 645.8
|
460.4 µg/mL
Interval 301.7 to 702.4
|
925.8 µg/mL
Interval 586.3 to 1461.8
|
|
Total IgG Secretion Antibody Titers in CVS Samples at Years 7, 8, 9, and 10 in a Subset of Subjects
IgG secretion antibodies [Year 10]
|
315.3 µg/mL
Interval 237.9 to 417.8
|
373.5 µg/mL
Interval 259.9 to 536.8
|
622.9 µg/mL
Interval 405.2 to 957.5
|
SECONDARY outcome
Timeframe: At Years 5, 6 and 7Population: The analysis was performed on the ATP cohort for immunogenicity at Years 5, 6 and 7, which included all evaluable subjects from the ATP cohort for immunogenicity of the primary study HPV-014 (NCT00196937) and for whom immunogenicity data at Years 5, 6 and 7 were available.
Total IgG antibody titers are presented as GMTs and expressed in µg/mL.
Outcome measures
| Measure |
Cervarix 15-25 Years Group
n=68 Participants
Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 26-45 Years Group
n=65 Participants
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 46-55 Years Group
n=60 Participants
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
|---|---|---|---|
|
Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the ATP Cohort for Immunogenicity
Total IgG serum antibodies [Year 5]
|
19481.8 µg/mL
Interval 18076.2 to 20996.8
|
18388.2 µg/mL
Interval 16844.6 to 20073.3
|
17657.2 µg/mL
Interval 16046.7 to 19429.4
|
|
Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the ATP Cohort for Immunogenicity
Total IgG serum antibodies [Year 6]
|
13376.5 µg/mL
Interval 12498.7 to 14315.9
|
12262.7 µg/mL
Interval 11304.8 to 13301.8
|
12040.2 µg/mL
Interval 10854.4 to 13355.7
|
|
Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the ATP Cohort for Immunogenicity
Total IgG serum antibodies [Year 7]
|
13957.2 µg/mL
Interval 13116.6 to 14851.7
|
13179.4 µg/mL
Interval 12287.7 to 14135.7
|
12992.9 µg/mL
Interval 12096.9 to 13955.4
|
SECONDARY outcome
Timeframe: At Years 8, 9 and 10Population: The analysis was performed on the ATP cohort for immunogenicity at Years 8, 9 and 10, which included all evaluable subjects from the ATP cohort for immunogenicity of the primary study HPV-014 (NCT00196937) and for whom immunogenicity data at Years 8, 9 and 10 were available.
Total IgG antibody titers are presented as GMTs and expressed in µg/mL.
Outcome measures
| Measure |
Cervarix 15-25 Years Group
n=61 Participants
Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 26-45 Years Group
n=62 Participants
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 46-55 Years Group
n=55 Participants
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
|---|---|---|---|
|
Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the ATP Cohort for Immunogenicity
Total IgG serum antibodies [Year 8]
|
11059.5 µg/mL
Interval 10547.8 to 11596.0
|
10656.3 µg/mL
Interval 10057.6 to 11290.6
|
10605.7 µg/mL
Interval 10061.4 to 11179.5
|
|
Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the ATP Cohort for Immunogenicity
Total IgG serum antibodies [Year 9]
|
11212.2 µg/mL
Interval 10661.3 to 11791.6
|
10693.8 µg/mL
Interval 10067.0 to 11359.7
|
10427.8 µg/mL
Interval 9871.3 to 11015.6
|
|
Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the ATP Cohort for Immunogenicity
Total IgG serum antibodies [Year 10]
|
11071.3 µg/mL
Interval 10546.9 to 11621.8
|
10650.8 µg/mL
Interval 10079.2 to 11254.7
|
10535.0 µg/mL
Interval 9979.4 to 11121.5
|
SECONDARY outcome
Timeframe: At Years 5, 6 and 7Population: The analysis was performed on the TVC at Years 5, 6 and 7, which included all vaccinated subjects \[i.e. all subjects who received 3 doses of HPV vaccine in the primary study HPV-014 (NCT00196937)\] for whom data at Years 5, 6 and 7 were available.
Total IgG antibody titers are presented as GMTs and expressed in µg/mL.
Outcome measures
| Measure |
Cervarix 15-25 Years Group
n=69 Participants
Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 26-45 Years Group
n=68 Participants
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 46-55 Years Group
n=61 Participants
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
|---|---|---|---|
|
Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the TVC
Total IgG serum antibodies [Year 5]
|
19453.0 µg/mL
Interval 18068.5 to 20943.6
|
18092.4 µg/mL
Interval 16566.3 to 19759.1
|
17885.0 µg/mL
Interval 16224.1 to 19715.9
|
|
Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the TVC
Total IgG serum antibodies [Year 6]
|
13318.5 µg/mL
Interval 12458.3 to 14238.1
|
12173.1 µg/mL
Interval 11231.2 to 13193.9
|
12040.2 µg/mL
Interval 10854.4 to 13355.7
|
|
Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the TVC
Total IgG serum antibodies [Year 7]
|
13957.2 µg/mL
Interval 13116.6 to 14851.7
|
13059.5 µg/mL
Interval 12205.2 to 13973.6
|
13052.9 µg/mL
Interval 12160.9 to 14010.5
|
SECONDARY outcome
Timeframe: At Years 8, 9 and 10Population: The analysis was performed on the Total Vaccinated Cohort at Years 8, 9 and 10, which included all vaccinated subjects \[i.e. all subjects who received 3 doses of HPV vaccine in the primary study HPV-014 (NCT00196937)\] for whom data at Years 8, 9 and 10 were available.
Total IgG antibody titers are presented as GMTs and expressed in µg/mL.
Outcome measures
| Measure |
Cervarix 15-25 Years Group
n=62 Participants
Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 26-45 Years Group
n=66 Participants
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 46-55 Years Group
n=57 Participants
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
|---|---|---|---|
|
Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the TVC
Total IgG serum antibodies [Year 9]
|
11212.2 µg/mL
Interval 10661.3 to 11791.6
|
10693.8 µg/mL
Interval 10067.0 to 11359.7
|
10427.8 µg/mL
Interval 9871.3 to 11015.6
|
|
Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the TVC
Total IgG serum antibodies [Year 8]
|
11084.4 µg/mL
Interval 10578.2 to 11614.8
|
10602.4 µg/mL
Interval 10010.8 to 11229.1
|
10725.5 µg/mL
Interval 10151.1 to 11332.4
|
|
Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the TVC
Total IgG serum antibodies [Year 10]
|
11043.6 µg/mL
Interval 10526.3 to 11586.4
|
10511.3 µg/mL
Interval 9938.6 to 11117.0
|
10484.8 µg/mL
Interval 9947.5 to 11051.1
|
SECONDARY outcome
Timeframe: From Year 4 in primary study HPV-014 (NCT00196937) up to Year 5 in present HPV-060 studyPopulation: The analysis was based on the TVC at Year 5, which included all vaccinated subjects \[i.e. all subjects who received 3 doses of HPV vaccine in the primary study HPV-014 (NCT00196937)\] for whom data were available at Year 5.
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject, or may have evolved into one of the outcomes listed above. Related SAE = SAE assessed by the investigator as causally related to the study vaccine administered in study HPV-014 (NCT00196937).
Outcome measures
| Measure |
Cervarix 15-25 Years Group
n=153 Participants
Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 26-45 Years Group
n=184 Participants
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 46-55 Years Group
n=170 Participants
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
|---|---|---|---|
|
Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 4 in Primary Study HPV-014 (NCT00196937) to Year 5 in the Present Study
Fatal SAE(s)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 4 in Primary Study HPV-014 (NCT00196937) to Year 5 in the Present Study
Related SAE(s)
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Year 5 up to Year 6Population: The analysis was based on the TVC at Year 6, which included all vaccinated subjects \[i.e. all subjects who received 3 doses of HPV vaccine in the primary study HPV-014 (NCT00196937)\] for whom data were available at Year 6.
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject, or may have evolved into one of the outcomes listed above. Related SAE = SAE assessed by the investigator as causally related to the study vaccine administered in study HPV-014 (NCT00196937).
Outcome measures
| Measure |
Cervarix 15-25 Years Group
n=147 Participants
Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 26-45 Years Group
n=177 Participants
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 46-55 Years Group
n=164 Participants
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
|---|---|---|---|
|
Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 5 to Year 6
Fatal SAE(s)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 5 to Year 6
Related SAE(s)
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Year 6 up to Year 7Population: The analysis was based on the TVC at Year 7, which included all vaccinated subjects \[i.e. all subjects who received 3 doses of HPV vaccine in the primary study HPV-014 (NCT00196937)\] for whom data were available at Year 7.
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject, or may have evolved into one of the outcomes listed above. Related SAE = SAE assessed by the investigator as causally related to the study vaccine administered in study HPV-014 (NCT00196937).
Outcome measures
| Measure |
Cervarix 15-25 Years Group
n=149 Participants
Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 26-45 Years Group
n=165 Participants
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 46-55 Years Group
n=160 Participants
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
|---|---|---|---|
|
Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 6 to Year 7
Related SAE(s)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 6 to Year 7
Fatal SAE(s)
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Year 7 up to Year 8Population: The analysis was based on the TVC at Year 8, which included all vaccinated subjects \[i.e. all subjects who received 3 doses of HPV vaccine in the primary study HPV-014 (NCT00196937)\] for whom data were available at Year 8.
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject, or may have evolved into one of the outcomes listed above. Related SAE = SAE assessed by the investigator as causally related to the study vaccine administered in study HPV-014 (NCT00196937).
Outcome measures
| Measure |
Cervarix 15-25 Years Group
n=137 Participants
Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 26-45 Years Group
n=152 Participants
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 46-55 Years Group
n=141 Participants
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
|---|---|---|---|
|
Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 7 to Year 8
Fatal SAE(s)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 7 to Year 8
Related SAE(s)
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Year 8 up to Year 9Population: The analysis was based on the TVC at Year 9, which included all vaccinated subjects \[i.e. all subjects who received 3 doses of HPV vaccine in the primary study HPV-014 (NCT00196937)\] for whom data were available at Year 9.
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject, or may have evolved into one of the outcomes listed above. Related SAE = SAE assessed by the investigator as causally related to the study vaccine administered in study HPV-014 (NCT00196937).
Outcome measures
| Measure |
Cervarix 15-25 Years Group
n=146 Participants
Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 26-45 Years Group
n=180 Participants
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 46-55 Years Group
n=157 Participants
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
|---|---|---|---|
|
Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 8 to Year 9
Fatal SAE(s)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 8 to Year 9
Related SAE(s)
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Year 9 up to Year 10Population: The analysis was based on the TVC at Year 10, which included all vaccinated subjects \[i.e. all subjects who received 3 doses of HPV vaccine in the primary study HPV-014 (NCT00196937)\] for whom data were available at Year 10.
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject, or may have evolved into one of the outcomes listed above. Related SAE = SAE assessed by the investigator as causally related to the study vaccine administered in study HPV-014 (NCT00196937).
Outcome measures
| Measure |
Cervarix 15-25 Years Group
n=142 Participants
Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 26-45 Years Group
n=172 Participants
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 46-55 Years Group
n=156 Participants
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
|---|---|---|---|
|
Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 9 to Year 10
Fatal SAE(s)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 9 to Year 10
Related SAE(s)
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Year 0 up to Year 10Population: The analysis was performed on the TVC that included all vaccinated subjects \[i.e. all subjects who received 3 doses of HPV vaccine in the primary study HPV-014 (NCT00196937)\] for whom data were available throughout the study.
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Related SAE = SAE assessed by the investigator as causally related to the study vaccine administered in study HPV-014 (NCT00196937).
Outcome measures
| Measure |
Cervarix 15-25 Years Group
n=159 Participants
Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 26-45 Years Group
n=194 Participants
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 46-55 Years Group
n=171 Participants
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
|---|---|---|---|
|
Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 0 to Year 10
Fatal SAE(s)
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 0 to Year 10
Related SAE(s)
|
0 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Cervarix 15-25 Years Group
Cervarix 26-45 Years Group
Cervarix 46-55 Years Group
Serious adverse events
| Measure |
Cervarix 15-25 Years Group
n=159 participants at risk
Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 26-45 Years Group
n=194 participants at risk
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
Cervarix 46-55 Years Group
n=171 participants at risk
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/159 • SAEs: Throughout the entire study period (from Year 0 up to the Year 10).
Other (non-serious) Adverse Events and solicited symptoms were not collected/assessed. This section displays the safety analysis on the subjects who participated in the primary study HPV-014 (NCT00196937), excluding those who were not selected or not consented for the present study HPV-060 (NCT00947115).
|
0.52%
1/194 • SAEs: Throughout the entire study period (from Year 0 up to the Year 10).
Other (non-serious) Adverse Events and solicited symptoms were not collected/assessed. This section displays the safety analysis on the subjects who participated in the primary study HPV-014 (NCT00196937), excluding those who were not selected or not consented for the present study HPV-060 (NCT00947115).
|
0.00%
0/171 • SAEs: Throughout the entire study period (from Year 0 up to the Year 10).
Other (non-serious) Adverse Events and solicited symptoms were not collected/assessed. This section displays the safety analysis on the subjects who participated in the primary study HPV-014 (NCT00196937), excluding those who were not selected or not consented for the present study HPV-060 (NCT00947115).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/159 • SAEs: Throughout the entire study period (from Year 0 up to the Year 10).
Other (non-serious) Adverse Events and solicited symptoms were not collected/assessed. This section displays the safety analysis on the subjects who participated in the primary study HPV-014 (NCT00196937), excluding those who were not selected or not consented for the present study HPV-060 (NCT00947115).
|
0.00%
0/194 • SAEs: Throughout the entire study period (from Year 0 up to the Year 10).
Other (non-serious) Adverse Events and solicited symptoms were not collected/assessed. This section displays the safety analysis on the subjects who participated in the primary study HPV-014 (NCT00196937), excluding those who were not selected or not consented for the present study HPV-060 (NCT00947115).
|
0.58%
1/171 • SAEs: Throughout the entire study period (from Year 0 up to the Year 10).
Other (non-serious) Adverse Events and solicited symptoms were not collected/assessed. This section displays the safety analysis on the subjects who participated in the primary study HPV-014 (NCT00196937), excluding those who were not selected or not consented for the present study HPV-060 (NCT00947115).
|
|
Reproductive system and breast disorders
Cervical displasia
|
0.00%
0/159 • SAEs: Throughout the entire study period (from Year 0 up to the Year 10).
Other (non-serious) Adverse Events and solicited symptoms were not collected/assessed. This section displays the safety analysis on the subjects who participated in the primary study HPV-014 (NCT00196937), excluding those who were not selected or not consented for the present study HPV-060 (NCT00947115).
|
0.52%
1/194 • SAEs: Throughout the entire study period (from Year 0 up to the Year 10).
Other (non-serious) Adverse Events and solicited symptoms were not collected/assessed. This section displays the safety analysis on the subjects who participated in the primary study HPV-014 (NCT00196937), excluding those who were not selected or not consented for the present study HPV-060 (NCT00947115).
|
0.00%
0/171 • SAEs: Throughout the entire study period (from Year 0 up to the Year 10).
Other (non-serious) Adverse Events and solicited symptoms were not collected/assessed. This section displays the safety analysis on the subjects who participated in the primary study HPV-014 (NCT00196937), excluding those who were not selected or not consented for the present study HPV-060 (NCT00947115).
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER