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Trial record 48 of 91 for:    cervarix

Evaluation of Immunogenicity and Safety of Two 2-dose Human Papillomavirus (HPV) Vaccine Schedules in 9-14 Year Old Girls

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: NCT01381575
Recruitment Status : Completed
First Posted : June 27, 2011
Results First Posted : December 5, 2013
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Infections, Papillomavirus
Intervention Biological: GSK Biologicals' HPV vaccine 580299
Enrollment 1447
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cervarix 1 Group Cervarix 2 Group Cervarix 3 Group
Hide Arm/Group Description Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm. Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm. Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Period Title: Overall Study
Started 550 482 415
Completed 548 472 408
Not Completed 2 10 7
Reason Not Completed
Other             2             10             0
Adverse Event             0             0             1
Lost to Follow-up             0             0             1
Protocol Violation             0             0             1
Withdrawal by Subject             0             0             4
Arm/Group Title Cervarix 1 Group Cervarix 2 Group Cervarix 3 Group Total
Hide Arm/Group Description Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm. Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm. Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm. Total of all reporting groups
Overall Number of Baseline Participants 550 482 415 1447
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 550 participants 482 participants 415 participants 1447 participants
11.6  (1.59) 19.6  (3.05) 11.4  (1.55) 13.83  (4.22)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 550 participants 482 participants 415 participants 1447 participants
Female
550
 100.0%
482
 100.0%
415
 100.0%
1447
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Subjects Seroconverted for Anti- Human Papilloma Virus 16 (Anti-HPV-16) and Anti-Human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Hide Description Seroconversion was defined as the appearance of antibodies (anti-HPV-16 titres ≥ 8 ELISA units per millilitre (EL.U/mL) and anti-HPV-18 titres ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination. A seronegative subject was a subject with anti-HPV-16/18 antibody concentration < 8/7 EL.U/mL. A seropositive subject was a subject with anti-HPV-16/18 antibody concentration ≥ 8/7 EL.U/mL.
Time Frame 1 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 with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title Cervarix 1 Group Cervarix 2 Group
Hide Arm/Group Description:
Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 493 382
Measure Type: Number
Unit of Measure: Subjects
Anti-HPV-16 [N= 488, 352] 488 352
Anti-HPV-18 [N=493, 382] 493 382
2.Primary Outcome
Title Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA).
Hide Description Antibody concentrations were and expressed as geometric mean concentrations (GMCs) and expressed as enzyme-linked immunosorbent assay [ELISA] units per millilitre (EL.U/mL), with the cut-off values of 8 EL.U/mL for HPV-016 and 7 EL.U/mL for HPV-018.
Time Frame 1 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 with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title Cervarix 1 Group Cervarix 2 Group
Hide Arm/Group Description:
Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 540 432
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-HPV-16 [N= 540, 432]
9413.3
(8853.4 to 10008.7)
9970.7
(9128.3 to 10890.9)
Anti-HPV-18 [N=536, 432]
5968.8
(5580.3 to 6384.3)
4880.3
(4486.4 to 5308.8)
3.Secondary Outcome
Title Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies
Hide Description Seroconversion was defined as the appearance of antibodies (anti-HPV-16 titres ≥ 8 EL.U/mL and anti-HPV-18 titres ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination. A seronegative subject was a subject with anti-HPV-16/18 antibody concentration < 8/7 EL.U/mL. A seropositive subject was a subject with anti-HPV-16/18 antibody concentration ≥ 8/7 EL.U/mL.
Time Frame At Months 0, 13, 18, 24 and 36
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 with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title Cervarix 3 Group
Hide Arm/Group Description:
Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 369
Measure Type: Number
Unit of Measure: Subjects
Anti-HPV-16, Day 0 (N=355) 0
Anti-HPV-16, Month 13 (N=355) 355
Anti-HPV-18, Day 0 (N=369) 0
Anti-HPV-18, Month 13 (N=369) 369
Anti-HPV-16, Month 18 (N=353) 353
Anti-HPV-18, Month 18 (N=366) 366
Anti-HPV-16, Month 24 (N=346) 346
Anti-HPV-18, Month 24 (N=360) 360
Anti-HPV-16, Month 36 (N=339) 339
Anti-HPV-18, Month 36 (N=355) 355
4.Secondary Outcome
Title Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA).
Hide Description Antibody concentrations were expressed as geometric mean titers (GMTs) and given in EL.U/mL, with the cut-off values of ≥ 8 ELISA units per millilitre (EL.U/mL) for HPV-016 and ≥ 7 EL.U/mL for HPV-018
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 According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title Cervarix 1 Group Cervarix 2 Group
Hide Arm/Group Description:
Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 540 432
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-HPV-16, Day 0 [N=540,432]
4.7
(4.5 to 5.0)
6.1
(5.6 to 6.8)
Anti-HPV-16, Month 7 [N=540,432]
9413.3
(8853.4 to 10008.7)
9970.7
(9128.3 to 10890.9)
Anti-HPV-16, Month 12 [N=532,425]
2680.3
(2510.7 to 2861.3)
3377.7
(3077.0 to 3707.8)
Anti-HPV-18, Day 0 [N=536,432]
3.9
(3.8 to 4.1)
4.4
(4.1 to 4.8)
Anti-HPV-18, Month 7 [N=536,432]
5968.8
(5580.3 to 6384.3)
4880.3
(4486.4 to 5308.8)
Anti-HPV-18, Month 12 [N=528,425]
1559.9
(1446.8 to 1681.8)
1500.7
(1361.3 to 1654.5)
Anti-HPV-16, Month 18 [N=522,413]
1742.8
(1627.9 to 1865.8)
1986.8
(1803.4 to 2188.8)
Anti-HPV-18, Month 18 [N=518,413]
891
(822.9 to 964.8)
854.4
(770.9 to 947)
Anti-HPV-16, Month 24 [N=517,405]
1499.1
(1402 to 1602.9)
1635.3
(1485.2 to 1800.5)
Anti-HPV-18, Month 24 [N=513,405]
734.3
(679.4 to 793.5)
679.5
(610.8 to 755.9)
Anti-HPV-16, Month 36 [N=504,399]
1218.4
(1135.4 to 1307.5)
1362.2
(1239.7 to 1496.7)
Anti-HPV-18, Month 36 [N=500,399]
578.8
(533.4 to 628.0)
557.4
(502.3 to 618.5)
5.Secondary Outcome
Title Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies
Hide Description Seroconversion was defined as the appearance of antibodies (anti-HPV-16 titres ≥ 8 EL.U/mL and anti-HPV-18 titres ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination. A seronegative subject was a subject with anti-HPV-16/18 antibody concentration < 8/7 EL.U/mL. A seropositive subject was a subject with anti-HPV-16/18 antibody concentration ≥ 8/7 EL.U/mL.
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 According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title Cervarix 1 Group Cervarix 2 Group
Hide Arm/Group Description:
Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 493 382
Measure Type: Number
Unit of Measure: Subjects
Anti-HPV-16, Day 0 [N= 488, 352] 0 0
Anti-HPV-16, Month 7 [N= 488, 352] 488 352
Anti-HPV-16, Month 12 [N= 480, 347] 480 347
Anti-HPV-18, Day 0 [N= 493, 382] 0 0
Anti-HPV-18, Month 7 [N= 493, 382] 493 382
Anti-HPV-18, Month 12 [N= 485, 376] 485 376
Anti-HPV-16, Month 18 [N=473,338] 473 338
Anti-HPV-18, Month 18 [N= 477,366] 476 366
Anti-HPV-16, Month 24 [N=468,334] 468 334
Anti-HPV-18, Month 24 [N=472,362] 471 362
Anti-HPV-16, Month 36 [N=455,330] 455 330
Anti-HPV-18, Month 36 [N=462,356] 461 355
6.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 any solicited local symptom regardless of their intensity grade. Grade 3 pain = Significant pain at rest, that prevented normal every day activity. Grade 3 redness/swelling = Redness/swelling above 50 millimeters (mm).
Time Frame During the 7-day period (Days 0-6) following any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects, i.e. subjects who received at least one dose of vaccine in this study, for whom data were available and symptom sheet completed.
Arm/Group Title Cervarix1 Group Cervarix 2 Group Cervarix 3 Group
Hide Arm/Group Description:
Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 550 480 413
Measure Type: Number
Unit of Measure: Subjects
Any Pain 499 461 381
Grade 3 Pain 50 53 48
Any Redness 247 212 197
Grade 3 Redness 4 10 3
Any Swelling 225 204 171
Grade 3 Swelling 5 6 6
7.Secondary Outcome
Title Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA).
Hide Description Antibody concentrations were expressed as geometric mean titers (GMTs) and given in EL.U/mL, with the cut-off values of ≥ 8 ELISA units per millilitre (EL.U/mL) for HPV-16 and ≥ 7 EL.U/mL for HPV-18.
Time Frame At Months 0, 13, 18, 24 and 36
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 with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title Cervarix 3 Group
Hide Arm/Group Description:
Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 394
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-HPV-16, Month 0 [N=394]
4.6
(4.4 to 4.9)
Anti-HPV-16, Month 13 [N=394]
11290.0
(10520.9 to 12115.4)
Anti-HPV-18, Month 0 [N=390]
3.8
(3.7 to 3.9)
Anti-HPV-18, Month 13 [N=390]
6601.0
(6116.3 to 7124.1)
Anti-HPV-16, Month 18 [N=391]
3248
(2991.4 to 3526.6)
Anti-HPV-18, Month 18 [N=387]
1858.1
(1703 to 2027.2)
Anti-HPV-16, Month 24 [N=385]
2170.4
(1996.3 to 2359.7)
Anti-HPV-18, Month 24 [N=381]
1175.7
(1071.7 to 1289.7)
Anti-HPV-16, Month 36 [N=378]
1544.7
(1424.9 to 1674.6)
Anti-HPV-18, Month 36 [N=375]
802.1
(732.6 to 878.3)
8.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, fever and urticaria. Any = Occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Any Fever = Axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C). Grade 3 symptom = Symptom that prevented normal activity. Grade 3 fever = Fever > 39.0 °C. Related = General symptom assessed by the investigator as causally related to the vaccination.
Time Frame During the 7-day period (Days 0-6) following any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects, i.e. subjects who received at least one dose of vaccine in this study, for whom data were available and symptom sheet completed.
Arm/Group Title Cervarix 1 Group Cervarix 2 Group Cervarix 3 Group
Hide Arm/Group Description:
Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 550 480 413
Measure Type: Number
Unit of Measure: Subjects
Any Artharlgia 111 107 93
Grade 3 Arthralgia 9 6 6
Related Arthralgia 105 102 83
Any Fatigue 247 310 215
Grade 3 Fatigue 14 25 21
Related Fatigue 221 294 185
Any Gastrointestinal symptoms 98 134 77
Grade 3 Gastrointestinal symptoms 7 11 7
Related Gastrointestinal symptoms 77 106 62
Any Headache 204 246 185
Grade 3 Headache 19 26 16
Related Headache 176 219 148
Any Myalgia 278 295 221
Grade 3 Myalgia 24 25 15
Related Myalgia 265 285 201
Any Rash 33 25 29
Grade 3 Rash 2 0 0
Related Rash 26 18 28
Any Fever 41 48 42
Grade 3 Fever 2 3 1
Related Fever 29 39 32
Any Urticaria 15 15 13
Grade 3 Urticaria 1 1 0
Related Urticaria 13 11 12
9.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 = Any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 = Unsolicited AE preventing normal activity. Related = Unsolicited AE assessed by the investigator as causally related to the study vaccination.
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 vaccinated subjects, i.e. subjects who received at least one dose of vaccine in this study, for whom data were available.
Arm/Group Title Cervarix 1 Group Cervarix 2 Group Cervarix 3 Group
Hide Arm/Group Description:
Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 550 482 415
Measure Type: Number
Unit of Measure: Subjects
Any unsolicited AEs 99 165 74
Grade 3 unsolicited AEs 2 17 6
Related unsolicited AEs 11 24 13
10.Secondary Outcome
Title Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)
Hide Description

pIMDs are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.

Note: Results up to Months 24 and 36 will be updated once they become available.

Time Frame From Day 0 up to Months 7, 13, 18, 24 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects, i.e. subjects who received at least one dose of vaccine in this study, for whom data were available.
Arm/Group Title Cervarix 1 Group Cervarix 2 Group Cervarix 3 Group
Hide Arm/Group Description:
Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 550 482 415
Measure Type: Number
Unit of Measure: Subjects
Any pIMDs, up to Month 7 2 1 NA [1] 
Any pIMDs, up to Month 13 2 2 2
Any pIMDs, up to Month 18 2 2 2
[1]
pIMDs were not assessed at Month 7 for this group.
11.Secondary Outcome
Title Number of Subjects With Medically Significant Conditions (MSCs)
Hide Description MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Time Frame From Day 0 to Months 7, 13, 24 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects, i.e. subjects who received at least one dose of vaccine in this study, for whom data were available.
Arm/Group Title Cervarix 1 Group Cervarix 2 Group Cervarix 3 Group
Hide Arm/Group Description:
Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 550 482 415
Measure Type: Number
Unit of Measure: Subjects
Any MSCs, up to Month 7 75 96 NA [1] 
Any MSCs, up to Month 13 99 124 61
Any MSCs, up to Month 18 112 138 72
Any MSCs, up to Month 24 113 140 72
Any MSCs, up to Month 36 134 153 87
[1]
Results for this group were only available after the last vaccination at Month 12.
12.Secondary Outcome
Title Number of Subjects With Pregnancies Ongoing and Their Outcome
Hide Description Specific pregnancy outcomes were elective termination with apparent congenital anomaly and ectopic pregnancy.
Time Frame From Day 0 up to Months 7, 13, 24 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on pregnant subjects from the Total Vaccinated cohort, which included all vaccinated subjects, i.e. subjects who received at least one dose of vaccine in this study, for whom data were available.
Arm/Group Title Cervarix 1 Group Cervarix 2 Group Cervarix 3 Group
Hide Arm/Group Description:
Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 1 34 1
Measure Type: Number
Unit of Measure: Subjects
Pregnancy ongoing, Month 7 0 7 NA [1] 
Elective termination no congenit. anomaly, Month 7 0 1 NA [1] 
Ectopic pregnancy, Month 7 0 1 NA [1] 
Ectopic pregnancy, Month 13 0 1 0
Elective termination no congenit.anomaly, Month 13 0 1 0
Live infant no congenital anomaly, Month 13 0 17 1
Pregnancy ongoing, Month 13 0 4 0
Stillbirth no congenital anomaly, Month 13 0 1 0
Ectopic pregnancy, Month 18 0 1 0
Elective termination no congenit.anomaly, Month 18 0 1 0
Live infant no congenit. anomaly, Month 18 0 20 1
Pregnancy ongoing, Month 18 0 1 0
Stillbirth no congenit. anomaly, Month 18 0 1 0
Ectopic pregnancy, Month 24 0 1 0
Elective termination no congenit.anomaly, Month 24 0 2 0
Live infant no congenit. anomaly, Month 24 0 23 1
Pregnancy ongoing, Month 24 1 7 0
Stillbirth no congenit. anomaly, Month 24 0 1 0
Ectopic pregnancy, Month 36 0 1 0
Elective termination no congenit.anomaly, Month 36 0 2 0
Live infant no congenit. anomaly, Month 36 1 30 1
Stillbirth no congenit. anomaly, Month 36 0 1 0
[1]
For this group, pregnancies and their outcomes were only assessed after the last vaccine dose at Month 12.
13.Secondary Outcome
Title Number of Subjects With Any Serious Adverse Events (SAEs)
Hide Description

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.

Time Frame From Day 0 up to Months 7, 13, 18, 24 and 36
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Hide Analysis Population Description
The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects, i.e. subjects who received at least one dose of vaccine in this study, for whom data were available.
Arm/Group Title Cervarix 1 Group Cervarix 2 Group Cervarix 3 Group
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Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 550 482 415
Measure Type: Number
Unit of Measure: Subjects
Any SAEs, up to Month 7 6 11 NA [1] 
Related SAEs, up to Month 7 0 0 NA [2] 
Any SAEs, up to Month 13 12 15 11
Related SAEs, up to Month 13 0 0 0
Any SAEs, up to Month 18 14 21 17
Related SAEs, up to Month 18 0 0 0
Any SAEs, up to Month 24 14 21 18
Related SAEs, up to Month 24 0 0 1
Any SAEs, up to Month 36 20 28 24
Related SAEs, up to Month 36 0 0 1
[1]
SAEs for this group were only assessed after the last vaccination at Month 12.
[2]
SAEs for this group were only assessed after the last vaccination at Month 12
14.Secondary Outcome
Title Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI)
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The CMI response was the measure of the cytokines production [i.e.interleukin-2 (IL-2), interferon gamma (IFN-γ), tumor necrosis factor alpha (TNF-α) and cluster of differentiation 40 Ligand (CD40L)] by HPV-antigen specific T lymphocytes and measured by intracellular cytokine staining (ICS) assay for HPV-16 The frequency was presented as number of of cytokine-positive cluster of differentiation (CD)4 i.e.CD4+/CD8+ cells per million CD4+/CD8+ cells.

All doubles= T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody titre lower than the cut-off value of 8 EL.U/mL) prior to vaccination. S+ = seropositive subjects (antibody titre ≥ 8 El.U/mL) prior to vaccination.

Time Frame At Day 0 and Months 7, 12, 24 and 36
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Hide Analysis Population Description
The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title Cervarix 1 Group Cervarix 2 Group
Hide Arm/Group Description:
Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 91 77
Median (Inter-Quartile Range)
Unit of Measure: cells/million T cells
Anti-HPV-16, CD4 all doubles, S-, Day 0 [N=86,72]
88.0
(56.0 to 152.0)
123.0
(67.0 to 185.5)
Anti-HPV-16, CD4 all doubles, S-, Month 7[N=72,54]
3935.5
(1838.5 to 6975.5)
3691.0
(1889.0 to 5214.0)
Anti-HPV-16, CD4 all doubles, S+, Day 0 [N=10,17]
66.0
(57.0 to 189.0)
87.0
(60.0 to 193.0)
Anti-HPV-16, CD4 all doubles, S+, Month 7[N=10,16]
4982.5
(1584.0 to 6610.0)
1672.0
(1233.5 to 2600.0)
Anti-HPV-16, CD4-d-CD40L, S-, Day 0 [N=86,72]
67.5
(42.0 to 130.0)
97.0
(52.5 to 131.0)
Anti-HPV-16, CD4-d-CD40L, S-, Month 7 [N=72,54]
3529.5
(1673.0 to 6384.0)
3392.0
(1692.0 to 4760.0)
Anti-HPV-16, CD4-d-CD40L, S+, Day 0 [N=10,17]
52.0
(38.0 to 161.0)
61.0
(40.0 to 164.0)
Anti-HPV-16, CD4-d-CD40L, S+, Month 7 [N=10,16]
4852.0
(1490.0 to 6368.0)
1581.5
(1087.0 to 2193.5)
Anti-HPV-16, CD4-d-IFNγ, S-, Day 0 [N=86,72]
43.0
(19.0 to 67.0)
43.5
(20.0 to 73.0)
Anti-HPV-16, CD4-d-IFNγ, S-, Month 7 [N=74,54]
823.5
(475.0 to 1488.0)
684.0
(474.0 to 1185.0)
Anti-HPV-16, CD4-d-IFNγ, S+, Day 0 [N=10,17]
37.0
(22.0 to 51.0)
49.0
(30.0 to 58.0)
Anti-HPV-16, CD4-d-IFNγ, S+, Month 7 [N=10,16]
778.0
(425.0 to 2351.0)
408.5
(270.0 to 863.0)
Anti-HPV-16, CD4-d-IL-2, S-, Day 0 [N=86,72]
58.5
(33.0 to 98.0)
86.5
(43.5 to 135.5)
Anti-HPV-16, CD4-d-IL-2, S-, Month 7 [N=72,54]
3794.0
(1709.0 to 6736.5)
3347.0
(1788.0 to 5010.0)
Anti-HPV-16, CD4-d-IL-2, S+, Day 0 [N=10,17]
53.0
(24.0 to 147.0)
72.0
(39.0 to 151.0)
Anti-HPV-16, CD4-d-IL-2, S+, Month 7 [N=10,16]
4807.5
(1450.0 to 6164.0)
1549.0
(1145.0 to 2436.5)
Anti-HPV-16, CD4-d-TNFα, S-, Day 0 [N=86,72]]
58.0
(35.0 to 93.0)
68.0
(31.0 to 118.5)
Anti-HPV-16, CD4-d-TNFα, S-, Month 7 [N=72,54]
2431.5
(1238.0 to 4743.5)
2713.5
(1224.0 to 3675.0)
Anti-HPV-16, CD4-d-TNFα, S+, Day 0 [N=10,17]
47.0
(35.0 to 113.0)
59.0
(49.0 to 84.0)
Anti-HPV-16, CD4-d-TNFα, S+, Month 7 [N=10,16]
2128.5
(1353.0 to 3523.0)
1185.0
(838.0 to 1913.5)
Anti-HPV-16, CD8-all doubles, S-, Day 0 [N=86,72]
11.0
(11.0 to 41.0)
11.0
(11.0 to 44.0)
Anti-HPV-16, CD8-all doubles, S-, Month 7[N=72,54]
11.0
(11.0 to 41.0)
11.0
(11.0 to 37.0)
Anti-HPV-16, CD8-all doubles, S+, Day 0 [N=10,17]
11.0
(11.0 to 58.0)
36.0
(26.0 to 43.0)
Anti-HPV-16, CD8-all doubles, S+, Month 7[N=10,16]
11.0
(11.0 to 11.0)
33.5
(11.0 to 43.5)
Anti-HPV-16, CD8-d-CD40L, S-, Day 0 [N=86,72]
7.0
(7.0 to 7.0)
7.0
(7.0 to 7.0)
Anti-HPV-16, CD8-d-CD40L, S-, Month 7 [N=72,54]
7.0
(7.0 to 7.0)
7.0
(7.0 to 7.0)
Anti-HPV-16, CD8-d-CD40L, S+, Day 0 [N=10,17]
7.0
(7.0 to 7.0)
7.0
(7.0 to 7.0)
Anti-HPV-16, CD8-d-CD40L, S+, Month 7 [N=10,16]
7.0
(7.0 to 7.0)
7.0
(7.0 to 22.0)
Anti-HPV-16, CD8-d-IFNγ, S-, Day 0 [N=86,72]
7.0
(7.0 to 32.0)
7.0
(7.0 to 37.0)
Anti-HPV-16, CD8-d-IFNγ, S-, Month 7 [N=72,54]
7.0
(7.0 to 34.5)
7.0
(7.0 to 27.0)
Anti-HPV-16, CD8-d-IFNγ, S+, Day 0 [N=10,17]
7.0
(7.0 to 54.0)
32.0
(22.0 to 39.0)
Anti-HPV-16, CD8-d-IFNγ, S+, Month 7 [N=10,16]
7.0
(7.0 to 7.0)
22.0
(7.0 to 35.0)
Anti-HPV-16, CD8-d-IL-2, S-, Day 0 [N=86,72]
7.0
(7.0 to 7.0)
7.0
(7.0 to 7.0)
Anti-HPV-16, CD8-d-IL-2, S-, Month 7 [N=72,54]
7.0
(7.0 to 7.0)
7.0
(7.0 to 7.0)
Anti-HPV-16, CD8-d-IL-2, S+, Day 0 [N=10,17]
7.0
(7.0 to 7.0)
7.0
(7.0 to 7.0)
Anti-HPV-16, CD8-d-IL-2, S+, Month 7 [N=10,16]
7.0
(7.0 to 7.0)
7.0
(7.0 to 38.0)
Anti-HPV-16, CD8-d-TNFα, S-, Day 0 [N=86,72]
7.0
(7.0 to 29.0)
7.0
(7.0 to 28.5)
Anti-HPV-16, CD8-d-TNFα, S-, Month 7 [N=72,54]
7.0
(7.0 to 33.0)
7.0
(7.0 to 32.0)
Anti-HPV-16, CD8-d-TNFα, S+, Day 0 [N=10,17]
7.0
(7.0 to 54.0)
22.0
(7.0 to 32.0)
Anti-HPV-16, CD8-d-TNFα, S+, Month 7 [N=10,16]
7.0
(7.0 to 7.0)
25.0
(7.0 to 38.0)
Anti-HPV-16, CD4 all doubles, S-, Mth 12 [N=87,74]
2510.0
(1374.0 to 5495.0)
2360.5
(1234.0 to 3463.0)
Anti-HPV-16, CD4 all doubles, S+, Mth 12 [N=11,16]
3317.0
(1003.0 to 3428.0)
1344.5
(874.0 to 3222.5)
Anti-HPV-16, CD4-d-CD40L, S-, Mth 12 [N=87,74]
2465.0
(1310.0 to 5324.0)
2316.5
(1218.0 to 3440.0)
Anti-HPV-16, CD4-d-CD40L, S+, Mth 12 [N=11,16]
3287.0
(975.0 to 3378.0)
1334.5
(850.0 to 3118.5)
Anti-HPV-16, CD4-d-IFNγ, S-, Mth 12 [N=87,74]
526.0
(181.0 to 999.0)
369.0
(207.0 to 718.0)
Anti-HPV-16, CD4-d-IFNγ, S+, Mth 12 [N=11,16]
527.0
(162.0 to 827.0)
365.5
(199.0 to 477.5)
Anti-HPV-16, CD4-d-IL-2, S-, Mth 12 [N=87,74]
2421.0
(1275.0 to 5181.0)
2273.0
(1164.0 to 3242.0)
Anti-HPV-16, CD4-d-IL-2, S+, Mth 12 [N=11,16]
3068.0
(877.0 to 3424.0)
1236.5
(814.5 to 3166.5)
Anti-HPV-16, CD4-d-TNFα, S-, Mth 12 [N=87,74]
1874.0
(812.0 to 4009.0)
1743.0
(933.0 to 2521.0)
Anti-HPV-16, CD4-d-TNFα, S+, Mth 12 [N=11,16]
2200.0
(875.0 to 2891.0)
1126.5
(685.0 to 2382.0)
Anti-HPV-16, CD8 all doubles, S-, Mth 12 [N=87,74]
11.0
(11.0 to 41.0)
35.0
(11.0 to 50.0)
Anti-HPV-16, CD8 all doubles, S+, Mth 12 [N=11,16]
52.0
(11.0 to 105.0)
29.0
(11.0 to 57.0)
Anti-HPV-16, CD8-d-CD40L, S-, Mth 12 [N=87,74]
7.0
(7.0 to 32.0)
7.0
(7.0 to 37.0)
Anti-HPV-16, CD8-d-CD40L, S+, Mth 12 [N=11,16]
45.0
(7.0 to 53.0)
15.0
(7.0 to 36.5)
Anti-HPV-16, CD8-d-IFNγ, S-, Mth 12 [N=87,74]
7.0
(7.0 to 37.0)
7.0
(7.0 to 46.0)
Anti-HPV-16, CD8-d-IFNγ, S+, Mth 12 [N=11,16]
46.0
(7.0 to 73.0)
15.0
(7.0 to 38.0)
Anti-HPV-16, CD8-d-IL-2, S-, Mth 12 [N=87,74]
7.0
(7.0 to 7.0)
7.0
(7.0 to 7.0)
Anti-HPV-16, CD8-d-IL-2, S+, Mth 12 [N=11,16]
7.0
(7.0 to 47.0)
7.0
(7.0 to 15.0)
Anti-HPV-16, CD8-d-TNFα, S-, Mth 12 [N=87,74]
7.0
(7.0 to 39.0)
7.0
(7.0 to 36.0)
Anti-HPV-16, CD8-d-TNFα, S+, Mth 12 [N=11,16]
8.0
(7.0 to 55.0)
15.0
(7.0 to 29.0)
Anti-HPV-16, CD4 all doubles, S-, Month24[N=80,70]
2698.0
(1217.5 to 5155.0)
2404.5
(1231.0 to 3641.0)
Anti-HPV-16, CD4 all doubles, S+, Month24[N=10,14]
2979.0
(1156.0 to 5489.0)
1368.5
(1019.0 to 2390.0)
Anti-HPV-16, CD4-d-CD40L, S-, Month 24 [N=80,70]
2443.0
(1096.0 to 4946.5)
2347.5
(1096.0 to 3323.0)
Anti-HPV-16, CD4-d-CD40L, S+, Month24 [N=10,14]
2863.5
(945.0 to 5382.0)
1217.0
(795.0 to 1720.0)
Anti-HPV-16, CD4-d-IFNγ, S-, Month 24 [N=80,70]
625.0
(277.5 to 1312.5)
451.0
(211.0 to 884.0)
Anti-HPV-16, CD4-d-IFNγ, S+, Month 24 [N=10,14]
686.0
(398.0 to 1471.0)
346.5
(222.0 to 527.0)
Anti-HPV-16, CD4-d-IL-2, S-, Month 24 [N=80,70]
2477.0
(1133.5 to 4734.0)
2292.5
(1168.0 to 3392.0)
Anti-HPV-16, CD4-d-IL-2, S+, Month 24 [N=10,14]
2858.0
(1026.0 to 5294.0)
1157.0
(846.0 to 1998.0)
Anti-HPV-16, CD4-d-TNFα, S-, Month 24 [N=80,70]
2181.5
(878.0 to 4279.5)
1973.0
(816.0 to 2758.0)
Anti-HPV-16, CD4-d-TNFα, S+, Month 24 [N=10,14]
2009.0
(1039.0 to 4190.0)
1061.5
(867.0 to 1867.0)
Anti-HPV-16, CD8-all doubles, S-, Month24[N=80,70]
11.0
(11.0 to 53.0)
11.0
(11.0 to 54.0)
Anti-HPV-16, CD8-all doubles, S+, Month24[N=10,14]
49.5
(12.0 to 63.0)
11.0
(11.0 to 31.0)
Anti-HPV-16, CD8-d-CD40L, S-, Month 24 [N=80,70]
7.0
(7.0 to 7.0)
7.0
(7.0 to 31.0)
Anti-HPV-16, CD8-d-CD40L, S+, Month 24 [N=10,14]
7.0
(7.0 to 46.0)
7.0
(7.0 to 7.0)
Anti-HPV-16, CD8-d-IFNγ, S-, Month 24 [N=80,70]
7.0
(7.0 to 37.5)
7.0
(7.0 to 42.0)
Anti-HPV-16, CD8-d-IFNγ, S+, Month 24 [N=10,14]
7.5
(7.0 to 46.0)
7.0
(7.0 to 19.0)
Anti-HPV-16, CD8-d-IL-2, S-, Month 24 [N=80,70]
7.0
(7.0 to 30.0)
7.0
(7.0 to 30.0)
Anti-HPV-16, CD8-d-IL-2, S+, Month 24 [N=10,14]
7.0
(7.0 to 48.0)
7.0
(7.0 to 7.0)
Anti-HPV-16, CD8-d-TNFα, S-, Month 24[N=80,70]
7.0
(7.0 to 34.5)
7.0
(7.0 to 24.0)
Anti-HPV-16, CD8-d-TNFα, S+, Month 24[N=10,14]
24.5
(7.0 to 45.0)
7.0
(7.0 to 7.0)
Anti-HPV-16, CD4 all doubles, S-, Month36[N=75,57]
1951
(1085.0 to 5130.0)
2073
(1012.0 to 2836.0)
Anti-HPV-16, CD4 all doubles, S+, Month36[N=7,12]
2180
(1293.0 to 3383.0)
1310
(939.0 to 2614.5)
Anti-HPV-16, CD4-d-CD40L, S-, Month 36 [N=75,57]
1935
(1048.0 to 5061.0)
2027
(978.0 to 2806.0)
Anti-HPV-16, CD4-d-CD40L, S+, Month36 [N=7,12]
2109
(1178.0 to 3343.0)
1279
(928.0 to 2496.5)
Anti-HPV-16, CD4-d-IFNγ, S-, Month 36 [N=75,57]
562
(273.0 to 1334.0)
391
(215.0 to 824.0)
Anti-HPV-16, CD4-d-IFNγ, S+, Month 36 [N=7,12]
651
(520.0 to 998.0)
564
(185.5 to 714.5)
Anti-HPV-16, CD4-d-IL-2, S-, Month 36 [N=75,57]
1881
(958.0 to 4912.0)
1922
(892.0 to 2708.0)
Anti-HPV-16, CD4-d-IL-2, S+, Month 36 [N=7,12]
2135
(1221.0 to 3291.0)
1243
(910.5 to 2382.5)
Anti-HPV-16, CD4-d-TNFα, S-, Month 36 [N=75,57]
1595
(700.0 to 3836.0)
1390
(672.0 to 2092.0)
Anti-HPV-16, CD4-d-TNFα, S+, Month 36 [N=7,12]
1138
(1031.0 to 2506.0)
1057
(732.0 to 2009.0)
Anti-HPV-16, CD8-all doubles, S-, Month36[N=75,57]
37
(11.0 to 72.0)
35
(11.0 to 59.0)
Anti-HPV-16, CD8-all doubles, S+, Month36[N=7,12]
27
(11.0 to 123.0)
11
(11.0 to 49.0)
Anti-HPV-16, CD8-d-CD40L, S-, Month 36 [N=75,57]
11
(7.0 to 52.0)
7
(7.0 to 32.0)
Anti-HPV-16, CD8-d-CD40L, S+, Month 36 [N=7,12]
7
(7.0 to 27.0)
7
(7.0 to 15.0)
Anti-HPV-16, CD8-d-IFNγ, S-, Month 36 [N=75,57]
11
(7.0 to 44.0)
25
(7.0 to 44.0)
Anti-HPV-16, CD8-d-IFNγ, S+, Month 36 [N=7,12]
7
(7.0 to 63.0)
7
(7.0 to 45.0)
Anti-HPV-16, CD8-d-IL-2, S-, Month 36 [N=75,57]
7
(7.0 to 7.0)
7
(7.0 to 7.0)
Anti-HPV-16, CD8-d-IL-2, S+, Month 36 [N=7,12]
7
(7.0 to 23.0)
7
(7.0 to 7.0)
Anti-HPV-16, CD8-d-TNFα, S-, Month 36[N=75,57]
7
(7.0 to 36.0)
7
(7.0 to 32.0)
Anti-HPV-16, CD8-d-TNFα, S+, Month 36[N=7,12]
7
(7.0 to 119.0)
7
(7.0 to 7.0)
15.Secondary Outcome
Title Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T Cell-mediated Immune Response (CMI)
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The CMI response was the measure of the cytokines production [IL-2, IFN-γ, TNF-α and CD40L] by HPV-antigen specific T lymphocytes and measured by intracellular cytokine staining (ICS) assay for HPV-18. The frequency was presented as number of cytokine-producing CD4+/CD8+ cells per million CD4+/CD8+ cells.

All doubles= T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody titer lower than the cut-off value of 7 EL.U/mL) prior to vaccination. S+ = seropositive subjects (antibody titer ≥ 7 EL.U/mL) prior to vaccination.

Time Frame At Day 0 and Months 7, 12, 24 and 36
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Hide Analysis Population Description
The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title Cervarix 1 Group Cervarix 2 Group
Hide Arm/Group Description:
Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 89 80
Median (Inter-Quartile Range)
Unit of Measure: cells/million T cells
Anti-HPV-18, CD4 all doubles, S-, Day 0 [N=83,74]
88.0
(58.0 to 129.0)
109.5
(75.0 to 175.0)
Anti-HPV-18, CD4 all doubles, S-, Month 7[N=69,58]
2629.0
(1606.0 to 4256.0)
1875.5
(1147.0 to 2565.0)
Anti-HPV-18, CD4 all doubles, S+, Day 0 [N=12,16]
112.5
(66.5 to 213.0)
128.0
(61.5 to 183.0)
Anti-HPV-18, CD4 all doubles, S+, Month 7[N=12,13]
1839.0
(828.0 to 3433.0)
1286.0
(667.0 to 2504.0)
Anti-HPV-18, CD4-d-CD40L, S-, Day 0 [N=83,74]
59.0
(35.0 to 105.0)
87.5
(56.0 to 420.0)
Anti-HPV-18, CD4-d-CD40L, S-, Month 7 [N=69,58]
2408.00
(1331.0 to 3721.0)
1709.5
(949.0 to 2324.0)
Anti-HPV-18, CD4-d-CD40L, S+, Day 0 [N=12,16]
102.0
(47.5 to 203.0)
110.5
(39.5 to 169.5)
Anti-HPV-18, CD4-d-CD40L, S+, Month 7 [N=12,13]
1719.5
(750.5 to 3203.5)
1232.0
(614.0 to 2211.0)
Anti-HPV-18, CD4-d-IFNγ, S-, Day 0 [N=83,74]
32.0
(19.0 to 55.0)
33.5
(19.0 to 70.0)
Anti-HPV-18, CD4-d-IFNγ, S-, Month 7 [N=69,58]
558.0
(220.0 to 952.0)
362.5
(192.0 to 554.0)
Anti-HPV-18, CD4-d-IFNγ, S+, Day 0 [N=12,16]
50.5
(13.0 to 69.0)
28.0
(19.0 to 51.5)
Anti-HPV-18, CD4-d-IFNγ, S+, Month 7 [N=12,13]
523.0
(188.0 to 963.5)
312.0
(191.0 to 533.0)
Anti-HPV-18, CD4-d-IL-2, S-, Day 0 [N=83,74]
58.0
(22.0 to 96.0)
73.0
(41.0 to 125.0)
Anti-HPV-18, CD4-d-IL-2, S-, Month 7[N=69,58]
2465.0
(1452.0 to 3904.0)
1760.0
(1026.0 to 2329.0)
Anti-HPV-18, CD4-d-IL-2, S+, Day 0 [N=12,16]
68.0
(34.5 to 129.0)
96.5
(46.5 to 140.5)
Anti-HPV-18, CD4-d-IL-2, S+, Month 7[N=12,13]
1704.0
(763.5 to 3223.0)
1220.0
(572.0 to 2282.0)
Anti-HPV-18, CD4-d-TNFα, S-, Day 0 [N=83,74]
53.0
(30.0 to 72.0)
73.0
(29.0 to 127.0)
Anti-HPV-18, CD4-d-TNFα, S-, Month 7 [N=69,58]
1602.0
(979.0 to 2822.0)
1384.0
(824.0 to 2030.0)
Anti-HPV-18, CD4-d-TNFα, S+, Day 0 [N=12,16]
56.0
(44.5 to 150.5)
68.0
(32.5 to 123.0)
Anti-HPV-18, CD4-d-TNFα, S+, Month 7 [N=12,13]
1362.0
(516.5 to 2634.5)
945.0
(498.0 to 2050.0)
Anti-HPV-18, CD8-all doubles, S-, Day 0 [N=83,74]
11.0
(11.0 to 36.0)
11.0
(11.0 to 33.0)
Anti-HPV-18, CD8-all doubles, S-, Month 7[N=69,58]
11.0
(11.0 to 37.0)
11.0
(11.0 to 32.0)
Anti-HPV-18, CD8-all doubles, S+, Day 0 [N=12,16]
11.0
(11.0 to 19.0)
11.0
(11.0 to 34.5)
Anti-HPV-18, CD8-all doubles, S+, Month 7[N=12,13]
11.0
(11.0 to 61.5)
11.0
(11.0 to 73.0)
Anti-HPV-18, CD8-d-CD40L, S-, Day 0 [N=83,74]
7.0
(7.0 to 7.0)
7.0
(7.0 to 7.0)
Anti-HPV-18, CD8-d-CD40L, S-, Month 7 [N=69,58]
7.0
(7.0 to 7.0)
7.0
(7.0 to 7.0)
Anti-HPV-18, CD8-d-CD40L, S+, Day 0 [N=12,16]
7.0
(7.0 to 7.0)
7.0
(7.0 to 7.0)
Anti-HPV-18, CD8-d-CD40L, S+, Month 7 [N=12,13]
7.0
(7.0 to 7.0)
7.0
(7.0 to 7.0)
Anti-HPV-18, CD8-d-IFNγ, S-, Day 0 [N=83,74]
7.0
(7.0 to 29.0)
7.0
(7.0 to 24.0)
Anti-HPV-18, CD8-d-IFNγ, S-, Month 7 [N=69,58]
7.0
(7.0 to 26.0)
7.0
(7.0 to 9.0)
Anti-HPV-18, CD8-d-IFNγ, S+, Day 0 [N=12,16]
7.0
(7.0 to 15.0)
7.0
(7.0 to 30.5)
Anti-HPV-18, CD8-d-IFNγ, S+, Month 7 [N=12,13]
7.0
(7.0 to 57.5)
7.0
(7.0 to 39.0)
Anti-HPV-18, CD8-d-IL-2, S-, Day 0 [N=83,74]
7.0
(7.0 to 7.0)
7.0
(7.0 to 7.0)
Anti-HPV-18, CD8-d-IL-2, S-, Month 7 [N=69,58]
7.0
(7.0 to 7.0)
7.0
(7.0 to 22.0)
Anti-HPV-18, CD8-d-IL-2, S+, Day 0 [N=12,16]
7.0
(7.0 to 7.0)
7.0
(7.0 to 7.0)
Anti-HPV-18, CD8-d-IL-2, S+, Month 7 [N=12,13]
7.0
(7.0 to 15.5)
7.0
(7.0 to 7.0)
Anti-HPV-18, CD8-d-TNFα, S-, Day 0 [N=83,74]
7.0
(7.0 to 12.0)
7.0
(7.0 to 8.0)
Anti-HPV-18, CD8-d-TNFα, S-, Month 7 [N=69,58]
7.0
(7.0 to 30.0)
7.0
(7.0 to 27.0)
Anti-HPV-18, CD8-d-TNFα, S+, Day 0 [N=12,16]
7.0
(7.0 to 15.0)
7.0
(7.0 to 30.5)
Anti-HPV-18, CD8-d-TNFα, S+, Month 7 [N=12,14]
7.0
(7.0 to 57.5)
7.0
(7.0 to 62.0)
Anti-HPV-18, CD4 all doubles, S-, Mth 12 [N=69,58]
2007.0
(1053.0 to 3437.0)
1269.0
(816.0 to 2360.0)
Anti-HPV-18, CD4 all doubles, S+, Mth 12 [N=12,13]
890.0
(576.0 to 2069.0)
764.0
(424.0 to 1771.0)
Anti-HPV-18, CD4-d-CD40L, S-, Mth 12 [N=69,58]
1956.0
(1019.0 to 3206.0)
1208.0
(808.0 to 2321.0)
Anti-HPV-18, CD4-d-CD40L, S+, Mth 12 [N=12,13]
850.0
(572.0 to 2008.0)
752.0
(402.0 to 1724.0)
Anti-HPV-18, CD4-d-IFNγ, S-, Mth 12 [N=69,58]
340.0
(132.0 to 640.0)
225.0
(115.0 to 407.0)
Anti-HPV-18, CD4-d-IFNγ, S+, Mth 12 [N=12,13]
239.0
(102.0 to 535.0)
153.5
(85.0 to 344.0)
Anti-HPV-18, CD4-d-IL-2, S-, Mth 12[N=69,58]
1839.0
(1009.0 to 3262.0)
1195.0
(756.0 to 2177.0)
Anti-HPV-18, CD4-d-IL-2, S+, Mth 12 [N=12,13]
868.0
(556.0 to 2022.0)
744.5
(318.0 to 1650.0)
Anti-HPV-18, CD4-d-TNFα, S-, Mth 12 [N=69,58]
1569.0
(715.0 to 2608.0)
1010.0
(603.0 to 1707.0)
Anti-HPV-18, CD4-d-TNFα, S+, Mth 12 [N=12,14]
635.0
(391.0 to 1696.0)
632.0
(372.0 to 1284.0)
Anti-HPV-18, CD8 all doubles, S-, Mth 12 [N=69,58]
13.0
(11.0 to 46.0)
33.0
(11.0 to 50.0)
Anti-HPV-18, CD8 all doubles, S+, Mth 12 [N=12,13]
47.0
(11.0 to 73.0)
11.0
(11.0 to 44.0)
Anti-HPV-18, CD8-d-CD40L, S-, Mth 12 [N=69,58]
7.0
(7.0 to 32.0)
7.0
(7.0 to 36.0)
Anti-HPV-18, CD8-d-CD40L, S+, Mth 12 [N=12,13]
32.0
(7.0 to 48.0)
7.0
(7.0 to 7.0)
Anti-HPV-18, CD8-d-IFNγ, S-, Mth 12 [N=69,58]
7.0
(7.0 to 32.0)
7.0
(7.0 to 38.0)
Anti-HPV-18, CD8-d-IFNγ, S+, Mth 12 [N=12,13]
25.0
(7.0 to 57.0)
7.0
(7.0 to 36.0)
Anti-HPV-18, CD8-d-IL-2, S-, Mth 12[N=69,58]
7.0
(7.0 to 25.0)
7.0
(7.0 to 7.0)
Anti-HPV-18, CD8-d-IL-2, S+, Mth 12 [N=12,13]
7.0
(7.0 to 25.0)
7.0
(7.0 to 23.0)
Anti-HPV-18, CD8-d-TNFα, S-, Mth 12 [N=69,58]
7.0
(7.0 to 31.0)
7.0
(7.0 to 35.0)
Anti-HPV-18, CD8-d-TNFα, S+, Mth 12 [N=12,14]
7.0
(7.0 to 55.0)
7.0
(7.0 to 15.0)
Anti-HPV-18, CD4 all doubles, S-, Month24[N=79,72]
1784.0
(874.0 to 3235.0)
1355.0
(650.5 to 2106.0)
Anti-HPV-18, CD4 all doubles, S+, Month24[N=10,13]
710.5
(523.0 to 2329.0)
777.0
(467.0 to 2002.0)
Anti-HPV-18, CD4-d-CD40L, S-, Month 24 [N=79,72]
1571.0
(743.0 to 3189.0)
1263.0
(600.5 to 1883.0)
Anti-HPV-18, CD4-d-CD40L, S+, Month24 [N=10,13]
652.0
(475.0 to 2151.0)
745.0
(394.0 to 1738.0)
Anti-HPV-18, CD4-d-IFNγ, S-, Month 24 [N=79,72]
304.0
(165.0 to 773.0)
210.5
(112.0 to 519.0)
Anti-HPV-18, CD4-d-IFNγ, S+, Month 24 [N=10,13]
295.5
(108.0 to 636.0)
160.0
(92.0 to 440.0)
Anti-HPV-18, CD4-d-IL-2, S-, Month 24 [N=79,72]
1636.0
(834.0 to 3092.0)
1302.5
(602.5 to 1977.5)
Anti-HPV-18, CD4-d-IL-2, S+, Month 24 [N=10,13]
652.5
(448.0 to 2269.0)
652.0
(395.0 to 1998.0)
Anti-HPV-18, CD4-d-TNFα, S-, Month 24 [N=79,72]
1427
(552.0 to 2492.0)
1074.5
(457.5 to 1580.0)
Anti-HPV-18, CD4-d-TNFα, S+, Month 24 [N=10,13]
601.0
(462.0 to 2122.0)
702.0
(360.0 to 1497.0)
Anti-HPV-18, CD8-all doubles, S-, Month24[N=79,72]
11.0
(11.0 to 50.0)
11.0
(11.0 to 43.0)
Anti-HPV-18, CD8-all doubles, S+, Month24[N=10,13]
19.5
(11.0 to 47.0)
11.0
(11.0 to 30.0)
Anti-HPV-18, CD8-d-CD40L, S-, Month 24 [N=79,72]
7.0
(7.0 to 7.0)
7.0
(7.0 to 7.0)
Anti-HPV-18, CD8-d-CD40L, S+, Month 24 [N=10,13]
7.0
(7.0 to 7.0)
7.0
(7.0 to 7.0)
Anti-HPV-18, CD8-d-IFNγ, S-, Month 24 [N=79,72]
7.0
(7.0 to 29.0)
7.0
(7.0 to 33.5)
Anti-HPV-18, CD8-d-IFNγ, S+, Month 24 [N=10,13]
7.0
(7.0 to 9.0)
7.0
(7.0 to 26.0)
Anti-HPV-18, CD8-d-IL-2, S-, Month 24 [N=79,72]
7.0
(7.0 to 24.0)
7.0
(7.0 to 14.5)
Anti-HPV-18, CD8-d-IL-2, S+, Month 24 [N=10,13]
7.0
(7.0 to 24.0)
7.0
(7.0 to 7.0)
Anti-HPV-18, CD8-d-TNFα, S-, Month 24 [N=79,72]
7.0
(7.0 to 32.0)
7.0
(7.0 to 33.0)
Anti-HPV-18, CD8-d-TNFα, S+, Month 24 [N=10,13]
7.0
(7.0 to 31.0)
7.0
(7.0 to 7.0)
Anti-HPV-18, CD4 all doubles, S-, Month36[N=72,56]
1609
(716.0 to 3322.0)
1246
(676.5 to 1751.0)
Anti-HPV-18, CD4 all doubles, S+, Month36[N=10,13]
808.5
(624.0 to 1764.0)
598
(367.0 to 1414.0)
Anti-HPV-18, CD4-d-CD40L, S-, Month 36 [N=72,56]
1543
(686.0 to 3258.0)
1222
(670.0 to 1665.0)
Anti-HPV-18, CD4-d-CD40L, S+, Month36 [N=10,13]
794
(604.0 to 1721.0)
594
(350.0 to 1356.0)
Anti-HPV-18, CD4-d-IFNγ, S-, Month 36 [N=72,56]
304.5
(168.5 to 757.0)
233.5
(114.5 to 485.5)
Anti-HPV-18, CD4-d-IFNγ, S+, Month 36 [N=10,13]
356
(278.0 to 417.0)
239
(102.0 to 422.0)
Anti-HPV-18, CD4-d-IL-2, S-, Month 36 [N=72,56]
1495
(661.0 to 3065.0)
1183.5
(586.5 to 1684.5)
Anti-HPV-18, CD4-d-IL-2, S+, Month 36 [N=10,13]
777
(589.0 to 1669.0)
554
(333.0 to 1370.0)
Anti-HPV-18, CD4-d-TNFα, S-, Month 36 [N=72,56]
1268
(473.5 to 2130.0)
868.5
(520.0 to 1296.5)
Anti-HPV-18, CD4-d-TNFα, S+, Month 36 [N=10,13]
652.5
(489.0 to 1590.0)
444
(294.0 to 996.0)
Anti-HPV-18, CD8-all doubles, S-, Month36[N=72,56]
32
(11.0 to 45.5)
29
(11.0 to 51.0)
Anti-HPV-18, CD8-all doubles, S+, Month36[N=10,13]
45
(11.0 to 85.0)
34
(11.0 to 50.0)
Anti-HPV-18, CD8-d-CD40L, S-, Month 36 [N=72,56]
7
(7.0 to 35.5)
7
(7.0 to 37.5)
Anti-HPV-18, CD8-d-CD40L, S+, Month 36 [N=10,13]
25
(7.0 to 61.0)
7
(7.0 to 30.0)
Anti-HPV-18, CD8-d-IFNγ, S-, Month 36 [N=72,56]
7
(7.0 to 40.5)
7
(7.0 to 34.5)
Anti-HPV-18, CD8-d-IFNγ, S+, Month 36 [N=10,13]
7
(7.0 to 39.0)
7
(7.0 to 40.0)
Anti-HPV-18, CD8-d-IL-2, S-, Month 36 [N=72,56]
7
(7.0 to 7.0)
7
(7.0 to 7.0)
Anti-HPV-18, CD8-d-IL-2, S+, Month 36 [N=10,13]
7
(7.0 to 39.0)
7
(7.0 to 7.0)
Anti-HPV-18, CD8-d-TNFα, S-, Month 36[N=72,56]
7
(7.0 to 32.0)
7
(7.0 to 35.0)
Anti-HPV-18, CD8-d-TNFα, S+, Month 36[N=10,13]
17
(7.0 to 57.0)
7
(7.0 to 29.0)
16.Secondary Outcome
Title Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI)
Hide Description The CMI response was the measure of the cytokines production [i.e.interleukin-2 (IL-2), interferon gamma (IFN-γ), tumor necrosis factor alpha (TNF-α) and cluster of differentiation 40 Ligand (CD40L)] by HPV-antigen specific T lymphocytes and measured by intracellular cytokine staining (ICS) assay for HPV-16 The frequency was presented as number of of cytokine-positive cluster of differentiation (CD)4 i.e.CD4+/CD8+ cells per million CD4+/CD8+ cells. All doubles= T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody titre lower than the cut-off value of 8 EL.U/mL) prior to vaccination. S+ = seropositive subjects (antibody titre ≥ 8 El.U/mL) prior to vaccination.
Time Frame At Months 0, 13, 18 and 36
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 with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title Cervarix 3 Group
Hide Arm/Group Description:
Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 83
Median (Inter-Quartile Range)
Unit of Measure: cells/million T cells
Anti-HPV-16, CD4 all doubles, S-, Month 0 [N=83]
96.0
(61.0 to 170.0)
Anti-HPV-16, CD4 all doubles, S-, Month 13 [N=79]
2399.0
(1514.0 to 4361.0)
Anti-HPV-16, CD4 all doubles, S+, Month 0 [N=7]
169.0
(77.0 to 277.0)
Anti-HPV-16, CD4 all doubles, S+, Month 13 [N=6]
2507.5
(1067.0 to 4212.0)
Anti-HPV-16, CD4-d-CD40L, S-, Month 0 [N=83]
89.0
(47.0 to 133.0)
Anti-HPV-16, CD4-d-CD40L, S-, Month 13 [N=79]
2356.0
(1510.0 to 4322.0)
Anti-HPV-16, CD4-d-CD40L, S+, Month 0 [N=7]
141.0
(73.0 to 261.0)
Anti-HPV-16, CD4-d-CD40L, S+, Month 13 [N=6]
2450.5
(1036.0 to 4139.0)
Anti-HPV-16, CD4-d-IFNγ, S-, Month 0 [N=83]
37.0
(20.0 to 60.0)
Anti-HPV-16, CD4-d-IFNγ, S-, Month 13 [N=79]
661.0
(292.0 to 1452.0)
Anti-HPV-16, CD4-d-IFNγ, S+, Month 0 [N=7]
68.0
(33.0 to 203.0)
Anti-HPV-16, CD4-d-IFNγ, S+, Month 13 [N=6]
644.0
(204.0 to 1163.0)
Anti-HPV-16, CD4-d-IL-2, S-, Month 0 [N=83]
63.0
(34.0 to 112.0)
Anti-HPV-16, CD4-d-IL-2, S-, Month 13 [N=79]
2220.0
(1406.0 to 4128.0)
Anti-HPV-16, CD4-d-IL-2, S+, Month 0 [N=7]
121.0
(47.0 to 191.0)
Anti-HPV-16, CD4-d-IL-2, S+, Month 13 [N=6]
2442.0
(835.0 to 4006.0)
Anti-HPV-16, CD4-d-TNFα, S-, Month 0 [N=83]
63.0
(36.0 to 102.0)
Anti-HPV-16, CD4-d-TNFα, S-, Month 13 [N=79]
1643.0
(907.0 to 3076.0)
Anti-HPV-16, CD4-d-TNFα, S+, Month 0 [N=7]
140.0
(32.0 to 164.0)
Anti-HPV-16, CD4-d-TNFα, S+, Month 13 [N=6]
1843.0
(584.0 to 2657.0)
Anti-HPV-16, CD8-all doubles, S-, Month 0 [N=83]
31.0
(11.0 to 55.0)
Anti-HPV-16, CD8-all doubles, S-, Month 13 [N=79]
11.0
(11.0 to 43.0)
Anti-HPV-16, CD8-all doubles, S+, Month 0 [N=7]
33.0
(11.0 to 59.0)
Anti-HPV-16, CD8-all doubles, S+, Month 13 [N=6]
43.0
(11.0 to 57.0)
Anti-HPV-16, CD8-d-CD40L, S-, Month 0 [N=83]
7.0
(7.0 to 35.0)
Anti-HPV-16, CD8-d-CD40L, S-, Month 13 [N=79]
7.0
(7.0 to 30.0)
Anti-HPV-16, CD8-d-CD40L, S+, Month 0 [N=7]
7.0
(7.0 to 35.0)
Anti-HPV-16, CD8-d-CD40L, S+, Month 13 [N=6]
7.0
(7.0 to 34.0)
Anti-HPV-16, CD8-d-IFNγ, S-, Month 0 [N=83]
23.0
(7.0 to 48.0)
Anti-HPV-16, CD8-d-IFNγ, S-, Month 13 [N=79]
7.0
(7.0 to 35.0)
Anti-HPV-16, CD8-d-IFNγ, S+, Month 0 [N=7]
29.0
(7.0 to 55.0)
Anti-HPV-16, CD8-d-IFNγ, S+, Month 13 [N=6]
25.5
(7.0 to 53.0)
Anti-HPV-16, CD8-d-IL-2, S-, Month 0 [N=83]
7.0
(7.0 to 7.0)
Anti-HPV-16, CD8-d-IL-2, S-, Month 13 [N=79]
7.0
(7.0 to 7.0)
Anti-HPV-16, CD8-d-IL-2, S+, Month 0 [N=7]
7.0
(7.0 to 7.0)
Anti-HPV-16, CD8-d-IL-2, S+, Month 13 [N=6]
7.0
(7.0 to 7.0)
Anti-HPV-16, CD8-d-TNFα, S-, Month 0 [N=83]
7.0
(7.0 to 27.0)
Anti-HPV-16, CD8-d-TNFα, S-, Month 13 [N=79]
7.0
(7.0 to 29.0)
Anti-HPV-16, CD8-d-TNFα, S+, Month 0 [N=7]
7.0
(7.0 to 7.0)
Anti-HPV-16, CD8-d-TNFα, S+, Month 13 [N=6]
20.5
(7.0 to 44.0)
Anti-HPV-16, CD4 all doubles, S-, Month18 [N=79]
1879.0
(1102.0 to 3449.0)
Anti-HPV-16, CD4 all doubles, S+, Month18 [N=5]
2299.0
(1597.0 to 4103.0)
Anti-HPV-16, CD4-d-CD40L, S-, Month 18 [N=79]
1831.0
(1048.0 to 3272.0)
Anti-HPV-16, CD4-d-CD40L, S+, Month18 [N=5]
2180.0
(1580.0 to 3862.0)
Anti-HPV-16, CD4-d-IFNγ, S-, Month18 [N=79]
396.0
(200.0 to 821.0)
Anti-HPV-16, CD4-d-IFNγ, S+, Month 18 [N=5]
685.0
(361.0 to 732.0)
Anti-HPV-16, CD4-d-IL-2, S-, Month 18 [N=79]
1830.0
(1023.0 to 3221.0)
Anti-HPV-16, CD4-d-IL-2, S+, Month 18 [N=5]
2249.0
(1510.0 to 3870.0)
Anti-HPV-16, CD4-d-TNFα, S-, Month 18 [N=79]
1326.0
(772.0 to 2627.0)
Anti-HPV-16, CD4-d-TNFα, S+, Month 18 [N=5]
1792.0
(1380.0 to 2700.0)
Anti-HPV-16, CD8-all doubles, S-, Month18 [N=79]
11.0
(11.0 to 53.0)
Anti-HPV-16, CD8-all doubles, S+, Month18 [N=5]
43.0
(11.0 to 52.0)
Anti-HPV-16, CD8-d-CD40L, S-, Month 18 [N=79]
7.0
(7.0 to 30.0)
Anti-HPV-16, CD8-d-CD40L, S+, Month 18 [N=5]
7.0
(7.0 to 7.0)
Anti-HPV-16, CD8-d-IFNγ, S-, Month 18 [N=79]
7.0
(7.0 to 37.0)
Anti-HPV-16, CD8-d-IFNγ, S+, Month 18 [N=5]
7.0
(7.0 to 33.0)
Anti-HPV-16, CD8-d-IL-2, S-, Month 18 [N=79]
7.0
(7.0 to 28.0)
Anti-HPV-16, CD8-d-IL-2, S+, Month 18 [N=5]
7.0
(7.0 to 7.0)
Anti-HPV-16, CD8-d-TNFα, S-, Month 18 [N=79]
7.0
(7.0 to 41.0)
Anti-HPV-16, CD8-d-TNFα, S+, Month 18 [N=5]
33.0
(7.0 to 39.0)
Anti-HPV-16, CD4 all doubles, S-, Month36 [N=70]
1786.5
(1064.0 to 3285.0)
Anti-HPV-16, CD4 all doubles, S+, Month36 [N=7]
1521
(297.0 to 3794.0)
Anti-HPV-16, CD4-d-CD40L, S-, Month 36 [N=70]
1763
(1048.0 to 3239.0)
Anti-HPV-16, CD4-d-CD40L, S+, Month36 [N=7]
1426
(280.0 to 3697.0)
Anti-HPV-16, CD4-d-IFNγ, S-, Month 36 [N=70]
646
(276.0 to 1282.0)
Anti-HPV-16, CD4-d-IFNγ, S+, Month 36 [N=7]
310
(72.0 to 1783.0)
Anti-HPV-16, CD4-d-IL-2, S-, Month 36 [N=70]
1670.5
(1009.0 to 3169.0)
Anti-HPV-16, CD4-d-IL-2, S+, Month 36 [N=7]
1028
(267.0 to 3629.0)
Anti-HPV-16, CD4-d-TNFα, S-, Month 36 [N=70]
1300.5
(693.0 to 2267.0)
Anti-HPV-16, CD4-d-TNFα, S+, Month 36 [N=7]
1202
(169.0 to 2745.0)
Anti-HPV-16, CD8-all doubles, S-, Month36 [N=70]
21.5
(11.0 to 52.0)
Anti-HPV-16, CD8-all doubles, S+, Month36 [N=7]
11
(11.0 to 89.0)
Anti-HPV-16, CD8-d-CD40L, S-, Month 36 [N=70]
7
(7.0 to 30.0)
Anti-HPV-16, CD8-d-CD40L, S+, Month 36 [N=7]
7
(7.0 to 46.0)
Anti-HPV-16, CD8-d-IFNγ, S-, Month 36 [N=70]
7
(7.0 to 38.0)
Anti-HPV-16, CD8-d-IFNγ, S+, Month 36 [N=7]
7
(7.0 to 46.0)
Anti-HPV-16, CD8-d-IL-2, S-, Month 36 [N=70]
7
(7.0 to 7.0)
Anti-HPV-16, CD8-d-IL-2, S+, Month 36 [N=7]
7
(7.0 to 46.0)
Anti-HPV-16, CD8-d-TNFα, S-, Month 36 [N=70]
7
(7.0 to 38.0)
Anti-HPV-16, CD8-d-TNFα, S+, Month 36 [N=7]
7
(7.0 to 7.0)
17.Secondary Outcome
Title Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T Cell-mediated Immune Response (CMI)
Hide Description The CMI response was the measure of the cytokines production [IL-2, IFN-γ, TNF-α and CD40L] by HPV-antigen specific T lymphocytes and measured by intracellular cytokine staining (ICS) assay for HPV-18. The frequency was presented as number of cytokine-producing CD4+/CD8+ cells per million CD4+/CD8+ cells. All doubles= T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody titre lower than the cut-off value of 7 EL.U/mL) prior to vaccination. S+ = seropositive subjects (antibody titre ≥ 7 EL.U/mL) prior to vaccination.
Time Frame At Months 0, 13, 18 and 36
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 with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title Cervarix 3 Group
Hide Arm/Group Description:
Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 88
Median (Inter-Quartile Range)
Unit of Measure: cells/million T-cells
Anti-HPV-18, CD4 all doubles, S-, Month 0 [N=88]
99.0
(60.0 to 147.0)
Anti-HPV-18, CD4 all doubles, S-, Month 13 [N=83]
1582.0
(1033.0 to 3107.0)
Anti-HPV-18, CD4 all doubles, S+, Month 0 [N=2]
107.5
(69.0 to 146.0)
Anti-HPV-18, CD4 all doubles, S+, Month 13 [N=2]
1968.5
(1753.0 to 2184.0)
Anti-HPV-18, CD4-d-CD40L, S-, Month 0 [N=88]
85.0
(41.5 to 126.0)
Anti-HPV-18, CD4-d-CD40L, S-, Month 13 [N=83]
1529.0
(1003.0 to 3036.0)
Anti-HPV-18, CD4-d-CD40L, S+, Month 0 [N=2]
103.5
(65.0 to 142.0)
Anti-HPV-18, CD4-d-CD40L, S+, Month 13 [N=2]
1904.5
(1656.0 to 2153.0)
Anti-HPV-18, CD4-d-IFNγ, S-, Month 0 [N=88]
36.0
(27.0 to 61.0)
Anti-HPV-18, CD4-d-IFNγ, S-, Month 13 [N=83]
349.0
(173.0 to 1221.0)
Anti-HPV-18, CD4-d-IFNγ, S+, Month 0 [N=2]
33.5
(24.0 to 43.0)
Anti-HPV-18, CD4-d-IFNγ, S+, Month 13 [N=2]
378.0
(307.0 to 449.0)
Anti-HPV-18, CD4-d-IL-2, S-, Month 0 [N=88]
60
(32.0 to 97.0)
Anti-HPV-18, CD4-d-IL-2, S-, Month 13 [N=83]
1452.0
(812.0 to 2851.0)
Anti-HPV-18, CD4-d-IL-2, S+, Month 0 [N=2]
46.5
(33.0 to 60.0)
Anti-HPV-18, CD4-d-IL-2, S+, Month 13 [N=2]
1845.0
(1544.0 to 2146.0)
Anti-HPV-18, CD4-d-TNFα, S-, Month 0 [N=88]
60.0
(34.0 to 97.0)
Anti-HPV-18, CD4-d-TNFα, S-, Month 13 [N=83]
1126.0
(649.0 to 2076.0)
Anti-HPV-18, CD4-d-TNFα, S+, Month 0 [N=2]
66.5
(29.0 to 104.0)
Anti-HPV-18, CD4-d-TNFα, S+, Month 13 [N=2]
1449.5
(1317.0 to 1582.0)
Anti-HPV-18, CD8-all doubles, S-, Month 0 [N=88]
11.0
(11.0 to 47.5)
Anti-HPV-18, CD8-all doubles, S-, Month 13 [N=83]
32.0
(11.0 to 53.0)
Anti-HPV-18, CD8-all doubles, S+, Month 0 [N=2]
29.0
(11.0 to 47.0)
Anti-HPV-18, CD8-all doubles, S+, Month 13 [N=2]
63.5
(39.0 to 88.0)
Anti-HPV-18, CD8-d-CD40L, S-, Month 0 [N=88]
7.0
(7.0 to 31.0)
Anti-HPV-18, CD8-d-CD40L, S-, Month 13 [N=83]
7.0
(7.0 to 38.0)
Anti-HPV-18, CD8-d-CD40L, S+, Month 0 [N=2]
25.0
(7.0 to 43.0)
Anti-HPV-18, CD8-d-CD40L, S+, Month 13 [N=2]
21.0
(7.0 to 35.0)
Anti-HPV-18, CD8-d-IFNγ, S-, Month 0 [N=88]
7.0
(7.0 to 41.5)
Anti-HPV-18, CD8-d-IFNγ, S-, Month 13 [N=83]
7.0
(7.0 to 44.0)
Anti-HPV-18, CD8-d-IFNγ, S+, Month 0 [N=2]
25.0
(7.0 to 43.0)
Anti-HPV-18, CD8-d-IFNγ, S+, Month 13 [N=2]
59.5
(35.0 to 84.0)
Anti-HPV-18, CD8-d-IL-2, S-, Month 0 [N=88]
7.0
(7.0 to 7.0)
Anti-HPV-18, CD8-d-IL-2, S-, Month 13 [N=83]
7.0
(7.0 to 19.0)
Anti-HPV-18, CD8-d-IL-2, S+, Month 0 [N=2]
7.0
(7.0 to 7.0)
Anti-HPV-18, CD8-d-IL-2, S+, Month 13 [N=2]
45.5
(7.0 to 84.0)
Anti-HPV-18, CD8-d-TNFα, S-, Month 0 [N=88]
7.0
(7.0 to 38.0)
Anti-HPV-18, CD8-d-TNFα, S-, Month 13 [N=83]
7.0
(7.0 to 31.0)
Anti-HPV-18, CD8-d-TNFα, S+, Month 0 [N=2]
7.0
(7.0 to 7.0)
Anti-HPV-18, CD8-d-TNFα, S+, Month 13 [N=2]
7.0
(7.0 to 7.0)
Anti-HPV-18, CD4 all doubles, S-, Month18 [N=82]
1165.5
(767.0 to 2116.0)
Anti-HPV-18, CD4 all doubles, S+, Month18 [N=2]
1250.0
(1156.0 to 1344.0)
Anti-HPV-18, CD4-d-CD40L, S-, Month 18 [N=82]
1140.5
(721.0 to 2098.0)
Anti-HPV-18, CD4-d-CD40L, S+, Month18 [N=2]
1174.5
(1110.0 to 1239.0)
Anti-HPV-18, CD4-d-IFNγ, S-, Month18 [N=82]
224.5
(107.0 to 572.0)
Anti-HPV-18, CD4-d-IFNγ, S+, Month 18 [N=2]
157.5
(136.0 to 179.0)
Anti-HPV-18, CD4-d-IL-2, S-, Month 18 [N=82]
1095.0
(710.0 to 1924.0)
Anti-HPV-18, CD4-d-IL-2, S+, Month 18 [N=2]
1151.0
(1078.0 to 1224.0)
Anti-HPV-18, CD4-d-TNFα, S-, Month 18 [N=82]
896.5
(537.0 to 1783.0)
Anti-HPV-18, CD4-d-TNFα, S+, Month 18 [N=2]
954.5
(873.0 to 1036.0)
Anti-HPV-18, CD8-all doubles, S-, Month18 [N=82]
33.5
(11.0 to 51.0)
Anti-HPV-18, CD8-all doubles, S+, Month18 [N=2]
11.0
(11.0 to 11.0)
Anti-HPV-18, CD8-d-CD40L, S-, Month 18 [N=82]
7.0
(7.0 to 34.0)
Anti-HPV-18, CD8-d-CD40L, S+, Month 18 [N=2]
7.0
(7.0 to 7.0)
Anti-HPV-18, CD8-d-IFNγ, S-, Month 18 [N=82]
7.0
(7.0 to 38.0)
Anti-HPV-18, CD8-d-IFNγ, S+, Month 18 [N=2]
7.0
(7.0 to 7.0)
Anti-HPV-18, CD8-d-IL-2, S-, Month 18 [N=82]
7.0
(7.0 to 7.0)
Anti-HPV-18, CD8-d-IL-2, S+, Month 18 [N=2]
7.0
(7.0 to 7.0)
Anti-HPV-18, CD8-d-TNFα, S-, Month 18 [N=82]
7.0
(7.0 to 40.0)
Anti-HPV-18, CD8-d-TNFα, S+, Month 18 [N=2]
7.0
(7.0 to 7.0)
Anti-HPV-18, CD4 all doubles, S-, Month36 [N=75]
1158
(606.0 to 2185.0)
Anti-HPV-18, CD4 all doubles, S+, Month36 [N=2]
1399.5
(1004.0 to 1795.0)
Anti-HPV-18, CD4-d-CD40L, S-, Month 36 [N=75]
1154
(563.0 to 2157.0)
Anti-HPV-18, CD4-d-CD40L, S+, Month36 [N=2]
1320
(918.0 to 1722.0)
Anti-HPV-18, CD4-d-IFNγ, S-, Month 36 [N=75]
318
(140.0 to 766.0)
Anti-HPV-18, CD4-d-IFNγ, S+, Month 36 [N=2]
389
(231.0 to 547.0)
Anti-HPV-18, CD4-d-IL-2, S-, Month 36 [N=75]
1086
(535.0 to 1974.0)
Anti-HPV-18, CD4-d-IL-2, S+, Month 36 [N=2]
1160
(827.0 to 1493.0)
Anti-HPV-18, CD4-d-TNFα, S-, Month 36 [N=75]
812
(384.0 to 1545.0)
Anti-HPV-18, CD4-d-TNFα, S+, Month 36 [N=2]
1127
(847.0 to 1407.0)
Anti-HPV-18, CD8-all doubles, S-, Month36 [N=75]
33
(11.0 to 56.0)
Anti-HPV-18, CD8-all doubles, S+, Month36 [N=2]
45
(11.0 to 79.0)
Anti-HPV-18, CD8-d-CD40L, S-, Month 36 [N=75]
7
(7.0 to 38.0)
Anti-HPV-18, CD8-d-CD40L, S+, Month 36 [N=2]
41
(7.0 to 75.0)
Anti-HPV-18, CD8-d-IFNγ, S-, Month 36 [N=75]
7
(7.0 to 44.0)
Anti-HPV-18, CD8-d-IFNγ, S+, Month 36 [N=2]
41
(7.0 to 75.0)
Anti-HPV-18, CD8-d-IL-2, S-, Month 36 [N=75]
7
(7.0 to 7.0)
Anti-HPV-18, CD8-d-IL-2, S+, Month 36 [N=2]
7
(7.0 to 7.0)
Anti-HPV-18, CD8-d-TNFα, S-, Month 36 [N=75]
7
(7.0 to 35.0)
Anti-HPV-18, CD8-d-TNFα, S+, Month 36 [N=2]
7
(7.0 to 7.0)
18.Secondary Outcome
Title Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B Cell-mediated Immune Response
Hide Description The cell-mediated immune response was assessed as being the frequency of B-cell memory of HPV-16 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration < 8 EL.U/mL) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ 8 EL.U/mL) prior to vaccination.
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 According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title Cervarix 1 Group Cervarix 2 Group
Hide Arm/Group Description:
Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 100 91
Median (Inter-Quartile Range)
Unit of Measure: cells/million B-cells
Anti-HPV-16, S-, Day 0 [N=79, 69]
1.0
(1.0 to 1.0)
1.0
(1.0 to 1.0)
Anti-HPV-16, S-, Month 7 [N=75, 55]
2210.0
(886.0 to 5171.0)
1692.0
(849.0 to 3449.0)
Anti-HPV-16, S-, Month 12 [N=59, 43]
801.0
(437.0 to 2553.0)
1136.0
(371.0 to 3215.0)
Anti-HPV-16, S+, Day 0 [N=10, 17]
1.0
(1.0 to 1.0)
16.0
(1.0 to 58.0)
Anti-HPV-16, S+, Month 7 [N=9, 15]
4467.0
(1513.0 to 8673.0)
1354.0
(197.0 to 4928.0)
Anti-HPV-16, S+, Month 12 [N=3, 10]
5018.0
(1064.0 to 5094.0)
785.0
(340.0 to 2517.0)
Anti-HPV-16, S-, Month 24 [N=78, 63]
305.5
(93.0 to 696.0)
590.0
(142.0 to 1130.0)
Anti-HPV-16, S+, Month 24 [N=8, 14]
621.0
(324.5 to 1751.5)
568.5
(22.0 to 1854.0)
Anti-HPV-16, S-, Month 36 [N=70, 53]
560.5
(157.0 to 1012.0)
448
(219.0 to 821.0)
Anti-HPV-16, S+, Month 36 [N=6, 13]
475
(414.0 to 822.0)
107
(1.0 to 1275.0)
19.Secondary Outcome
Title Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B Cell-mediated Immune Response
Hide Description The cell-mediated immune response was assessed as being the frequency of B-cell memory of HPV-18 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration < 7 EL.U/mL) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ 7 EL.U/mL) prior to vaccination.
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 According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination and B-cell pre-vaccination status.
Arm/Group Title Cervarix 1 Group Cervarix 2 Group
Hide Arm/Group Description:
Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 100 92
Median (Inter-Quartile Range)
Unit of Measure: cells/million B-cells
Anti-HPV-18, S-, Day 0 [N=78,71]
0.0
(0.0 to 0.0)
0.0
(0.0 to 0.0)
Anti-HPV-18, S-, Month 7 [N=73,58]
935.0
(407.0 to 2485.0)
838.0
(430.0 to 2062.0)
Anti-HPV-18, S+, Day 0 [N=11,16]
0.0
(0.0 to 85.0)
0.0
(0.0 to 11.0)
Anti-HPV-18, S+, Month 7 [N=11,13]
2175.0
(423.0 to 3414.0)
755.0
(180.0 to 2505.0)
Anti-HPV-18, S-, Month 24 [N=75, 65]
209.0
(53.0 to 664.0)
274.0
(71.0 to 829.0)
Anti-HPV-18, S+, Month 24 [N=11, 13]
299.0
(117.0 to 643.0)
352.0
(237.0 to 952.0)
Anti-HPV-18, S-, Month 36 [N=67,54]
269
(62.0 to 732.0)
284.5
(90.0 to 582.0)
Anti-HPV-18, S+, Month 36 [N=9,12]
154
(141.0 to 427.0)
93
(18.0 to 762.0)
20.Secondary Outcome
Title Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B Cell-mediated Immune Response
Hide Description The cell-mediated immune response was assessed as being the frequency of B-cell memory of HPV-16 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration < 8 EL.U/mL) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ 8 EL.U/mL) prior to vaccination.
Time Frame At Months 0, 13, 18 and 36
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 with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title Cervarix 3 Group
Hide Arm/Group Description:
Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 72
Median (Inter-Quartile Range)
Unit of Measure: cells/million T-cells
Anti-HPV-16, S-, Month 0 [N=71]
1.0
(1.0 to 7.0)
Anti-HPV-16, S-, Month 13 [N=72]
2825.0
(1429.5 to 5421.0)
Anti-HPV-16, S+, Month 0 [N=5]
1.0
(1.0 to 20.0)
Anti-HPV-16, S+, Month 13 [N=5]
5996.0
(919.0 to 7353.0)
Anti-HPV-16, S-, Month 18 [N=65]
769.0
(418.0 to 1825.0)
Anti-HPV-16, S+, Month 18 [N=4]
1469.0
(454.0 to 2520.5)
Anti-HPV-16, S-, Month 36 [N=67]
613
(322.0 to 1301.0)
Anti-HPV-16, S+, Month 36 [N=6]
425
(102.0 to 714.0)
21.Secondary Outcome
Title Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B Cell-mediated Immune Response
Hide Description

The cell-mediated immune response was assessed as being the frequency of B-cell memory of HPV-18 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration < 7 EL.U/mL) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ 7 EL.U/mL) prior to vaccination.

For this group, results were only made available one month after the last vaccine dose, at Month 13.

Time Frame At Months 0, 13, 18 and 36
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Hide Analysis Population Description
The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title Cervarix 3 Group
Hide Arm/Group Description:
Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 75
Median (Inter-Quartile Range)
Unit of Measure: cells/million B-cells
Anti-HPV-18, S-, Month 0 [N=75]
0.0
(0.0 to 0.0)
Anti-HPV-18, S-, Month 13 [N=75]
1165.0
(632.0 to 1780.0)
Anti-HPV-18, S+, Month 0 [N=1]
48.0
(48.0 to 48.0)
Anti-HPV-18, S+, Month 13 [N=2]
758.0
(114.0 to 1402.0)
Anti-HPV-18, S-, Month 18 [N=68]
561.5
(132.0 to 1142.0)
Anti-HPV-18, S+, Month 18 [N=1]
938.0
(938.0 to 938.0)
Anti-HPV-18, S-, Month 36 [N=72]
361
(112.0 to 724.0)
Anti-HPV-18, S+, Month 36 [N=1]
1231
(1231.0 to 1231.0)
22.Secondary Outcome
Title Number of Subjects Completing the Vaccination Course
Hide Description The number of subjects completing the vaccination course was assessed as the number of subjects with at least one dose received during the study.
Time Frame Up to Month 13
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Hide Analysis Population Description
The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects, i.e. subjects who received at least one dose of vaccine in this study, for whom data were available.
Arm/Group Title Cervarix 1 Group Cervarix 2 Group Cervarix 3 Group
Hide Arm/Group Description:
Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 550 482 415
Measure Type: Number
Unit of Measure: Subjects
550 482 415
23.Secondary Outcome
Title Anti-HPV-16 and Anti-HPV-18 Antibody Titres (by Pseudovirion-Based Neutralisation Assay [PBNA])
Hide Description Antibody titers were given as Geometric mean titers (GMTs). The cut-off of the assay were ≥ 40 ED50 for anti-HPV-16 and anti-HPV-18.
Time Frame At Months 0, 13, 18, 24 and 36
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Hide Analysis Population Description
The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title Cervarix 3 Group
Hide Arm/Group Description:
Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 94
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
Anti-HPV-16, Month 0 [N=94]
20.0
(20.0 to 20.0)
Anti-HPV-16, Month 13 [N=94]
77202.4
(62934.5 to 94705.1)
Anti-HPV-18, Month 0 [N=94]
20.0
(20.0 to 20.0)
Anti-HPV-18, Month 13 [N=94]
40052.6
(33593.3 to 47753.8)
Anti-HPV-16, Month 18 [N=93]
16637.8
(13322.1 to 20778.6)
Anti-HPV-18, Month 18 [N=93]
9313.7
(7626.1 to 11374.8)
Anti-HPV-16, Month 24 [N=92]
9964.3
(8169.7 to 12153.0)
Anti-HPV-18, Month 24 [N=92]
5373.2
(4340.4 to 6651.8)
Anti-HPV-16, Month 36 [N=88]
9214.3
(7112.3 to 11937.5)
Anti-HPV-18, Month 36 [N=88]
4046.4
(3278.0 to 4994.8)
24.Secondary Outcome
Title Anti-HPV-16 and Anti-HPV-18 Antibody Titres (by Pseudovirion-Based Neutralisation Assay [PBNA])
Hide Description Antibody titers were given as Geometric mean titers (GMTs). The cut-off of the assay were ≥ 40 ED50 for anti-HPV-16 and anti-HPV-18.
Time Frame At Day 0 and Months 7, 12, 18, 24 and 36
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Hide Analysis Population Description
The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title Cervarix 1 Group Cervarix 2 Group
Hide Arm/Group Description:
Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 103 99
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
Anti-HPV-16, Day 0 [N=103, 99]
21.2
(18.9 to 23.9)
23.2
(20.7 to 26.1)
Anti-HPV-16, Month 7 [N=103, 99]
77611.5
(63321.3 to 95126.5)
30254.7
(23616.3 to 38759.1)
Anti-HPV-16, Month 12 [N=101, 98]
14540.1
(11855.1 to 17833.2)
15273.8
(11814.3 to 19746.4)
Anti-HPV-18, Day 0 [N=103, 99]
21.0
(19.0 to 23.3)
22.2
(20.4 to 24.2)
Anti-HPV-18, Month 7 [N=103, 92]
23276.4
(19557.5 to 27702.6)
13709.2
(10863.6 to 17300.2)
Anti-HPV-18, Month 12 [N=101, 98]
5703.4
(4609.6 to 7056.8)
5083.3
(3834.2 to 6739.4)
Anti-HPV-16, Month 18 [N=99,97]
7308.9
(5958 to 8966.1)
8092.7
(6178.6 to 10599.8)
Anti-HPV-18, Month 18 [N=99,97]
3833.7
(3065.2 to 4795)
2941.7
(2213 to 3910.3)
Anti-HPV-16, Month 24 [N=99,97]
6181.4
(5104.7 to 7485.3)
7289.7
(5501.1 to 9659.7)
Anti-HPV-18, Month 24 [N=99,97]
2789.0
(2230.9 to 3486.7)
2559.9
(1902.2 to 3445.2)
Anti-HPV-16, Month 36 [N=96,92]
7762.7
(6218.6 to 9690.1)
5063.7
(3800.4 to 6746.9)
Anti-HPV-18, Month 36 [N=95,92]
2416.4
(1905.9 to 3063.5)
1956.2
(1488.5 to 2570.7)
Time Frame Solicited symptoms were collected during the 7-day period (Days 0-6) after vaccination.Unsolicited AEs were collected during the 30-day period (Days 0-29) after vaccination. SAEs were collected from Day 0 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 1 Group Cervarix 2 Group Cervarix 3 Group
Hide Arm/Group Description Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm. Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm. Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
All-Cause Mortality
Cervarix 1 Group Cervarix 2 Group Cervarix 3 Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cervarix 1 Group Cervarix 2 Group Cervarix 3 Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   20/550 (3.64%)   28/482 (5.81%)   24/415 (5.78%) 
Blood and lymphatic system disorders       
Lymphadenitis * 1  1/550 (0.18%)  0/482 (0.00%)  1/415 (0.24%) 
Cardiac disorders       
Supraventricular tachycardia  1  0/550 (0.00%)  0/482 (0.00%)  1/415 (0.24%) 
Endocrine disorders       
Autoimmune thyroiditis * 1  1/550 (0.18%)  0/482 (0.00%)  0/415 (0.00%) 
Eye disorders       
Strabismus * 1  1/550 (0.18%)  0/482 (0.00%)  0/415 (0.00%) 
Gastrointestinal disorders       
Abdominal strangulated hernia * 1  1/550 (0.18%)  0/482 (0.00%)  0/415 (0.00%) 
Abdominal pain * 1  1/550 (0.18%)  0/482 (0.00%)  0/415 (0.00%) 
Abdominal pain lower  1  0/550 (0.00%)  0/482 (0.00%)  1/415 (0.24%) 
Anal haemorrhage  1  1/550 (0.18%)  0/482 (0.00%)  0/415 (0.00%) 
Constipation  1  0/550 (0.00%)  0/482 (0.00%)  1/415 (0.24%) 
Dyspepsia  1  0/550 (0.00%)  0/482 (0.00%)  1/415 (0.24%) 
Faecaloma  1  0/550 (0.00%)  0/482 (0.00%)  1/415 (0.24%) 
Gastritis  1  1/550 (0.18%)  0/482 (0.00%)  0/415 (0.00%) 
Nausea  1  1/550 (0.18%)  0/482 (0.00%)  0/415 (0.00%) 
Chronic gastritis * 1  1/550 (0.18%)  0/482 (0.00%)  0/415 (0.00%) 
General disorders       
Anaphylactic reaction * 1  1/550 (0.18%)  0/482 (0.00%)  0/415 (0.00%) 
Hepatobiliary disorders       
Cholelithiasis * 1  1/550 (0.18%)  0/482 (0.00%)  0/415 (0.00%) 
Immune system disorders       
Drug hypersensitivity  1  0/550 (0.00%)  0/482 (0.00%)  1/415 (0.24%) 
Infections and infestations       
Dengue fever * 1  1/550 (0.18%)  3/482 (0.62%)  3/415 (0.72%) 
Gastroenteritis * 1  2/550 (0.36%)  1/482 (0.21%)  2/415 (0.48%) 
Gastroenteritis bacterial * 1  0/550 (0.00%)  1/482 (0.21%)  1/415 (0.24%) 
Influenza * 1  0/550 (0.00%)  1/482 (0.21%)  0/415 (0.00%) 
Tubo-ovarian abscess * 1  1/550 (0.18%)  0/482 (0.00%)  0/415 (0.00%) 
Acute tonsillitis * 1  0/550 (0.00%)  0/482 (0.00%)  1/415 (0.24%) 
Tonsillitis * 1  0/550 (0.00%)  1/482 (0.21%)  0/415 (0.00%) 
Otitis media chronic * 1  1/550 (0.18%)  0/482 (0.00%)  0/415 (0.00%) 
Appendicitis  1  0/550 (0.00%)  2/482 (0.41%)  2/415 (0.48%) 
Infectious mononucleosis  1  0/550 (0.00%)  0/482 (0.00%)  1/415 (0.24%) 
Pelvic inflammatory disease  1  0/550 (0.00%)  1/482 (0.21%)  0/415 (0.00%) 
Peritonitis  1  0/550 (0.00%)  1/482 (0.21%)  0/415 (0.00%) 
Pneumonia  1  0/550 (0.00%)  1/482 (0.21%)  0/415 (0.00%) 
Salpingitis  1  0/550 (0.00%)  1/482 (0.21%)  0/415 (0.00%) 
Salpingo-oophoritis  1  0/550 (0.00%)  1/482 (0.21%)  0/415 (0.00%) 
Tonsillitis  1 [1]  1/550 (0.18%)  1/482 (0.21%)  0/415 (0.00%) 
Otitis media acute * 1  1/550 (0.18%)  0/482 (0.00%)  0/415 (0.00%) 
Pelvic infection * 1  0/550 (0.00%)  1/482 (0.21%)  0/415 (0.00%) 
Pharyngitis * 1  1/550 (0.18%)  0/482 (0.00%)  0/415 (0.00%) 
Viral infection * 1  0/550 (0.00%)  0/482 (0.00%)  1/415 (0.24%) 
Appendicitis * 1 [2]  0/550 (0.00%)  0/482 (0.00%)  1/415 (0.24%) 
Appendicitis * 1 [1]  0/550 (0.00%)  3/482 (0.62%)  5/415 (1.20%) 
Dengue fever * 1 [1]  1/550 (0.18%)  4/482 (0.83%)  3/415 (0.72%) 
Acute tonsillitis * 1 [1]  0/550 (0.00%)  0/482 (0.00%)  2/415 (0.48%) 
Influenza * 1 [1]  1/550 (0.18%)  1/482 (0.21%)  0/415 (0.00%) 
Peritonitis * 1 [1]  0/550 (0.00%)  1/482 (0.21%)  1/415 (0.24%) 
Dengue fever * 1 [2]  1/550 (0.18%)  3/482 (0.62%)  1/415 (0.24%) 
Gastroenteritis * 1 [2]  1/550 (0.18%)  1/482 (0.21%)  1/415 (0.24%) 
Dengue fever * 1 [3]  0/550 (0.00%)  2/482 (0.41%)  0/0 
Gastroenteritis * 1 [3]  1/550 (0.18%)  0/482 (0.00%)  0/0 
Gastroenteritis bacterial * 1 [3]  0/550 (0.00%)  1/482 (0.21%)  0/0 
Injury, poisoning and procedural complications       
Foot fracture * 1  1/550 (0.18%)  0/482 (0.00%)  0/415 (0.00%) 
Forearm fracture * 1  1/550 (0.18%)  0/482 (0.00%)  0/415 (0.00%) 
Carbon monoxide poisoning  1  1/550 (0.18%)  0/482 (0.00%)  0/415 (0.00%) 
Intentional overdose  1  1/550 (0.18%)  0/482 (0.00%)  0/415 (0.00%) 
Ligament rupture  1  0/550 (0.00%)  1/482 (0.21%)  0/415 (0.00%) 
Road traffic accident  1  0/550 (0.00%)  1/482 (0.21%)  0/415 (0.00%) 
Traumatic intracranial haemorrhage  1  0/550 (0.00%)  1/482 (0.21%)  0/415 (0.00%) 
Alcohol poisoning * 1  0/550 (0.00%)  0/482 (0.00%)  1/415 (0.24%) 
Metabolism and nutrition disorders       
Hypovolaemia  1  0/550 (0.00%)  1/482 (0.21%)  1/415 (0.24%) 
Type 1 diabetes mellitus  1  1/550 (0.18%)  0/482 (0.00%)  0/415 (0.00%) 
Hypovolaemia * 1 [2]  0/550 (0.00%)  1/482 (0.21%)  0/415 (0.00%) 
Musculoskeletal and connective tissue disorders       
Synovial cyst * 1  0/550 (0.00%)  1/482 (0.21%)  0/415 (0.00%) 
Systemic lupus erythematosus  1  0/550 (0.00%)  0/482 (0.00%)  1/415 (0.24%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Medulloblastoma * 1  0/550 (0.00%)  1/482 (0.21%)  0/415 (0.00%) 
Cholesteatoma  1  1/550 (0.18%)  0/482 (0.00%)  0/415 (0.00%) 
Synovial sarcoma * 1  0/550 (0.00%)  1/482 (0.21%)  0/415 (0.00%) 
Uterine leiomyoma * 1  0/550 (0.00%)  1/482 (0.21%)  0/415 (0.00%) 
Nervous system disorders       
Convulsion  1  1/550 (0.18%)  0/482 (0.00%)  0/415 (0.00%) 
Seizure * 1  1/550 (0.18%)  0/482 (0.00%)  0/415 (0.00%) 
VIIth nerve paralysis * 1  0/550 (0.00%)  0/482 (0.00%)  1/415 (0.24%) 
Pregnancy, puerperium and perinatal conditions       
Hyperemesis gravidarum * 1  0/550 (0.00%)  1/482 (0.21%)  0/415 (0.00%) 
Premature baby * 1  0/550 (0.00%)  1/482 (0.21%)  0/415 (0.00%) 
Abortion threatened * 1  0/550 (0.00%)  1/482 (0.21%)  0/415 (0.00%) 
Postpartum haemorrhage * 1  0/550 (0.00%)  1/482 (0.21%)  0/415 (0.00%) 
Stillbirth * 1  0/550 (0.00%)  1/482 (0.21%)  0/415 (0.00%) 
Psychiatric disorders       
Schizoaffective disorder  1 [2]  0/550 (0.00%)  1/482 (0.21%)  0/415 (0.00%) 
Psychotic disorder  1  0/550 (0.00%)  1/482 (0.21%)  0/415 (0.00%) 
Schizoaffective disorder * 1  0/550 (0.00%)  2/482 (0.41%)  0/415 (0.00%) 
Renal and urinary disorders       
IgA nephropathy * 1  1/550 (0.18%)  0/482 (0.00%)  0/415 (0.00%) 
Reproductive system and breast disorders       
Ovarian cyst ruptured * 1  0/550 (0.00%)  1/482 (0.21%)  0/415 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Transient tachypnoea of the newborn * 1  0/550 (0.00%)  1/482 (0.21%)  0/415 (0.00%) 
Respiratory disorder  1  1/550 (0.18%)  0/482 (0.00%)  0/415 (0.00%) 
Tonsillar hypertrophy * 1  0/550 (0.00%)  0/482 (0.00%)  1/415 (0.24%) 
Surgical and medical procedures       
Ectopic pregnancy termination * 1  0/550 (0.00%)  1/482 (0.21%)  0/415 (0.00%) 
Vascular disorders       
Circulatory collapse  1  0/550 (0.00%)  0/482 (0.00%)  1/415 (0.24%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
[1]
up to Month 36
[2]
up to Month 13
[3]
SAEs for Cervarix 3 Group were assessed only after the last vaccination at Month 12
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cervarix 1 Group Cervarix 2 Group Cervarix 3 Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   499/550 (90.73%)   461/482 (95.64%)   381/415 (91.81%) 
General disorders       
Pain  1  499/550 (90.73%)  461/480 (96.04%)  381/413 (92.25%) 
Redness  1  247/550 (44.91%)  212/480 (44.17%)  197/413 (47.70%) 
Swelling  1  225/550 (40.91%)  204/480 (42.50%)  171/413 (41.40%) 
Arthralgia  1  111/550 (20.18%)  107/480 (22.29%)  93/413 (22.52%) 
Fatigue  1  247/550 (44.91%)  310/480 (64.58%)  215/413 (52.06%) 
Gastrointestinal symptoms  1  98/550 (17.82%)  134/480 (27.92%)  77/413 (18.64%) 
Headache  1  204/550 (37.09%)  246/480 (51.25%)  185/413 (44.79%) 
Myalgia  1  278/550 (50.55%)  295/480 (61.46%)  221/413 (53.51%) 
Rash  1  33/550 (6.00%)  25/480 (5.21%)  29/413 (7.02%) 
Fever  1  41/550 (7.45%)  48/480 (10.00%)  42/413 (10.17%) 
Infections and infestations       
Nasopharyngitis * 1  22/550 (4.00%)  27/482 (5.60%)  14/415 (3.37%) 
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: NCT01381575     History of Changes
Other Study ID Numbers: 114700
First Submitted: June 17, 2011
First Posted: June 27, 2011
Results First Submitted: June 28, 2013
Results First Posted: December 5, 2013
Last Update Posted: April 25, 2017