Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 62 of 91 for:    cervarix

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 : March 31, 2017
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 CervarixTM 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: Month 7
Started 359 358 358
Completed 358 353 352
Not Completed 1 5 6
Reason Not Completed
Withdrawal by Subject             1             5             6
Period Title: Month 12
Started 359 358 358
Completed 356 348 350
Not Completed 3 10 8
Reason Not Completed
Withdrawal by Subject             2             6             3
Lost to Follow-up             1             4             5
Period Title: Month 18
Started 359 358 358
Completed 356 347 349
Not Completed 3 11 9
Reason Not Completed
Withdrawal by Subject             2             6             3
Lost to Follow-up             1             4             5
Other             0             1             1
Period Title: Month 24
Started 359 358 358
Completed 355 344 349
Not Completed 4 14 9
Reason Not Completed
Withdrawal by Subject             2             8             3
Lost to Follow-up             2             4             6
Migrated/moved from study area             0             2             0
Period Title: Month 36
Started 351 339 346
Completed 351 339 346
Not Completed 0 0 0
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 CervarixTM 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%
1.Primary Outcome
Title Number of Seroconverted Subjects for Anti-HPV-16/18, as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
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 EL.U/mL, respectively), in the serum of subjects seronegative before vaccination in the primary study.
Time Frame One month after the last dose of study vaccine (Month 7)
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 time of the analysis.
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 CervarixTM 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 337 334 334
Measure Type: Number
Unit of Measure: Subjects
Anti-HPV-16 (N=337,334,334) 337 334 334
Anti-HPV-18 (N=337,334,334) 337 334 334
Show Statistical Analysis 1 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 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, in 9-14 year-old females, 1 month after the last dose (Month 7).

Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority with respect to seroconversion will be shown if, at Months 12, 18, 24 and 36, 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 - Cervarix 2 dose Group) is 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]
Show Statistical Analysis 2 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, in 9-14 year-old females, 1 month after the last dose (Month 7).

Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority with respect to seroconversion will be shown if, at Months 12, 18, 24 and 36, 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 - Cervarix 2 dose Group) is 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 Concentrations Assessed by ELISA
Hide Description Anti-HPV 16/18 antibody concentrations were presented as geometric mean concentrations (GMC) and expressed in ELISA units per milliliter (EL.U/mL) based on ELISA.
Time Frame One month after the last dose of study vaccine (Month 7)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis.
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 CervarixTM 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 337 334 334
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-HPV-16 (N=337,334,334)
8311.4
(7745.8 to 8918.3)
5061
(4604.1 to 5563.3)
4864
(4481.9 to 5278.7)
Anti-HPV-18 (N=337,334,334)
5249.7
(4835.4 to 5699.5)
1213
(1098.7 to 1339.1)
1654.5
(1485.8 to 1842.4)
Show Statistical Analysis 1 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 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, in 9-14 year-old females, 1 month after the last dose (Month 7).

Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority with respect to GMT will be shown if, at Months 12, 18, 24 and 36, 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/Cervarix 2 dose Group) is 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]
Show Statistical Analysis 2 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, in 9-14 year-old females, 1 month after the last dose (Month 7).

Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority with respect to GMT will be shown if, at Months 12, 18, 24 and 36, 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/Cervarix 2 dose Group) is 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%
0.2 to 0.26
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
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).

Superiority will be shown if the lower limit of the 95% CI for the ratio of GMTs (Cervarix 2 dose Group divided by Gardasil 2 dose Group) is above 1.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
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 4.52
Confidence Interval (2-Sided) 95%
3.97 to 5.13
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
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).

Superiority will be shown if the lower limit of the 95% CI for the ratio of GMTs (Cervarix 2 dose Group divided by Gardasil 2 dose Group) is above 1.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
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 1.69
Confidence Interval (2-Sided) 95%
1.49 to 1.91
Estimation Comments [Not Specified]
3.Primary Outcome
Title Anti-HPV-16/18 Seroconversion Rates Assessed by ELISA
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 3.1 and 3.2 international units per milliliter (IU/mL), respectively], in the serum of subjects who were seronegative before vaccination in the primary study.

The assay cut-offs used for analyses at Month 36 were modified to 3.1 and 3.2 IU/mL, after applying the conversion factor from EL.U/mL to IU/mL.

Time Frame At Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis.
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 CervarixTM 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 324 313 321
Measure Type: Number
Unit of Measure: Subjects
Anti-HPV-16, Month 36 (N=324,313,321) 324 310 320
Anti-HPV-18, Month 36 (N=324,313,321) 324 270 298
4.Primary Outcome
Title Anti-HPV-16/18 Antibody Concentrations Assessed by ELISA
Hide Description

Anti-HPV 16/18 antibody concentrations were presented as geometric mean titers (GMT) and expressed in IU/mL.

Assay cut-offs used for analyses at Month 36 were modified to 3.1 and 3.2 IU/mL respectively, after applying the conversion factor from EL.U/mL to IU/mL.

Time Frame At Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis.
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 CervarixTM 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 324 313 321
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
Anti-HPV-16, Month 36 (N=324,313,321)
175.2
(160.6 to 191.2)
61.6
(54.1 to 70.1)
77.8
(70.2 to 86.3)
Anti-HPV-18, Month 36 (N=324,313,321)
85.5
(77.0 to 95.0)
12.5
(11.0 to 14.3)
21.1
(18.3 to 24.3)
5.Secondary Outcome
Title Anti-HPV-16/18 Seroconversion Rates Assessed by ELISA
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 EL.U/mL, respectively) in the serum of subjects seronegative before vaccination in the primary study.
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 ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis.
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 CervarixTM 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 337 334 334
Measure Type: Number
Unit of Measure: Subjects
Anti-HPV-16, Day 0 (N=337,334,334) 7 7 12
Anti-HPV-18, Day 0 (N=337,334,334) 3 3 1
Anti-HPV-16, Month 12 (N=331,325,327) 330 325 327
Anti-HPV-18, Month 12 (N=331,325,327) 330 324 327
Anti-HPV-16, Month 18 (N=329,327,330) 329 326 330
Anti-HPV-18, Month 18 (N=329,327,330) 329 310 322
Anti-HPV-16, Month 24 (N=324,320,324) 324 319 324
Anti-HPV-18, Month 24 (N=324,320,324) 324 298 313
Anti-HPV-16, Month 36 (N=324,313,321) 324 310 321
Anti-HPV-18, Month 36 (N=324,313,321) 324 270 298
6.Secondary Outcome
Title Anti-HPV-16/18 Antibody Concentrations Assessed by ELISA
Hide Description Anti-HPV 16/18 antibody concentrations were presented as geometric mean concentrations (GMC) and expressed in ELISA units per milliliter (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 ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis.
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 CervarixTM 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 337 334 334
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-HPV-16, Day 0 (N=337,334,334)
9.8
(9.5 to 10.2)
9.8
(9.5 to 10.1)
10.0
(9.7 to 10.3)
Anti-HPV-18, Day 0 (N=337,334,334)
9.1
(9.0 to 9.2)
9.1
(9.0 to 9.2)
9
(9.0 to 9.1)
Anti-HPV-16, Month 12 (N=331,325,327)
2247.9
(2052.2 to 2462.2)
1283.9
(1152.1 to 1430.8)
1610.5
(1468.9 to 1765.8)
Anti-HPV-18, Month 12 (N=331,325,327)
1311.4
(1187.3 to 1448.4)
266.0
(236.2 to 299.4)
477.8
(422.7 to 540.1)
Anti-HPV-16, Month 18 (N=329,327,330)
1516.2
(1393.4 to 1649.8)
675.8
(600 to 761.1)
828
(749.8 to 914.4)
Anti-HPV-18, Month 18 (N=329,327,330)
763.1
(691.3 to 842.5)
133.8
(117.6 to 152.1)
230.8
(202.1 to 263.6)
Anti-HPV-16, Month 24 (N=324,320,324)
1317.5
(1213.9 to 1430)
514.4
(456.9 to 579.2)
639.9
(579.6 to 706.6)
Anti-HPV-18, Month 24 (N=324,317,324)
628.6
(569.4 to 694)
107.8
(94.8 to 122.6)
182.2
(159.6 to 208)
Anti-HPV-16, Month 36 (N=324,313,321)
1068.9
(979.6 to 1166.5)
375.4
(329.6 to 427.5)
475.3
(428.7 to 527.0)
Anti-HPV-18, Month 36 (N=324,313,321)
487.8
(439.3 to 541.8)
71.3
(62.3 to 81.5)
120.2
(104.3 to 138.5)
7.Secondary Outcome
Title Anti-HPV-16/18 Seroconversion Rates Assessed by Pseudovirion-based Neutralization Assay (PBNA) in a Subset of Subjects
Hide Description Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers respectively greater than or equal to ≥ 40 ED50) in the serum of subjects seronegative before vaccination in the primary study.
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 ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis.
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 CervarixTM 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 92 95 93
Measure Type: Number
Unit of Measure: Subjects
Anti-HPV-16, Day 0 (N=92,95,93) 0 1 0
Anti-HPV-18, Day 0 (N=92,95,93) 0 0 0
Anti-HPV-16, Month 7 (N=92,95,93) 92 95 93
Anti-HPV-18, Month 7 (N=92,95,93) 92 95 93
Anti-HPV-16, Month 12 (N=90,93,91) 90 93 91
Anti-HPV-18, Month 12 (N=90,93,91) 90 91 91
Anti-HPV-16, Month 18 (N=90,92,91) 90 89 90
Anti-HPV-18, Month 18 (N=89,92,92) 89 81 90
Anti-HPV-16, Month 24 (N=88,88,92) 88 88 91
Anti-HPV-18, Month 24 (N=88,86,92) 88 77 89
Anti-HPV-16, Month 36 (N=89,87,91) 89 87 91
Anti-HPV-18, Month 36 (N=89,87,91) 89 75 86
8.Secondary Outcome
Title Anti-HPV-16/18 Antibody Titers Assessed by PBNA in a Subset of Subjects
Hide Description Anti-HPV 16/18 antibody titers were presented as geometric mean titers (GMT) and expressed in titers using the PBNA.
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 ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis.
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 CervarixTM 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 92 95 93
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
Anti-HPV-16, Day 0 (N=92,95,93)
20.0
(20.0 to 20.0)
20.2
(19.8 to 20.5)
20.0
(20.0 to 20.0)
Anti-HPV-18, Day 0 (N=92,95,93)
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 (N=92,95,93)
51043.8
(42657.9 to 61078.3)
19119.4
(15249 to 23972.1)
21377.9
(16900.1 to 27042.2)
Anti-HPV-18, Month 7 (N=92,95,93)
23228
(18677 to 28887.8)
4709.9
(3604.2 to 6154.9)
8009.4
(6111.1 to 10497.4)
Anti-HPV-16, Month 12 (N=90,93,91)
10635.3
(8555.9 to 13220.0)
3959.4
(3039.1 to 5158.4)
5858.1
(4610.9 to 7442.8)
Anti-HPV-18, Month 12 (N=90,93,91)
3651.5
(2903.6 to 4592.1)
656.3
(493.6 to 872.6)
1734.2
(1268.4 to 2371.0)
Anti-HPV-16, Month 18 (N=90,92,91)
8388.4
(6647.7 to 10584.9)
1953.5
(1386.6 to 2752.3)
2988.9
(2227.2 to 4011.2)
Anti-HPV-18, Month 18 (N=89,92,92)
2381.1
(1858.7 to 3050.2)
283.1
(209.4 to 382.7)
805.7
(574.4 to 1130.2)
Anti-HPV-16, Month 24 (N=88,88,92)
5059.5
(4112.2 to 6225.1)
1138.1
(845.5 to 1531.9)
1965.5
(1510.6 to 2557.3)
Anti-HPV-18, Month 24 (N=88,86,92)
1725.1
(1359.3 to 2189.4)
234.6
(175.8 to 313.2)
568.0
(419.0 to 770.1)
Anti-HPV-16, Month 36 (N=89,87,91)
4357.8
(3577.8 to 5307.9)
1071.7
(811.2 to 1415.7)
1577.0
(1210.4 to 2054.5)
Anti-HPV-18, Month 36 (N=89,87,91)
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 Assessed by PBNA in a Subset of Subjects
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 ≥ 40 ED50) in the serum of subjects seronegative before vaccination in the primary study.
Time Frame At Months 24 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets 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 CervarixTM 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 98 92 99
Measure Type: Number
Unit of Measure: Subjects
Anti-HPV-16, Month 24 (N=96,91,99) 95 91 98
Anti-HPV-18, Month 24 (N=96,89,99) 96 80 95
Anti-HPV-16, Month 36 (N=98,92,98) 97 92 98
Anti-HPV-18, Month 36 (N=97,92,98) 97 80 92
10.Secondary Outcome
Title Anti-HPV-16/18 Antibody Titers Assessed by PBNA in a Subset of Subjects
Hide Description Anti-HPV 16/18 antibody titers were presented as geometric mean titers (GMT) and expressed in titers using the PBNA.
Time Frame At Months 24 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets 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 CervarixTM 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 98 92 99
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Anti-HPV-16, Month 24 (N=96,91,99)
4609.1
(3673.5 to 5782.9)
1133.9
(848.1 to 1516.0)
1948.1
(1515.0 to 2505.0)
Anti-HPV-18, Month 24 (N=96,89,99)
1638.6
(1297.9 to 2068.8)
237.2
(179.1 to 314.3)
573.0
(425.0 to 772.5)
Anti-HPV-16, Month 36 (N=98,92,98)
4011.7
(3229.7 to 4983.0)
1058.4
(806.3 to 1389.2)
1517.2
(1174.7 to 1959.4)
Anti-HPV-18, Month 36 (N=97,92,98)
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 CMI
Hide Description Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-γ), Tumour necrosis factor-alpha (TNF-α) and CD40-ligand (CD40-L).
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 ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis.
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 CervarixTM 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 68 70
Median (Inter-Quartile Range)
Unit of Measure: T-cells/million cells
CD4+ All doubles, Anti-HPV-16, Day 0 (N=57,47,55)
14
(1 to 97)
22
(1 to 73)
33
(1 to 80)
CD4+ All doubles, Anti-HPV-18, Day 0 (N=57,46,56)
20
(1 to 83)
19
(1 to 101)
24
(1 to 91.5)
CD4+ All doubles, Anti-HPV-16, Month 7(N=68,63,65)
1604.5
(634.5 to 3253.5)
853
(429 to 1324)
1131
(694 to 1969)
CD4+ All doubles, Anti-HPV-18, Month 7(N=67,63,66)
897
(522 to 2497)
459
(240 to 761)
654.5
(384 to 1284)
CD4+ All doubles, Anti-HPV-16, Month12(N=71,66,70)
1121
(659 to 2340)
622.5
(316 to 1261)
844.5
(546 to 1652)
CD4+ All doubles, Anti-HPV-18, Month12(N=71,68,70)
789
(400 to 1492)
355
(209 to 673.5)
465.5
(205 to 901)
CD4-d-CD40L, Anti-HPV-16,Day 0 (N=57,47,55)
10
(1 to 78)
14
(1 to 73)
30
(1 to 80)
CD4-d-CD40L, Anti-HPV-18,Day 0 (N=57,46,56)
14
(1 to 83)
27
(1 to 101)
25.5
(1 to 68.5)
CD4-d-CD40L, Anti-HPV-16,Month 7(N=68,63.65)
1507.5
(631.5 to 3043)
779
(426 to 1219)
1054
(670 to 1938)
CD4-d-CD40L, Anti-HPV-18,Month7 (N=67,63,66)
866
(509 to 2379)
418
(227 to 775)
616.5
(344 to 1193)
CD4-d-CD40L, Anti-HPV-16,Month 12(N=71,66,70)
990
(594 to 2236)
592.5
(280 to 1135)
805
(469 to 1545)
CD4-d-CD40L, Anti-HPV-18,Month 12(N=71,68,70)
688
(346 to 1435)
340.5
(168 to 604.5)
404
(219 to 737)
CD4-d- IFNγ, Anti-HPV-16,Day 0 (N=57,47,55)
1
(1 to 30)
14
(1 to 42)
1
(1 to 28)
CD4-d- IFNγ, Anti-HPV-18,Day 0(N=57,46,56)
14
(1 to 32)
7
(1 to 35)
1.5
(1 to 31.5)
CD4-d- IFNγ, Anti-HPV-16,Month 7(N=68,63,65)
351
(164.5 to 829)
314
(141 to 602)
398
(193 to 708)
CD4-d- IFNγ, Anti-HPV-18,Month 7(N=67,63,66)
218
(108 to 631)
127
(70 to 247)
181.5
(70 to 371)
CD4-d- IFNγ, Anti-HPV-16,Month 12(N=71,66,70)
326
(110 to 688)
241.5
(86 to 606)
337
(135 to 734)
CD4-d- IFNγ, Anti-HPV-18,Month 12(N=71,68,70)
174
(87 to 444)
114
(56.5 to 259.5)
155.5
(56 to 315)
CD4-d-IL-2, Anti-HPV-16,Day 0 (N=57,47,55)
16
(1 to 71)
24
(1 to 68)
33
(1 to 58)
CD4-d-IL-2, Anti-HPV-18, Day 0 (N=57,46,56)
1
(1 to 42)
30
(1 to 66)
20
(1 to 58)
CD4-d-IL-2, Anti-HPV-16,Month 7(N=68,63,65)
1323
(537 to 2702.5)
710
(368 to 1058)
875
(580 to 1431)
CD4-d-IL-2, Anti-HPV-18,Month 7(N=67,63,66)
737
(420 to 2185)
321
(206 to 573)
503
(295 to 869)
CD4-d-IL-2, Anti-HPV-16,Month 12(N=71,66,70)
922
(528 to 2050)
487.5
(285 to 991)
702.5
(450 to 1379)
CD4-d-IL-2, Anti-HPV-18,Month 12(N=71,68,70)
620
(311 to 1157)
274
(164.5 to 550.5)
380
(160 to 705)
CD4-d-TNFα, Anti-HPV-16,Day 0 (N=57,47,55)
6
(1 to 52)
32
(1 to 73)
16
(1 to 71)
CD4-d-TNFα, Anti-HPV-18,Day 0 (N=57,46,56)
24
(1 to 73)
19
(1 to 82)
21
(1 to 57)
CD4-d-TNFα, Anti-HPV-16,Month 7(N=68,63,65)
1103
(432 to 2399)
605
(276 to 919)
804
(458 to 1512)
CD4-d-TNFα, Anti-HPV-18,Month 7(N=67,63,66)
647
(371 to 1765)
319
(153 to 594)
517
(272 to 978)
CD4-d-TNFα, Anti-HPV-16,Month 12(N=71,66,70)
884
(488 to 1924)
527
(210 to 1033)
725
(383 to 1445)
CD4-d-TNFα, Anti-HPV-18,Month 12(N=71,68,70)
674
(290 to 1272)
299
(144.5 to 600)
403
(175 to 771)
CD8-All Doubles, Anti-HPV-16, Day 0 (N=57,47,55)
1
(1 to 14)
2
(1 to 43)
1
(1 to 32)
CD8-All Doubles, Anti-HPV-18, Day 0 (N=57,46,56)
1
(1 to 10)
1
(1 to 29)
1
(1 to 23.5)
CD8-All Doubles, Anti-HPV-16,Month 7(N=68,63,65)
1
(1 to 33)
1
(1 to 40)
1
(1 to 33)
CD8-All Doubles, Anti-HPV-18,Month 7(N=67,63,66)
1
(1 to 19)
1
(1 to 37)
1
(1 to 40)
CD8-All Doubles, Anti-HPV-16,Month 12(N=71,66,70)
1
(1 to 31)
1
(1 to 44)
1
(1 to 32)
CD8-All Doubles, Anti-HPV-18,Month 12(N=71,68,70)
1
(1 to 27)
1
(1 to 32.5)
1
(1 to 20)
CD8-d-CD40L, Anti-HPV-16, Day 0 (N=57,47,55)
1
(1 to 1)
1
(1 to 3)
1
(1 to 1)
CD8-d-CD40L, Anti-HPV-18, Day 0 (N=57,46,56)
1
(1 to 1)
1
(1 to 1)
1
(1 to 1)
CD8-d-CD40L, Anti-HPV-16,Month 7(N=68,63,65)
1
(1 to 1)
1
(1 to 28)
1
(1 to 24)
CD8-d-CD40L, Anti-HPV-18,Month 7(N=67,63,66)
1
(1 to 1)
1
(1 to 24)
1
(1 to 20)
CD8-d-CD40L, Anti-HPV-16,Month 12(N=71,66,70)
1
(1 to 1)
1
(1 to 1)
1
(1 to 3)
CD8-d-CD40L, Anti-HPV-18,Month 12(N=71,68,70)
1
(1 to 1)
1
(1 to 1)
1
(1 to 1)
CD8-d-IFNγ, Anti-HPV-16, Day 0 (N=57,47,55)
1
(1 to 1)
1
(1 to 36)
1
(1 to 30)
CD8-d-IFNγ, Anti-HPV-18, Day 0 (N=57,46,56)
1
(1 to 2)
1
(1 to 24)
1
(1 to 14)
CD8-d-IFNγ, Anti-HPV-16,Month 7(N=68,63,65)
1
(1 to 31)
1
(1 to 36)
1
(1 to 30)
CD8-d-IFNγ, Anti-HPV-18,Month 7(N=67,63,66)
1
(1 to 1)
1
(1 to 27)
1
(1 to 28)
CD8-d-IFNγ, Anti-HPV-16,Month 12(N=71,66,70)
1
(1 to 28)
1
(1 to 29)
1
(1 to 28)
CD8-d-IFNγ, Anti-HPV-18, Month 12 (N=71,68,70)
1
(1 to 26)
1
(1 to 32.5)
1
(1 to 10)
CD8-d-IL-2, Anti-HPV-16, Day 0 (N=57,47,55)
1
(1 to 1)
1
(1 to 1)
1
(1 to 1)
CD8-d-IL-2, Anti-HPV-18,Day 0 (N=57,46,56)
1
(1 to 1)
1
(1 to 1)
1
(1 to 1)
CD8-d-IL-2, Anti-HPV-16,Month 7(N=68,63,65)
1
(1 to 1)
1
(1 to 1)
1
(1 to 1)
CD8-d-IL-2, Anti-HPV-18,Month 7(N=67,63,66)
1
(1 to 1)
1
(1 to 1)
1
(1 to 1)
CD8-d-IL-2, Anti-HPV-16,Month 12(N=71,66,70)
1
(1 to 1)
1
(1 to 1)
1
(1 to 1)
CD8-d-IL-2, Anti-HPV-18,Month 12(N=71,68,70)
1
(1 to 1)
1
(1 to 1)
1
(1 to 1)
CD8-d-TNFα, Anti-HPV-16, Day 0 (N=57,47,55)
1
(1 to 1)
1
(1 to 36)
1
(1 to 22)
CD8-d-TNFα, Anti-HPV-18, Day 0 (N=57,46,56)
1
(1 to 25)
1
(1 to 30)
1
(1 to 13.5)
CD8-d-TNFα, Anti-HPV-16,Month 7(N=68,63,65)
1
(1 to 26)
1
(1 to 25)
1
(1 to 22)
CD8-d-TNFα, Anti-HPV-18,Month 7(N67,63,66)
1
(1 to 1)
1
(1 to 1)
1
(1 to 23)
CD8-d-TNFα, Anti-HPV-16,Month 12(N=71,66,70)
1
(1 to 1)
1
(1 to 25)
1
(1 to 29)
CD8-d-TNFα, Anti-HPV-18,Month 12(N=71,68,70)
1
(1 to 8)
1
(1 to 21.5)
1
(1 to 24)
CD4+ All doubles, Anti-HPV-16,Month 24(N=66,65,71)
1097
(489 to 2410)
738
(360 to 1109)
974
(573 to 1838)
CD4+ All doubles, Anti-HPV-18,Month 24(N=65,65,70)
630
(301 to 1383)
348
(202 to 549)
561.5
(258 to 972)
CD4-d-CD40L, Anti-HPV-16,Month 24(N=66,65,71)
1083
(510 to 2269)
734
(346 to 1084)
964
(582 to 1802)
CD4-d-CD40L, Anti-HPV-18,Month 24(N=65,65,70)
587
(282 to 1344)
333
(206 to 534)
563.5
(289 to 940)
CD4-d- IFNγ, Anti-HPV-16,Month 24(N=66,65,71)
276
(111 to 781)
315
(128 to 519)
431
(157 to 777)
CD4-d- IFNγ, Anti-HPV-18,Month 24(N=65,65,70)
169
(59 to 440)
106
(51 to 227)
218
(63 to 362)
CD4-d-IL-2, Anti-HPV-16,Month 24(N=66,65,71)
879.5
(429 to 1711)
574
(280 to 898)
687
(479 to 1480)
CD4-d-IL-2, Anti-HPV-18,Month 24(N=65,65,70)
494
(238 to 926)
248
(138 to 415)
400.5
(206 to 713)
CD4-d-TNFα, Anti-HPV-16,Month 24(N=66,65,71)
755
(375 to 1668)
524
(235 to 876)
791
(416 to 1516)
CD4-d-TNFα, Anti-HPV-18,Month 24(N=65,65,70)
479
(183 to 1036)
238
(130 to 478)
519
(228 to 793)
CD8-All Doubles, Anti-HPV-16,Month 24(N=66,65,71)
1
(1 to 29)
1
(1 to 1)
1
(1 to 2)
CD8-All Doubles, Anti-HPV-18,Month 24(N=65,65,70)
1
(1 to 30)
1
(1 to 30)
1
(1 to 31)
CD8-d-CD40L, Anti-HPV-16,Month 24(N=66,65,71)
1
(1 to 23)
1
(1 to 1)
1
(1 to 1)
CD8-d-CD40L, Anti-HPV-18,Month 24(N=65,65,70)
1
(1 to 1)
1
(1 to 1)
1
(1 to 23)
CD8-d-IFNγ, Anti-HPV-16,Month 24(N=66,65,71)
1
(1 to 19)
1
(1 to 1)
1
(1 to 3)
CD8-d-IFNγ, Anti-HPV-18,Month 24(N=65,65,70)
1
(1 to 1)
1
(1 to 23)
1
(1 to 23)
CD8-d-IL-2, Anti-HPV-16,Month 24(N=66,65,71)
1
(1 to 1)
1
(1 to 1)
1
(1 to 1)
CD8-d-IL-2, Anti-HPV-18,Month 24(N=65,65,70)
1
(1 to 1)
1
(1 to 1)
1
(1 to 1)
CD8-d-TNFα, Anti-HPV-16,Month 24(N=66,65,71)
1
(1 to 27)
1
(1 to 1)
1
(1 to 1)
CD8-d-TNFα, Anti-HPV-18,Month 24(N=65,65,70)
1
(1 to 18)
1
(1 to 23)
1
(1 to 21)
CD4+ All doubles, Anti-HPV-16,Month 36(N=58,55,64)
1012.0
(427.0 to 2373.0)
685.0
(385.0 to 1321.0)
842.5
(437.5 to 1624.0)
CD4+ All doubles, Anti-HPV-18,Month 36(N=57,55,63)
682.0
(313.0 to 1425.0)
350.0
(196.0 to 665.0)
516.0
(270.0 to 1029.0)
CD4-d-CD40L, Anti-HPV-16,Month 36(N=58,55,64)
957.0
(465.0 to 2303.0)
685.0
(349.0 to 1321.0)
778.5
(416.5 to 1560.5)
CD4-d-CD40L, Anti-HPV-18,Month 36(N=57,55,63)
671.0
(290.0 to 1435.0)
337.0
(204.0 to 648.0)
499.0
(264.0 to 1020.0)
CD4-d-IFNγ, Anti-HPV-16,Month 36(N=58,55,64)
253.5
(81.0 to 667.0)
301.0
(134.0 to 571.0)
270.5
(129.0 to 666.5)
CD4-d-IFNγ, Anti-HPV-18,Month 36(N=57,55,63)
193.0
(51.0 to 376.0)
109.0
(27.0 to 230.0)
155.0
(45.0 to 314.0)
CD4-d-IL-2, Anti-HPV-16,Month 36(N=58,55,64)
784.0
(331.0 to 1673.0)
517.0
(295.0 to 1014.0)
680.0
(308.0 to 1245.5)
CD4-d-IL-2, Anti-HPV-18,Month 36(N=57,55,63)
507.0
(213.0 to 1069.0)
274.0
(137.0 to 467.0)
341.0
(168.0 to 798.0)
CD4-d-TNFα, Anti-HPV-16,Month 36(N=58,55,64)
786.5
(343.0 to 1930.0)
547.0
(282.0 to 1005.0)
724.5
(368.0 to 1338.0)
CD4-d-TNFα, Anti-HPV-18,Month 36(N=57,55,63)
588.0
(250.0 to 1138.0)
301.0
(120.0 to 453.0)
479.0
(200.0 to 808.0)
CD8-All doubles, Anti-HPV-16,Month 36(N=58,55,64)
1.0
(1.0 to 48.0)
1.0
(1.0 to 28.0)
1.0
(1.0 to 38.5)
CD8-All doubles, Anti-HPV-18,Month 36(N=57,55,63)
4.0
(1.0 to 40.0)
2.0
(1.0 to 41.0)
1.0
(1.0 to 28.0)
CD8-d-CD40L, Anti-HPV-16,Month 36(N=58,55,64)
1.0
(1.0 to 31.0)
1.0
(1.0 to 24.0)
1.0
(1.0 to 29.0)
CD8-d-CD40L, Anti-HPV-18,Month 36(N=57,55,63)
1.0
(1.0 to 6.0)
1.0
(1.0 to 27.0)
1.0
(1.0 to 28.0)
CD8-d-IFNγ, Anti-HPV-16,Month 36(N=58,55,64)
1.0
(1.0 to 47.0)
1.0
(1.0 to 25.0)
1.0
(1.0 to 33.0)
CD8-d-IFNγ, Anti-HPV-18,Month 36(N=57,55,63)
1.0
(1.0 to 31.0)
2.0
(1.0 to 40.0)
1.0
(1.0 to 25.0)
CD8-d-IL-2, Anti-HPV-16,Month 36(N=58,55,64)
1.0
(1.0 to 1.0)
1.0
(1.0 to 1.0)
1.0
(1.0 to 1.0)
CD8-d-IL-2, Anti-HPV-18,Month 36(N=57,55,63)
1.0
(1.0 to 1.0)
1.0
(1.0 to 1.0)
1.0
(1.0 to 1.0)
CD8-d-TNFα, Anti-HPV-16,Month 36(N=58,55,64)
1.0
(1.0 to 24.0)
1.0
(1.0 to 1.0)
1.0
(1.0 to 26.0)
CD8-d-TNFα, Anti-HPV-18,Month 36(N=57,55,63)
1.0
(1.0 to 31.0)
1.0
(1.0 to 21.0)
1.0
(1.0 to 12.0)
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.
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 ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis.
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 CervarixTM 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 76 72 80
Median (Inter-Quartile Range)
Unit of Measure: B-cells/million cells
HPV-16, PRE (N=74,59,73)
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
HPV-18, PRE (N=74,59,73)
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
HPV-16, Month 7 (N=76,72,80)
1605.5
(593.5 to 3483.5)
1097.5
(449 to 2068)
687
(115.5 to 1966.5)
HPV-18, Month 7 (N=76,72,80)
593.5
(103.5 to 1771)
80
(0 to 376)
111
(0 to 391)
HPV-16, Month 12 (N=56,56,57)
396.5
(89 to 1044)
248
(61.5 to 756)
281
(47 to 974)
HPV-18, Month 12 (N=56,56,57)
252
(77 to 635)
67
(0 to 182.5)
65
(0 to 220)
HPV-16, Month 24 (N=52,50,61)
254.5
(13 to 706)
204
(16 to 578)
256
(68 to 600)
HPV-18, Month 24 (N=52,50,61)
125.5
(31 to 370.5)
45
(0 to 143)
110
(0 to 287)
HPV-16, Month 36 (N=59,54,53)
353.0
(91.0 to 927.0)
382.5
(166.0 to 614.0)
246.0
(21.0 to 565.0)
HPV-18, Month 36 (N=59,54,53)
116.0
(1.0 to 329.0)
25.0
(1.0 to 228.0)
63.0
(1.0 to 150.0)
13.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related 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. Relationship analysis was not performed.
Time Frame During the 7-day period (Days 0-6) following vaccination (across doses)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets 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 CervarixTM 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: Number
Unit of Measure: Subjects
Any Pain 329 276 295
Grade 3 Pain 42 17 18
Any Redness 191 134 157
Grade 3 Redness 0 0 2
Any Swelling 163 98 118
Grade 3 Swelling 5 0 2
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 > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time Frame During the 7-day period (Days 0-6) following vaccination (across doses)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets 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 CervarixTM 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: Number
Unit of Measure: Subjects
Any Arthralgia 68 81 67
Grade 3 Arthralgia 6 4 1
Related Arthralgia 51 55 51
Any Fatigue 192 199 193
Grade 3 Fatigue 18 15 7
Related Fatigue 151 151 143
Any Gastrointestinal 55 74 69
Grade 3 Gastrointestinal 5 6 3
Related Gastrointestinal 31 49 40
Any Headache 147 133 151
Grade 3 Headache 17 7 4
Related Headache 106 88 100
Any Myalgia 166 143 136
Grade 3 Mylagia 8 8 6
Related Myalgia 128 111 100
Any Rash 26 16 18
Grade 3 Rash 0 0 0
Related Rash 16 10 12
Any Temperature 53 59 47
Grade 3 Temperature 7 2 4
Related Temperature 35 31 30
Any Urticaria 27 13 25
Grade 3 Urticaria 4 1 0
Related Urticaria 15 11 9
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 period (Days 0-29) post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets 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 CervarixTM 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: Number
Unit of Measure: Subjects
Subjects with any AE(s) 91 96 101
Subjects with any Grade 3 AE(s) 18 8 20
Subjects with any Related AE(s) 8 14 15
16.Secondary Outcome
Title Number of Subjects With Potentially Immune Mediated Diseases (pIMDs)
Hide Description Note: Results beyond Month 24 will be updated when validated results become available.
Time Frame From Day 0 to Month 36 (throughout the study period)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets 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 CervarixTM 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: Number
Unit of Measure: Subjects
Subjects with any pIMD(s), Month 7 2 1 0
Subjects with any pIMD(s), Month 12 3 3 0
Subjects with any pIMD(s), Month 18 3 3 0
Subjects with any pIMD(s), Month 24 3 3 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 to Month 36 (throughout the study period)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets 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 CervarixTM 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: Number
Unit of Measure: Subjects
Subjects with any MSC(s), Month 7 43 49 39
Subjects with any MSC(s), Month 12 52 57 47
Subjects with any MSC(s), Month 18 65 64 54
Subjects with any MSC(s), Month 24 71 75 56
Subjects with any MSC(s), Month 36 77 79 63
18.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame From Day 0 to Month 36 (throughout the study period)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets 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 CervarixTM 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: Number
Unit of Measure: Subjects
21 11 14
19.Secondary Outcome
Title Number of Subjects Starting a Concomitant Medication
Hide Description The outcome presents the number of subjects starting any concomitant medication, as well as any antipyretic, any prophylactic antipyretic and any antibiotic.
Time Frame During the 30-day (Days 0-29) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets 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 CervarixTM 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: Number
Unit of Measure: Subjects
Any concomitant medication 127 126 129
Any antipyretic 76 86 81
Any antibiotic 23 27 33
Prophylactic antipyretic 5 2 2
Prophylactic antibiotic 0 0 0
20.Secondary Outcome
Title Number of Subjects Starting a Concomitant Medication
Hide Description The outcome presents the number of subjects starting any concomitant medication, as well as any antipyretic, any prophylactic antipyretic and any antibiotic.
Time Frame From Day 0 to Month 36 (throughout the study period)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets 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 CervarixTM 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 359 358 354
Measure Type: Number
Unit of Measure: Subjects
Any antipyretic, M7 [N=359,358,354] 68 74 71
Any concomitant medication, M7 [N=359,358,354] 127 127 129
Any antibiotic, M7 [N=359,358,354] 23 27 32
Any concomitant medication, M12 [N=356,348,350] 158 138 153
Any antipyretic, M12 [N=356,348,350] 90 80 81
Any antibiotic, M12 [N=356,348,350] 37 33 43
Any concomitant medication, M18 [N=356,347,349] 158 138 153
Any antipyretic, M18 [N=356,347,349] 90 80 81
Any antibiotic, M18 [N=356,347,349] 37 33 43
Prophylactic antipyretic, M12 [N=356,348,350] 5 2 2
Prophylactic antipyretic, M18 [N=356,347,349] 5 2 2
Any concomitant medication, M24 [N=355,344,349] 163 146 157
Any antipyretic, M24 [N=355,344,349] 94 82 80
Prophylactic antipyretic, M24 [N=356,347,349] 5 2 2
Any antibiotic, M24 [N=355,344,349] 43 38 46
Any concomitant medication, M36 [N=351,339,346] 166 147 158
Any antipyretic, M36 [N=351,339,346] 105 97 94
Prophylactic antipyretic, M36 [N=351,339,346] 5 2 2
Any antibiotic, M36 [N=351,339,346] 48 40 49
Prophylactic antibiotic, M36 [N=351,339,346] 0 0 0
21.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 Throughout the study period (From Day 0 up to Month 36)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets 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 CervarixTM 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: Number
Unit of Measure: Subjects
357 352 354
22.Secondary Outcome
Title Number of Subjects With Pregnancies
Hide Description Note: No pregnancies were reported up to the Month 36 time point.
Time Frame Throughout the study period (From Day 0 up to Month 36)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort 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 CervarixTM 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: Number
Unit of Measure: Subjects
Subjects with any pregnancy, M12 0 0 0
Subjects with any pregnancy, M18 0 0 0
Subjects with any pregnancy, M24 0 0 0
Subjects with any pregnancy, M36 0 0 0
Time Frame Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs throughout the study period (up to Month 36).
Adverse Event Reporting Description For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the 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 CervarixTM 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   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cervarix 2 Dose Group Gardasil 2 Dose Group Gardasil 3 Dose Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   21/359 (5.85%)   11/358 (3.07%)   14/358 (3.91%) 
Blood and lymphatic system disorders       
Lymphadenitis  1  0/359 (0.00%)  0/358 (0.00%)  1/358 (0.28%) 
Ear and labyrinth disorders       
Vertigo positional  1  0/359 (0.00%)  0/358 (0.00%)  1/358 (0.28%) 
Gastrointestinal disorders       
Abdominal pain  1  0/359 (0.00%)  0/358 (0.00%)  1/358 (0.28%) 
Abdominal pain lower  1  0/359 (0.00%)  1/358 (0.28%)  0/358 (0.00%) 
Colitis ulcerative  1  1/359 (0.28%)  0/358 (0.00%)  0/358 (0.00%) 
Mouth cyst  1  0/359 (0.00%)  1/358 (0.28%)  0/358 (0.00%) 
Immune system disorders       
Anaphylactic reaction  1  1/359 (0.28%)  0/358 (0.00%)  0/358 (0.00%) 
Anaphylactic shock  1  0/359 (0.00%)  0/358 (0.00%)  1/358 (0.28%) 
Infections and infestations       
Gastroenteritis  1  3/359 (0.84%)  0/358 (0.00%)  0/358 (0.00%) 
Upper respiratory tract infection  1  2/359 (0.56%)  0/358 (0.00%)  1/358 (0.28%) 
Appendicitis  1  1/359 (0.28%)  1/358 (0.28%)  0/358 (0.00%) 
Pneumonia  1  1/359 (0.28%)  0/358 (0.00%)  1/358 (0.28%) 
Epstein-Barr virus infection  1  1/359 (0.28%)  0/358 (0.00%)  0/358 (0.00%) 
Gastroenteritis rotavirus  1  1/359 (0.28%)  0/358 (0.00%)  0/358 (0.00%) 
Gastroenteritis viral  1  0/359 (0.00%)  1/358 (0.28%)  0/358 (0.00%) 
Influenza  1  0/359 (0.00%)  0/358 (0.00%)  1/358 (0.28%) 
Lung abscess  1  0/359 (0.00%)  1/358 (0.28%)  0/358 (0.00%) 
Peritonitis  1  0/359 (0.00%)  1/358 (0.28%)  0/358 (0.00%) 
Post procedural infection  1  1/359 (0.28%)  0/358 (0.00%)  0/358 (0.00%) 
Tonsillitis  1  1/359 (0.28%)  0/358 (0.00%)  0/358 (0.00%) 
Viral infection  1  0/359 (0.00%)  1/358 (0.28%)  0/358 (0.00%) 
Vulval ulceration  1  0/359 (0.00%)  0/358 (0.00%)  1/358 (0.28%) 
Injury, poisoning and procedural complications       
Foot fracture  1  2/359 (0.56%)  0/358 (0.00%)  0/358 (0.00%) 
Ankle fracture  1  0/359 (0.00%)  0/358 (0.00%)  1/358 (0.28%) 
Contusion  1  1/359 (0.28%)  0/358 (0.00%)  0/358 (0.00%) 
Forearm fracture  1  1/359 (0.28%)  0/358 (0.00%)  0/358 (0.00%) 
Foreign body  1  1/359 (0.28%)  0/358 (0.00%)  0/358 (0.00%) 
Joint dislocation  1  0/359 (0.00%)  1/358 (0.28%)  0/358 (0.00%) 
Overdose  1  0/359 (0.00%)  0/358 (0.00%)  1/358 (0.28%) 
Tendon injury  1  0/359 (0.00%)  0/358 (0.00%)  1/358 (0.28%) 
Musculoskeletal and connective tissue disorders       
Juvenile idiopathic arthritis  1  1/359 (0.28%)  0/358 (0.00%)  0/358 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Teratoma  1  0/359 (0.00%)  1/358 (0.28%)  0/358 (0.00%) 
Nervous system disorders       
Epilepsy  1  0/359 (0.00%)  1/358 (0.28%)  0/358 (0.00%) 
Presyncope  1  0/359 (0.00%)  0/358 (0.00%)  1/358 (0.28%) 
Seizure  1  0/359 (0.00%)  1/358 (0.28%)  0/358 (0.00%) 
Syncope  1  1/359 (0.28%)  0/358 (0.00%)  0/358 (0.00%) 
Tension headache  1  0/359 (0.00%)  0/358 (0.00%)  1/358 (0.28%) 
Pregnancy, puerperium and perinatal conditions       
Abortion spontaneous incomplete  1  0/359 (0.00%)  0/358 (0.00%)  1/358 (0.28%) 
Psychiatric disorders       
Completed suicide  1  0/359 (0.00%)  0/358 (0.00%)  1/358 (0.28%) 
Depression  1  0/359 (0.00%)  0/358 (0.00%)  1/358 (0.28%) 
Reproductive system and breast disorders       
Menorrhagia  1  0/359 (0.00%)  0/358 (0.00%)  1/358 (0.28%) 
Respiratory, thoracic and mediastinal disorders       
Asthma  1  2/359 (0.56%)  1/358 (0.28%)  0/358 (0.00%) 
Skin and subcutaneous tissue disorders       
Eczema  1  0/359 (0.00%)  1/358 (0.28%)  0/358 (0.00%) 
Erythema nodosum  1  1/359 (0.28%)  0/358 (0.00%)  0/358 (0.00%) 
Vascular disorders       
Orthostatic hypotension  1  1/359 (0.28%)  0/358 (0.00%)  0/358 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Show Other (Not Including Serious) Adverse Events 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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   329/359 (91.64%)   276/358 (77.09%)   295/358 (82.40%) 
General disorders       
Pain  1  329/359 (91.64%)  276/358 (77.09%)  295/358 (82.40%) 
Redness  1  191/359 (53.20%)  134/358 (37.43%)  157/358 (43.85%) 
Swelling  1  163/359 (45.40%)  98/358 (27.37%)  118/358 (32.96%) 
Arthralgia  1  68/359 (18.94%)  81/358 (22.63%)  67/358 (18.72%) 
Fatigue  1  192/359 (53.48%)  199/358 (55.59%)  193/358 (53.91%) 
Gastrointesinal  1  55/359 (15.32%)  74/358 (20.67%)  69/358 (19.27%) 
Headache  1  147/359 (40.95%)  133/358 (37.15%)  151/358 (42.18%) 
Myalgia  1  166/359 (46.24%)  143/358 (39.94%)  136/358 (37.99%) 
Rash  1  26/359 (7.24%)  16/358 (4.47%)  18/358 (5.03%) 
Temperature  1  53/359 (14.76%)  59/358 (16.48%)  47/358 (13.13%) 
Urticaria  1  27/359 (7.52%)  13/358 (3.63%)  25/358 (6.98%) 
Infections and infestations       
Upper respiratory tract infection * 1  27/359 (7.52%)  29/358 (8.10%)  31/358 (8.66%) 
Nasopharyngitis * 1  8/359 (2.23%)  11/358 (3.07%)  20/358 (5.59%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
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
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01462357     History of Changes
Other Study ID Numbers: 115411
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: March 31, 2017