Trial Outcomes & Findings for Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Human Papillomavirus (HPV) Vaccine (GSK-580299) and Merck's Gardasil Vaccine When Administered According to Alternative 2-dose Schedules in 9-14 Year Old Females (NCT NCT01462357)
NCT ID: NCT01462357
Last Updated: 2019-11-15
Results Overview
Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers greater than or equal to (≥) 19 and 18 ELISA units per milliliter (EL.U/mL), respectively), in the serum of subjects seronegative before vaccination.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1079 participants
Primary outcome timeframe
At Month 7 (i.e. one month after the last dose of study vaccine)
Results posted on
2019-11-15
Participant Flow
1079 subjects entered this study, of which 4 subjects signed an informed consent but did not receive a single dose of the vaccine and were hence not counted as starting the study.
Participant milestones
| Measure |
Cervarix 2 Dose Group
Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 2 Dose Group
Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 3 Dose Group
Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|---|
|
Overall Study
STARTED
|
359
|
358
|
358
|
|
Overall Study
COMPLETED
|
351
|
339
|
346
|
|
Overall Study
NOT COMPLETED
|
8
|
19
|
12
|
Reasons for withdrawal
| Measure |
Cervarix 2 Dose Group
Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 2 Dose Group
Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 3 Dose Group
Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
11
|
3
|
|
Overall Study
Migrated/moved from study area
|
2
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
5
|
7
|
Baseline Characteristics
Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Human Papillomavirus (HPV) Vaccine (GSK-580299) and Merck's Gardasil Vaccine When Administered According to Alternative 2-dose Schedules in 9-14 Year Old Females
Baseline characteristics by cohort
| Measure |
Cervarix 2 Dose Group
n=359 Participants
Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 2 Dose Group
n=358 Participants
Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 3 Dose Group
n=358 Participants
Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Total
n=1075 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
11.5 Years
STANDARD_DEVIATION 1.64 • n=5 Participants
|
11.5 Years
STANDARD_DEVIATION 1.56 • n=7 Participants
|
11.6 Years
STANDARD_DEVIATION 1.64 • n=5 Participants
|
11.53 Years
STANDARD_DEVIATION 1.61 • n=4 Participants
|
|
Sex: Female, Male
Female
|
359 Participants
n=5 Participants
|
358 Participants
n=7 Participants
|
358 Participants
n=5 Participants
|
1075 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
African Heritage / African American
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian - Central / South Asian Heritage
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
179 Participants
n=5 Participants
|
178 Participants
n=7 Participants
|
179 Participants
n=5 Participants
|
536 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
81 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
242 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White - Arabic / North African Heritage
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White - Caucasian / European Heritage
|
89 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
258 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White - Caucasian / African Heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African - White / Caucasian Heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At Month 7 (i.e. one month after the last dose of study vaccine)Population: The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the specified time point and who were seronegative before vaccination.
Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers greater than or equal to (≥) 19 and 18 ELISA units per milliliter (EL.U/mL), respectively), in the serum of subjects seronegative before vaccination.
Outcome measures
| Measure |
Cervarix 2 Dose Group
n=334 Participants
Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 2 Dose Group
n=331 Participants
Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 3 Dose Group
n=333 Participants
Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|---|
|
Number of Seroconverted Subjects for Anti-HPV-16/18 Antibodies as Assessed by Enzyme-Linked Immunosorbent Assay (ELISA) at Month 7 Based on the ATP Cohort for Immunogenicity
Anti-HPV-16
|
330 Participants
|
327 Participants
|
322 Participants
|
|
Number of Seroconverted Subjects for Anti-HPV-16/18 Antibodies as Assessed by Enzyme-Linked Immunosorbent Assay (ELISA) at Month 7 Based on the ATP Cohort for Immunogenicity
Anti-HPV-18
|
334 Participants
|
331 Participants
|
333 Participants
|
PRIMARY outcome
Timeframe: At Month 7 (i.e. one month after the last dose of study vaccine)Population: The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the specified time point and who were seronegative before vaccination.
Anti-HPV 16/18 antibody titers were presented as Geometric Mean Titers (GMTs) and expressed in EL.U/mL.
Outcome measures
| Measure |
Cervarix 2 Dose Group
n=334 Participants
Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 2 Dose Group
n=331 Participants
Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 3 Dose Group
n=333 Participants
Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|---|
|
Anti-HPV-16/18 Antibody Titers as Assessed by ELISA at Month 7 Based on the ATP Cohort for Immunogenicity
Anti-HPV-16
|
8244.1 EL.U/mL
Interval 7678.3 to 8851.7
|
5056.0 EL.U/mL
Interval 4596.5 to 5561.5
|
4807.4 EL.U/mL
Interval 4420.8 to 5227.7
|
|
Anti-HPV-16/18 Antibody Titers as Assessed by ELISA at Month 7 Based on the ATP Cohort for Immunogenicity
Anti-HPV-18
|
5277.4 EL.U/mL
Interval 4858.6 to 5732.4
|
1207.2 EL.U/mL
Interval 1092.9 to 1333.4
|
1653.5 EL.U/mL
Interval 1484.4 to 1841.8
|
PRIMARY outcome
Timeframe: At Month 7 (i.e. one month after the last dose of study vaccine)Population: The analysis was based on the TVC which included all subjects, regardless of serostatus, who received at least one dose of vaccine in this study and for whom data were available at the specified time point.
Anti-HPV 16/18 antibody titers were presented as Geometric Mean Titers (GMTs) and expressed in EL.U/mL.
Outcome measures
| Measure |
Cervarix 2 Dose Group
n=357 Participants
Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 2 Dose Group
n=353 Participants
Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 3 Dose Group
n=351 Participants
Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|---|
|
Anti-HPV-16/18 Antibody Titers as Assessed by ELISA at Month 7 Based on the Total Vaccinated Cohort (TVC)
Anti-HPV-16
|
8256.4 EL.U/mL
Interval 7650.3 to 8910.6
|
4886.1 EL.U/mL
Interval 4435.4 to 5382.6
|
4789.2 EL.U/mL
Interval 4409.6 to 5201.4
|
|
Anti-HPV-16/18 Antibody Titers as Assessed by ELISA at Month 7 Based on the Total Vaccinated Cohort (TVC)
Anti-HPV-18
|
5267.8 EL.U/mL
Interval 4857.1 to 5713.2
|
1166.3 EL.U/mL
Interval 1056.0 to 1288.2
|
1635.8 EL.U/mL
Interval 1470.0 to 1820.4
|
SECONDARY outcome
Timeframe: At Day 0 and Months 12, 18, 24 and 36Population: The analysis was based on the Month 36 ATP cohort for immunogenicity, which included subjects who returned for blood sampling at Month 36, for whom data concerning immunogenicity outcome measures were available at the specified time points and who were seronegative before vaccination.
Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers ≥ 19 and 18 EL.U/mL, respectively) in the serum of subjects seronegative before vaccination.
Outcome measures
| Measure |
Cervarix 2 Dose Group
n=322 Participants
Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 2 Dose Group
n=310 Participants
Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 3 Dose Group
n=320 Participants
Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|---|
|
Anti-HPV-16/18 Seroconversion Rates as Assessed by ELISA
Anti-HPV-16, Day 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anti-HPV-16/18 Seroconversion Rates as Assessed by ELISA
Anti-HPV-18, Day 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anti-HPV-16/18 Seroconversion Rates as Assessed by ELISA
Anti-HPV-16, Month 12
|
316 Participants
|
305 Participants
|
308 Participants
|
|
Anti-HPV-16/18 Seroconversion Rates as Assessed by ELISA
Anti-HPV-18, Month 12
|
320 Participants
|
309 Participants
|
319 Participants
|
|
Anti-HPV-16/18 Seroconversion Rates as Assessed by ELISA
Anti-HPV-16, Month 18
|
316 Participants
|
304 Participants
|
309 Participants
|
|
Anti-HPV-16/18 Seroconversion Rates as Assessed by ELISA
Anti-HPV-18, Month 18
|
320 Participants
|
294 Participants
|
313 Participants
|
|
Anti-HPV-16/18 Seroconversion Rates as Assessed by ELISA
Anti-HPV-16, Month 24
|
314 Participants
|
303 Participants
|
307 Participants
|
|
Anti-HPV-16/18 Seroconversion Rates as Assessed by ELISA
Anti-HPV-18, Month 24
|
318 Participants
|
287 Participants
|
308 Participants
|
|
Anti-HPV-16/18 Seroconversion Rates as Assessed by ELISA
Anti-HPV-16, Month 36
|
318 Participants
|
304 Participants
|
308 Participants
|
|
Anti-HPV-16/18 Seroconversion Rates as Assessed by ELISA
Anti-HPV-18, Month 36
|
322 Participants
|
267 Participants
|
297 Participants
|
SECONDARY outcome
Timeframe: At Day 0 and Months 12, 18, 24 and 36Population: The analysis was based on the Month 36 ATP cohort for immunogenicity, which included subjects who returned for blood sampling at Month 36, for whom data concerning immunogenicity outcome measures were available at the specified time points and who were seronegative before vaccination.
Anti-HPV 16/18 antibody titers were presented as GMTs and expressed in EL.U/mL based on ELISA.
Outcome measures
| Measure |
Cervarix 2 Dose Group
n=322 Participants
Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 2 Dose Group
n=310 Participants
Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 3 Dose Group
n=320 Participants
Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|---|
|
Anti-HPV-16/18 Antibody Titers as Assessed by ELISA
Anti-HPV-16, Day 0
|
9.5 EL.U/mL
Interval 9.5 to 9.5
|
9.5 EL.U/mL
Interval 9.5 to 9.5
|
9.5 EL.U/mL
Interval 9.5 to 9.5
|
|
Anti-HPV-16/18 Antibody Titers as Assessed by ELISA
Anti-HPV-18, Day 0
|
9.0 EL.U/mL
Interval 9.0 to 9.0
|
9.0 EL.U/mL
Interval 9.0 to 9.0
|
9.0 EL.U/mL
Interval 9.0 to 9.0
|
|
Anti-HPV-16/18 Antibody Titers as Assessed by ELISA
Anti-HPV-16, Month 12
|
2209.2 EL.U/mL
Interval 2014.0 to 2423.4
|
1294.8 EL.U/mL
Interval 1160.4 to 1444.9
|
1600.7 EL.U/mL
Interval 1457.3 to 1758.2
|
|
Anti-HPV-16/18 Antibody Titers as Assessed by ELISA
Anti-HPV-18, Month 12
|
1299.3 EL.U/mL
Interval 1176.2 to 1435.6
|
266.6 EL.U/mL
Interval 236.3 to 300.8
|
478.5 EL.U/mL
Interval 422.8 to 541.6
|
|
Anti-HPV-16/18 Antibody Titers as Assessed by ELISA
Anti-HPV-16, Month 18
|
1488.8 EL.U/mL
Interval 1365.5 to 1623.3
|
684.4 EL.U/mL
Interval 605.8 to 773.2
|
824.0 EL.U/mL
Interval 744.4 to 912.2
|
|
Anti-HPV-16/18 Antibody Titers as Assessed by ELISA
Anti-HPV-18, Month 18
|
754.2 EL.U/mL
Interval 682.6 to 833.2
|
134.8 EL.U/mL
Interval 118.1 to 154.0
|
231.3 EL.U/mL
Interval 202.4 to 264.4
|
|
Anti-HPV-16/18 Antibody Titers as Assessed by ELISA
Anti-HPV-16, Month 24
|
1285.0 EL.U/mL
Interval 1181.1 to 1398.0
|
514.1 EL.U/mL
Interval 455.4 to 580.3
|
637.1 EL.U/mL
Interval 575.8 to 704.9
|
|
Anti-HPV-16/18 Antibody Titers as Assessed by ELISA
Anti-HPV-18, Month 24
|
613.7 EL.U/mL
Interval 555.0 to 678.6
|
106.3 EL.U/mL
Interval 93.2 to 121.3
|
182.0 EL.U/mL
Interval 159.3 to 208.0
|
|
Anti-HPV-16/18 Antibody Titers as Assessed by ELISA
Anti-HPV-16, Month 36
|
1061.4 EL.U/mL
Interval 971.8 to 1159.4
|
379.8 EL.U/mL
Interval 333.4 to 432.7
|
472.4 EL.U/mL
Interval 425.0 to 525.0
|
|
Anti-HPV-16/18 Antibody Titers as Assessed by ELISA
Anti-HPV-18, Month 36
|
486.5 EL.U/mL
Interval 437.8 to 540.6
|
71.0 EL.U/mL
Interval 62.0 to 81.2
|
119.1 EL.U/mL
Interval 103.4 to 137.1
|
SECONDARY outcome
Timeframe: At Month 36Population: The analysis was based on the Month 36 ATP cohort for immunogenicity, which included subjects who returned for blood sampling at Month 36, for whom data concerning immunogenicity outcome measures were available at the specified time point and who were seronegative before vaccination.
Data at Month 36 were also expressed as International Units per milliliter (IU/mL). Conversion factor from EU/mL to IU/mL was determined to be 1/6.1 for HPV-16 and 1/5.7 for HPV-18, using the WHO International Standards (NIBSC codes 05-134 and 10-140 for HPV-16 and HPV-18, respectively). The assay cut-offs were therefore 3.1 IU/mL and 3.2 IU/mL for anti-HPV-16 and anti-HPV-18 antibodies, respectively.
Outcome measures
| Measure |
Cervarix 2 Dose Group
n=322 Participants
Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 2 Dose Group
n=310 Participants
Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 3 Dose Group
n=320 Participants
Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|---|
|
Anti-HPV-16/18 Antibody Titers as Assessed by ELISA at Month 36
Anti-HPV-16
|
174.0 IU/mL
Interval 159.3 to 190.1
|
62.3 IU/mL
Interval 54.7 to 71.0
|
77.4 IU/mL
Interval 69.6 to 86.0
|
|
Anti-HPV-16/18 Antibody Titers as Assessed by ELISA at Month 36
Anti-HPV-18
|
85.3 IU/mL
Interval 76.7 to 94.8
|
12.5 IU/mL
Interval 10.9 to 14.3
|
20.9 IU/mL
Interval 18.2 to 24.1
|
SECONDARY outcome
Timeframe: At Day 0 and Months 7, 12, 18, 24 and 36Population: The analysis was based on the Month 36 ATP cohort for immunogenicity, which included a subset of approximately 100 subjects per study group, who returned for blood sampling at Month 36, for whom immunogenicity data were available at the specified time point and who were seronegative before vaccination.
Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers ≥40 ED50) in the serum of subjects seronegative before vaccination. The assay was performed on a subset of approximately 100 subjects per study group.
Outcome measures
| Measure |
Cervarix 2 Dose Group
n=89 Participants
Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 2 Dose Group
n=87 Participants
Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 3 Dose Group
n=91 Participants
Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|---|
|
Anti-HPV-16/18 Seroconversion Rates as Assessed by Pseudovirion-based Neutralization Assay (PBNA) in a Subset of Subjects, Based on the Month 36 ATP Cohort for Immunogenicity
Anti-HPV-16, Day 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anti-HPV-16/18 Seroconversion Rates as Assessed by Pseudovirion-based Neutralization Assay (PBNA) in a Subset of Subjects, Based on the Month 36 ATP Cohort for Immunogenicity
Anti-HPV-18, Day 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anti-HPV-16/18 Seroconversion Rates as Assessed by Pseudovirion-based Neutralization Assay (PBNA) in a Subset of Subjects, Based on the Month 36 ATP Cohort for Immunogenicity
Anti-HPV-16, Month 7
|
89 Participants
|
85 Participants
|
91 Participants
|
|
Anti-HPV-16/18 Seroconversion Rates as Assessed by Pseudovirion-based Neutralization Assay (PBNA) in a Subset of Subjects, Based on the Month 36 ATP Cohort for Immunogenicity
Anti-HPV-18, Month 7
|
89 Participants
|
87 Participants
|
91 Participants
|
|
Anti-HPV-16/18 Seroconversion Rates as Assessed by Pseudovirion-based Neutralization Assay (PBNA) in a Subset of Subjects, Based on the Month 36 ATP Cohort for Immunogenicity
Anti-HPV-16, Month 12
|
88 Participants
|
85 Participants
|
91 Participants
|
|
Anti-HPV-16/18 Seroconversion Rates as Assessed by Pseudovirion-based Neutralization Assay (PBNA) in a Subset of Subjects, Based on the Month 36 ATP Cohort for Immunogenicity
Anti-HPV-18, Month 12
|
88 Participants
|
86 Participants
|
91 Participants
|
|
Anti-HPV-16/18 Seroconversion Rates as Assessed by Pseudovirion-based Neutralization Assay (PBNA) in a Subset of Subjects, Based on the Month 36 ATP Cohort for Immunogenicity
Anti-HPV-16, Month 18
|
88 Participants
|
83 Participants
|
89 Participants
|
|
Anti-HPV-16/18 Seroconversion Rates as Assessed by Pseudovirion-based Neutralization Assay (PBNA) in a Subset of Subjects, Based on the Month 36 ATP Cohort for Immunogenicity
Anti-HPV-18, Month 18
|
87 Participants
|
77 Participants
|
89 Participants
|
|
Anti-HPV-16/18 Seroconversion Rates as Assessed by Pseudovirion-based Neutralization Assay (PBNA) in a Subset of Subjects, Based on the Month 36 ATP Cohort for Immunogenicity
Anti-HPV-16, Month 24
|
86 Participants
|
83 Participants
|
90 Participants
|
|
Anti-HPV-16/18 Seroconversion Rates as Assessed by Pseudovirion-based Neutralization Assay (PBNA) in a Subset of Subjects, Based on the Month 36 ATP Cohort for Immunogenicity
Anti-HPV-18, Month 24
|
86 Participants
|
75 Participants
|
88 Participants
|
|
Anti-HPV-16/18 Seroconversion Rates as Assessed by Pseudovirion-based Neutralization Assay (PBNA) in a Subset of Subjects, Based on the Month 36 ATP Cohort for Immunogenicity
Anti-HPV-16, Month 36
|
89 Participants
|
85 Participants
|
91 Participants
|
|
Anti-HPV-16/18 Seroconversion Rates as Assessed by Pseudovirion-based Neutralization Assay (PBNA) in a Subset of Subjects, Based on the Month 36 ATP Cohort for Immunogenicity
Anti-HPV-18, Month 36
|
89 Participants
|
75 Participants
|
86 Participants
|
SECONDARY outcome
Timeframe: At Day 0 and Months 7, 12, 18, 24 and 36Population: The analysis was based on the Month 36 ATP cohort for immunogenicity, which included a subset of approximately 100 subjects per study group, who returned for blood sampling at Month 36, for whom immunogenicity data were available at the specified time point and who were seronegative before vaccination.
Anti-HPV 16/18 antibody titers were presented as GMT and expressed in titers using the PBNA. The assay was performed on a subset of approximately 100 subjects per study group.
Outcome measures
| Measure |
Cervarix 2 Dose Group
n=89 Participants
Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 2 Dose Group
n=87 Participants
Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 3 Dose Group
n=91 Participants
Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|---|
|
Anti-HPV-16/18 Antibody Titers as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 ATP Cohort for Immunogenicity
Anti-HPV-16, Day 0
|
20.0 Titers
Interval 20.0 to 20.0
|
20.0 Titers
Interval 20.0 to 20.0
|
20.0 Titers
Interval 20.0 to 20.0
|
|
Anti-HPV-16/18 Antibody Titers as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 ATP Cohort for Immunogenicity
Anti-HPV-18, Day 0
|
20.0 Titers
Interval 20.0 to 20.0
|
20.0 Titers
Interval 20.0 to 20.0
|
20.0 Titers
Interval 20.0 to 20.0
|
|
Anti-HPV-16/18 Antibody Titers as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 ATP Cohort for Immunogenicity
Anti-HPV-16, Month 7
|
52868.5 Titers
Interval 44171.0 to 63278.5
|
19130.1 Titers
Interval 15166.8 to 24129.0
|
22182.7 Titers
Interval 17611.7 to 27940.1
|
|
Anti-HPV-16/18 Antibody Titers as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 ATP Cohort for Immunogenicity
Anti-HPV-18, Month 7
|
24068.5 Titers
Interval 19293.2 to 30025.8
|
4726.5 Titers
Interval 3600.9 to 6204.0
|
8243.9 Titers
Interval 6276.2 to 10828.4
|
|
Anti-HPV-16/18 Antibody Titers as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 ATP Cohort for Immunogenicity
Anti-HPV-16, Month 12
|
10695.9 Titers
Interval 8564.9 to 13357.1
|
4280.1 Titers
Interval 3245.9 to 5643.6
|
5843.8 Titers
Interval 4599.8 to 7424.1
|
|
Anti-HPV-16/18 Antibody Titers as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 ATP Cohort for Immunogenicity
Anti-HPV-18, Month 12
|
3683.3 Titers
Interval 2914.4 to 4655.2
|
689.0 Titers
Interval 517.2 to 917.8
|
1788.6 Titers
Interval 1308.6 to 2444.7
|
|
Anti-HPV-16/18 Antibody Titers as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 ATP Cohort for Immunogenicity
Anti-HPV-16, Month 18
|
8436.3 Titers
Interval 6650.6 to 10701.4
|
2129.7 Titers
Interval 1512.8 to 2998.1
|
2987.2 Titers
Interval 2218.5 to 4022.3
|
|
Anti-HPV-16/18 Antibody Titers as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 ATP Cohort for Immunogenicity
Anti-HPV-18, Month 18
|
2426.3 Titers
Interval 1885.7 to 3121.7
|
295.7 Titers
Interval 217.0 to 402.8
|
812.1 Titers
Interval 577.0 to 1143.0
|
|
Anti-HPV-16/18 Antibody Titers as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 ATP Cohort for Immunogenicity
Anti-HPV-16, Month 24
|
5036.7 Titers
Interval 4097.8 to 6190.7
|
1211.8 Titers
Interval 893.8 to 1642.9
|
1967.2 Titers
Interval 1507.5 to 2567.2
|
|
Anti-HPV-16/18 Antibody Titers as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 ATP Cohort for Immunogenicity
Anti-HPV-18, Month 24
|
1763.0 Titers
Interval 1384.5 to 2245.0
|
237.1 Titers
Interval 177.2 to 317.1
|
573.1 Titers
Interval 421.5 to 779.3
|
|
Anti-HPV-16/18 Antibody Titers as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 ATP Cohort for Immunogenicity
Anti-HPV-16, Month 36
|
4357.8 Titers
Interval 3577.8 to 5307.9
|
1128.9 Titers
Interval 857.4 to 1486.4
|
1577.0 Titers
Interval 1210.4 to 2054.5
|
|
Anti-HPV-16/18 Antibody Titers as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 ATP Cohort for Immunogenicity
Anti-HPV-18, Month 36
|
1613.9 Titers
Interval 1267.6 to 2054.7
|
185.8 Titers
Interval 140.4 to 245.8
|
472.8 Titers
Interval 345.8 to 646.4
|
SECONDARY outcome
Timeframe: At Day 0 and Months 7, 12, 18, 24 and 36Population: The analysis was based on the Month 36 TVC, which included a subset of approximately 100 subjects per study group, who received at least one dose of vaccine in this study, for whom data were available at the specified time points and who were seronegative before vaccination.
Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers ≥40 ED50) in the serum of subjects seronegative before vaccination. The assay was performed on a subset of approximately 100 subjects per study group.
Outcome measures
| Measure |
Cervarix 2 Dose Group
n=99 Participants
Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 2 Dose Group
n=92 Participants
Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 3 Dose Group
n=98 Participants
Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|---|
|
Anti-HPV-16/18 Seroconversion Rates as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 TVC
Anti-HPV-16, Day 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anti-HPV-16/18 Seroconversion Rates as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 TVC
Anti-HPV-18, Day 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anti-HPV-16/18 Seroconversion Rates as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 TVC
Anti-HPV-16, Month 7
|
99 Participants
|
90 Participants
|
98 Participants
|
|
Anti-HPV-16/18 Seroconversion Rates as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 TVC
Anti-HPV-18, Month 7
|
99 Participants
|
92 Participants
|
98 Participants
|
|
Anti-HPV-16/18 Seroconversion Rates as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 TVC
Anti-HPV-16, Month 12
|
97 Participants
|
90 Participants
|
98 Participants
|
|
Anti-HPV-16/18 Seroconversion Rates as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 TVC
Anti-HPV-18, Month 12
|
98 Participants
|
91 Participants
|
98 Participants
|
|
Anti-HPV-16/18 Seroconversion Rates as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 TVC
Anti-HPV-16, Month 18
|
97 Participants
|
88 Participants
|
96 Participants
|
|
Anti-HPV-16/18 Seroconversion Rates as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 TVC
Anti-HPV-18, Month 18
|
97 Participants
|
82 Participants
|
96 Participants
|
|
Anti-HPV-16/18 Seroconversion Rates as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 TVC
Anti-HPV-16, Month 24
|
95 Participants
|
87 Participants
|
97 Participants
|
|
Anti-HPV-16/18 Seroconversion Rates as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 TVC
Anti-HPV-18, Month 24
|
96 Participants
|
79 Participants
|
94 Participants
|
|
Anti-HPV-16/18 Seroconversion Rates as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 TVC
Anti-HPV-16, Month 36
|
97 Participants
|
90 Participants
|
98 Participants
|
|
Anti-HPV-16/18 Seroconversion Rates as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 TVC
Anti-HPV-18, Month 36
|
97 Participants
|
80 Participants
|
92 Participants
|
SECONDARY outcome
Timeframe: At Day 0 and Months 7, 12, 18, 24 and 36Population: The analysis was based on the Month 36 TVC, which included a subset of approximately 100 subjects per study group, who received at least one dose of vaccine in this study, for whom data were available at the specified time points and who were seronegative before vaccination.
Anti-HPV 16/18 antibody titers were presented as GMT and expressed in titers using the PBNA. The assay was performed on a subset of approximately 100 subjects per study group.
Outcome measures
| Measure |
Cervarix 2 Dose Group
n=99 Participants
Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 2 Dose Group
n=92 Participants
Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 3 Dose Group
n=98 Participants
Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|---|
|
Anti-HPV-16/18 Antibody Titers as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 TVC
Anti-HPV-16, Day 0
|
20.0 Titers
Interval 20.0 to 20.0
|
20.0 Titers
Interval 20.0 to 20.0
|
20.0 Titers
Interval 20.0 to 20.0
|
|
Anti-HPV-16/18 Antibody Titers as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 TVC
Anti-HPV-18, Day 0
|
20.0 Titers
Interval 20.0 to 20.0
|
20.0 Titers
Interval 20.0 to 20.0
|
20.0 Titers
Interval 20.0 to 20.0
|
|
Anti-HPV-16/18 Antibody Titers as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 TVC
Anti-HPV-16, Month 7
|
50000.7 Titers
Interval 39742.9 to 62906.0
|
18573.7 Titers
Interval 14876.8 to 23189.3
|
22294.2 Titers
Interval 17763.8 to 27980.0
|
|
Anti-HPV-16/18 Antibody Titers as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 TVC
Anti-HPV-18, Month 7
|
23576.9 Titers
Interval 18922.5 to 29376.2
|
4563.7 Titers
Interval 3519.5 to 5917.8
|
8042.1 Titers
Interval 6186.1 to 10454.8
|
|
Anti-HPV-16/18 Antibody Titers as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 TVC
Anti-HPV-16, Month 12
|
10039.6 Titers
Interval 7884.1 to 12784.5
|
4174.9 Titers
Interval 3207.5 to 5434.2
|
5766.0 Titers
Interval 4573.8 to 7268.9
|
|
Anti-HPV-16/18 Antibody Titers as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 TVC
Anti-HPV-18, Month 12
|
3546.9 Titers
Interval 2829.7 to 4445.8
|
670.3 Titers
Interval 510.0 to 880.9
|
1801.4 Titers
Interval 1333.0 to 2434.2
|
|
Anti-HPV-16/18 Antibody Titers as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 TVC
Anti-HPV-16, Month 18
|
7508.8 Titers
Interval 5819.8 to 9688.0
|
2070.2 Titers
Interval 1494.9 to 2866.9
|
2961.5 Titers
Interval 2233.9 to 3926.2
|
|
Anti-HPV-16/18 Antibody Titers as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 TVC
Anti-HPV-18, Month 18
|
2240.5 Titers
Interval 1763.3 to 2846.9
|
294.5 Titers
Interval 219.5 to 395.1
|
797.6 Titers
Interval 576.3 to 1104.0
|
|
Anti-HPV-16/18 Antibody Titers as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 TVC
Anti-HPV-16, Month 24
|
4609.1 Titers
Interval 3673.5 to 5782.9
|
1193.9 Titers
Interval 889.6 to 1602.3
|
1932.0 Titers
Interval 1499.4 to 2489.5
|
|
Anti-HPV-16/18 Antibody Titers as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 TVC
Anti-HPV-18, Month 24
|
1638.6 Titers
Interval 1297.9 to 2068.8
|
239.7 Titers
Interval 181.2 to 317.1
|
564.6 Titers
Interval 418.1 to 762.5
|
|
Anti-HPV-16/18 Antibody Titers as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 TVC
Anti-HPV-16, Month 36
|
4011.7 Titers
Interval 3229.7 to 4983.0
|
1111.4 Titers
Interval 849.1 to 1454.6
|
1517.2 Titers
Interval 1174.7 to 1959.4
|
|
Anti-HPV-16/18 Antibody Titers as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 TVC
Anti-HPV-18, Month 36
|
1513.7 Titers
Interval 1197.5 to 1913.2
|
185.8 Titers
Interval 142.2 to 242.7
|
468.6 Titers
Interval 346.3 to 634.0
|
SECONDARY outcome
Timeframe: At Day 0 and Months 7, 12, 24 and 36Population: The analysis was based on the Month 36 ATP cohort for immunogenicity, which included a sub-cohort of approximately 100 subjects per study group, who returned for blood sampling at Month 36 and for whom data concerning immunogenicity outcome measures were available at the specified time point.
Among immune markers expressed were Interleukin-2 (IL-2), Interferon-gamma (IFN-γ), Tumour necrosis factor-alpha (TNF-α) and CD40-ligand (CD40-L). The assay was performed on a sub-cohort of approximately 100 subjects per study group.
Outcome measures
| Measure |
Cervarix 2 Dose Group
n=67 Participants
Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 2 Dose Group
n=60 Participants
Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 3 Dose Group
n=74 Participants
Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|---|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4-d-CD40L, Anti-HPV-18, Month 7
|
866 T-cells/million cells
Interval 496.0 to 2483.0
|
386.5 T-cells/million cells
Interval 237.0 to 708.0
|
574 T-cells/million cells
Interval 328.0 to 1224.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4-d-CD40L, Anti-HPV-16, Month 12
|
889 T-cells/million cells
Interval 591.0 to 2236.0
|
524 T-cells/million cells
Interval 280.0 to 1135.0
|
761.5 T-cells/million cells
Interval 484.0 to 1425.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-d-IL-2, Anti-HPV-16, Month 12
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-d-IL-2, Anti-HPV-18, Month 12
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-d-IL-2, Anti-HPV-16, Month 24
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-d-IL-2, Anti-HPV-18, Month 24
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-d-IL-2, Anti-HPV-16, Month 36
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-d-IL-2, Anti-HPV-18, Month 36
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-d-TNFα, Anti-HPV-16, Day 0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
1 T-cells/million cells
Interval 1.0 to 36.0
|
1 T-cells/million cells
Interval 1.0 to 16.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-d-TNFα, Anti-HPV-18, Day 0
|
1 T-cells/million cells
Interval 1.0 to 27.0
|
1 T-cells/million cells
Interval 1.0 to 29.0
|
1 T-cells/million cells
Interval 1.0 to 26.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-d-TNFα, Anti-HPV-16, Month 7
|
1 T-cells/million cells
Interval 1.0 to 28.0
|
1 T-cells/million cells
Interval 1.0 to 26.0
|
1 T-cells/million cells
Interval 1.0 to 18.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-d-TNFα, Anti-HPV-18, Month 7
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
1 T-cells/million cells
Interval 1.0 to 2.0
|
1 T-cells/million cells
Interval 1.0 to 24.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-d-TNFα, Anti-HPV-16, Month 12
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
1 T-cells/million cells
Interval 1.0 to 25.0
|
1 T-cells/million cells
Interval 1.0 to 28.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-d-TNFα, Anti-HPV-18, Month 12
|
1 T-cells/million cells
Interval 1.0 to 8.0
|
1 T-cells/million cells
Interval 1.0 to 21.0
|
1 T-cells/million cells
Interval 1.0 to 24.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-d-TNFα, Anti-HPV-16, Month 24
|
1 T-cells/million cells
Interval 1.0 to 20.0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-d-TNFα, Anti-HPV-18, Month 24
|
1 T-cells/million cells
Interval 1.0 to 28.0
|
1 T-cells/million cells
Interval 1.0 to 7.0
|
1 T-cells/million cells
Interval 1.0 to 18.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-d-TNFα, Anti-HPV-16, Month 36
|
1 T-cells/million cells
Interval 1.0 to 24.0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
1 T-cells/million cells
Interval 1.0 to 26.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-d-TNFα, Anti-HPV-18, Month 36
|
1 T-cells/million cells
Interval 1.0 to 31.0
|
1 T-cells/million cells
Interval 1.0 to 21.0
|
1 T-cells/million cells
Interval 1.0 to 12.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4+ All doubles, Anti-HPV-16, Day 0
|
10 T-cells/million cells
Interval 1.0 to 78.0
|
22 T-cells/million cells
Interval 1.0 to 90.0
|
33 T-cells/million cells
Interval 1.0 to 80.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4+ All doubles, Anti-HPV-18, Day 0
|
28 T-cells/million cells
Interval 1.0 to 83.0
|
47.5 T-cells/million cells
Interval 1.0 to 102.0
|
26 T-cells/million cells
Interval 1.0 to 92.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4+ All doubles, Anti-HPV-16, Month 7
|
1662 T-cells/million cells
Interval 644.0 to 3221.0
|
872 T-cells/million cells
Interval 479.0 to 1275.0
|
1121 T-cells/million cells
Interval 694.0 to 1890.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4+ All doubles, Anti-HPV-18, Month 7
|
897 T-cells/million cells
Interval 496.0 to 2497.0
|
427 T-cells/million cells
Interval 259.0 to 744.0
|
640 T-cells/million cells
Interval 355.0 to 1304.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4+ All doubles, Anti-HPV-16, Month 12
|
916 T-cells/million cells
Interval 641.0 to 2340.0
|
585.5 T-cells/million cells
Interval 316.0 to 1250.0
|
819.5 T-cells/million cells
Interval 554.0 to 1623.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4+ All doubles, Anti-HPV-18, Month 12
|
789 T-cells/million cells
Interval 384.0 to 1492.0
|
327 T-cells/million cells
Interval 184.0 to 658.0
|
446 T-cells/million cells
Interval 205.0 to 824.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4+ All doubles, Anti-HPV-16, Month 24
|
1068.5 T-cells/million cells
Interval 495.0 to 2410.0
|
750.5 T-cells/million cells
Interval 366.5 to 1142.5
|
968.5 T-cells/million cells
Interval 588.0 to 1830.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4+ All doubles, Anti-HPV-18, Month 24
|
645 T-cells/million cells
Interval 311.0 to 1406.0
|
352 T-cells/million cells
Interval 196.5 to 503.0
|
578 T-cells/million cells
Interval 267.0 to 972.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4+ All doubles, Anti-HPV-16, Month 36
|
1012 T-cells/million cells
Interval 427.0 to 2373.0
|
685 T-cells/million cells
Interval 385.0 to 1321.0
|
842.5 T-cells/million cells
Interval 437.5 to 1624.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4+ All doubles, Anti-HPV-18, Month 36
|
682 T-cells/million cells
Interval 313.0 to 1425.0
|
350 T-cells/million cells
Interval 196.0 to 665.0
|
516 T-cells/million cells
Interval 270.0 to 1029.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4-d-CD40L, Anti-HPV-16, Day 0
|
1 T-cells/million cells
Interval 1.0 to 73.0
|
14 T-cells/million cells
Interval 1.0 to 72.0
|
30 T-cells/million cells
Interval 1.0 to 73.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4-d-CD40L, Anti-HPV-18, Day 0
|
14 T-cells/million cells
Interval 1.0 to 83.0
|
39.5 T-cells/million cells
Interval 1.0 to 102.0
|
27.5 T-cells/million cells
Interval 1.0 to 70.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4-d-CD40L, Anti-HPV-16, Month 7
|
1515 T-cells/million cells
Interval 638.0 to 3098.0
|
779 T-cells/million cells
Interval 456.0 to 1211.0
|
1025.5 T-cells/million cells
Interval 670.0 to 1848.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4-d-CD40L, Anti-HPV-18, Month 12
|
688 T-cells/million cells
Interval 344.0 to 1435.0
|
317 T-cells/million cells
Interval 147.0 to 633.0
|
383.5 T-cells/million cells
Interval 214.0 to 729.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4-d-CD40L, Anti-HPV-16, Month 24
|
1045.5 T-cells/million cells
Interval 518.0 to 2269.0
|
736 T-cells/million cells
Interval 348.0 to 1101.5
|
937 T-cells/million cells
Interval 588.0 to 1801.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4-d-CD40L, Anti-HPV-18, Month 24
|
639 T-cells/million cells
Interval 310.0 to 1374.0
|
332 T-cells/million cells
Interval 204.0 to 510.5
|
564 T-cells/million cells
Interval 289.0 to 940.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4-d-CD40L, Anti-HPV-16, Month 36
|
957 T-cells/million cells
Interval 465.0 to 2303.0
|
685 T-cells/million cells
Interval 349.0 to 1321.0
|
778.5 T-cells/million cells
Interval 416.5 to 1560.5
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4-d-CD40L, Anti-HPV-18, Month 36
|
671 T-cells/million cells
Interval 290.0 to 1435.0
|
337 T-cells/million cells
Interval 204.0 to 648.0
|
499 T-cells/million cells
Interval 264.0 to 1020.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4-d- IFNγ, Anti-HPV-16, Day 0
|
12 T-cells/million cells
Interval 1.0 to 30.0
|
19 T-cells/million cells
Interval 1.0 to 42.0
|
1 T-cells/million cells
Interval 1.0 to 28.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4-d- IFNγ, Anti-HPV-18, Day 0
|
14 T-cells/million cells
Interval 1.0 to 33.0
|
13.5 T-cells/million cells
Interval 1.0 to 36.0
|
3.5 T-cells/million cells
Interval 1.0 to 30.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4-d- IFNγ, Anti-HPV-16, Month 7
|
365 T-cells/million cells
Interval 161.0 to 881.0
|
320 T-cells/million cells
Interval 157.0 to 533.0
|
422.5 T-cells/million cells
Interval 206.0 to 708.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4-d- IFNγ, Anti-HPV-18, Month 7
|
242 T-cells/million cells
Interval 111.0 to 712.0
|
133.5 T-cells/million cells
Interval 83.0 to 240.0
|
181 T-cells/million cells
Interval 78.0 to 409.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4-d- IFNγ, Anti-HPV-16, Month 12
|
326 T-cells/million cells
Interval 110.0 to 644.0
|
235 T-cells/million cells
Interval 108.0 to 501.0
|
356 T-cells/million cells
Interval 135.0 to 734.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4-d- IFNγ, Anti-HPV-18, Month 12
|
175 T-cells/million cells
Interval 87.0 to 444.0
|
112 T-cells/million cells
Interval 55.0 to 240.0
|
164 T-cells/million cells
Interval 57.0 to 315.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4-d- IFNγ, Anti-HPV-16, Month 24
|
300.5 T-cells/million cells
Interval 119.0 to 781.0
|
317.5 T-cells/million cells
Interval 146.5 to 514.0
|
421 T-cells/million cells
Interval 157.0 to 767.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4-d- IFNγ, Anti-HPV-18, Month 24
|
171 T-cells/million cells
Interval 68.0 to 462.0
|
112 T-cells/million cells
Interval 49.5 to 229.5
|
220 T-cells/million cells
Interval 65.0 to 348.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4-d-IFNγ, Anti-HPV-16, Month 36
|
253.5 T-cells/million cells
Interval 81.0 to 667.0
|
301 T-cells/million cells
Interval 134.0 to 571.0
|
270.5 T-cells/million cells
Interval 129.0 to 666.5
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4-d-IFNγ, Anti-HPV-18, Month 36
|
193 T-cells/million cells
Interval 51.0 to 376.0
|
109 T-cells/million cells
Interval 27.0 to 230.0
|
155 T-cells/million cells
Interval 45.0 to 314.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4-d-IL-2, Anti-HPV-16, Day 0
|
14 T-cells/million cells
Interval 1.0 to 52.0
|
25 T-cells/million cells
Interval 1.0 to 72.0
|
33 T-cells/million cells
Interval 1.0 to 56.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4-d-IL-2, Anti-HPV-18, Day 0
|
1 T-cells/million cells
Interval 1.0 to 49.0
|
36.5 T-cells/million cells
Interval 1.0 to 76.0
|
22 T-cells/million cells
Interval 1.0 to 60.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4-d-IL-2, Anti-HPV-16, Month 7
|
1357 T-cells/million cells
Interval 537.0 to 2660.0
|
712.5 T-cells/million cells
Interval 378.0 to 1037.0
|
866 T-cells/million cells
Interval 561.0 to 1420.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4-d-IL-2, Anti-HPV-18, Month 7
|
737 T-cells/million cells
Interval 420.0 to 2185.0
|
304 T-cells/million cells
Interval 206.0 to 573.0
|
486 T-cells/million cells
Interval 281.0 to 959.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4-d-IL-2, Anti-HPV-16, Month 12
|
832 T-cells/million cells
Interval 493.0 to 2050.0
|
479 T-cells/million cells
Interval 283.0 to 946.0
|
674.5 T-cells/million cells
Interval 450.0 to 1316.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4-d-IL-2, Anti-HPV-18, Month 12
|
620 T-cells/million cells
Interval 304.0 to 1157.0
|
259 T-cells/million cells
Interval 144.0 to 547.0
|
354 T-cells/million cells
Interval 155.0 to 622.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4-d-IL-2, Anti-HPV-16, Month 24
|
855 T-cells/million cells
Interval 390.0 to 1711.0
|
579.5 T-cells/million cells
Interval 270.5 to 934.5
|
700 T-cells/million cells
Interval 479.0 to 1459.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4-d-IL-2, Anti-HPV-18, Month 24
|
494 T-cells/million cells
Interval 252.0 to 994.0
|
240 T-cells/million cells
Interval 125.5 to 387.5
|
426 T-cells/million cells
Interval 216.0 to 695.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4-d-IL-2, Anti-HPV-16, Month 36
|
784 T-cells/million cells
Interval 331.0 to 1673.0
|
517 T-cells/million cells
Interval 295.0 to 1014.0
|
680 T-cells/million cells
Interval 308.0 to 1245.5
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4-d-IL-2, Anti-HPV-18, Month 36
|
507 T-cells/million cells
Interval 213.0 to 1069.0
|
274 T-cells/million cells
Interval 137.0 to 467.0
|
341 T-cells/million cells
Interval 168.0 to 798.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4-d-TNFα, Anti-HPV-16, Day 0
|
6 T-cells/million cells
Interval 1.0 to 50.0
|
33 T-cells/million cells
Interval 1.0 to 82.0
|
16 T-cells/million cells
Interval 1.0 to 69.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4-d-TNFα, Anti-HPV-18, Day 0
|
27 T-cells/million cells
Interval 1.0 to 75.0
|
22.5 T-cells/million cells
Interval 1.0 to 82.0
|
23 T-cells/million cells
Interval 1.0 to 60.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4-d-TNFα, Anti-HPV-16, Month 7
|
1111 T-cells/million cells
Interval 430.0 to 2386.0
|
625 T-cells/million cells
Interval 292.0 to 899.0
|
796 T-cells/million cells
Interval 458.0 to 1448.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4-d-TNFα, Anti-HPV-18, Month 7
|
647 T-cells/million cells
Interval 336.0 to 1415.0
|
283.5 T-cells/million cells
Interval 168.0 to 594.0
|
457 T-cells/million cells
Interval 266.0 to 978.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4-d-TNFα, Anti-HPV-16, Month 12
|
790 T-cells/million cells
Interval 488.0 to 1924.0
|
482 T-cells/million cells
Interval 210.0 to 932.0
|
716 T-cells/million cells
Interval 457.0 to 1445.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4-d-TNFα, Anti-HPV-18, Month 12
|
674 T-cells/million cells
Interval 288.0 to 1272.0
|
266 T-cells/million cells
Interval 133.0 to 588.0
|
384.5 T-cells/million cells
Interval 175.0 to 714.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4-d-TNFα, Anti-HPV-16, Month 24
|
795.5 T-cells/million cells
Interval 343.0 to 1668.0
|
563.5 T-cells/million cells
Interval 241.5 to 895.0
|
760.5 T-cells/million cells
Interval 443.0 to 1494.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4-d-TNFα, Anti-HPV-18, Month 24
|
510 T-cells/million cells
Interval 183.0 to 1164.0
|
239 T-cells/million cells
Interval 127.5 to 440.5
|
522 T-cells/million cells
Interval 228.0 to 710.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4-d-TNFα, Anti-HPV-16, Month 36
|
786.5 T-cells/million cells
Interval 343.0 to 1930.0
|
547 T-cells/million cells
Interval 282.0 to 1005.0
|
724.5 T-cells/million cells
Interval 368.0 to 1338.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD4-d-TNFα, Anti-HPV-18, Month 36
|
588 T-cells/million cells
Interval 250.0 to 1138.0
|
301 T-cells/million cells
Interval 120.0 to 453.0
|
479 T-cells/million cells
Interval 200.0 to 808.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-All Doubles, Anti-HPV-16, Day 0
|
1 T-cells/million cells
Interval 1.0 to 14.0
|
4 T-cells/million cells
Interval 1.0 to 49.0
|
1 T-cells/million cells
Interval 1.0 to 25.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-All Doubles, Anti-HPV-18, Day 0
|
1 T-cells/million cells
Interval 1.0 to 16.0
|
1 T-cells/million cells
Interval 1.0 to 29.0
|
1 T-cells/million cells
Interval 1.0 to 22.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-All Doubles, Anti-HPV-16, Month 7
|
1 T-cells/million cells
Interval 1.0 to 34.0
|
1 T-cells/million cells
Interval 1.0 to 41.0
|
1 T-cells/million cells
Interval 1.0 to 30.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-All Doubles, Anti-HPV-18, Month 7
|
1 T-cells/million cells
Interval 1.0 to 19.0
|
1 T-cells/million cells
Interval 1.0 to 40.0
|
1 T-cells/million cells
Interval 1.0 to 40.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-All Doubles, Anti-HPV-16, Month 12
|
1 T-cells/million cells
Interval 1.0 to 31.0
|
1 T-cells/million cells
Interval 1.0 to 29.0
|
1 T-cells/million cells
Interval 1.0 to 29.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-All Doubles, Anti-HPV-18, Month 12
|
1 T-cells/million cells
Interval 1.0 to 27.0
|
1 T-cells/million cells
Interval 1.0 to 27.0
|
1 T-cells/million cells
Interval 1.0 to 20.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-All Doubles, Anti-HPV-16, Month 24
|
1 T-cells/million cells
Interval 1.0 to 25.0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-All Doubles, Anti-HPV-18, Month 24
|
1 T-cells/million cells
Interval 1.0 to 32.0
|
1 T-cells/million cells
Interval 1.0 to 23.0
|
1 T-cells/million cells
Interval 1.0 to 28.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-All doubles, Anti-HPV-16, Month 36
|
1 T-cells/million cells
Interval 1.0 to 48.0
|
1 T-cells/million cells
Interval 1.0 to 28.0
|
1 T-cells/million cells
Interval 1.0 to 38.5
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-All doubles, Anti-HPV-18, Month 36
|
4 T-cells/million cells
Interval 1.0 to 40.0
|
2 T-cells/million cells
Interval 1.0 to 41.0
|
1 T-cells/million cells
Interval 1.0 to 28.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-d-CD40L, Anti-HPV-16, Day 0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
1 T-cells/million cells
Interval 1.0 to 26.0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-d-CD40L, Anti-HPV-18, Day 0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-d-CD40L, Anti-HPV-16, Month 7
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
1 T-cells/million cells
Interval 1.0 to 29.0
|
1 T-cells/million cells
Interval 1.0 to 24.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-d-CD40L, Anti-HPV-18, Month 7
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
1 T-cells/million cells
Interval 1.0 to 24.0
|
1 T-cells/million cells
Interval 1.0 to 23.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-d-CD40L, Anti-HPV-16, Month 12
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
1 T-cells/million cells
Interval 1.0 to 3.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-d-CD40L, Anti-HPV-18, Month 12
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-d-CD40L, Anti-HPV-16, Month 24
|
1 T-cells/million cells
Interval 1.0 to 16.0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-d-CD40L, Anti-HPV-18, Month 24
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
1 T-cells/million cells
Interval 1.0 to 18.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-d-CD40L, Anti-HPV-16, Month 36
|
1 T-cells/million cells
Interval 1.0 to 31.0
|
1 T-cells/million cells
Interval 1.0 to 24.0
|
1 T-cells/million cells
Interval 1.0 to 29.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-d-CD40L, Anti-HPV-18, Month 36
|
1 T-cells/million cells
Interval 1.0 to 6.0
|
1 T-cells/million cells
Interval 1.0 to 27.0
|
1 T-cells/million cells
Interval 1.0 to 28.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-d-IFNγ, Anti-HPV-16, Day 0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
1 T-cells/million cells
Interval 1.0 to 39.0
|
1 T-cells/million cells
Interval 1.0 to 26.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-d-IFNγ, Anti-HPV-18, Day 0
|
1 T-cells/million cells
Interval 1.0 to 2.0
|
1 T-cells/million cells
Interval 1.0 to 23.0
|
1 T-cells/million cells
Interval 1.0 to 18.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-d-IFNγ, Anti-HPV-16, Month 7
|
1 T-cells/million cells
Interval 1.0 to 32.0
|
1 T-cells/million cells
Interval 1.0 to 40.0
|
1 T-cells/million cells
Interval 1.0 to 30.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-d-IFNγ, Anti-HPV-18, Month 7
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
1 T-cells/million cells
Interval 1.0 to 28.0
|
1 T-cells/million cells
Interval 1.0 to 28.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-d-IFNγ, Anti-HPV-16, Month 12
|
1 T-cells/million cells
Interval 1.0 to 28.0
|
1 T-cells/million cells
Interval 1.0 to 26.0
|
1 T-cells/million cells
Interval 1.0 to 27.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-d-IFNγ, Anti-HPV-18, Month 12
|
1 T-cells/million cells
Interval 1.0 to 22.0
|
1 T-cells/million cells
Interval 1.0 to 26.0
|
1 T-cells/million cells
Interval 1.0 to 10.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-d-IFNγ, Anti-HPV-16, Month 24
|
1 T-cells/million cells
Interval 1.0 to 16.0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-d-IFNγ, Anti-HPV-18, Month 24
|
1 T-cells/million cells
Interval 1.0 to 18.0
|
1 T-cells/million cells
Interval 1.0 to 23.0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-d-IFNγ, Anti-HPV-16, Month 36
|
1 T-cells/million cells
Interval 1.0 to 47.0
|
1 T-cells/million cells
Interval 1.0 to 25.0
|
1 T-cells/million cells
Interval 1.0 to 33.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-d-IFNγ, Anti-HPV-18, Month 36
|
1 T-cells/million cells
Interval 1.0 to 31.0
|
2 T-cells/million cells
Interval 1.0 to 40.0
|
1 T-cells/million cells
Interval 1.0 to 25.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-d-IL-2, Anti-HPV-16, Day 0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-d-IL-2, Anti-HPV-18, Day 0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-d-IL-2, Anti-HPV-16, Month 7
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
|
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
CD8-d-IL-2, Anti-HPV-18, Month 7
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
1 T-cells/million cells
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: At Day 0 and Months 7, 12, 24 and 36Population: The analysis was based on the Month 36 ATP cohort for immunogenicity, which included a sub-cohort of approximately 100 subjects per study group, who returned for blood sampling at Month 36 and for whom data concerning immunogenicity outcome measures were available at the specified time point.
The frequency of B-cell Elispot response to HPV-16/18 by overall status was presented. The assay was performed on a sub-cohort of approximately 100 subjects per study group.
Outcome measures
| Measure |
Cervarix 2 Dose Group
n=71 Participants
Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 2 Dose Group
n=65 Participants
Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 3 Dose Group
n=76 Participants
Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|---|
|
B-cell-mediated Immune Responses in the Sub-cohort for CMI
HPV-16, Day 0
|
1 B-cells/million cells
Interval 1.0 to 1.0
|
1 B-cells/million cells
Interval 1.0 to 1.0
|
1 B-cells/million cells
Interval 1.0 to 1.0
|
|
B-cell-mediated Immune Responses in the Sub-cohort for CMI
HPV-18, Day 0
|
1 B-cells/million cells
Interval 1.0 to 1.0
|
1 B-cells/million cells
Interval 1.0 to 1.0
|
1 B-cells/million cells
Interval 1.0 to 1.0
|
|
B-cell-mediated Immune Responses in the Sub-cohort for CMI
HPV-16, Month 7
|
1733 B-cells/million cells
Interval 577.0 to 3733.0
|
1254 B-cells/million cells
Interval 495.0 to 2173.0
|
733 B-cells/million cells
Interval 106.5 to 1966.5
|
|
B-cell-mediated Immune Responses in the Sub-cohort for CMI
HPV-18, Month 7
|
558 B-cells/million cells
Interval 106.0 to 1847.0
|
155 B-cells/million cells
Interval 1.0 to 379.0
|
111 B-cells/million cells
Interval 1.0 to 343.5
|
|
B-cell-mediated Immune Responses in the Sub-cohort for CMI
HPV-16, Month 12
|
408 B-cells/million cells
Interval 90.0 to 1186.0
|
278 B-cells/million cells
Interval 66.0 to 794.0
|
289 B-cells/million cells
Interval 66.0 to 982.0
|
|
B-cell-mediated Immune Responses in the Sub-cohort for CMI
HPV-18, Month 12
|
249 B-cells/million cells
Interval 73.0 to 658.0
|
69 B-cells/million cells
Interval 1.0 to 184.0
|
69 B-cells/million cells
Interval 1.0 to 250.0
|
|
B-cell-mediated Immune Responses in the Sub-cohort for CMI
HPV-16, Month 24
|
270 B-cells/million cells
Interval 49.0 to 724.0
|
218.5 B-cells/million cells
Interval 28.0 to 651.0
|
249 B-cells/million cells
Interval 37.0 to 601.0
|
|
B-cell-mediated Immune Responses in the Sub-cohort for CMI
HPV-18, Month 24
|
128.5 B-cells/million cells
Interval 35.0 to 402.0
|
57.5 B-cells/million cells
Interval 1.0 to 203.0
|
111 B-cells/million cells
Interval 1.0 to 317.0
|
|
B-cell-mediated Immune Responses in the Sub-cohort for CMI
HPV-16, Month 36
|
353 B-cells/million cells
Interval 91.0 to 927.0
|
382.5 B-cells/million cells
Interval 166.0 to 614.0
|
246 B-cells/million cells
Interval 21.0 to 565.0
|
|
B-cell-mediated Immune Responses in the Sub-cohort for CMI
HPV-18, Month 36
|
116 B-cells/million cells
Interval 1.0 to 329.0
|
25 B-cells/million cells
Interval 1.0 to 228.0
|
63 B-cells/million cells
Interval 1.0 to 150.0
|
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 and who had their symptom sheet completed.
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 2 Dose Group
n=359 Participants
Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 2 Dose Group
n=357 Participants
Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 3 Dose Group
n=356 Participants
Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain - Dose 1
|
311 Participants
|
235 Participants
|
231 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain - Dose 2
|
193 Participants
|
183 Participants
|
215 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain - Dose 3
|
280 Participants
|
194 Participants
|
222 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain - Across doses
|
329 Participants
|
276 Participants
|
295 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain - Dose 1
|
22 Participants
|
4 Participants
|
6 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain - Dose 2
|
8 Participants
|
8 Participants
|
8 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain - Dose 3
|
23 Participants
|
11 Participants
|
10 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain - Across doses
|
42 Participants
|
17 Participants
|
18 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness - Dose 1
|
137 Participants
|
84 Participants
|
87 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness - Dose 2
|
100 Participants
|
84 Participants
|
99 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness - Dose 3
|
133 Participants
|
92 Participants
|
102 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness - Across doses
|
191 Participants
|
134 Participants
|
157 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness - Dose 1
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness - Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness - Dose 3
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness - Across doses
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling - Dose 1
|
112 Participants
|
44 Participants
|
39 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling - Dose 2
|
63 Participants
|
35 Participants
|
76 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling - Dose 3
|
113 Participants
|
67 Participants
|
85 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling - Across doses
|
163 Participants
|
98 Participants
|
118 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling - Dose 1
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling - Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling - Dose 3
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling - Across doses
|
5 Participants
|
0 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 and who had their symptom sheet completed.
Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\] 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 2 Dose Group
n=359 Participants
Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 2 Dose Group
n=357 Participants
Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 3 Dose Group
n=356 Participants
Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Urticaria - Dose 3
|
6 Participants
|
4 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Arthralgia - Dose 1
|
44 Participants
|
50 Participants
|
39 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Arthralgia - Dose 2
|
23 Participants
|
30 Participants
|
34 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Arthralgia - Dose 3
|
31 Participants
|
38 Participants
|
35 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Arthralgia - Across doses
|
68 Participants
|
81 Participants
|
67 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Arthralgia - Dose 1
|
5 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Arthralgia - Dose 2
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Arthralgia - Dose 3
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Arthralgia - Across doses
|
6 Participants
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Arthralgia - Dose 1
|
29 Participants
|
32 Participants
|
28 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Arthralgia - Dose 2
|
17 Participants
|
17 Participants
|
18 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Arthralgia - Dose 3
|
20 Participants
|
27 Participants
|
27 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Arthralgia - Across doses
|
51 Participants
|
55 Participants
|
51 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue - Dose 1
|
163 Participants
|
157 Participants
|
168 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue - Dose 2
|
103 Participants
|
104 Participants
|
119 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue - Dose 3
|
108 Participants
|
97 Participants
|
103 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue - Across doses
|
192 Participants
|
199 Participants
|
193 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue - Dose 1
|
7 Participants
|
10 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue - Dose 2
|
12 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature - Dose 3
|
19 Participants
|
12 Participants
|
15 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue - Dose 3
|
7 Participants
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue - Across doses
|
18 Participants
|
15 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue - Dose 1
|
103 Participants
|
102 Participants
|
98 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue - Dose 2
|
68 Participants
|
66 Participants
|
67 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue - Dose 3
|
70 Participants
|
67 Participants
|
67 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue - Across doses
|
152 Participants
|
151 Participants
|
143 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal - Dose 1
|
34 Participants
|
52 Participants
|
44 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal - Dose 2
|
19 Participants
|
22 Participants
|
23 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal - Dose 3
|
16 Participants
|
29 Participants
|
24 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal - Across doses
|
55 Participants
|
74 Participants
|
70 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal - Dose 1
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal - Dose 2
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal - Dose 3
|
1 Participants
|
4 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal - Across doses
|
5 Participants
|
6 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal - Dose 1
|
21 Participants
|
26 Participants
|
22 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal - Dose 2
|
8 Participants
|
17 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal - Dose 3
|
10 Participants
|
20 Participants
|
17 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal - Across doses
|
32 Participants
|
49 Participants
|
40 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache - Dose 1
|
102 Participants
|
87 Participants
|
90 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache - Dose 2
|
62 Participants
|
64 Participants
|
73 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache - Dose 3
|
63 Participants
|
54 Participants
|
65 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache - Across doses
|
147 Participants
|
133 Participants
|
151 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache - Dose 1
|
7 Participants
|
6 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache - Dose 2
|
6 Participants
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache - Dose 3
|
7 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache - Across doses
|
17 Participants
|
7 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache - Dose 1
|
61 Participants
|
51 Participants
|
48 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache - Dose 2
|
39 Participants
|
37 Participants
|
41 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache - Dose 3
|
45 Participants
|
33 Participants
|
42 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache - Across doses
|
107 Participants
|
88 Participants
|
100 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia - Dose 1
|
131 Participants
|
101 Participants
|
101 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia - Dose 2
|
59 Participants
|
60 Participants
|
80 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia - Dose 3
|
77 Participants
|
68 Participants
|
72 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia - Across doses
|
166 Participants
|
143 Participants
|
136 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia - Dose 1
|
5 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia - Dose 2
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia - Dose 3
|
3 Participants
|
4 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia - Across doses
|
8 Participants
|
8 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia - Dose 1
|
91 Participants
|
70 Participants
|
67 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia - Dose 2
|
36 Participants
|
40 Participants
|
51 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia - Dose 3
|
50 Participants
|
49 Participants
|
46 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia - Across doses
|
128 Participants
|
111 Participants
|
100 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Rash - Dose 1
|
14 Participants
|
7 Participants
|
10 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Rash - Dose 2
|
10 Participants
|
5 Participants
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Rash - Dose 3
|
7 Participants
|
5 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Rash - Across doses
|
25 Participants
|
16 Participants
|
18 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
|
6 Participants
|
5 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Rash - Dose 2
|
6 Participants
|
3 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Rash - Dose 3
|
6 Participants
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Rash - Across doses
|
16 Participants
|
10 Participants
|
12 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature ( ≥ 37.5°C) - Dose 1
|
19 Participants
|
23 Participants
|
18 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature ( ≥ 37.5°C) - Dose 2
|
13 Participants
|
21 Participants
|
19 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature ( ≥ 37.5°C) - Dose 3
|
32 Participants
|
22 Participants
|
22 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature ( ≥ 37.5°C) - Across doses
|
53 Participants
|
59 Participants
|
47 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature ( > 39.0°C) - Dose 1
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature ( > 39.0°C) - Dose 2
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature ( > 39.0°C) - Dose 3
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature ( > 39.0°C) - Across doses
|
7 Participants
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature - Dose 1
|
13 Participants
|
11 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature - Dose 2
|
8 Participants
|
9 Participants
|
11 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature - Across doses
|
35 Participants
|
31 Participants
|
30 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Urticaria - Dose 1
|
15 Participants
|
7 Participants
|
12 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Urticaria - Dose 2
|
8 Participants
|
5 Participants
|
12 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Urticaria - Dose 3
|
11 Participants
|
4 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Urticaria - Across doses
|
28 Participants
|
13 Participants
|
25 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Urticaria - Dose 1
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Urticaria - Dose 2
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Urticaria - Dose 3
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Urticaria - Across doses
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Urticaria - Dose 1
|
7 Participants
|
6 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Urticaria - Dose 2
|
5 Participants
|
4 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Urticaria - Across doses
|
15 Participants
|
11 Participants
|
9 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.
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 2 Dose Group
n=359 Participants
Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 2 Dose Group
n=358 Participants
Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 3 Dose Group
n=358 Participants
Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Subjects with any AE(s)
|
91 Participants
|
96 Participants
|
101 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Subjects with any Grade 3 AE(s)
|
18 Participants
|
8 Participants
|
20 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Subjects with any Related AE(s)
|
8 Participants
|
14 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: From Day 0 up to Month 12Population: The analysis was based on the TVC, which included all subjects with at least one study vaccine administered.
pIMDs were defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Outcome measures
| Measure |
Cervarix 2 Dose Group
n=359 Participants
Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 2 Dose Group
n=358 Participants
Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 3 Dose Group
n=358 Participants
Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|---|
|
Number of Subjects With Potentially Immune Mediated Diseases (pIMDs)
|
3 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 0 up to Month 36 (throughout the study period)Population: The analysis was based on the TVC, which included all subjects with at least one study vaccine administered.
MSCs were defined as AEs prompting emergency room (ER) or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.
Outcome measures
| Measure |
Cervarix 2 Dose Group
n=359 Participants
Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 2 Dose Group
n=358 Participants
Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 3 Dose Group
n=358 Participants
Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|---|
|
Number of Subjects With Medically Significant Conditions (MSCs)
|
77 Participants
|
79 Participants
|
63 Participants
|
SECONDARY outcome
Timeframe: From Day 0 up to Month 36 (throughout the study period)Population: The analysis was based on the TVC, which included all subjects with at least one study vaccine administered.
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
Outcome measures
| Measure |
Cervarix 2 Dose Group
n=359 Participants
Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 2 Dose Group
n=358 Participants
Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 3 Dose Group
n=358 Participants
Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
21 Participants
|
11 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: From Day 0 up to Month 36 (throughout the study period)Population: The analysis was based on the TVC, which included all subjects with at least one study vaccine administered.
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Related = an event assessed by the investigator as causally related to the investigational product, to study participation or to GSK concomitant products.
Outcome measures
| Measure |
Cervarix 2 Dose Group
n=359 Participants
Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 2 Dose Group
n=358 Participants
Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 3 Dose Group
n=358 Participants
Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|---|
|
Number of Subjects With SAEs Related to the Investigational Product, to Study Participation, to GSK Concomitant Products or Any Fatal SAE
Related SAE(s)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With SAEs Related to the Investigational Product, to Study Participation, to GSK Concomitant Products or Any Fatal SAE
Fatal SAE(s)
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From Day 0 up to Month 36 (throughout the study period)Population: The analysis was based on the TVC, which included all subjects with the study vaccine administered and who reported any pregnancies and outcomes of reported pregnancies.
Outcomes of pregnancies were Live infant NO apparent congenital anomaly (ACA), Live infant congenital anomaly (CA), Elective termination NO ACA, Elective termination CA, Ectopic pregnancy, Spontaneous abortion NO ACA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up and Pregnancy ongoing.
Outcome measures
| Measure |
Cervarix 2 Dose Group
Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 2 Dose Group
Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 3 Dose Group
n=1 Participants
Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|---|
|
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Live infant NO ACA
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Live infant CA
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Elective termination NO ACA
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Elective termination CA
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Ectopic pregnancy
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Spontaneous abortion NO ACA
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Stillbirth NO ACA
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Stillbirth CA
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Lost to follow up
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Pregnancy ongoing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 0 up to Month 36 (throughout the study period) 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.
The number of subjects who have used any concomitant medication, as well as any antipyretic, any prophylactic antipyretic and any antibiotic.
Outcome measures
| Measure |
Cervarix 2 Dose Group
n=359 Participants
Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 2 Dose Group
n=358 Participants
Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 3 Dose Group
n=358 Participants
Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|---|
|
Number of Subjects Using a Concomitant Medication Throughout the Study Period
Any, Dose 1
|
85 Participants
|
87 Participants
|
93 Participants
|
|
Number of Subjects Using a Concomitant Medication Throughout the Study Period
Any antipyretic, Dose 1
|
51 Participants
|
53 Participants
|
47 Participants
|
|
Number of Subjects Using a Concomitant Medication Throughout the Study Period
Prophylactic antipyretic, Dose 1
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Using a Concomitant Medication Throughout the Study Period
Any antibiotic, Dose 1
|
15 Participants
|
13 Participants
|
23 Participants
|
|
Number of Subjects Using a Concomitant Medication Throughout the Study Period
Prophylactic antibiotic, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Using a Concomitant Medication Throughout the Study Period
Any, Dose 2
|
52 Participants
|
55 Participants
|
47 Participants
|
|
Number of Subjects Using a Concomitant Medication Throughout the Study Period
Any antipyretic, Dose 2
|
32 Participants
|
26 Participants
|
29 Participants
|
|
Number of Subjects Using a Concomitant Medication Throughout the Study Period
Prophylactic antipyretic, Dose 2
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects Using a Concomitant Medication Throughout the Study Period
Any antibiotic, Dose 2
|
8 Participants
|
13 Participants
|
12 Participants
|
|
Number of Subjects Using a Concomitant Medication Throughout the Study Period
Prophylactic antibiotic, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Using a Concomitant Medication Throughout the Study Period
Any, Dose 3
|
90 Participants
|
83 Participants
|
81 Participants
|
|
Number of Subjects Using a Concomitant Medication Throughout the Study Period
Any antipyretic, Dose 3
|
48 Participants
|
45 Participants
|
38 Participants
|
|
Number of Subjects Using a Concomitant Medication Throughout the Study Period
Prophylactic antipyretic, Dose 3
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Using a Concomitant Medication Throughout the Study Period
Any antibiotic, Dose 3
|
28 Participants
|
21 Participants
|
24 Participants
|
|
Number of Subjects Using a Concomitant Medication Throughout the Study Period
Prophylactic antibiotic, Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Using a Concomitant Medication Throughout the Study Period
Any, Across doses
|
171 Participants
|
157 Participants
|
161 Participants
|
|
Number of Subjects Using a Concomitant Medication Throughout the Study Period
Any antipyretic, Across doses
|
110 Participants
|
102 Participants
|
95 Participants
|
|
Number of Subjects Using a Concomitant Medication Throughout the Study Period
Prophylactic antipyretic, Across doses
|
5 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects Using a Concomitant Medication Throughout the Study Period
Any antibiotic, Across doses
|
48 Participants
|
42 Participants
|
50 Participants
|
|
Number of Subjects Using a Concomitant Medication Throughout the Study Period
Prophylactic antibiotic, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 0 up to Month 36 (throughout the study period)Population: The analysis was based on the TVC, which included all subjects with at least one study vaccine administered.
The number of subjects who have completed the three-dose vaccination schedule in all groups.
Outcome measures
| Measure |
Cervarix 2 Dose Group
n=359 Participants
Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 2 Dose Group
n=358 Participants
Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 3 Dose Group
n=358 Participants
Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|---|
|
Number of Subjects Completing the Vaccination Schedule
|
351 Participants
|
339 Participants
|
346 Participants
|
Adverse Events
Cervarix 2 Dose Group
Serious events: 21 serious events
Other events: 343 other events
Deaths: 0 deaths
Gardasil 2 Dose Group
Serious events: 11 serious events
Other events: 321 other events
Deaths: 0 deaths
Gardasil 3 Dose Group
Serious events: 14 serious events
Other events: 324 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Cervarix 2 Dose Group
n=359 participants at risk
Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 2 Dose Group
n=358 participants at risk
Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 3 Dose Group
n=358 participants at risk
Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.56%
2/359 • Number of events 2 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.28%
1/358 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Infections and infestations
Gastroenteritis
|
0.84%
3/359 • Number of events 3 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.56%
2/359 • Number of events 2 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.28%
1/358 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Infections and infestations
Appendicitis
|
0.28%
1/359 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.28%
1/358 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.56%
2/359 • Number of events 2 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Infections and infestations
Pneumonia
|
0.28%
1/359 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.28%
1/358 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/359 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.28%
1/358 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/359 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.28%
1/358 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous incomplete
|
0.00%
0/359 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.28%
1/358 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Immune system disorders
Anaphylactic reaction
|
0.28%
1/359 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/359 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.28%
1/358 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/359 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.28%
1/358 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.28%
1/359 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/359 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.28%
1/358 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.28%
1/359 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Psychiatric disorders
Depression
|
0.00%
0/359 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.28%
1/358 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/359 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.28%
1/358 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/359 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.28%
1/358 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Infections and infestations
Epstein-Barr virus infection
|
0.28%
1/359 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.28%
1/359 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.28%
1/359 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.28%
1/359 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.28%
1/359 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/359 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.28%
1/358 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Infections and infestations
Influenza
|
0.00%
0/359 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.28%
1/358 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/359 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.28%
1/358 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Musculoskeletal and connective tissue disorders
Juvenile idiopathic arthritis
|
0.28%
1/359 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Infections and infestations
Lung abscess
|
0.00%
0/359 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.28%
1/358 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/359 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.28%
1/358 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/359 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.28%
1/358 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Gastrointestinal disorders
Mouth cyst
|
0.00%
0/359 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.28%
1/358 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Vascular disorders
Orthostatic hypotension
|
0.28%
1/359 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/359 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.28%
1/358 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Infections and infestations
Peritonitis
|
0.00%
0/359 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.28%
1/358 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Infections and infestations
Post procedural infection
|
0.28%
1/359 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Nervous system disorders
Presyncope
|
0.00%
0/359 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.28%
1/358 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Nervous system disorders
Seizure
|
0.00%
0/359 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.28%
1/358 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Nervous system disorders
Syncope
|
0.28%
1/359 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/359 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.28%
1/358 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Nervous system disorders
Tension headache
|
0.00%
0/359 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.28%
1/358 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Teratoma
|
0.00%
0/359 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.28%
1/358 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Infections and infestations
Tonsillitis
|
0.28%
1/359 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/359 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.28%
1/358 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Infections and infestations
Viral infection
|
0.00%
0/359 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.28%
1/358 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Reproductive system and breast disorders
Vulval ulceration
|
0.00%
0/359 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.00%
0/358 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
0.28%
1/358 • Number of events 1 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
Other adverse events
| Measure |
Cervarix 2 Dose Group
n=359 participants at risk
Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 2 Dose Group
n=358 participants at risk
Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
Gardasil 3 Dose Group
n=358 participants at risk
Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.9%
68/359 • Number of events 98 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
22.9%
82/358 • Number of events 119 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
18.7%
67/358 • Number of events 108 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
53.2%
191/359 • Number of events 370 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
37.7%
135/358 • Number of events 261 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
43.9%
157/358 • Number of events 288 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
General disorders
Fatigue
|
53.5%
192/359 • Number of events 374 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
55.6%
199/358 • Number of events 359 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
53.9%
193/358 • Number of events 390 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
15.3%
55/359 • Number of events 69 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
20.7%
74/358 • Number of events 103 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
19.6%
70/358 • Number of events 91 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Nervous system disorders
Headache
|
41.5%
149/359 • Number of events 241 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
37.4%
134/358 • Number of events 213 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
42.5%
152/358 • Number of events 232 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
46.2%
166/359 • Number of events 267 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
40.2%
144/358 • Number of events 230 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
38.0%
136/358 • Number of events 254 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Infections and infestations
Nasopharyngitis
|
2.2%
8/359 • Number of events 10 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
3.1%
11/358 • Number of events 12 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
5.6%
20/358 • Number of events 22 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
General disorders
Pain
|
91.6%
329/359 • Number of events 784 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
77.4%
277/358 • Number of events 613 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
82.4%
295/358 • Number of events 669 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
General disorders
Pyrexia
|
16.4%
59/359 • Number of events 70 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
17.9%
64/358 • Number of events 71 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
14.8%
53/358 • Number of events 65 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.2%
26/359 • Number of events 32 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
4.5%
16/358 • Number of events 17 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
5.0%
18/358 • Number of events 23 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
General disorders
Swelling
|
45.4%
163/359 • Number of events 288 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
27.4%
98/358 • Number of events 146 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
33.0%
118/358 • Number of events 200 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Infections and infestations
Upper respiratory tract infection
|
7.5%
27/359 • Number of events 31 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
8.1%
29/358 • Number of events 33 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
8.7%
31/358 • Number of events 34 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
7.8%
28/359 • Number of events 36 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
3.6%
13/358 • Number of events 16 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
|
7.0%
25/358 • Number of events 33 • Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
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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