Trial Outcomes & Findings for Human Papilloma Virus (HPV) Vaccine Immunogenicity and Safety Trial in Young and Adult Women With GSK Biologicals' HPV-16/18 (NCT NCT00196937)
NCT ID: NCT00196937
Last Updated: 2019-12-11
Results Overview
Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies \[i.e. antibody titer greater than or equal to (≥) the cut-off value\] in the sera of subjects seronegative before vaccination. Cut-off values were 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies. Data for the Cervarix (46-55 Years) Group are presented in the Secondary Outcomes as per Protocol.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
667 participants
Primary outcome timeframe
At Month 7
Results posted on
2019-12-11
Participant Flow
Out of the 667 enrolled subjects, 1 subject was excluded for not receiving vaccination and the actual starting number was 666.
Participant milestones
| Measure |
Cervarix (15-25 Years) Group
Women aged 15 to 25 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
Cervarix (26-45 Years) Group
Women aged 26 to 45 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
Cervarix (46-55 Years) Group
Women aged 46 to 55 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Overall Study
STARTED
|
229
|
226
|
211
|
|
Overall Study
COMPLETED
|
220
|
221
|
204
|
|
Overall Study
NOT COMPLETED
|
9
|
5
|
7
|
Reasons for withdrawal
| Measure |
Cervarix (15-25 Years) Group
Women aged 15 to 25 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
Cervarix (26-45 Years) Group
Women aged 26 to 45 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
Cervarix (46-55 Years) Group
Women aged 46 to 55 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Overall Study
Serious Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Non-serious adverse event
|
1
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
3
|
|
Overall Study
Other
|
3
|
1
|
1
|
Baseline Characteristics
Human Papilloma Virus (HPV) Vaccine Immunogenicity and Safety Trial in Young and Adult Women With GSK Biologicals' HPV-16/18
Baseline characteristics by cohort
| Measure |
Cervarix (15-25 Years) Group
n=229 Participants
Women aged 15 to 25 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
Cervarix (26-45 Years) Group
n=226 Participants
Women aged 26 to 45 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
Cervarix (46-55 Years) Group
n=211 Participants
Women aged 46 to 55 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
Total
n=666 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
20.9 years
STANDARD_DEVIATION 2.67 • n=93 Participants
|
35.5 years
STANDARD_DEVIATION 6.02 • n=4 Participants
|
49.6 years
STANDARD_DEVIATION 2.80 • n=27 Participants
|
34.9 years
STANDARD_DEVIATION 12.38 • n=483 Participants
|
|
Sex: Female, Male
Female
|
229 Participants
n=93 Participants
|
226 Participants
n=4 Participants
|
211 Participants
n=27 Participants
|
666 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
229 Participants
n=93 Participants
|
225 Participants
n=4 Participants
|
211 Participants
n=27 Participants
|
665 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: At Month 7Population: The analysis was based the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis and who were seronegative before vaccination.
Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies \[i.e. antibody titer greater than or equal to (≥) the cut-off value\] in the sera of subjects seronegative before vaccination. Cut-off values were 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies. Data for the Cervarix (46-55 Years) Group are presented in the Secondary Outcomes as per Protocol.
Outcome measures
| Measure |
Cervarix (15-25 Years) Group
n=202 Participants
Women aged 15 to 25 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
Cervarix (26-45 Years) Group
n=185 Participants
Women aged 26 to 45 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
Cervarix (46-55 Years) Group
Women aged 46 to 55 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Number of Seroconverted Subjects for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies, in Women 15 to 25 Years of Age and Women 26 to 45 Years of Age
Anti-HPV-16
|
191 Participants
|
164 Participants
|
—
|
|
Number of Seroconverted Subjects for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies, in Women 15 to 25 Years of Age and Women 26 to 45 Years of Age
Anti-HPV-18
|
202 Participants
|
185 Participants
|
—
|
PRIMARY outcome
Timeframe: At Months 18, 24, 36 and 48Population: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis and who were seronegative before vaccination.
Anti-HPV 16/18 antibody titers were detected in sera samples and presented as Geometric Mean Titers (GMT), expressed in EL.U/mL. Data for pre-vaccination, Month 2, Month 7 and Month 12 are presented in the Secondary Outcomes as per Protocol.
Outcome measures
| Measure |
Cervarix (15-25 Years) Group
n=224 Participants
Women aged 15 to 25 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
Cervarix (26-45 Years) Group
n=219 Participants
Women aged 26 to 45 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
Cervarix (46-55 Years) Group
n=201 Participants
Women aged 46 to 55 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Months 18, 24, 36 and 48
Anti-HPV-16 (Month 18)
|
2197.9 EL.U/mL
Interval 1870.5 to 2582.6
|
933.3 EL.U/mL
Interval 771.4 to 1129.1
|
578.5 EL.U/mL
Interval 486.2 to 688.2
|
|
Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Months 18, 24, 36 and 48
Anti-HPV-16 (Month 24)
|
1730.7 EL.U/mL
Interval 1462.3 to 2048.5
|
733.0 EL.U/mL
Interval 603.7 to 890.1
|
472.9 EL.U/mL
Interval 396.8 to 563.6
|
|
Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Months 18, 24, 36 and 48
Anti-HPV-16 (Month 36)
|
1491.5 EL.U/mL
Interval 1260.9 to 1764.1
|
607.2 EL.U/mL
Interval 502.8 to 733.3
|
363.9 EL.U/mL
Interval 301.6 to 439.1
|
|
Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Months 18, 24, 36 and 48
Anti-HPV-16 (Month 48)
|
1382.7 EL.U/mL
Interval 1166.6 to 1638.9
|
524.2 EL.U/mL
Interval 437.7 to 627.9
|
324.0 EL.U/mL
Interval 272.2 to 385.5
|
|
Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Months 18, 24, 36 and 48
Anti-HPV-18 (Month 18)
|
816.0 EL.U/mL
Interval 694.1 to 959.3
|
328.4 EL.U/mL
Interval 275.3 to 391.7
|
247.9 EL.U/mL
Interval 210.1 to 292.4
|
|
Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Months 18, 24, 36 and 48
Anti-HPV-18 (Month 24)
|
673.6 EL.U/mL
Interval 568.3 to 798.4
|
280.8 EL.U/mL
Interval 235.3 to 335.1
|
185.7 EL.U/mL
Interval 156.3 to 220.6
|
|
Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Months 18, 24, 36 and 48
Anti-HPV-18 (Month 36)
|
539.9 EL.U/mL
Interval 280.6 to 1038.8
|
220.1 EL.U/mL
Interval 184.5 to 262.5
|
136.9 EL.U/mL
Interval 114.9 to 163.0
|
|
Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Months 18, 24, 36 and 48
Anti-HPV-18 (Month 48)
|
475.5 EL.U/mL
Interval 400.9 to 564.1
|
189.0 EL.U/mL
Interval 159.3 to 224.2
|
122.9 EL.U/mL
Interval 102.3 to 147.6
|
SECONDARY outcome
Timeframe: At Month 7Population: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis and who were seronegative before vaccination.
Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination. Cut-off values were 8 EL.U/mL for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies. Seroconversion results at Month 7 for the Cervarix (15-25 Years) Group and for the Cervarix (26-45 Years) Group are presented in the Primary Outcome Measure 1.
Outcome measures
| Measure |
Cervarix (15-25 Years) Group
n=172 Participants
Women aged 15 to 25 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
Cervarix (26-45 Years) Group
Women aged 26 to 45 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
Cervarix (46-55 Years) Group
Women aged 46 to 55 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies, in Women 46 - 55 Years of Age
Anti-HPV-16
|
136 Participants
|
—
|
—
|
|
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies, in Women 46 - 55 Years of Age
Anti-HPV-18
|
172 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At PRE and Months 2, 7 and 12Population: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis and who were seronegative before vaccination.
Anti-HPV 16/18 antibody titers were detected in sera samples and presented as GMT, expressed in EL.U/mL. Data for Months 18, 24, 36 and 48 are presented in the Primary Outcome Measure 2 as per Protocol.
Outcome measures
| Measure |
Cervarix (15-25 Years) Group
n=224 Participants
Women aged 15 to 25 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
Cervarix (26-45 Years) Group
n=219 Participants
Women aged 26 to 45 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
Cervarix (46-55 Years) Group
n=201 Participants
Women aged 46 to 55 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Pre-vaccination (PRE) and Months 2, 7 and 12
Anti-HPV-16 (PRE)
|
4.0 EL.U/mL
Interval 4.0 to 4.0
|
4.0 EL.U/mL
Interval 4.0 to 4.0
|
4.0 EL.U/mL
Interval 4.0 to 4.0
|
|
Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Pre-vaccination (PRE) and Months 2, 7 and 12
Anti-HPV-16 (Month 2)
|
3090.0 EL.U/mL
Interval 2791.9 to 3419.9
|
1824.6 EL.U/mL
Interval 1600.5 to 2080.1
|
1269.9 EL.U/mL
Interval 1100.1 to 1465.9
|
|
Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Pre-vaccination (PRE) and Months 2, 7 and 12
Anti-HPV-16 (Month 7)
|
7908.4 EL.U/mL
Interval 6874.0 to 9098.5
|
4029.2 EL.U/mL
Interval 3402.7 to 4771.0
|
2566.8 EL.U/mL
Interval 2181.2 to 3020.6
|
|
Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Pre-vaccination (PRE) and Months 2, 7 and 12
Anti-HPV-16 (Month 12)
|
3055.3 EL.U/mL
Interval 2620.4 to 3562.4
|
1563.7 EL.U/mL
Interval 1313.4 to 1861.8
|
926.2 EL.U/mL
Interval 787.2 to 1089.7
|
|
Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Pre-vaccination (PRE) and Months 2, 7 and 12
Anti-HPV-18 (PRE)
|
3.5 EL.U/mL
Interval 3.5 to 3.5
|
3.5 EL.U/mL
Interval 3.5 to 3.5
|
3.5 EL.U/mL
Interval 3.5 to 3.5
|
|
Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Pre-vaccination (PRE) and Months 2, 7 and 12
Anti-HPV-18 (Month 2)
|
2229.0 EL.U/mL
Interval 1995.0 to 2490.5
|
1390.3 EL.U/mL
Interval 1230.2 to 1571.2
|
957.2 EL.U/mL
Interval 842.2 to 1088.0
|
|
Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Pre-vaccination (PRE) and Months 2, 7 and 12
Anti-HPV-18 (Month 7)
|
3499.3 EL.U/mL
Interval 3098.7 to 3951.6
|
1837.3 EL.U/mL
Interval 1602.1 to 2107.0
|
1313.0 EL.U/mL
Interval 1145.6 to 1504.9
|
|
Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Pre-vaccination (PRE) and Months 2, 7 and 12
Anti-HPV-18 (Month 12)
|
1284.6 EL.U/mL
Interval 1112.7 to 1483.2
|
619.8 EL.U/mL
Interval 526.8 to 729.2
|
430.2 EL.U/mL
Interval 370.5 to 499.7
|
SECONDARY outcome
Timeframe: At Month 2 and Month 12Population: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis and who were seronegative before vaccination.
Seroconversion was defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination. Cut-off values were 8 EL.U/mL for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies. Seroconversion results at Month 7 are presented in the Primary Outcome Measure 1 for Cervarix (15-25 Years) Group and Cervarix (26-45 Years) Group and in the Secondary Outcome Measure 3 for the Cervarix (46-55 Years) Group.
Outcome measures
| Measure |
Cervarix (15-25 Years) Group
n=207 Participants
Women aged 15 to 25 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
Cervarix (26-45 Years) Group
n=186 Participants
Women aged 26 to 45 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
Cervarix (46-55 Years) Group
n=175 Participants
Women aged 46 to 55 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies at Month 2 and Month 12
Anti-HPV-16 (Month 2)
|
195 Participants
|
164 Participants
|
139 Participants
|
|
Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies at Month 2 and Month 12
Anti-HPV-16 (Month 12)
|
183 Participants
|
163 Participants
|
134 Participants
|
|
Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies at Month 2 and Month 12
Anti-HPV-18 (Month 2)
|
207 Participants
|
186 Participants
|
175 Participants
|
|
Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies at Month 2 and Month 12
Anti-HPV-18 (Month 12)
|
192 Participants
|
182 Participants
|
169 Participants
|
SECONDARY outcome
Timeframe: During the 7-day period (from the day of vaccination up to 6 subsequent days) following vaccination after each dose and across dosesPopulation: The analysis was based on the Total Vaccinated Cohort (TVC), which included all subjects with at least one study vaccine administered, on subjects with symptom sheets completed and for whom data were available.
Assessed solicited general symptoms were arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever above (\>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
Cervarix (15-25 Years) Group
n=227 Participants
Women aged 15 to 25 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
Cervarix (26-45 Years) Group
n=226 Participants
Women aged 26 to 45 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
Cervarix (46-55 Years) Group
n=207 Participants
Women aged 46 to 55 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever - Across doses
|
128 Participants
|
116 Participants
|
81 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Arthralgia - Dose 1
|
21 Participants
|
15 Participants
|
22 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Arthralgia - Dose 2
|
17 Participants
|
22 Participants
|
26 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Arthralgia - Dose 3
|
22 Participants
|
20 Participants
|
22 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Arthralgia - Across doses
|
45 Participants
|
43 Participants
|
47 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Arthralgia - Dose 1
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Arthralgia - Dose 2
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Arthralgia - Dose 3
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Arthralgia - Across doses
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Arthralgia - Dose 1
|
14 Participants
|
7 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Arthralgia - Dose 2
|
11 Participants
|
9 Participants
|
12 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Arthralgia - Dose 3
|
14 Participants
|
11 Participants
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Arthralgia - Across doses
|
28 Participants
|
23 Participants
|
22 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue - Dose 1
|
85 Participants
|
72 Participants
|
47 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue - Dose 2
|
68 Participants
|
53 Participants
|
48 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue - Dose 3
|
84 Participants
|
68 Participants
|
50 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue - Across doses
|
128 Participants
|
116 Participants
|
81 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue - Dose 1
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue - Dose 2
|
3 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue - Dose 3
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue - Across doses
|
5 Participants
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue - Dose 1
|
46 Participants
|
34 Participants
|
25 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue - Dose 2
|
46 Participants
|
24 Participants
|
23 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue - Dose 3
|
54 Participants
|
40 Participants
|
30 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue - Across doses
|
86 Participants
|
60 Participants
|
44 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever - Dose 1
|
10 Participants
|
7 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever - Dose 2
|
9 Participants
|
7 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever - Dose 3
|
5 Participants
|
8 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever - Dose 1
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever - Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever - Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever - Across doses
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever - Dose 1
|
7 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever - Dose 2
|
4 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever - Dose 3
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever - Across doses
|
11 Participants
|
6 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal - Dose 1
|
34 Participants
|
18 Participants
|
12 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal - Dose 2
|
25 Participants
|
11 Participants
|
14 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal - Dose 3
|
16 Participants
|
14 Participants
|
12 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal - Across doses
|
51 Participants
|
33 Participants
|
31 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal - Dose 1
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal - Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal - Dose 3
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal - Across doses
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal - Dose 1
|
22 Participants
|
4 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal - Dose 2
|
15 Participants
|
6 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal - Dose 3
|
11 Participants
|
10 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal - Across doses
|
30 Participants
|
15 Participants
|
16 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache - Dose 1
|
77 Participants
|
62 Participants
|
50 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache - Dose 2
|
63 Participants
|
43 Participants
|
44 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache - Dose 3
|
64 Participants
|
47 Participants
|
39 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache - Across doses
|
123 Participants
|
100 Participants
|
82 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache - Dose 1
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache - Dose 2
|
5 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache - Dose 3
|
4 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache - Across doses
|
10 Participants
|
5 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache - Dose 1
|
42 Participants
|
27 Participants
|
25 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache - Dose 2
|
34 Participants
|
25 Participants
|
17 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache - Dose 3
|
40 Participants
|
25 Participants
|
23 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache - Across doses
|
77 Participants
|
48 Participants
|
46 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia - Dose 1
|
93 Participants
|
49 Participants
|
48 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia - Dose 2
|
69 Participants
|
50 Participants
|
42 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia - Dose 3
|
71 Participants
|
64 Participants
|
41 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia - Across doses
|
126 Participants
|
97 Participants
|
83 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia - Dose 1
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia - Dose 2
|
4 Participants
|
5 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia - Dose 3
|
4 Participants
|
6 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia - Across doses
|
8 Participants
|
9 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia - Dose 1
|
71 Participants
|
32 Participants
|
30 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia - Dose 2
|
52 Participants
|
28 Participants
|
23 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia - Dose 3
|
58 Participants
|
38 Participants
|
20 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia - Across doses
|
96 Participants
|
62 Participants
|
48 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Rash - Dose 1
|
6 Participants
|
7 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Rash - Dose 2
|
4 Participants
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Rash - Dose 3
|
10 Participants
|
5 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Rash - Across doses
|
16 Participants
|
14 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Rash - Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Rash - Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Rash - Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Rash - Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Rash - Dose 1
|
5 Participants
|
6 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Rash - Dose 2
|
3 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Rash - Dose 3
|
9 Participants
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Rash - Across doses
|
13 Participants
|
11 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Urticaria - Dose 1
|
5 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Urticaria - Dose 2
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Urticaria - Dose 3
|
6 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Urticaria - Across doses
|
10 Participants
|
7 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Urticaria - Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Urticaria - Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Urticaria - Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Urticaria - Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Urticaria - Dose 1
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Urticaria - Dose 2
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Urticaria - Dose 3
|
5 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Urticaria - Across doss
|
7 Participants
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: During the 7-day period (from the day of vaccination up to 6 subsequent days) following vaccination after each dose and across dosesPopulation: The analysis was based on the TVC, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets completed and for whom data were available.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimetres (mm) of injection site.
Outcome measures
| Measure |
Cervarix (15-25 Years) Group
n=227 Participants
Women aged 15 to 25 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
Cervarix (26-45 Years) Group
n=226 Participants
Women aged 26 to 45 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
Cervarix (46-55 Years) Group
n=207 Participants
Women aged 46 to 55 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain - Dose 1
|
197 Participants
|
182 Participants
|
141 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain - Dose 2
|
186 Participants
|
162 Participants
|
120 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain - Dose 3
|
179 Participants
|
172 Participants
|
124 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain - Across doses
|
220 Participants
|
210 Participants
|
171 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain - Dose 1
|
6 Participants
|
6 Participants
|
3 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain - Dose 2
|
11 Participants
|
6 Participants
|
4 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain - Dose 3
|
13 Participants
|
7 Participants
|
3 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain - Across doses
|
23 Participants
|
15 Participants
|
9 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness - Dose 1
|
77 Participants
|
80 Participants
|
70 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness - Dose 2
|
70 Participants
|
80 Participants
|
60 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness - Dose 3
|
90 Participants
|
85 Participants
|
65 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness - Across doses
|
133 Participants
|
126 Participants
|
101 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness - Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness - Dose 2
|
0 Participants
|
4 Participants
|
2 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness - Dose 3
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness - Across doses
|
0 Participants
|
6 Participants
|
2 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling - Dose 1
|
36 Participants
|
52 Participants
|
37 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling - Dose 2
|
49 Participants
|
61 Participants
|
47 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling - Dose 3
|
66 Participants
|
70 Participants
|
60 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling - Across doses
|
96 Participants
|
100 Participants
|
83 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling - Dose 1
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling - Dose 2
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling - Dose 3
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling - Across doses
|
3 Participants
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: During the 30-day (from the day of vaccination up to 29 subsequent days) post-vaccination periodPopulation: The analysis was based on the TVC, which included all subjects with at least one study vaccine administered and for whom data were available.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
Cervarix (15-25 Years) Group
n=229 Participants
Women aged 15 to 25 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
Cervarix (26-45 Years) Group
n=226 Participants
Women aged 26 to 45 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
Cervarix (46-55 Years) Group
n=211 Participants
Women aged 46 to 55 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Subjects with any AE(s)
|
43 Participants
|
46 Participants
|
28 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Subjects with any Grade 3 AE(s)
|
2 Participants
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Subjects with any Related AE(s)
|
13 Participants
|
18 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: During the entire study period (from Day 0 up to Month 48)Population: The analysis was based on the TVC (up to Month 7), which included all subjects with at least one study vaccine administered and on the Extended Follow-up (EFU) Vaccinated cohort (Month 7 to Month 48) which included subjects who received 3 doses of vaccine in the primary phase of the study and for whom data were available.
An SAE is any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study subject, or may have evolved into one of the outcomes listed above.
Outcome measures
| Measure |
Cervarix (15-25 Years) Group
n=229 Participants
Women aged 15 to 25 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
Cervarix (26-45 Years) Group
n=226 Participants
Women aged 26 to 45 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
Cervarix (46-55 Years) Group
n=211 Participants
Women aged 46 to 55 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events (SAE)
Day 0 to Month 7
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects Reporting Serious Adverse Events (SAE)
Month 7 to Month 12
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Serious Adverse Events (SAE)
Month 12 to Month 18
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects Reporting Serious Adverse Events (SAE)
Month 18 to Month 24
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Serious Adverse Events (SAE)
Month 24 to Month 36
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Serious Adverse Events (SAE)
Month 36 to Month 48
|
0 Participants
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: During the entire study period (from Day 0 up to Month 48)Population: The analysis was based on the TVC (data up to Month 7), which included all subjects with at least one study vaccine administered and on the EFU Vaccinated cohort (data from Month 7 to Month 48) which included subjects who received 3 doses of vaccine in the primary phase of the study and for whom data were available.
NOCDs assessed include chronic diseases such as autoimmune disorders, diabetes, allergies also asthma and pathognomic signs/symptoms of these diseases.
Outcome measures
| Measure |
Cervarix (15-25 Years) Group
n=229 Participants
Women aged 15 to 25 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
Cervarix (26-45 Years) Group
n=226 Participants
Women aged 26 to 45 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
Cervarix (46-55 Years) Group
n=211 Participants
Women aged 46 to 55 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs)
Day 0 to Month 7
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs)
Month 7 to Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs)
Month 12 to Month 18
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs)
Month 18 to Month 24
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs)
Month 24 to Month 36
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs)
Month 36 to Month 48
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the entire study period (from Day 0 up to Month 48)Population: The analysis was based on the TVC (data up to Month 7), which included all subjects with at least one study vaccine administered and on the EFU Vaccinated cohort (data from Month 7 to Month 48) which included subjects who received 3 doses of vaccine in the primary phase of the study and for whom data were available.
Medically significant conditions are AEs prompting emergency room or physician visits that were not related to common diseases or routine visits for physical examination or vaccination, or SAEs that were not related to common diseases.
Outcome measures
| Measure |
Cervarix (15-25 Years) Group
n=229 Participants
Women aged 15 to 25 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
Cervarix (26-45 Years) Group
n=226 Participants
Women aged 26 to 45 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
Cervarix (46-55 Years) Group
n=211 Participants
Women aged 46 to 55 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Number of Subjects Reporting Medically Significant Conditions
Day 0 to Day 29
|
12 Participants
|
12 Participants
|
11 Participants
|
|
Number of Subjects Reporting Medically Significant Conditions
Day 30 to Month 7
|
8 Participants
|
8 Participants
|
10 Participants
|
|
Number of Subjects Reporting Medically Significant Conditions
Month 7 to Month 12
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects Reporting Medically Significant Conditions
Month 12 to Month 18
|
3 Participants
|
5 Participants
|
6 Participants
|
|
Number of Subjects Reporting Medically Significant Conditions
Month 18 to Month 24
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects Reporting Medically Significant Conditions
Month 24 to Month 36
|
5 Participants
|
4 Participants
|
6 Participants
|
|
Number of Subjects Reporting Medically Significant Conditions
Month 36 to Month 48
|
1 Participants
|
7 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: At Months 18 and 24Population: The analysis was based on a subset of subjects from the TVC for whom CVS samples were available and who received at least one dose of vaccine in this study.
Anti-HPV 16/18 antibody titers were detected in CVS samples and presented as GMTs, expressed in EL.U/mL based on ELISA.
Outcome measures
| Measure |
Cervarix (15-25 Years) Group
n=59 Participants
Women aged 15 to 25 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
Cervarix (26-45 Years) Group
n=51 Participants
Women aged 26 to 45 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
Cervarix (46-55 Years) Group
n=41 Participants
Women aged 46 to 55 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Anti-HPV-16/18 Antibody Titers Assessed by ELISA in a Subset of Subjects in Cervical Secretions (CVS) Samples
Anti-HPV-16 (Month 18)
|
63.6 EL.U/mL
Interval 43.0 to 94.2
|
50.7 EL.U/mL
Interval 32.7 to 78.5
|
56.1 EL.U/mL
Interval 36.3 to 86.7
|
|
Anti-HPV-16/18 Antibody Titers Assessed by ELISA in a Subset of Subjects in Cervical Secretions (CVS) Samples
Anti-HPV-16 (Month 24)
|
59.2 EL.U/mL
Interval 44.3 to 79.3
|
52.7 EL.U/mL
Interval 36.5 to 76.2
|
68.8 EL.U/mL
Interval 41.0 to 115.4
|
|
Anti-HPV-16/18 Antibody Titers Assessed by ELISA in a Subset of Subjects in Cervical Secretions (CVS) Samples
Anti-HPV-18 (Month 18)
|
28.4 EL.U/mL
Interval 17.5 to 46.0
|
38.5 EL.U/mL
Interval 21.5 to 68.9
|
21.2 EL.U/mL
Interval 15.2 to 29.6
|
|
Anti-HPV-16/18 Antibody Titers Assessed by ELISA in a Subset of Subjects in Cervical Secretions (CVS) Samples
Anti-HPV-18 (Month 24)
|
23.3 EL.U/mL
Interval 17.4 to 31.3
|
32.4 EL.U/mL
Interval 21.5 to 48.8
|
31.2 EL.U/mL
Interval 19.2 to 50.5
|
SECONDARY outcome
Timeframe: At Months 18 and 24Population: The analysis was based on a subset of subjects from the TVC for whom CVS samples were available and who received at least one dose of vaccine in this study.
Seropositivity was defined as total IgG ≥ 0 microgram per milliliter (µg/mL) and was detected in sera and in CVS samples by ELISA.
Outcome measures
| Measure |
Cervarix (15-25 Years) Group
n=59 Participants
Women aged 15 to 25 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
Cervarix (26-45 Years) Group
n=51 Participants
Women aged 26 to 45 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
Cervarix (46-55 Years) Group
n=51 Participants
Women aged 46 to 55 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Number of Subjects Seropositive for Total Immunoglobulin-G (IgG) in Blood (Serum) and in Cervical Samples (Secretion) in a Subset of Subjects
IgG serum (Month 18)
|
44 Participants
|
51 Participants
|
51 Participants
|
|
Number of Subjects Seropositive for Total Immunoglobulin-G (IgG) in Blood (Serum) and in Cervical Samples (Secretion) in a Subset of Subjects
IgG serum (Month 24)
|
59 Participants
|
51 Participants
|
41 Participants
|
|
Number of Subjects Seropositive for Total Immunoglobulin-G (IgG) in Blood (Serum) and in Cervical Samples (Secretion) in a Subset of Subjects
IgG secretion (Month 18)
|
39 Participants
|
47 Participants
|
39 Participants
|
|
Number of Subjects Seropositive for Total Immunoglobulin-G (IgG) in Blood (Serum) and in Cervical Samples (Secretion) in a Subset of Subjects
IgG secretion (Month 24)
|
57 Participants
|
50 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: During the entire study period (from Day 0 up to Month 48)Population: The analysis was based on the TVC, which included all subjects with at least one vaccine administration documented and for whom data were available.
Outcomes of pregnancies were: Abnormal infant / Congenital anomaly, Elective termination, Missed abortion, Normal infant, Premature birth, Spontaneous abortion / Miscarriage and Outcome unknown.
Outcome measures
| Measure |
Cervarix (15-25 Years) Group
n=229 Participants
Women aged 15 to 25 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
Cervarix (26-45 Years) Group
n=226 Participants
Women aged 26 to 45 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
Cervarix (46-55 Years) Group
n=211 Participants
Women aged 46 to 55 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Abnormal infant / Congenital anomaly
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Elective termination
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Missed abortion
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Normal infant
|
19 Participants
|
21 Participants
|
1 Participants
|
|
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Premature birth
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Spontaneous abortion / Miscarriage
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Outcome unknown
|
1 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Cervarix (15-25 Years) Group
Serious events: 6 serious events
Other events: 224 other events
Deaths: 0 deaths
Cervarix (26-45 Years) Group
Serious events: 8 serious events
Other events: 216 other events
Deaths: 0 deaths
Cervarix (46-55 Years) Group
Serious events: 11 serious events
Other events: 182 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Cervarix (15-25 Years) Group
n=229 participants at risk
Women aged 15 to 25 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
Cervarix (26-45 Years) Group
n=226 participants at risk
Women aged 26 to 45 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
Cervarix (46-55 Years) Group
n=211 participants at risk
Women aged 46 to 55 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Psychiatric disorders
Depression
|
0.00%
0/229 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.00%
0/226 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.47%
1/211 • Number of events 1 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/229 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.00%
0/226 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.47%
1/211 • Number of events 1 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
|
Nervous system disorders
Multiple sclerosis
|
0.44%
1/229 • Number of events 1 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.00%
0/226 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.00%
0/211 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
|
Nervous system disorders
Optic neuritis
|
0.00%
0/229 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.44%
1/226 • Number of events 1 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.00%
0/211 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.44%
1/229 • Number of events 1 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.00%
0/226 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.00%
0/211 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.44%
1/229 • Number of events 1 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.00%
0/226 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.00%
0/211 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
|
Ear and labyrinth disorders
Vestibular neuronitis
|
0.00%
0/229 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.00%
0/226 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.47%
1/211 • Number of events 1 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/229 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.00%
0/226 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.47%
1/211 • Number of events 1 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
|
Nervous system disorders
Carotid artery dissection
|
0.00%
0/229 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.00%
0/226 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.47%
1/211 • Number of events 1 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
|
Reproductive system and breast disorders
Cervical polyp
|
0.00%
0/229 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.44%
1/226 • Number of events 1 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.00%
0/211 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.44%
1/229 • Number of events 1 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.00%
0/226 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.00%
0/211 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/229 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.00%
0/226 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.47%
1/211 • Number of events 1 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/229 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.00%
0/226 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.47%
1/211 • Number of events 1 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/229 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.44%
1/226 • Number of events 1 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.00%
0/211 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
|
Reproductive system and breast disorders
Abortion spontaneous
|
0.44%
1/229 • Number of events 1 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.44%
1/226 • Number of events 1 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.00%
0/211 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/229 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.00%
0/226 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
1.4%
3/211 • Number of events 3 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
|
Reproductive system and breast disorders
Premature labour
|
0.44%
1/229 • Number of events 1 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.00%
0/226 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.00%
0/211 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
|
Infections and infestations
Viral infection
|
0.44%
1/229 • Number of events 1 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.00%
0/226 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.00%
0/211 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/229 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.44%
1/226 • Number of events 1 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.00%
0/211 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/229 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.00%
0/226 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.47%
1/211 • Number of events 1 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.00%
0/229 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.88%
2/226 • Number of events 2 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.00%
0/211 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous complete
|
0.00%
0/229 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.88%
2/226 • Number of events 2 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
0.00%
0/211 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
Other adverse events
| Measure |
Cervarix (15-25 Years) Group
n=229 participants at risk
Women aged 15 to 25 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
Cervarix (26-45 Years) Group
n=226 participants at risk
Women aged 26 to 45 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
Cervarix (46-55 Years) Group
n=211 participants at risk
Women aged 46 to 55 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
General disorders
Pain
|
96.1%
220/229 • Number of events 220 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
92.9%
210/226 • Number of events 210 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
81.0%
171/211 • Number of events 171 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
|
General disorders
Redness
|
58.1%
133/229 • Number of events 133 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
55.8%
126/226 • Number of events 126 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
47.9%
101/211 • Number of events 101 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
|
General disorders
Swelling
|
41.9%
96/229 • Number of events 96 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
44.2%
100/226 • Number of events 100 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
39.3%
83/211 • Number of events 83 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
|
General disorders
Arthralgia
|
19.7%
45/229 • Number of events 45 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
19.0%
43/226 • Number of events 43 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
22.3%
47/211 • Number of events 47 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
|
General disorders
Fatigue
|
55.9%
128/229 • Number of events 128 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
51.3%
116/226 • Number of events 116 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
38.4%
81/211 • Number of events 81 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
|
General disorders
Fever
|
9.2%
21/229 • Number of events 21 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
8.4%
19/226 • Number of events 19 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
2.4%
5/211 • Number of events 5 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
|
General disorders
Gastrointestinal symptoms
|
22.3%
51/229 • Number of events 51 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
14.6%
33/226 • Number of events 33 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
14.7%
31/211 • Number of events 31 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
|
General disorders
Headache
|
53.7%
123/229 • Number of events 123 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
44.2%
100/226 • Number of events 100 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
38.9%
82/211 • Number of events 82 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
|
General disorders
Myalgia
|
55.0%
126/229 • Number of events 126 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
42.9%
97/226 • Number of events 97 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
39.3%
83/211 • Number of events 83 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
|
General disorders
Rash
|
7.0%
16/229 • Number of events 16 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
6.2%
14/226 • Number of events 14 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
3.3%
7/211 • Number of events 7 • Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 48).
The number of events for reported SAEs and AEs (all/related) was not available and encoded as equal to the number of subjects affected.
|
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