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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01462357
Recruitment Status : Completed
First Posted : October 31, 2011
Results First Posted : March 28, 2016
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Infections, Papillomavirus
Interventions Biological: Cervarix
Biological: Gardasil
Drug: Placebo
Enrollment 1079
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Cervarix 2 Dose Group Gardasil 2 Dose Group Gardasil 3 Dose Group
Hide Arm/Group Description 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. 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. 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.
Period Title: Overall Study
Started 359 358 358
Completed 351 339 346
Not Completed 8 19 12
Reason Not Completed
Death             0             0             1
Withdrawal by Subject             3             11             3
Migrated/moved from study area             2             3             1
Lost to Follow-up             3             5             7
Arm/Group Title Cervarix 2 Dose Group Gardasil 2 Dose Group Gardasil 3 Dose Group Total
Hide Arm/Group Description 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 359 358 358 1075
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 359 participants 358 participants 358 participants 1075 participants
11.5  (1.64) 11.5  (1.56) 11.6  (1.64) 11.53  (1.61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 359 participants 358 participants 358 participants 1075 participants
Female
359
 100.0%
358
 100.0%
358
 100.0%
1075
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 359 participants 358 participants 358 participants 1075 participants
African Heritage / African American
4
   1.1%
6
   1.7%
4
   1.1%
14
   1.3%
Asian - Central / South Asian Heritage
1
   0.3%
1
   0.3%
2
   0.6%
4
   0.4%
Asian - East Asian Heritage
179
  49.9%
178
  49.7%
179
  50.0%
536
  49.9%
Asian - South East Asian Heritage
81
  22.6%
78
  21.8%
83
  23.2%
242
  22.5%
White - Arabic / North African Heritage
5
   1.4%
7
   2.0%
7
   2.0%
19
   1.8%
White - Caucasian / European Heritage
89
  24.8%
86
  24.0%
83
  23.2%
258
  24.0%
White - Caucasian / African Heritage
0
   0.0%
1
   0.3%
0
   0.0%
1
   0.1%
African - White / Caucasian Heritage
0
   0.0%
1
   0.3%
0
   0.0%
1
   0.1%
1.Primary Outcome
Title 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
Hide Description 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.
Time Frame At Month 7 (i.e. one month after the last dose of study vaccine)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cervarix 2 Dose Group Gardasil 2 Dose Group Gardasil 3 Dose Group
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 334 331 333
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-HPV-16 Number Analyzed 330 participants 327 participants 322 participants
330
 100.0%
327
 100.0%
322
 100.0%
Anti-HPV-18 Number Analyzed 334 participants 331 participants 333 participants
334
 100.0%
331
 100.0%
333
 100.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cervarix 2 Dose Group, Gardasil 2 Dose Group
Comments Immune response to anti-HPV-16 in terms of seroconversion rates (SCR): To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is non-inferior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, 1 month after the last dose (Month 7), in initially seronegative subjects.
Type of Statistical Test Non-Inferiority
Comments Non-inferiority with respect to seroconversion was shown if, one month after the last dose, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% confidence interval (CI) for the difference (Gardasil 2 dose Group minus Cervarix 2 dose Group) was below 5%.
Method of Estimation Estimation Parameter Difference in SCR
Estimated Value 0
Confidence Interval (2-Sided) 95%
-1.16 to 1.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cervarix 2 Dose Group, Gardasil 2 Dose Group
Comments Immune response to anti-HPV-18 in terms of SCR: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is non-inferior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, 1 month after the last dose (Month 7), in initially seronegative subjects.
Type of Statistical Test Non-Inferiority
Comments Non-inferiority with respect to seroconversion was shown if, one month after the last dose, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% confidence interval (CI) for the difference (Gardasil 2 dose Group minus Cervarix 2 dose Group) was below 5%.
Method of Estimation Estimation Parameter Difference in SCR
Estimated Value 0
Confidence Interval (2-Sided) 95%
-1.15 to 1.14
Estimation Comments [Not Specified]
2.Primary Outcome
Title Anti-HPV-16/18 Antibody Titers as Assessed by ELISA at Month 7 Based on the ATP Cohort for Immunogenicity
Hide Description Anti-HPV 16/18 antibody titers were presented as Geometric Mean Titers (GMTs) and expressed in EL.U/mL.
Time Frame At Month 7 (i.e. one month after the last dose of study vaccine)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cervarix 2 Dose Group Gardasil 2 Dose Group Gardasil 3 Dose Group
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 334 331 333
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-HPV-16 Number Analyzed 330 participants 327 participants 322 participants
8244.1
(7678.3 to 8851.7)
5056.0
(4596.5 to 5561.5)
4807.4
(4420.8 to 5227.7)
Anti-HPV-18 Number Analyzed 334 participants 331 participants 333 participants
5277.4
(4858.6 to 5732.4)
1207.2
(1092.9 to 1333.4)
1653.5
(1484.4 to 1841.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cervarix 2 Dose Group, Gardasil 2 Dose Group
Comments Immune response to anti-HPV-16 in terms of Geometric Mean Titers (GMT): To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is non-inferior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, 1 month after the last dose (Month 7), in initially seronegative subjects.
Type of Statistical Test Non-Inferiority
Comments Non-inferiority with respect to GMT was shown if, one month after the last dose, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% CI for the GMT ratio (Gardasil 2 dose Group divided by Cervarix 2 dose Group) was below 2.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 0.61
Confidence Interval (2-Sided) 95%
0.54 to 0.69
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cervarix 2 Dose Group, Gardasil 2 Dose Group
Comments Immune response to anti-HPV-18 in terms of GMT: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is non-inferior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, 1 month after the last dose (Month 7), in initially seronegative subjects.
Type of Statistical Test Non-Inferiority
Comments Non-inferiority with respect to GMT was shown if, one month after the last dose, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% confidence interval (CI) for the GMT ratio (Gardasil 2 dose Group divided by Cervarix 2 dose Group) was below 2.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 0.23
Confidence Interval (2-Sided) 95%
0.20 to 0.26
Estimation Comments [Not Specified]
3.Primary Outcome
Title Anti-HPV-16/18 Antibody Titers as Assessed by ELISA at Month 7 Based on the Total Vaccinated Cohort (TVC)
Hide Description Anti-HPV 16/18 antibody titers were presented as Geometric Mean Titers (GMTs) and expressed in EL.U/mL.
Time Frame At Month 7 (i.e. one month after the last dose of study vaccine)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cervarix 2 Dose Group Gardasil 2 Dose Group Gardasil 3 Dose Group
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 357 353 351
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-HPV-16
8256.4
(7650.3 to 8910.6)
4886.1
(4435.4 to 5382.6)
4789.2
(4409.6 to 5201.4)
Anti-HPV-18
5267.8
(4857.1 to 5713.2)
1166.3
(1056 to 1288.2)
1635.8
(1470 to 1820.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cervarix 2 Dose Group, Gardasil 2 Dose Group
Comments Anti-HPV-18 immune response: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is superior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, in 9-14 year-old females, 1 month after the last dose (Month 7) regardless of serostatus.
Type of Statistical Test Superiority
Comments Superiority was shown if the lower limit of the 95% CI for the ratio of GMTs (Cervarix 2 dose Group divided by Gardasil 2 dose Group) was above 1 for anti-HPV-18 antibodies.
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 4.52
Confidence Interval (2-Sided) 95%
3.97 to 5.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cervarix 2 Dose Group, Gardasil 2 Dose Group
Comments Anti-HPV-16 immune response: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is superior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, in 9-14 year-old females, 1 month after the last dose (Month 7) regardless of serostatus.
Type of Statistical Test Superiority
Comments Superiority was shown if the lower limit of the 95% CI for the ratio of GMTs (Cervarix 2 dose Group divided by Gardasil 2 dose Group) was above 1 for anti-HPV-16 antibodies.
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.69
Confidence Interval (2-Sided) 95%
1.49 to 1.91
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Anti-HPV-16/18 Seroconversion Rates as Assessed by ELISA
Hide Description 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.
Time Frame At Day 0 and Months 12, 18, 24 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cervarix 2 Dose Group Gardasil 2 Dose Group Gardasil 3 Dose Group
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 322 310 320
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-HPV-16, Day 0 Number Analyzed 318 participants 306 participants 309 participants
0
   0.0%
0
   0.0%
0
   0.0%
Anti-HPV-18, Day 0 Number Analyzed 322 participants 310 participants 320 participants
0
   0.0%
0
   0.0%
0
   0.0%
Anti-HPV-16, Month 12 Number Analyzed 317 participants 305 participants 308 participants
316
  99.7%
305
 100.0%
308
 100.0%
Anti-HPV-18, Month 12 Number Analyzed 321 participants 309 participants 319 participants
320
  99.7%
309
 100.0%
319
 100.0%
Anti-HPV-16, Month 18 Number Analyzed 316 participants 305 participants 309 participants
316
 100.0%
304
  99.7%
309
 100.0%
Anti-HPV-18, Month 18 Number Analyzed 320 participants 309 participants 320 participants
320
 100.0%
294
  95.1%
313
  97.8%
Anti-HPV-16, Month 24 Number Analyzed 314 participants 304 participants 307 participants
314
 100.0%
303
  99.7%
307
 100.0%
Anti-HPV-18, Month 24 Number Analyzed 318 participants 308 participants 318 participants
318
 100.0%
287
  93.2%
308
  96.9%
Anti-HPV-16, Month 36 Number Analyzed 318 participants 306 participants 309 participants
318
 100.0%
304
  99.3%
308
  99.7%
Anti-HPV-18, Month 36 Number Analyzed 322 participants 310 participants 320 participants
322
 100.0%
267
  86.1%
297
  92.8%
5.Secondary Outcome
Title Anti-HPV-16/18 Antibody Titers as Assessed by ELISA
Hide Description Anti-HPV 16/18 antibody titers were presented as GMTs and expressed in EL.U/mL based on ELISA.
Time Frame At Day 0 and Months 12, 18, 24 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cervarix 2 Dose Group Gardasil 2 Dose Group Gardasil 3 Dose Group
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 322 310 320
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-HPV-16, Day 0 Number Analyzed 318 participants 306 participants 309 participants
9.5
(9.5 to 9.5)
9.5
(9.5 to 9.5)
9.5
(9.5 to 9.5)
Anti-HPV-18, Day 0 Number Analyzed 322 participants 310 participants 320 participants
9.0
(9.0 to 9.0)
9.0
(9.0 to 9.0)
9.0
(9.0 to 9.0)
Anti-HPV-16, Month 12 Number Analyzed 317 participants 305 participants 308 participants
2209.2
(2014 to 2423.4)
1294.8
(1160.4 to 1444.9)
1600.7
(1457.3 to 1758.2)
Anti-HPV-18, Month 12 Number Analyzed 321 participants 309 participants 319 participants
1299.3
(1176.2 to 1435.6)
266.6
(236.3 to 300.8)
478.5
(422.8 to 541.6)
Anti-HPV-16, Month 18 Number Analyzed 316 participants 305 participants 309 participants
1488.8
(1365.5 to 1623.3)
684.4
(605.8 to 773.2)
824.0
(744.4 to 912.2)
Anti-HPV-18, Month 18 Number Analyzed 320 participants 309 participants 320 participants
754.2
(682.6 to 833.2)
134.8
(118.1 to 154)
231.3
(202.4 to 264.4)
Anti-HPV-16, Month 24 Number Analyzed 314 participants 304 participants 307 participants
1285.0
(1181.1 to 1398.0)
514.1
(455.4 to 580.3)
637.1
(575.8 to 704.9)
Anti-HPV-18, Month 24 Number Analyzed 318 participants 308 participants 318 participants
613.7
(555.0 to 678.6)
106.3
(93.2 to 121.3)
182.0
(159.3 to 208.0)
Anti-HPV-16, Month 36 Number Analyzed 318 participants 306 participants 309 participants
1061.4
(971.8 to 1159.4)
379.8
(333.4 to 432.7)
472.4
(425 to 525.0)
Anti-HPV-18, Month 36 Number Analyzed 322 participants 310 participants 320 participants
486.5
(437.8 to 540.6)
71.0
(62.0 to 81.2)
119.1
(103.4 to 137.1)
6.Secondary Outcome
Title Anti-HPV-16/18 Antibody Titers as Assessed by ELISA at Month 36
Hide Description 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.
Time Frame At Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cervarix 2 Dose Group Gardasil 2 Dose Group Gardasil 3 Dose Group
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 322 310 320
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
Anti-HPV-16 Number Analyzed 318 participants 306 participants 309 participants
174.0
(159.3 to 190.1)
62.3
(54.7 to 71.0)
77.4
(69.6 to 86.0)
Anti-HPV-18 Number Analyzed 322 participants 310 participants 320 participants
85.3
(76.7 to 94.8)
12.5
(10.9 to 14.3)
20.9
(18.2 to 24.1)
7.Secondary Outcome
Title 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
Hide Description 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.
Time Frame At Day 0 and Months 7, 12, 18, 24 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cervarix 2 Dose Group Gardasil 2 Dose Group Gardasil 3 Dose Group
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 89 87 91
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-HPV-16, Day 0 Number Analyzed 89 participants 85 participants 91 participants
0
   0.0%
0
   0.0%
0
   0.0%
Anti-HPV-18, Day 0 Number Analyzed 89 participants 87 participants 91 participants
0
   0.0%
0
   0.0%
0
   0.0%
Anti-HPV-16, Month 7 Number Analyzed 89 participants 85 participants 91 participants
89
 100.0%
85
 100.0%
91
 100.0%
Anti-HPV-18, Month 7 Number Analyzed 89 participants 87 participants 91 participants
89
 100.0%
87
 100.0%
91
 100.0%
Anti-HPV-16, Month 12 Number Analyzed 88 participants 85 participants 91 participants
88
 100.0%
85
 100.0%
91
 100.0%
Anti-HPV-18, Month 12 Number Analyzed 88 participants 87 participants 91 participants
88
 100.0%
86
  98.9%
91
 100.0%
Anti-HPV-16, Month 18 Number Analyzed 88 participants 85 participants 90 participants
88
 100.0%
83
  97.6%
89
  98.9%
Anti-HPV-18, Month 18 Number Analyzed 87 participants 87 participants 91 participants
87
 100.0%
77
  88.5%
89
  97.8%
Anti-HPV-16, Month 24 Number Analyzed 86 participants 83 participants 91 participants
86
 100.0%
83
 100.0%
90
  98.9%
Anti-HPV-18, Month 24 Number Analyzed 86 participants 83 participants 91 participants
86
 100.0%
75
  90.4%
88
  96.7%
Anti-HPV-16, Month 36 Number Analyzed 89 participants 85 participants 91 participants
89
 100.0%
85
 100.0%
91
 100.0%
Anti-HPV-18, Month 36 Number Analyzed 89 participants 87 participants 91 participants
89
 100.0%
75
  86.2%
86
  94.5%
8.Secondary Outcome
Title Anti-HPV-16/18 Antibody Titers as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 ATP Cohort for Immunogenicity
Hide Description 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.
Time Frame At Day 0 and Months 7, 12, 18, 24 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cervarix 2 Dose Group Gardasil 2 Dose Group Gardasil 3 Dose Group
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 89 87 91
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Anti-HPV-16, Day 0 Number Analyzed 89 participants 85 participants 91 participants
20.0
(20.0 to 20.0)
20.0
(20.0 to 20.0)
20.0
(20.0 to 20.0)
Anti-HPV-18, Day 0 Number Analyzed 89 participants 87 participants 91 participants
20.0
(20.0 to 20.0)
20.0
(20.0 to 20.0)
20.0
(20.0 to 20.0)
Anti-HPV-16, Month 7 Number Analyzed 89 participants 85 participants 91 participants
52868.5
(44171.0 to 63278.5)
19130.1
(15166.8 to 24129.0)
22182.7
(17611.7 to 27940.1)
Anti-HPV-18, Month 7 Number Analyzed 89 participants 87 participants 91 participants
24068.5
(19293.2 to 30025.8)
4726.5
(3600.9 to 6204.0)
8243.9
(6276.2 to 10828.4)
Anti-HPV-16, Month 12 Number Analyzed 88 participants 85 participants 91 participants
10695.9
(8564.9 to 13357.1)
4280.1
(3245.9 to 5643.6)
5843.8
(4599.8 to 7424.1)
Anti-HPV-18, Month 12 Number Analyzed 88 participants 87 participants 91 participants
3683.3
(2914.4 to 4655.2)
689.0
(517.2 to 917.8)
1788.6
(1308.6 to 2444.7)
Anti-HPV-16, Month 18 Number Analyzed 88 participants 85 participants 90 participants
8436.3
(6650.6 to 10701.4)
2129.7
(1512.8 to 2998.1)
2987.2
(2218.5 to 4022.3)
Anti-HPV-18, Month 18 Number Analyzed 87 participants 87 participants 91 participants
2426.3
(1885.7 to 3121.7)
295.7
(217.0 to 402.8)
812.1
(577.0 to 1143.0)
Anti-HPV-16, Month 24 Number Analyzed 86 participants 83 participants 91 participants
5036.7
(4097.8 to 6190.7)
1211.8
(893.8 to 1642.9)
1967.2
(1507.5 to 2567.2)
Anti-HPV-18, Month 24 Number Analyzed 86 participants 83 participants 91 participants
1763.0
(1384.5 to 2245.0)
237.1
(177.2 to 317.1)
573.1
(421.5 to 779.3)
Anti-HPV-16, Month 36 Number Analyzed 89 participants 85 participants 91 participants
4357.8
(3577.8 to 5307.9)
1128.9
(857.4 to 1486.4)
1577.0
(1210.4 to 2054.5)
Anti-HPV-18, Month 36 Number Analyzed 89 participants 87 participants 91 participants
1613.9
(1267.6 to 2054.7)
185.8
(140.4 to 245.8)
472.8
(345.8 to 646.4)
9.Secondary Outcome
Title Anti-HPV-16/18 Seroconversion Rates as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 TVC
Hide Description 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.
Time Frame At Day 0 and Months 7, 12, 18, 24 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cervarix 2 Dose Group Gardasil 2 Dose Group Gardasil 3 Dose Group
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 99 92 98
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-HPV-16, Day 0 Number Analyzed 99 participants 90 participants 98 participants
0
   0.0%
0
   0.0%
0
   0.0%
Anti-HPV-18, Day 0 Number Analyzed 99 participants 92 participants 98 participants
0
   0.0%
0
   0.0%
0
   0.0%
Anti-HPV-16, Month 7 Number Analyzed 99 participants 90 participants 98 participants
99
 100.0%
90
 100.0%
98
 100.0%
Anti-HPV-18, Month 7 Number Analyzed 99 participants 92 participants 98 participants
99
 100.0%
92
 100.0%
98
 100.0%
Anti-HPV-16, Month 12 Number Analyzed 98 participants 90 participants 98 participants
97
  99.0%
90
 100.0%
98
 100.0%
Anti-HPV-18, Month 12 Number Analyzed 98 participants 92 participants 98 participants
98
 100.0%
91
  98.9%
98
 100.0%
Anti-HPV-16, Month 18 Number Analyzed 98 participants 90 participants 97 participants
97
  99.0%
88
  97.8%
96
  99.0%
Anti-HPV-18, Month 18 Number Analyzed 97 participants 92 participants 98 participants
97
 100.0%
82
  89.1%
96
  98.0%
Anti-HPV-16, Month 24 Number Analyzed 96 participants 87 participants 98 participants
95
  99.0%
87
 100.0%
97
  99.0%
Anti-HPV-18, Month 24 Number Analyzed 96 participants 87 participants 98 participants
96
 100.0%
79
  90.8%
94
  95.9%
Anti-HPV-16, Month 36 Number Analyzed 98 participants 90 participants 98 participants
97
  99.0%
90
 100.0%
98
 100.0%
Anti-HPV-18, Month 36 Number Analyzed 97 participants 92 participants 98 participants
97
 100.0%
80
  87.0%
92
  93.9%
10.Secondary Outcome
Title Anti-HPV-16/18 Antibody Titers as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 TVC
Hide Description 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.
Time Frame At Day 0 and Months 7, 12, 18, 24 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cervarix 2 Dose Group Gardasil 2 Dose Group Gardasil 3 Dose Group
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 99 92 98
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Anti-HPV-16, Day 0 Number Analyzed 99 participants 90 participants 98 participants
20.0
(20.0 to 20.0)
20.0
(20.0 to 20.0)
20.0
(20.0 to 20.0)
Anti-HPV-18, Day 0 Number Analyzed 99 participants 92 participants 98 participants
20.0
(20.0 to 20.0)
20.0
(20.0 to 20.0)
20.0
(20.0 to 20.0)
Anti-HPV-16, Month 7 Number Analyzed 99 participants 90 participants 98 participants
50000.7
(39742.9 to 62906.0)
18573.7
(14876.8 to 23189.3)
22294.2
(17763.8 to 27980.0)
Anti-HPV-18, Month 7 Number Analyzed 99 participants 92 participants 98 participants
23576.9
(18922.5 to 29376.2)
4563.7
(3519.5 to 5917.8)
8042.1
(6186.1 to 10454.8)
Anti-HPV-16, Month 12 Number Analyzed 98 participants 90 participants 98 participants
10039.6
(7884.1 to 12784.5)
4174.9
(3207.5 to 5434.2)
5766.0
(4573.8 to 7268.9)
Anti-HPV-18, Month 12 Number Analyzed 98 participants 92 participants 98 participants
3546.9
(2829.7 to 4445.8)
670.3
(510.0 to 880.9)
1801.4
(1333.0 to 2434.2)
Anti-HPV-16, Month 18 Number Analyzed 98 participants 90 participants 97 participants
7508.8
(5819.8 to 9688.0)
2070.2
(1494.9 to 2866.9)
2961.5
(2233.9 to 3926.2)
Anti-HPV-18, Month 18 Number Analyzed 97 participants 92 participants 98 participants
2240.5
(1763.3 to 2846.9)
294.5
(219.5 to 395.1)
797.6
(576.3 to 1104.0)
Anti-HPV-16, Month 24 Number Analyzed 96 participants 87 participants 98 participants
4609.1
(3673.5 to 5782.9)
1193.9
(889.6 to 1602.3)
1932.0
(1499.4 to 2489.5)
Anti-HPV-18, Month 24 Number Analyzed 96 participants 87 participants 98 participants
1638.6
(1297.9 to 2068.8)
239.7
(181.2 to 317.1)
564.6
(418.1 to 762.5)
Anti-HPV-16, Month 36 Number Analyzed 98 participants 90 participants 98 participants
4011.7
(3229.7 to 4983.0)
1111.4
(849.1 to 1454.6)
1517.2
(1174.7 to 1959.4)
Anti-HPV-18, Month 36 Number Analyzed 97 participants 92 participants 98 participants
1513.7
(1197.5 to 1913.2)
185.8
(142.2 to 242.7)
468.6
(346.3 to 634.0)
11.Secondary Outcome
Title T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
Hide Description 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.
Time Frame At Day 0 and Months 7, 12, 24 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cervarix 2 Dose Group Gardasil 2 Dose Group Gardasil 3 Dose Group
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 67 60 74
Median (Inter-Quartile Range)
Unit of Measure: T-cells/million cells
CD4+ All doubles, Anti-HPV-16, Day 0 Number Analyzed 53 participants 42 participants 53 participants
10
(1 to 78)
22
(1 to 90)
33
(1 to 80)
CD4+ All doubles, Anti-HPV-18, Day 0 Number Analyzed 53 participants 42 participants 54 participants
28
(1 to 83)
47.5
(1 to 102)
26
(1 to 92)
CD4+ All doubles, Anti-HPV-16, Month 7 Number Analyzed 63 participants 58 participants 62 participants
1662
(644 to 3221)
872
(479 to 1275)
1121
(694 to 1890)
CD4+ All doubles, Anti-HPV-18, Month 7 Number Analyzed 63 participants 58 participants 63 participants
897
(496 to 2497)
427
(259 to 744)
640
(355 to 1304)
CD4+ All doubles, Anti-HPV-16, Month 12 Number Analyzed 67 participants 58 participants 66 participants
916
(641 to 2340)
585.5
(316 to 1250)
819.5
(554 to 1623)
CD4+ All doubles, Anti-HPV-18, Month 12 Number Analyzed 67 participants 59 participants 66 participants
789
(384 to 1492)
327
(184 to 658)
446
(205 to 824)
CD4+ All doubles, Anti-HPV-16, Month 24 Number Analyzed 66 participants 60 participants 74 participants
1068.5
(495 to 2410)
750.5
(366.5 to 1142.5)
968.5
(588 to 1830)
CD4+ All doubles, Anti-HPV-18, Month 24 Number Analyzed 65 participants 60 participants 73 participants
645
(311 to 1406)
352
(196.5 to 503)
578
(267 to 972)
CD4+ All doubles, Anti-HPV-16, Month 36 Number Analyzed 58 participants 55 participants 64 participants
1012
(427 to 2373)
685
(385 to 1321)
842.5
(437.5 to 1624)
CD4+ All doubles, Anti-HPV-18, Month 36 Number Analyzed 57 participants 55 participants 63 participants
682
(313 to 1425)
350
(196 to 665)
516
(270 to 1029)
CD4-d-CD40L, Anti-HPV-16, Day 0 Number Analyzed 53 participants 42 participants 53 participants
1
(1 to 73)
14
(1 to 72)
30
(1 to 73)
CD4-d-CD40L, Anti-HPV-18, Day 0 Number Analyzed 53 participants 42 participants 54 participants
14
(1 to 83)
39.5
(1 to 102)
27.5
(1 to 70)
CD4-d-CD40L, Anti-HPV-16, Month 7 Number Analyzed 63 participants 58 participants 62 participants
1515
(638 to 3098)
779
(456 to 1211)
1025.5
(670 to 1848)
CD4-d-CD40L, Anti-HPV-18, Month 7 Number Analyzed 63 participants 58 participants 63 participants
866
(496 to 2483)
386.5
(237 to 708)
574
(328 to 1224)
CD4-d-CD40L, Anti-HPV-16, Month 12 Number Analyzed 67 participants 58 participants 66 participants
889
(591 to 2236)
524
(280 to 1135)
761.5
(484 to 1425)
CD4-d-CD40L, Anti-HPV-18, Month 12 Number Analyzed 67 participants 59 participants 66 participants
688
(344 to 1435)
317
(147 to 633)
383.5
(214 to 729)
CD4-d-CD40L, Anti-HPV-16, Month 24 Number Analyzed 66 participants 60 participants 74 participants
1045.5
(518 to 2269)
736
(348 to 1101.5)
937
(588 to 1801)
CD4-d-CD40L, Anti-HPV-18, Month 24 Number Analyzed 65 participants 60 participants 73 participants
639
(310 to 1374)
332
(204 to 510.5)
564
(289 to 940)
CD4-d-CD40L, Anti-HPV-16, Month 36 Number Analyzed 58 participants 55 participants 64 participants
957
(465 to 2303)
685
(349 to 1321)
778.5
(416.5 to 1560.5)
CD4-d-CD40L, Anti-HPV-18, Month 36 Number Analyzed 57 participants 55 participants 63 participants
671
(290 to 1435)
337
(204 to 648)
499
(264 to 1020)
CD4-d- IFNγ, Anti-HPV-16, Day 0 Number Analyzed 53 participants 42 participants 53 participants
12
(1 to 30)
19
(1 to 42)
1
(1 to 28)
CD4-d- IFNγ, Anti-HPV-18, Day 0 Number Analyzed 53 participants 42 participants 54 participants
14
(1 to 33)
13.5
(1 to 36)
3.5
(1 to 30)
CD4-d- IFNγ, Anti-HPV-16, Month 7 Number Analyzed 63 participants 58 participants 62 participants
365
(161 to 881)
320
(157 to 533)
422.5
(206 to 708)
CD4-d- IFNγ, Anti-HPV-18, Month 7 Number Analyzed 63 participants 58 participants 63 participants
242
(111 to 712)
133.5
(83 to 240)
181
(78 to 409)
CD4-d- IFNγ, Anti-HPV-16, Month 12 Number Analyzed 67 participants 58 participants 66 participants
326
(110 to 644)
235
(108 to 501)
356
(135 to 734)
CD4-d- IFNγ, Anti-HPV-18, Month 12 Number Analyzed 67 participants 59 participants 66 participants
175
(87 to 444)
112
(55 to 240)
164
(57 to 315)
CD4-d- IFNγ, Anti-HPV-16, Month 24 Number Analyzed 66 participants 60 participants 74 participants
300.5
(119 to 781)
317.5
(146.5 to 514)
421
(157 to 767)
CD4-d- IFNγ, Anti-HPV-18, Month 24 Number Analyzed 65 participants 60 participants 73 participants
171
(68 to 462)
112
(49.5 to 229.5)
220
(65 to 348)
CD4-d-IFNγ, Anti-HPV-16, Month 36 Number Analyzed 58 participants 55 participants 64 participants
253.5
(81 to 667)
301
(134 to 571)
270.5
(129 to 666.5)
CD4-d-IFNγ, Anti-HPV-18, Month 36 Number Analyzed 57 participants 55 participants 63 participants
193
(51 to 376)
109
(27 to 230)
155
(45 to 314)
CD4-d-IL-2, Anti-HPV-16, Day 0 Number Analyzed 53 participants 42 participants 53 participants
14
(1 to 52)
25
(1 to 72)
33
(1 to 56)
CD4-d-IL-2, Anti-HPV-18, Day 0 Number Analyzed 53 participants 42 participants 54 participants
1
(1 to 49)
36.5
(1 to 76)
22
(1 to 60)
CD4-d-IL-2, Anti-HPV-16, Month 7 Number Analyzed 63 participants 58 participants 62 participants
1357
(537 to 2660)
712.5
(378 to 1037)
866
(561 to 1420)
CD4-d-IL-2, Anti-HPV-18, Month 7 Number Analyzed 63 participants 58 participants 63 participants
737
(420 to 2185)
304
(206 to 573)
486
(281 to 959)
CD4-d-IL-2, Anti-HPV-16, Month 12 Number Analyzed 67 participants 58 participants 66 participants
832
(493 to 2050)
479
(283 to 946)
674.5
(450 to 1316)
CD4-d-IL-2, Anti-HPV-18, Month 12 Number Analyzed 67 participants 59 participants 66 participants
620
(304 to 1157)
259
(144 to 547)
354
(155 to 622)
CD4-d-IL-2, Anti-HPV-16, Month 24 Number Analyzed 66 participants 60 participants 74 participants
855
(390 to 1711)
579.5
(270.5 to 934.5)
700
(479 to 1459)
CD4-d-IL-2, Anti-HPV-18, Month 24 Number Analyzed 65 participants 60 participants 73 participants
494
(252 to 994)
240
(125.5 to 387.5)
426
(216 to 695)
CD4-d-IL-2, Anti-HPV-16, Month 36 Number Analyzed 58 participants 55 participants 64 participants
784
(331 to 1673)
517
(295 to 1014)
680
(308 to 1245.5)
CD4-d-IL-2, Anti-HPV-18, Month 36 Number Analyzed 57 participants 55 participants 63 participants
507
(213 to 1069)
274
(137 to 467)
341
(168 to 798)
CD4-d-TNFα, Anti-HPV-16, Day 0 Number Analyzed 53 participants 42 participants 53 participants
6
(1 to 50)
33
(1 to 82)
16
(1 to 69)
CD4-d-TNFα, Anti-HPV-18, Day 0 Number Analyzed 53 participants 42 participants 54 participants
27
(1 to 75)
22.5
(1 to 82)
23
(1 to 60)
CD4-d-TNFα, Anti-HPV-16, Month 7 Number Analyzed 63 participants 58 participants 62 participants
1111
(430 to 2386)
625
(292 to 899)
796
(458 to 1448)
CD4-d-TNFα, Anti-HPV-18, Month 7 Number Analyzed 63 participants 58 participants 63 participants
647
(336 to 1415)
283.5
(168 to 594)
457
(266 to 978)
CD4-d-TNFα, Anti-HPV-16, Month 12 Number Analyzed 67 participants 58 participants 66 participants
790
(488 to 1924)
482
(210 to 932)
716
(457 to 1445)
CD4-d-TNFα, Anti-HPV-18, Month 12 Number Analyzed 67 participants 59 participants 66 participants
674
(288 to 1272)
266
(133 to 588)
384.5
(175 to 714)
CD4-d-TNFα, Anti-HPV-16, Month 24 Number Analyzed 66 participants 60 participants 74 participants
795.5
(343 to 1668)
563.5
(241.5 to 895)
760.5
(443 to 1494)
CD4-d-TNFα, Anti-HPV-18, Month 24 Number Analyzed 65 participants 60 participants 73 participants
510
(183 to 1164)
239
(127.5 to 440.5)
522
(228 to 710)
CD4-d-TNFα, Anti-HPV-16, Month 36 Number Analyzed 58 participants 55 participants 64 participants
786.5
(343 to 1930)
547
(282 to 1005)
724.5
(368 to 1338)
CD4-d-TNFα, Anti-HPV-18, Month 36 Number Analyzed 57 participants 55 participants 63 participants
588
(250 to 1138)
301
(120 to 453)
479
(200 to 808)
CD8-All Doubles, Anti-HPV-16, Day 0 Number Analyzed 53 participants 42 participants 53 participants
1
(1 to 14)
4
(1 to 49)
1
(1 to 25)
CD8-All Doubles, Anti-HPV-18, Day 0 Number Analyzed 53 participants 42 participants 54 participants
1
(1 to 16)
1
(1 to 29)
1
(1 to 22)
CD8-All Doubles, Anti-HPV-16, Month 7 Number Analyzed 63 participants 58 participants 62 participants
1
(1 to 34)
1
(1 to 41)
1
(1 to 30)
CD8-All Doubles, Anti-HPV-18, Month 7 Number Analyzed 63 participants 58 participants 63 participants
1
(1 to 19)
1
(1 to 40)
1
(1 to 40)
CD8-All Doubles, Anti-HPV-16, Month 12 Number Analyzed 67 participants 58 participants 66 participants
1
(1 to 31)
1
(1 to 29)
1
(1 to 29)
CD8-All Doubles, Anti-HPV-18, Month 12 Number Analyzed 67 participants 59 participants 66 participants
1
(1 to 27)
1
(1 to 27)
1
(1 to 20)
CD8-All Doubles, Anti-HPV-16, Month 24 Number Analyzed 66 participants 60 participants 74 participants
1
(1 to 25)
1
(1 to 1)
1
(1 to 1)
CD8-All Doubles, Anti-HPV-18, Month 24 Number Analyzed 65 participants 60 participants 73 participants
1
(1 to 32)
1
(1 to 23)
1
(1 to 28)
CD8-All doubles, Anti-HPV-16, Month 36 Number Analyzed 58 participants 55 participants 64 participants
1
(1 to 48)
1
(1 to 28)
1
(1 to 38.5)
CD8-All doubles, Anti-HPV-18, Month 36 Number Analyzed 57 participants 55 participants 63 participants
4
(1 to 40)
2
(1 to 41)
1
(1 to 28)
CD8-d-CD40L, Anti-HPV-16, Day 0 Number Analyzed 53 participants 42 participants 53 participants
1
(1 to 1)
1
(1 to 26)
1
(1 to 1)
CD8-d-CD40L, Anti-HPV-18, Day 0 Number Analyzed 53 participants 42 participants 54 participants
1
(1 to 1)
1
(1 to 1)
1
(1 to 1)
CD8-d-CD40L, Anti-HPV-16, Month 7 Number Analyzed 63 participants 58 participants 62 participants
1
(1 to 1)
1
(1 to 29)
1
(1 to 24)
CD8-d-CD40L, Anti-HPV-18, Month 7 Number Analyzed 63 participants 58 participants 63 participants
1
(1 to 1)
1
(1 to 24)
1
(1 to 23)
CD8-d-CD40L, Anti-HPV-16, Month 12 Number Analyzed 67 participants 58 participants 66 participants
1
(1 to 1)
1
(1 to 1)
1
(1 to 3)
CD8-d-CD40L, Anti-HPV-18, Month 12 Number Analyzed 67 participants 59 participants 66 participants
1
(1 to 1)
1
(1 to 1)
1
(1 to 1)
CD8-d-CD40L, Anti-HPV-16, Month 24 Number Analyzed 66 participants 60 participants 74 participants
1
(1 to 16)
1
(1 to 1)
1
(1 to 1)
CD8-d-CD40L, Anti-HPV-18, Month 24 Number Analyzed 65 participants 60 participants 73 participants
1
(1 to 1)
1
(1 to 1)
1
(1 to 18)
CD8-d-CD40L, Anti-HPV-16, Month 36 Number Analyzed 58 participants 55 participants 64 participants
1
(1 to 31)
1
(1 to 24)
1
(1 to 29)
CD8-d-CD40L, Anti-HPV-18, Month 36 Number Analyzed 57 participants 55 participants 63 participants
1
(1 to 6)
1
(1 to 27)
1
(1 to 28)
CD8-d-IFNγ, Anti-HPV-16, Day 0 Number Analyzed 53 participants 42 participants 53 participants
1
(1 to 1)
1
(1 to 39)
1
(1 to 26)
CD8-d-IFNγ, Anti-HPV-18, Day 0 Number Analyzed 53 participants 42 participants 54 participants
1
(1 to 2)
1
(1 to 23)
1
(1 to 18)
CD8-d-IFNγ, Anti-HPV-16, Month 7 Number Analyzed 63 participants 58 participants 62 participants
1
(1 to 32)
1
(1 to 40)
1
(1 to 30)
CD8-d-IFNγ, Anti-HPV-18, Month 7 Number Analyzed 63 participants 58 participants 63 participants
1
(1 to 1)
1
(1 to 28)
1
(1 to 28)
CD8-d-IFNγ, Anti-HPV-16, Month 12 Number Analyzed 67 participants 58 participants 66 participants
1
(1 to 28)
1
(1 to 26)
1
(1 to 27)
CD8-d-IFNγ, Anti-HPV-18, Month 12 Number Analyzed 67 participants 59 participants 66 participants
1
(1 to 22)
1
(1 to 26)
1
(1 to 10)
CD8-d-IFNγ, Anti-HPV-16, Month 24 Number Analyzed 66 participants 60 participants 74 participants
1
(1 to 16)
1
(1 to 1)
1
(1 to 1)
CD8-d-IFNγ, Anti-HPV-18, Month 24 Number Analyzed 65 participants 60 participants 73 participants
1
(1 to 18)
1
(1 to 23)
1
(1 to 1)
CD8-d-IFNγ, Anti-HPV-16, Month 36 Number Analyzed 58 participants 55 participants 64 participants
1
(1 to 47)
1
(1 to 25)
1
(1 to 33)
CD8-d-IFNγ, Anti-HPV-18, Month 36 Number Analyzed 57 participants 55 participants 63 participants
1
(1 to 31)
2
(1 to 40)
1
(1 to 25)
CD8-d-IL-2, Anti-HPV-16, Day 0 Number Analyzed 53 participants 42 participants 53 participants
1
(1 to 1)
1
(1 to 1)
1
(1 to 1)
CD8-d-IL-2, Anti-HPV-18, Day 0 Number Analyzed 53 participants 42 participants 54 participants
1
(1 to 1)
1
(1 to 1)
1
(1 to 1)
CD8-d-IL-2, Anti-HPV-16, Month 7 Number Analyzed 63 participants 58 participants 62 participants
1
(1 to 1)
1
(1 to 1)
1
(1 to 1)
CD8-d-IL-2, Anti-HPV-18, Month 7 Number Analyzed 63 participants 58 participants 63 participants
1
(1 to 1)
1
(1 to 1)
1
(1 to 1)
CD8-d-IL-2, Anti-HPV-16, Month 12 Number Analyzed 67 participants 58 participants 66 participants
1
(1 to 1)
1
(1 to 1)
1
(1 to 1)
CD8-d-IL-2, Anti-HPV-18, Month 12 Number Analyzed 67 participants 59 participants 66 participants
1
(1 to 1)
1
(1 to 1)
1
(1 to 1)
CD8-d-IL-2, Anti-HPV-16, Month 24 Number Analyzed 66 participants 60 participants 74 participants
1
(1 to 1)
1
(1 to 1)
1
(1 to 1)
CD8-d-IL-2, Anti-HPV-18, Month 24 Number Analyzed 65 participants 60 participants 73 participants
1
(1 to 1)
1
(1 to 1)
1
(1 to 1)
CD8-d-IL-2, Anti-HPV-16, Month 36 Number Analyzed 58 participants 55 participants 64 participants
1
(1 to 1)
1
(1 to 1)
1
(1 to 1)
CD8-d-IL-2, Anti-HPV-18, Month 36 Number Analyzed 57 participants 55 participants 63 participants
1
(1 to 1)
1
(1 to 1)
1
(1 to 1)
CD8-d-TNFα, Anti-HPV-16, Day 0 Number Analyzed 53 participants 42 participants 53 participants
1
(1 to 1)
1
(1 to 36)
1
(1 to 16)
CD8-d-TNFα, Anti-HPV-18, Day 0 Number Analyzed 53 participants 42 participants 54 participants
1
(1 to 27)
1
(1 to 29)
1
(1 to 26)
CD8-d-TNFα, Anti-HPV-16, Month 7 Number Analyzed 63 participants 58 participants 62 participants
1
(1 to 28)
1
(1 to 26)
1
(1 to 18)
CD8-d-TNFα, Anti-HPV-18, Month 7 Number Analyzed 63 participants 58 participants 63 participants
1
(1 to 1)
1
(1 to 2)
1
(1 to 24)
CD8-d-TNFα, Anti-HPV-16, Month 12 Number Analyzed 67 participants 58 participants 66 participants
1
(1 to 1)
1
(1 to 25)
1
(1 to 28)
CD8-d-TNFα, Anti-HPV-18, Month 12 Number Analyzed 67 participants 59 participants 66 participants
1
(1 to 8)
1
(1 to 21)
1
(1 to 24)
CD8-d-TNFα, Anti-HPV-16, Month 24 Number Analyzed 66 participants 60 participants 74 participants
1
(1 to 20)
1
(1 to 1)
1
(1 to 1)
CD8-d-TNFα, Anti-HPV-18, Month 24 Number Analyzed 65 participants 60 participants 73 participants
1
(1 to 28)
1
(1 to 7)
1
(1 to 18)
CD8-d-TNFα, Anti-HPV-16, Month 36 Number Analyzed 58 participants 55 participants 64 participants
1
(1 to 24)
1
(1 to 1)
1
(1 to 26)
CD8-d-TNFα, Anti-HPV-18, Month 36 Number Analyzed 57 participants 55 participants 63 participants
1
(1 to 31)
1
(1 to 21)
1
(1 to 12)
12.Secondary Outcome
Title B-cell-mediated Immune Responses in the Sub-cohort for CMI
Hide Description 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.
Time Frame At Day 0 and Months 7, 12, 24 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cervarix 2 Dose Group Gardasil 2 Dose Group Gardasil 3 Dose Group
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 71 65 76
Median (Inter-Quartile Range)
Unit of Measure: B-cells/million cells
HPV-16, Day 0 Number Analyzed 69 participants 55 participants 70 participants
1
(1 to 1)
1
(1 to 1)
1
(1 to 1)
HPV-18, Day 0 Number Analyzed 69 participants 55 participants 70 participants
1
(1 to 1)
1
(1 to 1)
1
(1 to 1)
HPV-16, Month 7 Number Analyzed 71 participants 65 participants 76 participants
1733
(577 to 3733)
1254
(495 to 2173)
733
(106.5 to 1966.5)
HPV-18, Month 7 Number Analyzed 71 participants 65 participants 76 participants
558
(106 to 1847)
155
(1 to 379)
111
(1 to 343.5)
HPV-16, Month 12 Number Analyzed 51 participants 51 participants 53 participants
408
(90 to 1186)
278
(66 to 794)
289
(66 to 982)
HPV-18, Month 12 Number Analyzed 51 participants 51 participants 53 participants
249
(73 to 658)
69
(1 to 184)
69
(1 to 250)
HPV-16, Month 24 Number Analyzed 54 participants 46 participants 63 participants
270
(49 to 724)
218.5
(28 to 651)
249
(37 to 601)
HPV-18, Month 24 Number Analyzed 54 participants 46 participants 63 participants
128.5
(35 to 402)
57.5
(1 to 203)
111
(1 to 317)
HPV-16, Month 36 Number Analyzed 59 participants 54 participants 53 participants
353
(91 to 927)
382.5
(166 to 614)
246
(21 to 565)
HPV-18, Month 36 Number Analyzed 59 participants 54 participants 53 participants
116
(1 to 329)
25
(1 to 228)
63
(1 to 150)
13.Secondary Outcome
Title Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Hide Description 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.
Time Frame During the 7-day period (from the day of vaccination up to 6 subsequent days) following vaccination after each dose and across doses
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cervarix 2 Dose Group Gardasil 2 Dose Group Gardasil 3 Dose Group
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 359 357 356
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain - Dose 1 Number Analyzed 359 participants 357 participants 356 participants
311
  86.6%
235
  65.8%
231
  64.9%
Any Pain - Dose 2 Number Analyzed 357 participants 353 participants 354 participants
193
  54.1%
183
  51.8%
215
  60.7%
Any Pain - Dose 3 Number Analyzed 356 participants 348 participants 350 participants
280
  78.7%
194
  55.7%
222
  63.4%
Any Pain - Across doses Number Analyzed 359 participants 357 participants 356 participants
329
  91.6%
276
  77.3%
295
  82.9%
Grade 3 Pain - Dose 1 Number Analyzed 359 participants 357 participants 356 participants
22
   6.1%
4
   1.1%
6
   1.7%
Grade 3 Pain - Dose 2 Number Analyzed 357 participants 353 participants 354 participants
8
   2.2%
8
   2.3%
8
   2.3%
Grade 3 Pain - Dose 3 Number Analyzed 356 participants 348 participants 350 participants
23
   6.5%
11
   3.2%
10
   2.9%
Grade 3 Pain - Across doses Number Analyzed 359 participants 357 participants 356 participants
42
  11.7%
17
   4.8%
18
   5.1%
Any Redness - Dose 1 Number Analyzed 359 participants 357 participants 356 participants
137
  38.2%
84
  23.5%
87
  24.4%
Any Redness - Dose 2 Number Analyzed 357 participants 353 participants 354 participants
100
  28.0%
84
  23.8%
99
  28.0%
Any Redness - Dose 3 Number Analyzed 356 participants 348 participants 350 participants
133
  37.4%
92
  26.4%
102
  29.1%
Any Redness - Across doses Number Analyzed 359 participants 357 participants 356 participants
191
  53.2%
134
  37.5%
157
  44.1%
Grade 3 Redness - Dose 1 Number Analyzed 359 participants 357 participants 356 participants
0
   0.0%
0
   0.0%
1
   0.3%
Grade 3 Redness - Dose 2 Number Analyzed 357 participants 353 participants 354 participants
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 Redness - Dose 3 Number Analyzed 356 participants 348 participants 350 participants
0
   0.0%
0
   0.0%
1
   0.3%
Grade 3 Redness - Across doses Number Analyzed 359 participants 357 participants 356 participants
0
   0.0%
0
   0.0%
2
   0.6%
Any Swelling - Dose 1 Number Analyzed 359 participants 357 participants 356 participants
112
  31.2%
44
  12.3%
39
  11.0%
Any Swelling - Dose 2 Number Analyzed 357 participants 353 participants 354 participants
63
  17.6%
35
   9.9%
76
  21.5%
Any Swelling - Dose 3 Number Analyzed 356 participants 348 participants 350 participants
113
  31.7%
67
  19.3%
85
  24.3%
Any Swelling - Across doses Number Analyzed 359 participants 357 participants 356 participants
163
  45.4%
98
  27.5%
118
  33.1%
Grade 3 Swelling - Dose 1 Number Analyzed 359 participants 357 participants 356 participants
3
   0.8%
0
   0.0%
0
   0.0%
Grade 3 Swelling - Dose 2 Number Analyzed 357 participants 353 participants 354 participants
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 Swelling - Dose 3 Number Analyzed 356 participants 348 participants 350 participants
2
   0.6%
0
   0.0%
2
   0.6%
Grade 3 Swelling - Across doses Number Analyzed 359 participants 357 participants 356 participants
5
   1.4%
0
   0.0%
2
   0.6%
14.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Hide Description 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.
Time Frame During the 7-day period (from the day of vaccination up to 6 subsequent days) following vaccination after each dose and across doses
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cervarix 2 Dose Group Gardasil 2 Dose Group Gardasil 3 Dose Group
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 359 357 356
Measure Type: Count of Participants
Unit of Measure: Participants
Any Arthralgia - Dose 1 Number Analyzed 359 participants 357 participants 355 participants
44
  12.3%
50
  14.0%
39
  11.0%
Any Arthralgia - Dose 2 Number Analyzed 357 participants 353 participants 354 participants
23
   6.4%
30
   8.5%
34
   9.6%
Any Arthralgia - Dose 3 Number Analyzed 354 participants 347 participants 351 participants
31
   8.8%
38
  11.0%
35
  10.0%
Any Arthralgia - Across doses Number Analyzed 359 participants 357 participants 356 participants
68
  18.9%
81
  22.7%
67
  18.8%
Grade 3 Arthralgia - Dose 1 Number Analyzed 359 participants 357 participants 355 participants
5
   1.4%
1
   0.3%
1
   0.3%
Grade 3 Arthralgia - Dose 2 Number Analyzed 357 participants 353 participants 354 participants
1
   0.3%
2
   0.6%
1
   0.3%
Grade 3 Arthralgia - Dose 3 Number Analyzed 354 participants 347 participants 351 participants
2
   0.6%
3
   0.9%
1
   0.3%
Grade 3 Arthralgia - Across doses Number Analyzed 359 participants 357 participants 356 participants
6
   1.7%
4
   1.1%
1
   0.3%
Related Arthralgia - Dose 1 Number Analyzed 359 participants 357 participants 355 participants
29
   8.1%
32
   9.0%
28
   7.9%
Related Arthralgia - Dose 2 Number Analyzed 357 participants 353 participants 354 participants
17
   4.8%
17
   4.8%
18
   5.1%
Related Arthralgia - Dose 3 Number Analyzed 354 participants 347 participants 351 participants
20
   5.6%
27
   7.8%
27
   7.7%
Related Arthralgia - Across doses Number Analyzed 359 participants 357 participants 356 participants
51
  14.2%
55
  15.4%
51
  14.3%
Any Fatigue - Dose 1 Number Analyzed 359 participants 357 participants 355 participants
163
  45.4%
157
  44.0%
168
  47.3%
Any Fatigue - Dose 2 Number Analyzed 357 participants 353 participants 354 participants
103
  28.9%
104
  29.5%
119
  33.6%
Any Fatigue - Dose 3 Number Analyzed 354 participants 347 participants 351 participants
108
  30.5%
97
  28.0%
103
  29.3%
Any Fatigue - Across doses Number Analyzed 359 participants 357 participants 356 participants
192
  53.5%
199
  55.7%
193
  54.2%
Grade 3 Fatigue - Dose 1 Number Analyzed 359 participants 357 participants 355 participants
7
   1.9%
10
   2.8%
5
   1.4%
Grade 3 Fatigue - Dose 2 Number Analyzed 357 participants 353 participants 354 participants
12
   3.4%
3
   0.8%
2
   0.6%
Grade 3 Fatigue - Dose 3 Number Analyzed 354 participants 347 participants 351 participants
7
   2.0%
3
   0.9%
3
   0.9%
Grade 3 Fatigue - Across doses Number Analyzed 359 participants 357 participants 356 participants
18
   5.0%
15
   4.2%
7
   2.0%
Related Fatigue - Dose 1 Number Analyzed 359 participants 357 participants 355 participants
103
  28.7%
102
  28.6%
98
  27.6%
Related Fatigue - Dose 2 Number Analyzed 357 participants 353 participants 354 participants
68
  19.0%
66
  18.7%
67
  18.9%
Related Fatigue - Dose 3 Number Analyzed 354 participants 347 participants 351 participants
70
  19.8%
67
  19.3%
67
  19.1%
Related Fatigue - Across doses Number Analyzed 359 participants 357 participants 356 participants
152
  42.3%
151
  42.3%
143
  40.2%
Any Gastrointestinal - Dose 1 Number Analyzed 359 participants 357 participants 355 participants
34
   9.5%
52
  14.6%
44
  12.4%
Any Gastrointestinal - Dose 2 Number Analyzed 357 participants 353 participants 354 participants
19
   5.3%
22
   6.2%
23
   6.5%
Any Gastrointestinal - Dose 3 Number Analyzed 354 participants 347 participants 351 participants
16
   4.5%
29
   8.4%
24
   6.8%
Any Gastrointestinal - Across doses Number Analyzed 359 participants 357 participants 356 participants
55
  15.3%
74
  20.7%
70
  19.7%
Grade 3 Gastrointestinal - Dose 1 Number Analyzed 359 participants 357 participants 355 participants
3
   0.8%
2
   0.6%
2
   0.6%
Grade 3 Gastrointestinal - Dose 2 Number Analyzed 357 participants 353 participants 354 participants
2
   0.6%
1
   0.3%
0
   0.0%
Grade 3 Gastrointestinal - Dose 3 Number Analyzed 354 participants 347 participants 351 participants
1
   0.3%
4
   1.2%
2
   0.6%
Grade 3 Gastrointestinal - Across doses Number Analyzed 359 participants 357 participants 356 participants
5
   1.4%
6
   1.7%
3
   0.8%
Related Gastrointestinal - Dose 1 Number Analyzed 359 participants 357 participants 355 participants
21
   5.8%
26
   7.3%
22
   6.2%
Related Gastrointestinal - Dose 2 Number Analyzed 357 participants 353 participants 354 participants
8
   2.2%
17
   4.8%
6
   1.7%
Related Gastrointestinal - Dose 3 Number Analyzed 354 participants 347 participants 351 participants
10
   2.8%
20
   5.8%
17
   4.8%
Related Gastrointestinal - Across doses Number Analyzed 359 participants 357 participants 356 participants
32
   8.9%
49
  13.7%
40
  11.2%
Any Headache - Dose 1 Number Analyzed 359 participants 357 participants 355 participants
102
  28.4%
87
  24.4%
90
  25.4%
Any Headache - Dose 2 Number Analyzed 357 participants 353 participants 354 participants
62
  17.4%
64
  18.1%
73
  20.6%
Any Headache - Dose 3 Number Analyzed 354 participants 347 participants 351 participants
63
  17.8%
54
  15.6%
65
  18.5%
Any Headache - Across doses Number Analyzed 359 participants 357 participants 356 participants
147
  40.9%
133
  37.3%
151
  42.4%
Grade 3 Headache - Dose 1 Number Analyzed 359 participants 357 participants 355 participants
7
   1.9%
6
   1.7%
1
   0.3%
Grade 3 Headache - Dose 2 Number Analyzed 357 participants 353 participants 354 participants
6
   1.7%
2
   0.6%
4
   1.1%
Grade 3 Headache - Dose 3 Number Analyzed 354 participants 347 participants 351 participants
7
   2.0%
1
   0.3%
1
   0.3%
Grade 3 Headache - Across doses Number Analyzed 359 participants 357 participants 356 participants
17
   4.7%
7
   2.0%
4
   1.1%
Related Headache - Dose 1 Number Analyzed 359 participants 357 participants 355 participants
61
  17.0%
51
  14.3%
48
  13.5%
Related Headache - Dose 2 Number Analyzed 357 participants 353 participants 354 participants
39
  10.9%
37
  10.5%
41
  11.6%
Related Headache - Dose 3 Number Analyzed 354 participants 347 participants 351 participants
45
  12.7%
33
   9.5%
42
  12.0%
Related Headache - Across doses Number Analyzed 359 participants 357 participants 356 participants
107
  29.8%
88
  24.6%
100
  28.1%
Any Myalgia - Dose 1 Number Analyzed 359 participants 357 participants 355 participants
131
  36.5%
101
  28.3%
101
  28.5%
Any Myalgia - Dose 2 Number Analyzed 357 participants 353 participants 354 participants
59
  16.5%
60
  17.0%
80
  22.6%
Any Myalgia - Dose 3 Number Analyzed 354 participants 347 participants 351 participants
77
  21.8%
68
  19.6%
72
  20.5%
Any Myalgia - Across doses Number Analyzed 359 participants 357 participants 356 participants
166
  46.2%
143
  40.1%
136
  38.2%
Grade 3 Myalgia - Dose 1 Number Analyzed 359 participants 357 participants 355 participants
5
   1.4%
3
   0.8%
2
   0.6%
Grade 3 Myalgia - Dose 2 Number Analyzed 357 participants 353 participants 354 participants
2
   0.6%
3
   0.8%
2
   0.6%
Grade 3 Myalgia - Dose 3 Number Analyzed 354 participants 347 participants 351 participants
3
   0.8%
4
   1.2%
5
   1.4%
Grade 3 Myalgia - Across doses Number Analyzed 359 participants 357 participants 356 participants
8
   2.2%
8
   2.2%
6
   1.7%
Related Myalgia - Dose 1 Number Analyzed 359 participants 357 participants 355 participants
91
  25.3%
70
  19.6%
67
  18.9%
Related Myalgia - Dose 2 Number Analyzed 357 participants 353 participants 354 participants
36
  10.1%
40
  11.3%
51
  14.4%
Related Myalgia - Dose 3 Number Analyzed 354 participants 347 participants 351 participants
50
  14.1%
49
  14.1%
46
  13.1%
Related Myalgia - Across doses Number Analyzed 359 participants 357 participants 356 participants
128
  35.7%
111
  31.1%
100
  28.1%
Any Rash - Dose 1 Number Analyzed 359 participants 357 participants 355 participants
14
   3.9%
7
   2.0%
10
   2.8%
Any Rash - Dose 2 Number Analyzed 357 participants 353 participants 354 participants
10
   2.8%
5
   1.4%
8
   2.3%
Any Rash - Dose 3 Number Analyzed 354 participants 347 participants 351 participants
7
   2.0%
5
   1.4%
4
   1.1%
Any Rash - Across doses Number Analyzed 359 participants 357 participants 356 participants
25
   7.0%
16
   4.5%
18
   5.1%
Grade 3 Rash - Dose 1 Number Analyzed 359 participants 357 participants 356 participants
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 Rash - Dose 2 Number Analyzed 357 participants 353 participants 354 participants
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 Rash - Dose 3 Number Analyzed 354 participants 347 participants 351 participants
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 Rash - Across doses Number Analyzed 359 participants 357 participants 356 participants
0
   0.0%
0
   0.0%
0
   0.0%
Related Rash - Dose 1 Number Analyzed 359 participants 357 participants 355 participants
6
   1.7%
5
   1.4%
6
   1.7%
Related Rash - Dose 2 Number Analyzed 357 participants 353 participants 354 participants
6
   1.7%
3
   0.8%
4
   1.1%
Related Rash - Dose 3 Number Analyzed 354 participants 347 participants 351 participants
6
   1.7%
3
   0.9%
3
   0.9%
Related Rash - Across doses Number Analyzed 359 participants 357 participants 356 participants
16
   4.5%
10
   2.8%
12
   3.4%
Any Temperature ( ≥ 37.5°C) - Dose 1 Number Analyzed 359 participants 357 participants 355 participants
19
   5.3%
23
   6.4%
18
   5.1%
Any Temperature ( ≥ 37.5°C) - Dose 2 Number Analyzed 357 participants 353 participants 354 participants
13
   3.6%
21
   5.9%
19
   5.4%
Any Temperature ( ≥ 37.5°C) - Dose 3 Number Analyzed 354 participants 347 participants 351 participants
32
   9.0%
22
   6.3%
22
   6.3%
Any Temperature ( ≥ 37.5°C) - Across doses Number Analyzed 359 participants 357 participants 356 participants
53
  14.8%
59
  16.5%
47
  13.2%
Grade 3 Temperature ( > 39.0°C) - Dose 1 Number Analyzed 359 participants 357 participants 355 participants
2
   0.6%
2
   0.6%
2
   0.6%
Grade 3 Temperature ( > 39.0°C) - Dose 2 Number Analyzed 357 participants 353 participants 354 participants
0
   0.0%
0
   0.0%
2
   0.6%
Grade 3 Temperature ( > 39.0°C) - Dose 3 Number Analyzed 354 participants 347 participants 351 participants
6
   1.7%
0
   0.0%
0
   0.0%
Grade 3 Temperature ( > 39.0°C) - Across doses Number Analyzed 359 participants 357 participants 356 participants
7
   1.9%
2
   0.6%
4
   1.1%
Related Temperature - Dose 1 Number Analyzed 359 participants 357 participants 355 participants
13
   3.6%
11
   3.1%
7
   2.0%
Related Temperature - Dose 2 Number Analyzed 357 participants 353 participants 354 participants
8
   2.2%
9
   2.5%
11
   3.1%
Related Temperature - Dose 3 Number Analyzed 354 participants 347 participants 351 participants
19
   5.4%
12
   3.5%
15
   4.3%
Related Temperature - Across doses Number Analyzed 359 participants 357 participants 356 participants
35
   9.7%
31
   8.7%
30
   8.4%
Any Urticaria - Dose 1 Number Analyzed 359 participants 357 participants 355 participants
15
   4.2%
7
   2.0%
12
   3.4%
Any Urticaria - Dose 2 Number Analyzed 357 participants 353 participants 354 participants
8
   2.2%
5
   1.4%
12
   3.4%
Any Urticaria - Dose 3 Number Analyzed 354 participants 347 participants 351 participants
11
   3.1%
4
   1.2%
9
   2.6%
Any Urticaria - Across doses Number Analyzed 359 participants 357 participants 356 participants
28
   7.8%
13
   3.6%
25
   7.0%
Grade 3 Urticaria - Dose 1 Number Analyzed 359 participants 357 participants 355 participants
2
   0.6%
0
   0.0%
0
   0.0%
Grade 3 Urticaria - Dose 2 Number Analyzed 357 participants 353 participants 354 participants
0
   0.0%
1
   0.3%
0
   0.0%
Grade 3 Urticaria - Dose 3 Number Analyzed 354 participants 347 participants 351 participants
2
   0.6%
0
   0.0%
0
   0.0%
Grade 3 Urticaria - Across doses Number Analyzed 359 participants 357 participants 356 participants
4
   1.1%
1
   0.3%
0
   0.0%
Related Urticaria - Dose 1 Number Analyzed 359 participants 357 participants 355 participants
7
   1.9%
6
   1.7%
7
   2.0%
Related Urticaria - Dose 2 Number Analyzed 357 participants 353 participants 354 participants
5
   1.4%
4
   1.1%
4
   1.1%
Related Urticaria - Dose 3 Number Analyzed 354 participants 347 participants 351 participants
6
   1.7%
4
   1.2%
2
   0.6%
Related Urticaria - Across doses Number Analyzed 359 participants 357 participants 356 participants
15
   4.2%
11
   3.1%
9
   2.5%
15.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Hide Description 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.
Time Frame During the 30-day (from the day of vaccination up to 29 subsequent days) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the TVC, which included all subjects with at least one study vaccine administered.
Arm/Group Title Cervarix 2 Dose Group Gardasil 2 Dose Group Gardasil 3 Dose Group
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 359 358 358
Measure Type: Count of Participants
Unit of Measure: Participants
Subjects with any AE(s)
91
  25.3%
96
  26.8%
101
  28.2%
Subjects with any Grade 3 AE(s)
18
   5.0%
8
   2.2%
20
   5.6%
Subjects with any Related AE(s)
8
   2.2%
14
   3.9%
15
   4.2%
16.Secondary Outcome
Title Number of Subjects With Potentially Immune Mediated Diseases (pIMDs)
Hide Description 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.
Time Frame From Day 0 up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the TVC, which included all subjects with at least one study vaccine administered.
Arm/Group Title Cervarix 2 Dose Group Gardasil 2 Dose Group Gardasil 3 Dose Group
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 359 358 358
Measure Type: Count of Participants
Unit of Measure: Participants
3
   0.8%
3
   0.8%
0
   0.0%
17.Secondary Outcome
Title Number of Subjects With Medically Significant Conditions (MSCs)
Hide Description 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.
Time Frame From Day 0 up to Month 36 (throughout the study period)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the TVC, which included all subjects with at least one study vaccine administered.
Arm/Group Title Cervarix 2 Dose Group Gardasil 2 Dose Group Gardasil 3 Dose Group
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 359 358 358
Measure Type: Count of Participants
Unit of Measure: Participants
77
  21.4%
79
  22.1%
63
  17.6%
18.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
Time Frame From Day 0 up to Month 36 (throughout the study period)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the TVC, which included all subjects with at least one study vaccine administered.
Arm/Group Title Cervarix 2 Dose Group Gardasil 2 Dose Group Gardasil 3 Dose Group
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 359 358 358
Measure Type: Count of Participants
Unit of Measure: Participants
21
   5.8%
11
   3.1%
14
   3.9%
19.Secondary Outcome
Title Number of Subjects With SAEs Related to the Investigational Product, to Study Participation, to GSK Concomitant Products or Any Fatal SAE
Hide Description 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.
Time Frame From Day 0 up to Month 36 (throughout the study period)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the TVC, which included all subjects with at least one study vaccine administered.
Arm/Group Title Cervarix 2 Dose Group Gardasil 2 Dose Group Gardasil 3 Dose Group
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 359 358 358
Measure Type: Count of Participants
Unit of Measure: Participants
Related SAE(s)
0
   0.0%
0
   0.0%
0
   0.0%
Fatal SAE(s)
0
   0.0%
0
   0.0%
1
   0.3%
20.Secondary Outcome
Title Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Hide Description 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.
Time Frame From Day 0 up to Month 36 (throughout the study period)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cervarix 2 Dose Group Gardasil 2 Dose Group Gardasil 3 Dose Group
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 0 0 1
Measure Type: Count of Participants
Unit of Measure: Participants
Live infant NO ACA Number Analyzed 0 participants 0 participants 0 participants
0 0 0
Live infant CA Number Analyzed 0 participants 0 participants 0 participants
0 0 0
Elective termination NO ACA Number Analyzed 0 participants 0 participants 1 participants
0 0
1
 100.0%
Elective termination CA Number Analyzed 0 participants 0 participants 0 participants
0 0 0
Ectopic pregnancy Number Analyzed 0 participants 0 participants 0 participants
0 0 0
Spontaneous abortion NO ACA Number Analyzed 0 participants 0 participants 0 participants
0 0 0
Stillbirth NO ACA Number Analyzed 0 participants 0 participants 0 participants
0 0 0
Stillbirth CA Number Analyzed 0 participants 0 participants 0 participants
0 0 0
Lost to follow up Number Analyzed 0 participants 0 participants 0 participants
0 0 0
Pregnancy ongoing Number Analyzed 0 participants 0 participants 0 participants
0 0 0
Missing Number Analyzed 0 participants 0 participants 0 participants
0 0 0
21.Secondary Outcome
Title Number of Subjects Using a Concomitant Medication Throughout the Study Period
Hide Description The number of subjects who have used any concomitant medication, as well as any antipyretic, any prophylactic antipyretic and any antibiotic.
Time Frame From Day 0 up to Month 36 (throughout the study period) following vaccination after each dose and across doses
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the TVC, which included all subjects with at least one study vaccine administered.
Arm/Group Title Cervarix 2 Dose Group Gardasil 2 Dose Group Gardasil 3 Dose Group
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 359 358 358
Measure Type: Count of Participants
Unit of Measure: Participants
Any, Dose 1 Number Analyzed 359 participants 358 participants 358 participants
85
  23.7%
87
  24.3%
93
  26.0%
Any antipyretic, Dose 1 Number Analyzed 359 participants 358 participants 358 participants
51
  14.2%
53
  14.8%
47
  13.1%
Prophylactic antipyretic, Dose 1 Number Analyzed 359 participants 358 participants 358 participants
4
   1.1%
0
   0.0%
0
   0.0%
Any antibiotic, Dose 1 Number Analyzed 359 participants 358 participants 358 participants
15
   4.2%
13
   3.6%
23
   6.4%
Prophylactic antibiotic, Dose 1 Number Analyzed 359 participants 358 participants 358 participants
0
   0.0%
0
   0.0%
0
   0.0%
Any, Dose 2 Number Analyzed 358 participants 356 participants 356 participants
52
  14.5%
55
  15.4%
47
  13.2%
Any antipyretic, Dose 2 Number Analyzed 358 participants 356 participants 356 participants
32
   8.9%
26
   7.3%
29
   8.1%
Prophylactic antipyretic, Dose 2 Number Analyzed 358 participants 356 participants 356 participants
0
   0.0%
1
   0.3%
2
   0.6%
Any antibiotic, Dose 2 Number Analyzed 358 participants 356 participants 356 participants
8
   2.2%
13
   3.7%
12
   3.4%
Prophylactic antibiotic, Dose 2 Number Analyzed 358 participants 356 participants 356 participants
0
   0.0%
0
   0.0%
0
   0.0%
Any, Dose 3 Number Analyzed 357 participants 352 participants 354 participants
90
  25.2%
83
  23.6%
81
  22.9%
Any antipyretic, Dose 3 Number Analyzed 357 participants 352 participants 354 participants
48
  13.4%
45
  12.8%
38
  10.7%
Prophylactic antipyretic, Dose 3 Number Analyzed 357 participants 352 participants 354 participants
3
   0.8%
1
   0.3%
0
   0.0%
Any antibiotic, Dose 3 Number Analyzed 357 participants 352 participants 354 participants
28
   7.8%
21
   6.0%
24
   6.8%
Prophylactic antibiotic, Dose 3 Number Analyzed 357 participants 352 participants 354 participants
0
   0.0%
0
   0.0%
0
   0.0%
Any, Across doses Number Analyzed 359 participants 358 participants 358 participants
171
  47.6%
157
  43.9%
161
  45.0%
Any antipyretic, Across doses Number Analyzed 359 participants 358 participants 358 participants
110
  30.6%
102
  28.5%
95
  26.5%
Prophylactic antipyretic, Across doses Number Analyzed 359 participants 358 participants 358 participants
5
   1.4%
2
   0.6%
2
   0.6%
Any antibiotic, Across doses Number Analyzed 359 participants 358 participants 358 participants
48
  13.4%
42
  11.7%
50
  14.0%
Prophylactic antibiotic, Across doses Number Analyzed 359 participants 358 participants 358 participants
0
   0.0%
0
   0.0%
0
   0.0%
22.Secondary Outcome
Title Number of Subjects Completing the Vaccination Schedule
Hide Description The number of subjects who have completed the three-dose vaccination schedule in all groups.
Time Frame From Day 0 up to Month 36 (throughout the study period)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the TVC, which included all subjects with at least one study vaccine administered.
Arm/Group Title Cervarix 2 Dose Group Gardasil 2 Dose Group Gardasil 3 Dose Group
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 359 358 358
Measure Type: Count of Participants
Unit of Measure: Participants
351
  97.8%
339
  94.7%
346
  96.6%
Time Frame 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).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cervarix 2 Dose Group Gardasil 2 Dose Group Gardasil 3 Dose Group
Hide Arm/Group Description 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. 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. 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.
All-Cause Mortality
Cervarix 2 Dose Group Gardasil 2 Dose Group Gardasil 3 Dose Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/359 (0.00%)      0/358 (0.00%)      1/358 (0.28%)    
Hide Serious Adverse Events
Cervarix 2 Dose Group Gardasil 2 Dose Group Gardasil 3 Dose Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/359 (5.85%)      11/358 (3.07%)      14/358 (3.91%)    
Blood and lymphatic system disorders       
Lymphadenitis  1  0/359 (0.00%)  0 0/358 (0.00%)  0 1/358 (0.28%)  1
Ear and labyrinth disorders       
Vertigo positional  1  0/359 (0.00%)  0 0/358 (0.00%)  0 1/358 (0.28%)  1
Gastrointestinal disorders       
Abdominal pain  1  0/359 (0.00%)  0 0/358 (0.00%)  0 1/358 (0.28%)  1
Abdominal pain lower  1  0/359 (0.00%)  0 1/358 (0.28%)  1 0/358 (0.00%)  0
Colitis ulcerative  1  1/359 (0.28%)  1 0/358 (0.00%)  0 0/358 (0.00%)  0
Mouth cyst  1  0/359 (0.00%)  0 1/358 (0.28%)  1 0/358 (0.00%)  0
Immune system disorders       
Anaphylactic reaction  1  1/359 (0.28%)  1 0/358 (0.00%)  0 0/358 (0.00%)  0
Anaphylactic shock  1  0/359 (0.00%)  0 0/358 (0.00%)  0 1/358 (0.28%)  1
Infections and infestations       
Gastroenteritis  1  3/359 (0.84%)  3 0/358 (0.00%)  0 0/358 (0.00%)  0
Upper respiratory tract infection  1  2/359 (0.56%)  2 0/358 (0.00%)  0 1/358 (0.28%)  1
Appendicitis  1  1/359 (0.28%)  1 1/358 (0.28%)  1 0/358 (0.00%)  0
Pneumonia  1  1/359 (0.28%)  1 0/358 (0.00%)  0 1/358 (0.28%)  1
Epstein-Barr virus infection  1  1/359 (0.28%)  1 0/358 (0.00%)  0 0/358 (0.00%)  0
Gastroenteritis rotavirus  1  1/359 (0.28%)  1 0/358 (0.00%)  0 0/358 (0.00%)  0
Gastroenteritis viral  1  0/359 (0.00%)  0 1/358 (0.28%)  1 0/358 (0.00%)  0
Influenza  1  0/359 (0.00%)  0 0/358 (0.00%)  0 1/358 (0.28%)  1
Lung abscess  1  0/359 (0.00%)  0 1/358 (0.28%)  1 0/358 (0.00%)  0
Peritonitis  1  0/359 (0.00%)  0 1/358 (0.28%)  1 0/358 (0.00%)  0
Post procedural infection  1  1/359 (0.28%)  1 0/358 (0.00%)  0 0/358 (0.00%)  0
Tonsillitis  1  1/359 (0.28%)  1 0/358 (0.00%)  0 0/358 (0.00%)  0
Viral infection  1  0/359 (0.00%)  0 1/358 (0.28%)  1 0/358 (0.00%)  0
Injury, poisoning and procedural complications       
Foot fracture  1  2/359 (0.56%)  2 0/358 (0.00%)  0 0/358 (0.00%)  0
Ankle fracture  1  0/359 (0.00%)  0 0/358 (0.00%)  0 1/358 (0.28%)  1
Contusion  1  1/359 (0.28%)  1 0/358 (0.00%)  0 0/358 (0.00%)  0
Forearm fracture  1  1/359 (0.28%)  1 0/358 (0.00%)  0 0/358 (0.00%)  0
Foreign body  1  1/359 (0.28%)  1 0/358 (0.00%)  0 0/358 (0.00%)  0
Joint dislocation  1  0/359 (0.00%)  0 1/358 (0.28%)  1 0/358 (0.00%)  0
Overdose  1  0/359 (0.00%)  0 0/358 (0.00%)  0 1/358 (0.28%)  1
Tendon injury  1  0/359 (0.00%)  0 0/358 (0.00%)  0 1/358 (0.28%)  1
Musculoskeletal and connective tissue disorders       
Juvenile idiopathic arthritis  1  1/359 (0.28%)  1 0/358 (0.00%)  0 0/358 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Teratoma  1  0/359 (0.00%)  0 1/358 (0.28%)  1 0/358 (0.00%)  0
Nervous system disorders       
Epilepsy  1  0/359 (0.00%)  0 1/358 (0.28%)  1 0/358 (0.00%)  0
Presyncope  1  0/359 (0.00%)  0 0/358 (0.00%)  0 1/358 (0.28%)  1
Seizure  1  0/359 (0.00%)  0 1/358 (0.28%)  1 0/358 (0.00%)  0
Syncope  1  1/359 (0.28%)  1 0/358 (0.00%)  0 0/358 (0.00%)  0
Tension headache  1  0/359 (0.00%)  0 0/358 (0.00%)  0 1/358 (0.28%)  1
Pregnancy, puerperium and perinatal conditions       
Abortion spontaneous incomplete  1  0/359 (0.00%)  0 0/358 (0.00%)  0 1/358 (0.28%)  1
Psychiatric disorders       
Completed suicide  1  0/359 (0.00%)  0 0/358 (0.00%)  0 1/358 (0.28%)  1
Depression  1  0/359 (0.00%)  0 0/358 (0.00%)  0 1/358 (0.28%)  1
Reproductive system and breast disorders       
Menorrhagia  1  0/359 (0.00%)  0 0/358 (0.00%)  0 1/358 (0.28%)  1
Vulval ulceration  1  0/359 (0.00%)  0 0/358 (0.00%)  0 1/358 (0.28%)  1
Respiratory, thoracic and mediastinal disorders       
Asthma  1  2/359 (0.56%)  2 1/358 (0.28%)  1 0/358 (0.00%)  0
Skin and subcutaneous tissue disorders       
Eczema  1  0/359 (0.00%)  0 1/358 (0.28%)  1 0/358 (0.00%)  0
Erythema nodosum  1  1/359 (0.28%)  1 0/358 (0.00%)  0 0/358 (0.00%)  0
Vascular disorders       
Orthostatic hypotension  1  1/359 (0.28%)  1 0/358 (0.00%)  0 0/358 (0.00%)  0
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cervarix 2 Dose Group Gardasil 2 Dose Group Gardasil 3 Dose Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   343/359 (95.54%)      321/358 (89.66%)      324/358 (90.50%)    
Gastrointestinal disorders       
Gastrointestinal disorder  1  55/359 (15.32%)  69 74/358 (20.67%)  103 70/358 (19.55%)  91
General disorders       
Fatigue  1  192/359 (53.48%)  374 199/358 (55.59%)  359 193/358 (53.91%)  390
Pain  1  329/359 (91.64%)  784 277/358 (77.37%)  613 295/358 (82.40%)  669
Pyrexia  1  59/359 (16.43%)  70 64/358 (17.88%)  71 53/358 (14.80%)  65
Swelling  1  163/359 (45.40%)  288 98/358 (27.37%)  146 118/358 (32.96%)  200
Infections and infestations       
Nasopharyngitis  1  8/359 (2.23%)  10 11/358 (3.07%)  12 20/358 (5.59%)  22
Upper respiratory tract infection  1  27/359 (7.52%)  31 29/358 (8.10%)  33 31/358 (8.66%)  34
Musculoskeletal and connective tissue disorders       
Arthralgia  1  68/359 (18.94%)  98 82/358 (22.91%)  119 67/358 (18.72%)  108
Myalgia  1  166/359 (46.24%)  267 144/358 (40.22%)  230 136/358 (37.99%)  254
Nervous system disorders       
Headache  1  149/359 (41.50%)  241 134/358 (37.43%)  213 152/358 (42.46%)  232
Skin and subcutaneous tissue disorders       
Erythema  1  191/359 (53.20%)  370 135/358 (37.71%)  261 157/358 (43.85%)  288
Rash  1  26/359 (7.24%)  32 16/358 (4.47%)  17 18/358 (5.03%)  23
Urticaria  1  28/359 (7.80%)  36 13/358 (3.63%)  16 25/358 (6.98%)  33
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
EMail: GSKClinicalSupportHD@gsk.com
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01462357    
Other Study ID Numbers: 115411
2011-002035-26 ( EudraCT Number )
First Submitted: October 27, 2011
First Posted: October 31, 2011
Results First Submitted: August 11, 2014
Results First Posted: March 28, 2016
Last Update Posted: November 15, 2019