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Trial record 1 of 2 for:    cervarix 18-45
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Immunogenicity of GlaxoSmithKline Biological's Human Papillomavirus (HPV) Vaccine (580299) Versus Merck's Gardasil® in Healthy Females 18-45 Years of Age

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: NCT00423046
Recruitment Status : Completed
First Posted : January 17, 2007
Results First Posted : August 25, 2010
Last Update Posted : January 2, 2020
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
Conditions Infections, Papillomavirus
Papillomavirus Vaccines
Interventions Biological: GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM)
Biological: Gardasil ® (Merck & Co. Inc)
Biological: Placebo
Enrollment 1106
Recruitment Details  
Pre-assignment Details Subjects who missed Month 7 visit and/or one or more follow-up visits were permitted to attend the next scheduled follow-up visits.
Arm/Group Title Cervarix Group Gardasil Group
Hide Arm/Group Description Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm. Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Period Title: Overall Study
Started 553 553
Completed 213 [1] 208 [1]
Not Completed 340 345
Reason Not Completed
Other             340             345
[1]
Completed until Month 60
Arm/Group Title Cervarix Group Gardasil Group Total
Hide Arm/Group Description Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm. Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm. Total of all reporting groups
Overall Number of Baseline Participants 553 553 1106
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 553 participants 553 participants 1106 participants
30.3  (8.02) 30.2  (7.78) 30.25  (7.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 553 participants 553 participants 1106 participants
Female
553
 100.0%
553
 100.0%
1106
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Hide Description Titers are displayed as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum.
Time Frame At Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on subjects from the According-to-Protocol (ATP) cohort for immunogenicity aged 18 to 26 years and who were seronegative by Pseudovirion (PSV) neutralizing assay and deoxyribonucleic acid (DNA) negative for the corresponding type at baseline.
Arm/Group Title Cervarix Group Gardasil Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Overall Number of Participants Analyzed 118 131
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Anti-HPV-16 Number Analyzed 104 participants 103 participants
36791.8
(29265.6 to 46253.6)
10053.1
(8135.8 to 12422.1)
Anti-HPV-18 Number Analyzed 118 participants 131 participants
16486.9
(13383.4 to 20310.1)
2257.9
(1809.4 to 2817.7)
2.Secondary Outcome
Title Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Hide Description

Titers are given as Geometric Mean Titers (GMTs). Titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum.

Data for Month 7 on subjects aged 18 to 26 years are given in the outcome above as a primary outcome measure.

Time Frame At Month 6, 7, 12, 18, 24, 36, 48 and 60
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed by age group on subjects from the According-to-Protocol (ATP) cohort for immunogenicity who were seronegative by Pseudovirion neutralizing assay and deoxyribonucleic acid (DNA) negative for the corresponding type at baseline.
Arm/Group Title Cervarix Group Gardasil Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Overall Number of Participants Analyzed 118 130
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
Anti-HPV-16, 18-26-year, Month 6 Number Analyzed 104 participants 102 participants
1627.9
(1304.0 to 2032.3)
1592.4
(1204.3 to 2105.7)
Anti-HPV-16, 18-26-year, Month 12 Number Analyzed 101 participants 99 participants
14524.7
(11069.7 to 19058.0)
3265.2
(2544.7 to 4189.7)
Anti-HPV-16, 18-26-year, Month 18 Number Analyzed 100 participants 91 participants
6000.3
(4681.2 to 7691.0)
1182.7
(882.7 to 1584.8)
Anti-HPV-16, 18-26-year, Month 24 Number Analyzed 97 participants 89 participants
5184.2
(4015.0 to 6693.8)
893.5
(672.2 to 1187.9)
Anti-HPV-16, 18-26-year, Month 36 Number Analyzed 60 participants 62 participants
3844.7
(2803.6 to 5272.3)
653.2
(460.4 to 926.7)
Anti-HPV-16, 18-26-year, Month 48 Number Analyzed 54 participants 57 participants
3900.9
(2745.4 to 5542.6)
750.4
(505.1 to 1114.8)
Anti-HPV-16, 18-26-year, Month 60 Number Analyzed 35 participants 40 participants
4117.8
(2742.1 to 6183.7)
529.8
(343.2 to 817.9)
Anti-HPV-16, 27-35-year, Month 6 Number Analyzed 90 participants 84 participants
1263.1
(892.7 to 1787.2)
1014.1
(737.6 to 1394.1)
Anti-HPV-16, 27-35-year, Month 7 Number Analyzed 90 participants 85 participants
23907.9
(18912.7 to 30222.4)
4958.4
(3895.6 to 6311.2)
Anti-HPV-16, 27-35-year, Month 12 Number Analyzed 91 participants 85 participants
7419.2
(5592.1 to 9843.3)
1755.9
(1290.3 to 2389.7)
Anti-HPV-16, 27-35-year, Month 18 Number Analyzed 87 participants 83 participants
2907.9
(2229.2 to 3793.1)
689.8
(505.8 to 940.8)
Anti-HPV-16, 27-35-year, Month 24 Number Analyzed 84 participants 79 participants
2269.2
(1765.8 to 2916.2)
618.8
(447.4 to 856.0)
Anti-HPV-16, 27-35-year, Month 36 Number Analyzed 63 participants 49 participants
1897.6
(1418.9 to 2537.8)
501.7
(346.7 to 726.0)
Anti-HPV-16, 27-35-year, Month 48 Number Analyzed 54 participants 51 participants
2046.3
(1469.4 to 2849.8)
677.6
(433.0 to 1060.2)
Anti-HPV-16, 27-35-year, Month 60 Number Analyzed 43 participants 29 participants
1925.3
(1301.9 to 2847.4)
346.4
(214.9 to 558.4)
Anti-HPV-16, 36-45-year, Month 6 Number Analyzed 96 participants 81 participants
1729.8
(1214.8 to 2463.1)
1916.5
(1361.3 to 2698.2)
Anti-HPV-16, 36-45-year, Month 7 Number Analyzed 96 participants 83 participants
17301.5
(13605.3 to 22001.9)
7634.4
(5915.7 to 9852.5)
Anti-HPV-16, 36-45-year, Month 12 Number Analyzed 89 participants 83 participants
7110.4
(5386.3 to 9386.4)
2678.2
(1986.8 to 3610.2)
Anti-HPV-16, 36-45-year, Month 18 Number Analyzed 90 participants 82 participants
2344.0
(1807.7 to 3039.4)
994.8
(732.9 to 1350.4)
Anti-HPV-16, 36-45-year, Month 24 Number Analyzed 87 participants 80 participants
2058.5
(1592.2 to 2661.3)
874.7
(636.9 to 1201.3)
Anti-HPV-16, 36-45-year, Month 36 Number Analyzed 61 participants 57 participants
1794.2
(1278.1 to 2518.8)
823.7
(567.2 to 1196.1)
Anti-HPV-16, 36-45-year, Month 48 Number Analyzed 51 participants 54 participants
2081.4
(1378.1 to 3143.6)
1018.7
(645.3 to 1608.0)
Anti-HPV-16, 36-45-year, Month 60 Number Analyzed 46 participants 47 participants
1784.5
(1233.1 to 2582.6)
764.9
(468.3 to 1249.4)
Anti-HPV-18, 18-26-year, Month 6 Number Analyzed 118 participants 130 participants
686.2
(549.1 to 857.6)
234.1
(186.6 to 293.5)
Anti-HPV-18, 18-26-year, Month 12 Number Analyzed 112 participants 127 participants
4472.4
(3528.1 to 5669.3)
595.8
(469.0 to 756.9)
Anti-HPV-18, 18-26-year, Month 18 Number Analyzed 109 participants 114 participants
2256.1
(1761.5 to 2889.6)
249.3
(195.2 to 318.3)
Anti-HPV-18, 18-26-year, Month 24 Number Analyzed 106 participants 109 participants
1652.0
(1296.3 to 2105.4)
175.1
(132.8 to 230.8)
Anti-HPV-18, 18-26-year, Month 36 Number Analyzed 64 participants 76 participants
1593.7
(1177.2 to 2157.6)
127.8
(92.6 to 176.6)
Anti-HPV-18, 18-26-year, Month 48 Number Analyzed 59 participants 70 participants
1710.9
(1179.5 to 2481.8)
139.0
(98.7 to 195.8)
Anti-HPV-18, 18-26-year, Month 60 Number Analyzed 39 participants 52 participants
1522.9
(968.2 to 2395.4)
126.2
(84.0 to 189.5)
Anti-HPV-18, 27-35-year, Month 6 Number Analyzed 102 participants 100 participants
429.2
(326.4 to 564.4)
175.8
(132.8 to 232.6)
Anti-HPV-18, 27-35-year, Month 7 Number Analyzed 110 participants 102 participants
9501.6
(7518.5 to 12007.7)
1043.0
(789.6 to 1377.7)
Anti-HPV-18, 27-35-year, Month 12 Number Analyzed 105 participants 102 participants
2266.3
(1764.8 to 2910.1)
280.3
(209.2 to 375.5)
Anti-HPV-18, 27-35-year, Month 18 Number Analyzed 101 participants 99 participants
1302.2
(1011.3 to 1677.0)
133.3
(100.8 to 176.3)
Anti-HPV-18, 27-35-year, Month 24 Number Analyzed 98 participants 94 participants
1028.4
(801.4 to 1319.8)
116.2
(87.4 to 154.5)
Anti-HPV-18, 27-35-year, Month 36 Number Analyzed 75 participants 61 participants
942.8
(712.6 to 1247.3)
101.9
(69.6 to 149.2)
Anti-HPV-18, 27-35-year, Month 48 Number Analyzed 66 participants 59 participants
982.4
(741.4 to 1301.7)
76.9
(52.7 to 112.3)
Anti-HPV-18, 27-35-year, Month 60 Number Analyzed 54 participants 36 participants
967.2
(701.2 to 1334.1)
74.4
(46.8 to 118.2)
Anti-HPV-18, 36-45-year, Month 6 Number Analyzed 110 participants 89 participants
618.8
(446.6 to 857.4)
168.7
(126.9 to 224.3)
Anti-HPV-18, 36-45-year, Month 7 Number Analyzed 110 participants 91 participants
9845.5
(7834.7 to 12372.3)
1438.8
(1105.0 to 1873.4)
Anti-HPV-18, 36-45-year, Month 12 Number Analyzed 104 participants 91 participants
3032.4
(2320.8 to 3962.3)
433.9
(325.2 to 579.0)
Anti-HPV-18, 36-45-year, Month 18 Number Analyzed 103 participants 91 participants
1426.7
(1083.9 to 1877.9)
181.5
(136.8 to 240.8)
Anti-HPV-18, 36-45-year, Month 24 Number Analyzed 100 participants 88 participants
1040.0
(785.7 to 1376.6)
135.8
(99.0 to 186.2)
Anti-HPV-18, 36-45-year, Month 36 Number Analyzed 71 participants 61 participants
903.5
(625.1 to 1305.8)
103.2
(74.6 to 142.8)
Anti-HPV-18, 36-45-year, Month 48 Number Analyzed 61 participants 61 participants
784.5
(528.7 to 1164.2)
91.5
(67.0 to 125.0)
Anti-HPV-18, 36-45-year, Month 60 Number Analyzed 55 participants 51 participants
816.6
(554.7 to 1202.1)
105.3
(71.8 to 154.3)
3.Secondary Outcome
Title Number of Subjects With Antibody Titers (Neutralizing Assay) Against Other Oncongenic HPV Types Greater Than or Equal to the Cut-off Value
Hide Description Other oncogenic HPV types include HPV-31 and HPV-45. The titer value (=serum dilution giving a 50 percent reduction of the signal compared to a control without serum) used as the cut-off for seroconversion was 40 for both other oncogenic types HPV-31 and HPV-45.
Time Frame At Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed by age group on subjects from the According-to-Protocol (ATP) cohort for immunogenicity who were seronegative by Pseudovirion neutralizing assay and deoxyribonucleic acid (DNA) negative for the corresponding type at baseline.
Arm/Group Title Cervarix Group Gardasil Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Overall Number of Participants Analyzed 128 131
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-HPV-31, 18-26-year Number Analyzed 112 participants 130 participants
90
  80.4%
60
  46.2%
Anti-HPV-31, 27-35-year Number Analyzed 101 participants 102 participants
59
  58.4%
32
  31.4%
Anti-HPV-31, 36-45-year Number Analyzed 102 participants 99 participants
68
  66.7%
39
  39.4%
Anti-HPV-45, 18-26-year Number Analyzed 128 participants 131 participants
35
  27.3%
4
   3.1%
Anti-HPV-45, 27-35-year Number Analyzed 112 participants 111 participants
21
  18.8%
7
   6.3%
Anti-HPV-45, 36-45-year Number Analyzed 115 participants 105 participants
28
  24.3%
10
   9.5%
4.Secondary Outcome
Title Titers of Antibodies to Other Oncogenic HPV Types Measured by Neutralization Assay
Hide Description Other Oncogenic Types include HPV-31 and HPV-45. Titers were measured by neutralization assay and are given as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum
Time Frame At Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed by age group on subjects from the According-to-Protocol (ATP) cohort for immunogenicity with titer greater than or equal to 40 ED50 and who were seronegative by Pseudovirion neutralizing assay and deoxyribonucleic acid (DNA) negative for the corresponding type at baseline.
Arm/Group Title Cervarix Group Gardasil Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Overall Number of Participants Analyzed 128 131
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Anti-HPV-31, 18-26-year Number Analyzed 112 participants 130 participants
387.3
(288.1 to 520.7)
143.2
(110.4 to 185.8)
Anti-HPV-31, 27-35-year Number Analyzed 101 participants 102 participants
369.6
(271.0 to 504.2)
191.8
(122.9 to 299.5)
Anti-HPV-31, 36-45-year Number Analyzed 102 participants 99 participants
231.0
(165.5 to 322.3)
198.5
(142.5 to 276.6)
Anti-HPV-45, 18-26-year Number Analyzed 128 participants 131 participants
129.7
(87.7 to 191.7)
86.5
(11.4 to 655.1)
Anti-HPV-45, 27-35-year Number Analyzed 112 participants 111 participants
144.1
(84.0 to 247.3)
379.9
(90.4 to 1595.7)
Anti-HPV-45, 36-45-year Number Analyzed 115 participants 105 participants
157.6
(103.0 to 241.1)
79.0
(56.3 to 110.9)
5.Secondary Outcome
Title Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value
Hide Description The titer value (=serum dilution giving a 50 percent reduction of the signal compared to a control without serum) used as the cut-off for seroconversion was 40 for both HPV-16 and HPV-18.
Time Frame At Month 6, 7, 12, 18, 24, 36, 48 and 60
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed by age group on subjects from the According-to-Protocol (ATP) cohort for immunogenicity who were seronegative by Pseudovirion neutralizing assay and deoxyribonucleic acid (DNA) negative for the corresponding type at baseline.
Arm/Group Title Cervarix Group Gardasil Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Overall Number of Participants Analyzed 118 131
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-HPV-16, 18-26-year, Month 6 Number Analyzed 104 participants 102 participants
104
 100.0%
101
  99.0%
Anti-HPV-16, 18-26-year, Month 7 Number Analyzed 104 participants 103 participants
104
 100.0%
103
 100.0%
Anti-HPV-16, 18-26-year, Month 12 Number Analyzed 101 participants 99 participants
101
 100.0%
99
 100.0%
Anti-HPV-16, 18-26-year, Month 18 Number Analyzed 100 participants 91 participants
100
 100.0%
91
 100.0%
Anti-HPV-16, 18-26-year, Month 24 Number Analyzed 97 participants 89 participants
97
 100.0%
87
  97.8%
Anti-HPV-16, 18-26-year, Month 36 Number Analyzed 60 participants 62 participants
60
 100.0%
61
  98.4%
Anti-HPV-16, 18-26-year, Month 48 Number Analyzed 54 participants 57 participants
54
 100.0%
56
  98.2%
Anti-HPV-16, 18-26-year, Month 60 Number Analyzed 35 participants 40 participants
35
 100.0%
39
  97.5%
Anti-HPV-16, 27-35-year, Month 6 Number Analyzed 90 participants 84 participants
90
 100.0%
83
  98.8%
Anti-HPV-16, 27-35-year, Month 7 Number Analyzed 90 participants 85 participants
90
 100.0%
85
 100.0%
Anti-HPV-16, 27-35-year, Month 12 Number Analyzed 91 participants 85 participants
91
 100.0%
84
  98.8%
Anti-HPV-16, 27-35-year, Month 18 Number Analyzed 87 participants 83 participants
87
 100.0%
82
  98.8%
Anti-HPV-16, 27-35-year, Month 24 Number Analyzed 84 participants 79 participants
84
 100.0%
77
  97.5%
Anti-HPV-16, 27-35-year, Month 36 Number Analyzed 63 participants 49 participants
63
 100.0%
49
 100.0%
Anti-HPV-16, 27-35-year, Month 48 Number Analyzed 54 participants 51 participants
54
 100.0%
49
  96.1%
Anti-HPV-16, 27-35-year, Month 60 Number Analyzed 43 participants 29 participants
43
 100.0%
28
  96.6%
Anti-HPV-16, 36-45-year, Month 6 Number Analyzed 96 participants 81 participants
95
  99.0%
81
 100.0%
Anti-HPV-16, 36-45-year, Month 7 Number Analyzed 96 participants 83 participants
96
 100.0%
83
 100.0%
Anti-HPV-16, 36-45-year, Month 12 Number Analyzed 89 participants 83 participants
89
 100.0%
83
 100.0%
Anti-HPV-16, 36-45-year, Month 18 Number Analyzed 90 participants 82 participants
90
 100.0%
82
 100.0%
Anti-HPV-16, 36-45-year, Month 24 Number Analyzed 87 participants 80 participants
87
 100.0%
80
 100.0%
Anti-HPV-16, 36-45-year, Month 36 Number Analyzed 61 participants 57 participants
61
 100.0%
57
 100.0%
Anti-HPV-16, 36-45-year, Month 48 Number Analyzed 51 participants 54 participants
50
  98.0%
53
  98.1%
Anti-HPV-16, 36-45-year, Month 60 Number Analyzed 46 participants 47 participants
46
 100.0%
45
  95.7%
Anti-HPV-18, 18-26-year, Month 6 Number Analyzed 118 participants 130 participants
117
  99.2%
121
  93.1%
Anti-HPV-18, 18-26-year, Month 7 Number Analyzed 118 participants 131 participants
118
 100.0%
131
 100.0%
Anti-HPV-18, 18-26-year, Month 12 Number Analyzed 112 participants 127 participants
112
 100.0%
122
  96.1%
Anti-HPV-18, 18-26-year, Month 18 Number Analyzed 109 participants 114 participants
109
 100.0%
106
  93.0%
Anti-HPV-18, 18-26-year, Month 24 Number Analyzed 106 participants 109 participants
106
 100.0%
92
  84.4%
Anti-HPV-18, 18-26-year, Month 36 Number Analyzed 64 participants 76 participants
64
 100.0%
60
  78.9%
Anti-HPV-18, 18-26-year, Month 48 Number Analyzed 59 participants 70 participants
59
 100.0%
57
  81.4%
Anti-HPV-18, 18-26-year, Month 60 Number Analyzed 39 participants 52 participants
39
 100.0%
40
  76.9%
Anti-HPV-18, 27-35-year, Month 6 Number Analyzed 102 participants 100 participants
99
  97.1%
84
  84.0%
Anti-HPV-18, 27-35-year, Month 7 Number Analyzed 102 participants 101 participants
102
 100.0%
99
  98.0%
Anti-HPV-18, 27-35-year, Month 12 Number Analyzed 105 participants 102 participants
104
  99.0%
92
  90.2%
Anti-HPV-18, 27-35-year, Month 18 Number Analyzed 101 participants 99 participants
101
 100.0%
74
  74.7%
Anti-HPV-18, 27-35-year, Month 24 Number Analyzed 98 participants 94 participants
98
 100.0%
68
  72.3%
Anti-HPV-18, 27-35-year, Month 36 Number Analyzed 75 participants 61 participants
75
 100.0%
43
  70.5%
Anti-HPV-18, 27-35-year, Month 48 Number Analyzed 66 participants 59 participants
66
 100.0%
34
  57.6%
Anti-HPV-18, 27-35-year, Month 60 Number Analyzed 54 participants 36 participants
53
  98.1%
22
  61.1%
Anti-HPV-18, 36-45-year, Month 6 Number Analyzed 110 participants 89 participants
107
  97.3%
78
  87.6%
Anti-HPV-18, 36-45-year, Month 7 Number Analyzed 110 participants 91 participants
110
 100.0%
91
 100.0%
Anti-HPV-18, 36-45-year, Month 12 Number Analyzed 104 participants 91 participants
104
 100.0%
90
  98.9%
Anti-HPV-18, 36-45-year, Month 18 Number Analyzed 103 participants 91 participants
102
  99.0%
79
  86.8%
Anti-HPV-18, 36-45-year, Month 24 Number Analyzed 100 participants 88 participants
99
  99.0%
68
  77.3%
Anti-HPV-18, 36-45-year, Month 36 Number Analyzed 71 participants 61 participants
69
  97.2%
45
  73.8%
Anti-HPV-18, 36-45-year, Month 48 Number Analyzed 61 participants 61 participants
59
  96.7%
44
  72.1%
Anti-HPV-18, 36-45-year, Month 60 Number Analyzed 55 participants 51 participants
55
 100.0%
38
  74.5%
6.Secondary Outcome
Title Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Hide Description Cut-off values assessed were greater than or equal to 8 ELISA units per milliliter (EL.U/mL) for HPV-16 and greater than or equal to 7 EL.U/mL for HPV-18.
Time Frame At Month 6, 7, 12, 18, 24, 36, 48 and 60
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed by age group on subjects from the ATP cohort for immunogenicity who were seronegative (by ELISA) and DNA negative for the corresponding type at baseline.
Arm/Group Title Cervarix Group Gardasil Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Overall Number of Participants Analyzed 95 100
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-HPV-16, 18-26-year, Month 6 Number Analyzed 91 participants 85 participants
91
 100.0%
85
 100.0%
Anti-HPV-16, 18-26-year, Month 7 Number Analyzed 91 participants 86 participants
91
 100.0%
86
 100.0%
Anti-HPV-16, 18-26-year, Month 12 Number Analyzed 87 participants 81 participants
87
 100.0%
81
 100.0%
Anti-HPV-16, 18-26-year, Month 18 Number Analyzed 84 participants 76 participants
84
 100.0%
76
 100.0%
Anti-HPV-16, 18-26-year, Month 24 Number Analyzed 81 participants 73 participants
81
 100.0%
73
 100.0%
Anti-HPV-16, 18-26-year, Month 36 Number Analyzed 50 participants 53 participants
50
 100.0%
53
 100.0%
Anti-HPV-16, 18-26-year, Month 48 Number Analyzed 46 participants 47 participants
46
 100.0%
47
 100.0%
Anti-HPV-16, 18-26-year, Month 60 Number Analyzed 31 participants 35 participants
31
 100.0%
35
 100.0%
Anti-HPV-16, 27-35-year, Month 6 Number Analyzed 57 participants 55 participants
57
 100.0%
55
 100.0%
Anti-HPV-16, 27-35-year, Month 7 Number Analyzed 57 participants 56 participants
57
 100.0%
56
 100.0%
Anti-HPV-16, 27-35-year, Month 12 Number Analyzed 57 participants 57 participants
57
 100.0%
57
 100.0%
Anti-HPV-16, 27-35-year, Month 18 Number Analyzed 54 participants 53 participants
54
 100.0%
53
 100.0%
Anti-HPV-16, 27-35-year, Month 24 Number Analyzed 52 participants 51 participants
52
 100.0%
51
 100.0%
Anti-HPV-16, 27-35-year, Month 36 Number Analyzed 41 participants 35 participants
41
 100.0%
35
 100.0%
Anti-HPV-16, 27-35-year, Month 48 Number Analyzed 37 participants 36 participants
37
 100.0%
36
 100.0%
Anti-HPV-16, 27-35-year, Month 60 Number Analyzed 28 participants 20 participants
28
 100.0%
20
 100.0%
Anti-HPV-16, 36-45-year, Month 6 Number Analyzed 64 participants 52 participants
64
 100.0%
52
 100.0%
Anti-HPV-16, 36-45-year, Month 7 Number Analyzed 64 participants 52 participants
64
 100.0%
52
 100.0%
Anti-HPV-16, 36-45-year, Month 12 Number Analyzed 59 participants 53 participants
59
 100.0%
53
 100.0%
Anti-HPV-16, 36-45-year, Month 18 Number Analyzed 61 participants 52 participants
61
 100.0%
52
 100.0%
Anti-HPV-16, 36-45-year, Month 24 Number Analyzed 58 participants 50 participants
58
 100.0%
50
 100.0%
Anti-HPV-16, 36-45-year, Month 36 Number Analyzed 42 participants 36 participants
42
 100.0%
36
 100.0%
Anti-HPV-16, 36-45-year, Month 48 Number Analyzed 35 participants 36 participants
35
 100.0%
36
 100.0%
Anti-HPV-16, 36-45-year, Month 60 Number Analyzed 31 participants 31 participants
31
 100.0%
31
 100.0%
Anti-HPV-18, 18-26-year, Month 6 Number Analyzed 95 participants 99 participants
95
 100.0%
99
 100.0%
Anti-HPV-18, 18-26-year, Month 7 Number Analyzed 95 participants 100 participants
95
 100.0%
100
 100.0%
Anti-HPV-18, 18-26-year, Month 12 Number Analyzed 92 participants 97 participants
92
 100.0%
97
 100.0%
Anti-HPV-18, 18-26-year, Month 18 Number Analyzed 90 participants 88 participants
90
 100.0%
87
  98.9%
Anti-HPV-18, 18-26-year, Month 24 Number Analyzed 87 participants 85 participants
87
 100.0%
82
  96.5%
Anti-HPV-18, 18-26-year, Month 36 Number Analyzed 49 participants 60 participants
49
 100.0%
59
  98.3%
Anti-HPV-18, 18-26-year, Month 48 Number Analyzed 47 participants 53 participants
47
 100.0%
52
  98.1%
Anti-HPV-18, 18-26-year, Month 60 Number Analyzed 31 participants 40 participants
31
 100.0%
38
  95.0%
Anti-HPV-18, 27-35-year, Month 6 Number Analyzed 71 participants 66 participants
71
 100.0%
66
 100.0%
Anti-HPV-18, 27-35-year, Month 7 Number Analyzed 71 participants 67 participants
71
 100.0%
67
 100.0%
Anti-HPV-18, 27-35-year, Month 12 Number Analyzed 72 participants 68 participants
72
 100.0%
68
 100.0%
Anti-HPV-18, 27-35-year, Month 18 Number Analyzed 69 participants 66 participants
69
 100.0%
64
  97.0%
Anti-HPV-18, 27-35-year, Month 24 Number Analyzed 68 participants 63 participants
68
 100.0%
61
  96.8%
Anti-HPV-18, 27-35-year, Month 36 Number Analyzed 54 participants 43 participants
54
 100.0%
41
  95.3%
Anti-HPV-18, 27-35-year, Month 48 Number Analyzed 50 participants 39 participants
50
 100.0%
36
  92.3%
Anti-HPV-18, 27-35-year, Month 60 Number Analyzed 39 participants 26 participants
39
 100.0%
23
  88.5%
Anti-HPV-18, 36-45-year, Month 6 Number Analyzed 74 participants 67 participants
74
 100.0%
67
 100.0%
Anti-HPV-18, 36-45-year, Month 7 Number Analyzed 74 participants 68 participants
74
 100.0%
68
 100.0%
Anti-HPV-18, 36-45-year, Month 12 Number Analyzed 69 participants 70 participants
69
 100.0%
70
 100.0%
Anti-HPV-18, 36-45-year, Month 18 Number Analyzed 69 participants 71 participants
69
 100.0%
71
 100.0%
Anti-HPV-18, 36-45-year, Month 24 Number Analyzed 67 participants 68 participants
67
 100.0%
67
  98.5%
Anti-HPV-18, 36-45-year, Month 36 Number Analyzed 51 participants 52 participants
51
 100.0%
51
  98.1%
Anti-HPV-18, 36-45-year, Month 48 Number Analyzed 43 participants 51 participants
43
 100.0%
51
 100.0%
Anti-HPV-18 36-45-year, Month 60 Number Analyzed 39 participants 43 participants
39
 100.0%
41
  95.3%
7.Secondary Outcome
Title Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Hide Description Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
Time Frame At Month 6, 7, 12, 18, 24, 36, 48 and 60
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed by age group on subjects from the ATP cohort for immunogenicity who were seronegative (by ELISA) and DNA negative for the corresponding type at baseline.
Arm/Group Title Cervarix Group Gardasil Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Overall Number of Participants Analyzed 95 100
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-HPV-16, 18-26-year, Month 6 Number Analyzed 91 participants 85 participants
827.7
(697.4 to 982.4)
889.3
(710.1 to 1113.9)
Anti-HPV-16, 18-26-year, Month 7 Number Analyzed 91 participants 86 participants
8864.0
(7251.6 to 10834.9)
3248.8
(2742.3 to 3848.8)
Anti-HPV-16, 18-26-year, Month 12 Number Analyzed 87 participants 81 participants
3332.8
(2645.1 to 4199.2)
1137.3
(924.6 to 1398.8)
Anti-HPV-16, 18-26-year, Month 18 Number Analyzed 84 participants 76 participants
2266.3
(1813.2 to 2832.6)
560.1
(434.3 to 722.3)
Anti-HPV-16, 18-26-year, Month 24 Number Analyzed 81 participants 73 participants
1771.9
(1424.4 to 2204.3)
419.7
(320.6 to 549.5)
Anti-HPV-16, 18-26-year, Month 36 Number Analyzed 50 participants 53 participants
1373.2
(1026.0 to 1837.8)
297.7
(214.9 to 412.3)
Anti-HPV-16, 18-26-year, Month 48 Number Analyzed 46 participants 47 participants
1169.1
(872.6 to 1566.4)
247.1
(174.0 to 350.9)
Anti-HPV-16, 18-26-year, Month 60 Number Analyzed 31 participants 35 participants
1196.8
(830.3 to 1725.1)
231.9
(153.7 to 349.9)
Anti-HPV-16, 27-35-year, Month 6 Number Analyzed 57 participants 55 participants
414.0
(313.1 to 547.4)
715.8
(551.0 to 930.1)
Anti-HPV-16, 27-35-year, Month 7 Number Analyzed 57 participants 56 participants
5076.9
(3998.4 to 6446.3)
2203.1
(1754.3 to 2766.8)
Anti-HPV-16, 27-35-year, Month 12 Number Analyzed 57 participants 57 participants
1978.0
(1513.8 to 2584.4)
769.2
(596.8 to 991.4)
Anti-HPV-16, 27-35-year, Month 18 Number Analyzed 54 participants 53 participants
1177.3
(892.3 to 1553.3)
384.0
(281.1 to 524.6)
Anti-HPV-16, 27-35-year, Month 24 Number Analyzed 52 participants 51 participants
932.8
(713.3 to 1219.8)
300.6
(217.1 to 416.3)
Anti-HPV-16, 27-35-year, Month 36 Number Analyzed 41 participants 35 participants
746.3
(559.1 to 996.3)
201.9
(141.6 to 287.9)
Anti-HPV-16, 27-35-year, Month 48 Number Analyzed 37 participants 36 participants
608.2
(453.8 to 815.0)
188.7
(131.8 to 270.1)
Anti-HPV-16, 27-35-year, Month 60 Number Analyzed 28 participants 20 participants
602.7
(427.6 to 849.4)
155.7
(100.4 to 241.6)
Anti-HPV-16, 36-45-year, Month 6 Number Analyzed 64 participants 52 participants
536.2
(401.8 to 715.5)
690.4
(531.9 to 896.0)
Anti-HPV-16, 36-45-year, Month 7 Number Analyzed 64 participants 52 participants
3789.2
(2996.7 to 4791.4)
2064.7
(1705.2 to 2500.0)
Anti-HPV-16, 36-45-year, Month 12 Number Analyzed 59 participants 53 participants
1521.7
(1169.1 to 1980.7)
722.2
(586.4 to 889.6)
Anti-HPV-16, 36-45-year, Month 18 Number Analyzed 61 participants 52 participants
905.0
(696.9 to 1175.4)
382.7
(294.5 to 497.4)
Anti-HPV-16, 36-45-year, Month 24 Number Analyzed 58 participants 50 participants
713.9
(543.9 to 936.9)
308.4
(242.2 to 392.7)
Anti-HPV-16, 36-45-year, Month 36 Number Analyzed 42 participants 36 participants
540.0
(369.2 to 789.8)
237.1
(175.0 to 321.2)
Anti-HPV-16, 36-45-year, Month 48 Number Analyzed 35 participants 36 participants
462.2
(311.4 to 685.8)
225.9
(169.6 to 301.0)
Anti-HPV-16, 36-45-year, Month 60 Number Analyzed 31 participants 31 participants
430.3
(300.1 to 617.1)
199.0
(145.6 to 272.0)
Anti-HPV-18, 18-26-year, Month 6 Number Analyzed 95 participants 99 participants
538.7
(442.6 to 655.9)
155.4
(128.5 to 188.0)
Anti-HPV-18, 18-26-year, Month 7 Number Analyzed 95 participants 100 participants
4246.6
(3537.2 to 5098.2)
756.8
(625.8 to 915.2)
Anti-HPV-18, 18-26-year, Month 12 Number Analyzed 92 participants 97 participants
1477.9
(1189.9 to 1835.6)
194.0
(157.3 to 239.4)
Anti-HPV-18, 18-26-year, Month 18 Number Analyzed 90 participants 88 participants
825.0
(650.3 to 1046.8)
89.6
(70.1 to 114.6)
Anti-HPV-18, 18-26-year, Month 24 Number Analyzed 87 participants 85 participants
649.2
(512.5 to 822.5)
70.1
(53.6 to 91.6)
Anti-HPV-18, 18-26-year, Month 36 Number Analyzed 49 participants 60 participants
582.1
(418.1 to 810.4)
61.5
(44.7 to 84.7)
Anti-HPV-18, 18-26-year, Month 48 Number Analyzed 47 participants 53 participants
449.7
(319.0 to 633.8)
55.1
(39.9 to 75.9)
Anti-HPV-18, 18-26-year, Month 60 Number Analyzed 31 participants 40 participants
451.8
(281.7 to 724.6)
49.6
(33.0 to 74.6)
Anti-HPV-18, 27-35-year, Month 6 Number Analyzed 71 participants 66 participants
314.6
(245.7 to 403.0)
128.6
(100.1 to 165.2)
Anti-HPV-18, 27-35-year, Month 7 Number Analyzed 71 participants 67 participants
2726.3
(2232.7 to 3329.0)
503.4
(395.4 to 640.9)
Anti-HPV-18, 27-35-year, Month 12 Number Analyzed 72 participants 68 participants
892.4
(716.1 to 1112.0)
130.4
(101.1 to 168.1)
Anti-HPV-18, 27-35-year, Month 18 Number Analyzed 69 participants 66 participants
501.2
(397.6 to 631.9)
55.0
(41.8 to 72.4)
Anti-HPV-18, 27-35-year, Month 24 Number Analyzed 68 participants 63 participants
390.5
(311.0 to 490.4)
46.4
(35.6 to 60.6)
Anti-HPV-18, 27-35-year, Month 36 Number Analyzed 54 participants 43 participants
341.7
(265.0 to 440.5)
39.2
(27.3 to 56.2)
Anti-HPV-18, 27-35-year, Month 48 Number Analyzed 50 participants 39 participants
304.7
(232.4 to 399.5)
30.6
(21.1 to 44.4)
Anti-HPV-18, 27-35-year, Month 60 Number Analyzed 39 participants 26 participants
231.8
(183.6 to 292.7)
30.9
(19.0 to 50.3)
Anti-HPV-18, 36-45-year, Month 6 Number Analyzed 74 participants 67 participants
331.1
(253.0 to 433.2)
131.3
(104.1 to 165.6)
Anti-HPV-18, 36-45-year, Month 7 Number Analyzed 74 participants 68 participants
2709.6
(2188.3 to 3355.1)
636.2
(511.5 to 791.2)
Anti-HPV-18, 36-45-year, Month 12 Number Analyzed 69 participants 70 participants
838.8
(650.5 to 1081.7)
185.0
(148.0 to 231.3)
Anti-HPV-18, 36-45-year, Month 18 Number Analyzed 69 participants 71 participants
454.8
(355.6 to 581.7)
85.8
(68.8 to 107.1)
Anti-HPV-18, 36-45-year, Month 24 Number Analyzed 67 participants 68 participants
345.2
(266.4 to 447.2)
66.9
(51.5 to 86.9)
Anti-HPV-18, 36-45-year, Month 36 Number Analyzed 51 participants 52 participants
276.8
(199.8 to 383.3)
53.5
(40.2 to 71.3)
Anti-HPV-18, 36-45-year, Month 48 Number Analyzed 43 participants 51 participants
231.2
(167.9 to 318.4)
47.8
(37.2 to 61.3)
Anti-HPV-18, 36-45-year, Month 60 Number Analyzed 39 participants 43 participants
242.2
(170.3 to 344.6)
41.0
(30.5 to 55.0)
8.Secondary Outcome
Title Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Hide Description Other oncogenic types include HPV-31 and HPV-45. Cut-off values assessed were greater than or equal 59 EL.U/mL in the sera of subjects seronegative before vaccination.
Time Frame At Month 6, 7, 12, 18, 24, 36 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed by age group on subjects from the ATP cohort for immunogenicity who were seronegative (by ELISA) and DNA negative for the corresponding type at baseline.
Arm/Group Title Cervarix Group Gardasil Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Overall Number of Participants Analyzed 109 111
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-HPV-31, 18-26-year, Month 6 Number Analyzed 98 participants 110 participants
75
  76.5%
104
  94.5%
Anti-HPV-31, 18-26-year, Month 7 Number Analyzed 98 participants 111 participants
98
 100.0%
111
 100.0%
Anti-HPV-31, 18-26-year, Month 12 Number Analyzed 94 participants 106 participants
89
  94.7%
103
  97.2%
Anti-HPV-31, 18-26-year, Month 18 Number Analyzed 92 participants 96 participants
80
  87.0%
71
  74.0%
Anti-HPV-31, 18-26-year, Month 24 Number Analyzed 90 participants 90 participants
77
  85.6%
62
  68.9%
Anti-HPV-31, 18-26-year, Month 36 Number Analyzed 54 participants 65 participants
44
  81.5%
42
  64.6%
Anti-HPV-31, 18-26-year, Month 48 Number Analyzed 49 participants 59 participants
37
  75.5%
32
  54.2%
Anti-HPV-31, 27-35-year, Month 6 Number Analyzed 82 participants 80 participants
42
  51.2%
76
  95.0%
Anti-HPV-31, 27-35-year, Month 7 Number Analyzed 82 participants 81 participants
80
  97.6%
81
 100.0%
Anti-HPV-31, 27-35-year, Month 12 Number Analyzed 82 participants 81 participants
72
  87.8%
80
  98.8%
Anti-HPV-31, 27-35-year, Month 18 Number Analyzed 80 participants 80 participants
52
  65.0%
53
  66.3%
Anti-HPV-31, 27-35-year, Month 24 Number Analyzed 75 participants 75 participants
50
  66.7%
48
  64.0%
Anti-HPV-31, 27-35-year, Month 36 Number Analyzed 56 participants 54 participants
30
  53.6%
29
  53.7%
Anti-HPV-31, 27-35-year, Month 48 Number Analyzed 51 participants 52 participants
22
  43.1%
23
  44.2%
Anti-HPV-31, 36-45-year, Month 6 Number Analyzed 78 participants 77 participants
45
  57.7%
70
  90.9%
Anti-HPV-31, 36-45-year, Month 7 Number Analyzed 78 participants 78 participants
76
  97.4%
78
 100.0%
Anti-HPV-31, 36-45-year, Month 18 Number Analyzed 71 participants 77 participants
48
  67.6%
56
  72.7%
Anti-HPV-31, 36-45-year, Month 12 Number Analyzed 75 participants 78 participants
69
  92.0%
75
  96.2%
Anti-HPV-31, 36-45-year, Month 24 Number Analyzed 69 participants 76 participants
49
  71.0%
51
  67.1%
Anti-HPV-31, 36-45-year, Month 36 Number Analyzed 51 participants 59 participants
33
  64.7%
38
  64.4%
Anti-HPV-31, 36-45-year, Month 48 Number Analyzed 39 participants 55 participants
20
  51.3%
32
  58.2%
Anti-HPV-45, 18-26-year, Month 6 Number Analyzed 109 participants 108 participants
95
  87.2%
104
  96.3%
Anti-HPV-45, 18-26-year, Month 7 Number Analyzed 109 participants 109 participants
109
 100.0%
109
 100.0%
Anti-HPV-45, 18-26-year, Month 12 Number Analyzed 103 participants 107 participants
101
  98.1%
105
  98.1%
Anti-HPV-45, 18-26-year, Month 18 Number Analyzed 102 participants 96 participants
90
  88.2%
77
  80.2%
Anti-HPV-45, 18-26-year, Month 24 Number Analyzed 100 participants 92 participants
89
  89.0%
68
  73.9%
Anti-HPV-45, 18-26-year, Month 36 Number Analyzed 59 participants 64 participants
50
  84.7%
46
  71.9%
Anti-HPV-45, 18-26-year, Month 48 Number Analyzed 53 participants 57 participants
37
  69.8%
34
  59.6%
Anti-HPV-45, 27-35-year, Month 6 Number Analyzed 86 participants 85 participants
62
  72.1%
83
  97.6%
Anti-HPV-45, 27-35-year, Month 7 Number Analyzed 86 participants 86 participants
85
  98.8%
86
 100.0%
Anti-HPV-45, 27-35-year, Month 12 Number Analyzed 89 participants 87 participants
81
  91.0%
84
  96.6%
Anti-HPV-45, 27-35-year, Month 18 Number Analyzed 85 participants 82 participants
68
  80.0%
64
  78.0%
Anti-HPV-45, 27-35-year, Month 24 Number Analyzed 83 participants 76 participants
68
  81.9%
56
  73.7%
Anti-HPV-45, 27-35-year, Month 36 Number Analyzed 65 participants 49 participants
45
  69.2%
29
  59.2%
Anti-HPV-45, 27-35-year, Month 48 Number Analyzed 59 participants 48 participants
36
  61.0%
21
  43.8%
Anti-HPV-45, 36-45-year, Month 6 Number Analyzed 84 participants 78 participants
58
  69.0%
76
  97.4%
Anti-HPV-45, 36-45-year, Month 7 Number Analyzed 84 participants 80 participants
83
  98.8%
80
 100.0%
Anti-HPV-45, 36-45-year, Month 12 Number Analyzed 78 participants 82 participants
73
  93.6%
80
  97.6%
Anti-HPV-45, 36-45-year, Month 18 Number Analyzed 79 participants 80 participants
56
  70.9%
67
  83.8%
Anti-HPV-45, 36-45-year, Month 24 Number Analyzed 74 participants 78 participants
51
  68.9%
61
  78.2%
Anti-HPV-45, 36-45-year, Month 36 Number Analyzed 56 participants 60 participants
31
  55.4%
41
  68.3%
Anti-HPV-45, 36-45-year, Month 48 Number Analyzed 46 participants 58 participants
28
  60.9%
32
  55.2%
9.Secondary Outcome
Title Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Hide Description Other oncogenic types include HPV-31 and HPV-45. Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
Time Frame At Month 6, 7, 12, 18, 24, 36 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed by age group on subjects from the ATP cohort for immunogenicity who were seronegative (by ELISA) and DNA negative for the corresponding type at baseline.
Arm/Group Title Cervarix Group Gardasil Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Overall Number of Participants Analyzed 109 111
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-HPV-31, 18-26-year, Month 6 Number Analyzed 98 participants 110 participants
108.5
(89.0 to 132.2)
230.0
(191.7 to 276.0)
Anti-HPV-31, 18-26-year, Month 7 Number Analyzed 98 participants 111 participants
1245.8
(1013.0 to 1532.1)
865.9
(734.9 to 1020.2)
Anti-HPV-31, 18-26-year, Month 12 Number Analyzed 94 participants 106 participants
357.0
(280.6 to 454.3)
265.0
(221.9 to 316.4)
Anti-HPV-31, 18-26-year, Month 18 Number Analyzed 92 participants 96 participants
231.3
(180.8 to 295.8)
115.1
(93.4 to 141.9)
Anti-HPV-31, 18-26-year, Month 24 Number Analyzed 90 participants 90 participants
214.8
(167.5 to 275.3)
108.6
(86.0 to 137.1)
Anti-HPV-31, 18-26-year, Month 36 Number Analyzed 54 participants 65 participants
169.2
(125.4 to 228.3)
94.0
(73.5 to 120.4)
Anti-HPV-31, 18-26-year, Month 48 Number Analyzed 49 participants 59 participants
124.7
(91.8 to 169.4)
75.7
(58.2 to 98.4)
Anti-HPV-31, 27-35-year, Month 6 Number Analyzed 82 participants 80 participants
69.1
(55.1 to 86.8)
235.9
(188.0 to 296.0)
Anti-HPV-31, 27-35-year, Month 7 Number Analyzed 82 participants 81 participants
588.5
(462.7 to 748.4)
602.7
(500.0 to 726.4)
Anti-HPV-31, 27-35-year, Month 12 Number Analyzed 82 participants 81 participants
166.5
(130.3 to 212.8)
217.8
(180.4 to 262.9)
Anti-HPV-31, 27-35-year, Month 18 Number Analyzed 80 participants 80 participants
106.0
(81.4 to 138.0)
95.6
(75.8 to 120.7)
Anti-HPV-31, 27-35-year, Month 24 Number Analyzed 75 participants 75 participants
99.1
(76.7 to 128.1)
86.7
(67.7 to 111.1)
Anti-HPV-31, 27-35-year, Month 36 Number Analyzed 56 participants 54 participants
74.5
(56.0 to 99.1)
69.2
(52.4 to 91.4)
Anti-HPV-31, 27-35-year, Month 48 Number Analyzed 51 participants 52 participants
64.4
(48.4 to 85.8)
59.8
(46.0 to 77.7)
Anti-HPV-31, 36-45-year, Month 6 Number Analyzed 78 participants 77 participants
88.4
(67.0 to 116.7)
223.8
(169.4 to 295.6)
Anti-HPV-31, 36-45-year, Month 7 Number Analyzed 78 participants 78 participants
687.5
(551.2 to 857.4)
649.6
(519.6 to 811.9)
Anti-HPV-31, 36-45-year, Month 12 Number Analyzed 75 participants 78 participants
197.1
(154.5 to 251.5)
243.5
(191.6 to 309.4)
Anti-HPV-31, 36-45-year, Month 18 Number Analyzed 71 participants 77 participants
109.5
(83.1 to 144.4)
122.9
(93.2 to 162.1)
Anti-HPV-31, 36-45-year, Month 24 Number Analyzed 69 participants 76 participants
108.8
(83.5 to 141.7)
110.6
(83.2 to 147.0)
Anti-HPV-31, 36-45-year, Month 36 Number Analyzed 51 participants 59 participants
94.4
(69.6 to 128.1)
92.8
(69.5 to 124.0)
Anti-HPV-31, 36-45-year, Month 48 Number Analyzed 39 participants 55 participants
67.4
(49.3 to 92.1)
71.8
(54.8 to 94.0)
Anti-HPV-45, 18-26-year, Month 6 Number Analyzed 109 participants 108 participants
155.4
(130.2 to 185.5)
242.6
(203.3 to 289.6)
Anti-HPV-45, 18-26-year, Month 7 Number Analyzed 109 participants 109 participants
1248.1
(1040.8 to 1496.6)
1103.5
(938.9 to 1296.9)
Anti-HPV-45, 18-26-year, Month 12 Number Analyzed 103 participants 107 participants
348.0
(283.2 to 427.7)
277.8
(235.3 to 328.0)
Anti-HPV-45, 18-26-year, Month 18 Number Analyzed 102 participants 96 participants
216.2
(170.6 to 273.9)
127.1
(103.6 to 155.9)
Anti-HPV-45, 18-26-year, Month 24 Number Analyzed 100 participants 92 participants
192.9
(154.4 to 240.8)
114.0
(91.7 to 141.7)
Anti-HPV-45, 18-26-year, Month 36 Number Analyzed 59 participants 64 participants
140.5
(106.7 to 184.9)
95.2
(76.5 to 118.6)
Anti-HPV-45, 18-26-year, Month 48 Number Analyzed 53 participants 57 participants
99.8
(74.3 to 134.0)
75.6
(57.6 to 99.4)
Anti-HPV-45, 27-35-year, Month 6 Number Analyzed 86 participants 85 participants
103.3
(82.1 to 130.0)
260.7
(212.4 to 319.9)
Anti-HPV-45, 27-35-year, Month 7 Number Analyzed 86 participants 86 participants
720.6
(579.2 to 896.6)
828.8
(695.6 to 987.3)
Anti-HPV-45, 27-35-year, Month 12 Number Analyzed 89 participants 87 participants
212.1
(168.9 to 266.3)
242.3
(201.2 to 291.8)
Anti-HPV-45, 27-35-year, Month 18 Number Analyzed 85 participants 82 participants
135.3
(106.5 to 171.9)
102.0
(84.0 to 123.9)
Anti-HPV-45, 27-35-year, Month 24 Number Analyzed 83 participants 76 participants
125.9
(101.3 to 156.5)
100.6
(79.1 to 127.9)
Anti-HPV-45, 27-35-year, Month 36 Number Analyzed 65 participants 49 participants
94.3
(73.9 to 120.5)
73.5
(56.0 to 96.5)
Anti-HPV-45, 27-35-year, Month 48 Number Analyzed 59 participants 48 participants
79.1
(61.3 to 102.0)
60.2
(45.9 to 78.9)
Anti-HPV-45, 36-45-year, Month 6 Number Analyzed 84 participants 78 participants
103.0
(80.8 to 131.4)
258.8
(204.7 to 327.3)
Anti-HPV-45, 36-45-year, Month 7 Number Analyzed 84 participants 80 participants
634.3
(506.1 to 795.0)
985.1
(803.8 to 1207.4)
Anti-HPV-45, 36-45-year, Month 12 Number Analyzed 78 participants 82 participants
196.3
(154.8 to 248.8)
298.2
(243.1 to 365.8)
Anti-HPV-45, 36-45-year, Month 18 Number Analyzed 79 participants 80 participants
121.7
(93.5 to 158.5)
141.6
(113.3 to 177.0)
Anti-HPV-45, 36-45-year, Month 24 Number Analyzed 74 participants 78 participants
114.1
(87.6 to 148.8)
122.7
(97.2 to 155.0)
Anti-HPV-45, 36-45-year, Month 36 Number Analyzed 56 participants 60 participants
85.5
(63.9 to 114.5)
94.7
(73.6 to 121.8)
Anti-HPV-45, 36-45-year, Month 48 Number Analyzed 46 participants 58 participants
82.8
(61.8 to 111.0)
74.3
(57.8 to 95.5)
10.Secondary Outcome
Title Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells
Hide Description Number of cells were expressed as geometric mean, minimum and maximum values of specific CD4 cells producing at least 2 cytokines (CD40 Ligand, Interleukin-2, Tumor Necrosis Factor Alpha or Interferon-gamma) per million of CD4 T-cells.
Time Frame At Month 7, 12, 18, 24, 36 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Results are presented by age group for subjects HPV-16/18 seronegative (by PSV neutralizing assay), DNA negative and HPV-16/18 specific T-cell negative (i.e., with < 500 cells/million cells at baseline) from a subset of the ATP cohort for immunogenicity.
Arm/Group Title Cervarix Group Gardasil Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Overall Number of Participants Analyzed 17 18
Geometric Mean (Full Range)
Unit of Measure: cells per million CD4 T-cells
HPV-16, 18-26-year, Month 7 Number Analyzed 12 participants 13 participants
1285.6
(695.0 to 3040.0)
729.1
(277.0 to 2515.0)
HPV-16, 18-26-year, Month 12 Number Analyzed 10 participants 9 participants
1087.6
(400.0 to 3203.0)
421.3
(187.0 to 1239.0)
HPV-16, 18-26-year, Month 18 Number Analyzed 14 participants 8 participants
1194.4
(508.0 to 3902.0)
309.0
(26.0 to 1281.0)
HPV-16, 18-26-year, Month 24 Number Analyzed 13 participants 8 participants
1195.9
(632.0 to 2979.0)
323.5
(72.0 to 919.0)
HPV-16, 18-26-year, Month 36 Number Analyzed 6 participants 6 participants
838.3
(379.0 to 1309.0)
399.9
(175.0 to 789.0)
HPV-16, 18-26-year, Month 48 Number Analyzed 3 participants 6 participants
1272.4
(994.0 to 1658.0)
388.6
(208.0 to 958.0)
HPV-16, 27-35-year, Month 7 Number Analyzed 15 participants 12 participants
990.7
(54.0 to 4231.0)
637.1
(172.0 to 1990.0)
HPV-16, 27-35-year, Month 12 Number Analyzed 13 participants 9 participants
664.1
(112.0 to 1762.0)
493.3
(227.0 to 1230.0)
HPV-16, 27-35-year, Month 18 Number Analyzed 13 participants 8 participants
1134.4
(425.0 to 2158.0)
448.0
(127.0 to 1478.0)
HPV-16, 27-35-year, Month 24 Number Analyzed 12 participants 6 participants
919.8
(120.0 to 2341.0)
373.0
(81.0 to 853.0)
HPV-16, 27-35-year, Month 36 Number Analyzed 7 participants 4 participants
431.0
(1.0 to 2912.0)
85.9
(1.0 to 607.0)
HPV-16, 27-35-year, Month 48 Number Analyzed 5 participants 4 participants
307.7
(1.0 to 1930.0)
560.8
(285.0 to 1482.0)
HPV-16, 36-45-year, Month 7 Number Analyzed 13 participants 8 participants
979.7
(227.0 to 2773.0)
609.8
(347.0 to 1320.0)
HPV-16, 36-45-year, Month 12 Number Analyzed 10 participants 9 participants
707.7
(200.0 to 1495.0)
431.3
(120.0 to 936.0)
HPV-16, 36-45-year, Month 18 Number Analyzed 13 participants 9 participants
1116.8
(266.0 to 2840.0)
446.1
(41.0 to 1610.0)
HPV-16, 36-45-year, Month 24 Number Analyzed 8 participants 6 participants
1118.9
(447.0 to 1940.0)
789.3
(570.0 to 1090.0)
HPV-16, 36-45-year, Month 36 Number Analyzed 7 participants 5 participants
710.5
(71.0 to 1698.0)
494.2
(336.0 to 1105.0)
HPV-16, 36-45-year, Month 48 Number Analyzed 5 participants 4 participants
1247.9
(597.0 to 2503.0)
642.4
(367.0 to 1422.0)
HPV-18, 18-26-year, Month 7 Number Analyzed 11 participants 18 participants
998.8
(439.0 to 2344.0)
594.9
(122.0 to 1783.0)
HPV-18, 18-26-year, Month 12 Number Analyzed 8 participants 13 participants
716.4
(238.0 to 1413.0)
192.3
(1.0 to 906.0)
HPV-18, 18-26-year, Month 18 Number Analyzed 13 participants 13 participants
844.3
(346.0 to 2492.0)
264.2
(1.0 to 1214.0)
HPV-18, 18-26-year, Month 24 Number Analyzed 11 participants 12 participants
793.0
(296.0 to 2051.0)
197.4
(1.0 to 625.0)
HPV-18, 18-26-year, Month 36 Number Analyzed 5 participants 9 participants
622.6
(311.0 to 920.0)
211.4
(68.0 to 557.0)
HPV-18, 18-26-year, Month 48 Number Analyzed 3 participants 9 participants
927.7
(819.0 to 1055.0)
162.1
(13.0 to 676.0)
HPV-18, 27-35-year, Month 7 Number Analyzed 17 participants 14 participants
924.3
(217.0 to 2589.0)
680.7
(133.0 to 2427.0)
HPV-18, 27-35-year, Month 12 Number Analyzed 16 participants 11 participants
416.5
(1.0 to 2239.0)
471.2
(133.0 to 1134.0)
HPV-18, 27-35-year, Month 18 Number Analyzed 14 participants 11 participants
710.8
(102.0 to 1879.0)
568.4
(106.0 to 1919.0)
HPV-18, 27-35-year, Month 24 Number Analyzed 15 participants 7 participants
575.6
(67.0 to 2113.0)
355.8
(114.0 to 826.0)
HPV-18, 27-35-year, Month 36 Number Analyzed 9 participants 4 participants
265.4
(1.0 to 1646.0)
206.2
(27.0 to 748.0)
HPV-18, 27-35-year, Month 48 Number Analyzed 6 participants 3 participants
643.7
(119.0 to 2032.0)
426.7
(242.0 to 1198.0)
HPV-18, 36-45-year, Month 7 Number Analyzed 14 participants 8 participants
815.6
(147.0 to 2983.0)
212.2
(1.0 to 1424.0)
HPV-18, 36-45-year, Month 12 Number Analyzed 13 participants 8 participants
384.3
(1.0 to 1521.0)
405.0
(123.0 to 1044.0)
HPV-18, 36-45-year, Month 18 Number Analyzed 14 participants 9 participants
949.0
(106.0 to 2746.0)
195.4
(1.0 to 1204.0)
HPV-18, 36-45-year, Month 24 Number Analyzed 9 participants 6 participants
807.2
(327.0 to 1616.0)
520.5
(220.0 to 717.0)
HPV-18, 36-45-year, Month 36 Number Analyzed 8 participants 4 participants
337.4
(7.0 to 1293.0)
392.1
(203.0 to 772.0)
HPV-18, 36-45-year, Month 48 Number Analyzed 5 participants 3 participants
764.0
(231.0 to 2068.0)
612.2
(389.0 to 778.0)
11.Secondary Outcome
Title Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells
Hide Description

Data were expressed as geometric mean, minimum and maximum values of specific CD8 cells producing at least 2 cytokines (CD40 Ligand, Interleukin-2, Tumor Necrosis Factor Alpha or Interferon-gamma) per million of CD8 T-cells.

Analyses for further time points were not performed, as there was no response at these time points.

Time Frame At Month 7, 12 and 18
Hide Outcome Measure Data
Hide Analysis Population Description
Results are presented by age group for subjects HPV-16/18 seronegative (by PSV neutralizing assay), DNA negative and HPV-16/18 specific T-cell negative (i.e., with < 200 cells/million cells at baseline) from a subset of the ATP cohort for immunogenicity.
Arm/Group Title Cervarix Group Gardasil Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Overall Number of Participants Analyzed 24 23
Geometric Mean (Full Range)
Unit of Measure: cells per million CD8 T-cells
HPV-16, 18-26-year, Month 7 Number Analyzed 15 participants 21 participants
5.3
(1.0 to 258.0)
3.2
(1.0 to 107.0)
HPV-16, 18-26-year, Month 12 Number Analyzed 17 participants 21 participants
4.0
(1.0 to 96.0)
2.8
(1.0 to 102.0)
HPV-16, 18-26-year, Month 18 Number Analyzed 23 participants 22 participants
3.5
(1.0 to 336.0)
4.5
(1.0 to 73.0)
HPV-16, 27-35-year, Month 7 Number Analyzed 21 participants 23 participants
2.5
(1.0 to 89.0)
5.1
(1.0 to 302.0)
HPV-16, 27-35-year, Month 12 Number Analyzed 22 participants 18 participants
5.0
(1.0 to 133.0)
3.8
(1.0 to 205.0)
HPV-16, 27-35-year, Month 18 Number Analyzed 22 participants 20 participants
2.4
(1.0 to 76.0)
8.6
(1.0 to 112.0)
HPV-16, 36-45-year, Month 7 Number Analyzed 23 participants 14 participants
3.0
(1.0 to 422.0)
6.1
(1.0 to 222.0)
HPV-16, 36-45-year, Month 12 Number Analyzed 19 participants 22 participants
4.6
(1.0 to 123.0)
4.0
(1.0 to 247.0)
HPV-16, 36-45-year, Month 18 Number Analyzed 24 participants 18 participants
4.1
(1.0 to 111.0)
8.9
(1.0 to 412.0)
HPV-18, 18-26-year, Month 7 Number Analyzed 16 participants 20 participants
9.3
(1.0 to 148.0)
3.0
(1.0 to 426.0)
HPV-18, 18-26-year, Month 12 Number Analyzed 17 participants 21 participants
4.6
(1.0 to 197.0)
3.4
(1.0 to 104.0)
HPV-18, 18-26-year, Month 18 Number Analyzed 23 participants 22 participants
4.1
(1.0 to 533.0)
4.3
(1.0 to 94.0)
HPV-18, 27-35-year, Month 7 Number Analyzed 21 participants 23 participants
2.6
(1.0 to 131.0)
3.6
(1.0 to 173.0)
HPV-18, 27-35-year, Month 12 Number Analyzed 22 participants 18 participants
3.5
(1.0 to 251.0)
4.6
(1.0 to 78.0)
HPV-18, 27-35-year, Month 18 Number Analyzed 22 participants 20 participants
3.1
(1.0 to 476.0)
7.1
(1.0 to 790.0)
HPV-18, 36-45-year, Month 7 Number Analyzed 22 participants 14 participants
9.2
(1.0 to 202.0)
3.4
(1.0 to 220.0)
HPV-18, 36-45-year, Month 12 Number Analyzed 19 participants 20 participants
2.4
(1.0 to 111.0)
6.8
(1.0 to 261.0)
HPV-18, 36-45-year, Month 18 Number Analyzed 23 participants 18 participants
6.3
(1.0 to 161.0)
4.5
(1.0 to 668.0)
12.Secondary Outcome
Title Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells
Hide Description HPV-16 and HPV-18 Specific Memory B Cells were measured by Enzyme-linked immunosorbent spot (ELISPOT) assay and expressed as geometric mean, minimum and maximum values of specific B-cells per million of cells.
Time Frame At Month 7, 12, 18, 24, 36 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Results are presented by age group in subjects with detectable B-cells (>0) at defined time points, who were HPV-16/18 seronegative (by PSV neutralizing assay), DNA negative and HPV-16/18 specific B-cell negative at baseline from a subset of the ATP cohort for immunogenicity.
Arm/Group Title Cervarix Group Gardasil Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Overall Number of Participants Analyzed 19 15
Geometric Mean (Full Range)
Unit of Measure: cells per million B-cells
HPV-16, 18-26-year, Month 7 Number Analyzed 13 participants 13 participants
700.7
(223.0 to 3515.0)
358.5
(22.0 to 2802.0)
HPV-16, 18-26-year, Month 12 Number Analyzed 12 participants 6 participants
344.1
(93.0 to 1068.0)
192.3
(77.0 to 463.0)
HPV-16, 18-26-year, Month 18 Number Analyzed 13 participants 5 participants
262.1
(51.0 to 1067.0)
325.2
(35.0 to 1868.0)
HPV-16, 18-26-year, Month 24 Number Analyzed 10 participants 4 participants
233.5
(59.0 to 1777.0)
440.0
(30.0 to 1751.0)
HPV-16, 18-26-year, Month 36 Number Analyzed 4 participants 2 participants
207.7
(39.0 to 586.0)
505.4
(445.0 to 574.0)
HPV-16, 18-26-year, Month 48 Number Analyzed 3 participants 3 participants
219.7
(60.0 to 657.0)
130.0
(54.0 to 515.0)
HPV-16, 27-35-year, Month 7 Number Analyzed 17 participants 15 participants
898.0
(111.0 to 5058.0)
253.5
(62.0 to 767.0)
HPV-16, 27-35-year, Month 12 Number Analyzed 15 participants 12 participants
237.6
(27.0 to 2910.0)
202.8
(38.0 to 655.0)
HPV-16, 27-35-year, Month 18 Number Analyzed 14 participants 7 participants
216.5
(47.0 to 1846.0)
194.3
(94.0 to 816.0)
HPV-16, 27-35-year, Month 24 Number Analyzed 11 participants 8 participants
279.1
(49.0 to 962.0)
141.2
(29.0 to 715.0)
HPV-16, 27-35-year, Month 36 Number Analyzed 4 participants 6 participants
506.5
(270.0 to 1438.0)
142.1
(43.0 to 290.0)
HPV-16, 27-35-year, Month 48 Number Analyzed 4 participants 3 participants
354.3
(72.0 to 3847.0)
358.0
(251.0 to 456.0)
HPV-16, 36-45-year, Month 7 Number Analyzed 15 participants 7 participants
1476.0
(349.0 to 19927.0)
539.3
(114.0 to 7359.0)
HPV-16, 36-45-year, Month 12 Number Analyzed 13 participants 7 participants
363.7
(69.0 to 1549.0)
270.8
(37.0 to 2238.0)
HPV-16, 36-45-year, Month 18 Number Analyzed 12 participants 5 participants
301.3
(43.0 to 2053.0)
210.2
(156.0 to 264.0)
HPV-16, 36-45-year, Month 24 Number Analyzed 9 participants 4 participants
492.1
(133.0 to 1708.0)
338.0
(77.0 to 808.0)
HPV-16, 36-45-year, Month 36 Number Analyzed 3 participants 3 participants
503.9
(190.0 to 1052.0)
192.9
(118.0 to 468.0)
HPV-16, 36-45-year, Month 48 Number Analyzed 3 participants 1 participants
364.8
(127.0 to 741.0)
738.0
(738.0 to 738.0)
HPV-18, 18-26-year, Month 7 Number Analyzed 10 participants 14 participants
313.2
(41.0 to 792.0)
163.9
(22.0 to 630.0)
HPV-18, 18-26-year, Month 12 Number Analyzed 10 participants 6 participants
152.5
(30.0 to 918.0)
63.8
(28.0 to 181.0)
HPV-18, 18-26-year, Month 18 Number Analyzed 10 participants 8 participants
137.3
(31.0 to 1677.0)
76.4
(19.0 to 479.0)
HPV-18, 18-26-year, Month 24 Number Analyzed 9 participants 9 participants
255.5
(36.0 to 1456.0)
101.0
(34.0 to 668.0)
HPV-18, 18-26-year, Month 36 Number Analyzed 3 participants 3 participants
391.0
(87.0 to 2781.0)
114.1
(36.0 to 779.0)
HPV-18, 18-26-year, Month 48 Number Analyzed 3 participants 4 participants
124.7
(46.0 to 214.0)
118.0
(46.0 to 347.0)
HPV-18, 27-35-year, Month 7 Number Analyzed 18 participants 10 participants
433.4
(32.0 to 3375.0)
153.7
(42.0 to 530.0)
HPV-18, 27-35-year, Month 12 Number Analyzed 15 participants 7 participants
172.4
(10.0 to 972.0)
130.4
(20.0 to 409.0)
HPV-18, 27-35-year, Month 18 Number Analyzed 13 participants 6 participants
202.5
(28.0 to 869.0)
74.7
(15.0 to 710.0)
HPV-18, 27-35-year, Month 24 Number Analyzed 12 participants 4 participants
151.6
(14.0 to 606.0)
97.0
(45.0 to 226.0)
HPV-18, 27-35-year, Month 36 Number Analyzed 5 participants 4 participants
161.9
(53.0 to 629.0)
224.2
(47.0 to 829.0)
HPV-18, 27-35-year, Month 48 Number Analyzed 5 participants 3 participants
366.4
(13.0 to 2167.0)
134.2
(104.0 to 157.0)
HPV-18, 36-45-year, Month 7 Number Analyzed 19 participants 7 participants
785.7
(85.0 to 7635.0)
192.5
(76.0 to 517.0)
HPV-18, 36-45-year, Month 12 Number Analyzed 12 participants 4 participants
459.8
(110.0 to 2653.0)
242.8
(116.0 to 664.0)
HPV-18, 36-45-year, Month 18 Number Analyzed 12 participants 5 participants
436.9
(93.0 to 1753.0)
91.5
(23.0 to 349.0)
HPV-18, 36-45-year, Month 24 Number Analyzed 8 participants 5 participants
576.8
(154.0 to 1873.0)
106.6
(61.0 to 171.0)
HPV-18, 36-45-year, Month 36 Number Analyzed 4 participants 1 participants
376.6
(95.0 to 1161.0)
23.0
(23.0 to 23.0)
HPV-18, 36-45-year, Month 48 Number Analyzed 3 participants 2 participants
302.4
(190.0 to 543.0)
91.7
(69.0 to 122.0)
13.Secondary Outcome
Title Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS)
Hide Description Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
Time Frame At Month 7, 12, 18, 24, 36 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were done on those subjects from the ATP cohort for immunogenicity for whom CVS samples with less than 200 erythrocytes per microliter were available.
Arm/Group Title Cervarix Group Gardasil Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Overall Number of Participants Analyzed 51 57
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-HPV-16, Month 7 Number Analyzed 48 participants 57 participants
168.9
(114.4 to 249.4)
90.7
(62.6 to 131.6)
Anti-HPV-16, Month 12 Number Analyzed 51 participants 46 participants
129.7
(89.6 to 187.8)
46.8
(33.0 to 66.5)
Anti-HPV-16, Month 18 Number Analyzed 42 participants 43 participants
96.0
(64.8 to 142.3)
52.8
(35.6 to 78.3)
Anti-HPV-16, Month 24 Number Analyzed 45 participants 43 participants
85.0
(57.9 to 124.8)
45.1
(27.0 to 75.2)
Anti-HPV-16, Month 36 Number Analyzed 50 participants 44 participants
57.1
(39.6 to 82.4)
48.8
(30.8 to 77.4)
Anti-HPV-16, Month 48 Number Analyzed 31 participants 36 participants
32.7
(22.7 to 47.1)
72.2
(34.4 to 151.3)
Anti-HPV-18, Month 7 Number Analyzed 48 participants 57 participants
88.6
(65.0 to 120.8)
43.4
(30.1 to 62.6)
Anti-HPV-18, Month 12 Number Analyzed 51 participants 47 participants
59.0
(42.5 to 81.9)
29.1
(18.6 to 45.3)
Anti-HPV-18, Month 18 Number Analyzed 42 participants 43 participants
33.2
(21.3 to 51.8)
16.4
(10.4 to 25.9)
Anti-HPV-18, Month 24 Number Analyzed 45 participants 43 participants
43.9
(28.1 to 68.8)
21.5
(10.5 to 44.3)
Anti-HPV-18, Month 36 Number Analyzed 50 participants 44 participants
24.3
(18.0 to 32.8)
23.3
(12.3 to 44.0)
Anti-HPV-18, Month 48 Number Analyzed 31 participants 36 participants
16.6
(10.3 to 26.7)
20.2
(12.5 to 32.8)
14.Secondary Outcome
Title Number of Subjects Completing the 3-dose Vaccination Schedule
Hide Description [Not Specified]
Time Frame Up to Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
The number of subjects completing the 3-dose vaccination schedule was defined as the number of subjects who received the 3 active doses (placebo administrations are not reflected).
Arm/Group Title Cervarix Group Gardasil Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Overall Number of Participants Analyzed 553 553
Measure Type: Count of Participants
Unit of Measure: Participants
468
  84.6%
467
  84.4%
15.Secondary Outcome
Title Number of Subjects Reporting 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 millimeters (mm) of injection site. All solicited local symptoms were assessed as related to study vaccination.
Time Frame During the 7-day period (Day 0-6) following vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
Arm/Group Title Cervarix Group Gardasil Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Overall Number of Participants Analyzed 524 524
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain
487
  92.9%
375
  71.6%
Any Redness
232
  44.3%
134
  25.6%
Any Swelling
191
  36.5%
114
  21.8%
Grade 3 Pain
91
  17.4%
18
   3.4%
Grade 3 Redness
3
   0.6%
0
   0.0%
Grade 3 Swelling
5
   1.0%
3
   0.6%
16.Secondary Outcome
Title Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Hide Description Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time Frame During the 7-day period (Day 0-6) following vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
Arm/Group Title Cervarix Group Gardasil Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Overall Number of Participants Analyzed 526 525
Measure Type: Count of Participants
Unit of Measure: Participants
Any Arthralgia
114
  21.7%
81
  15.4%
Any Fatigue
262
  49.8%
209
  39.8%
Any Fever
76
  14.4%
58
  11.0%
Any Gastrointestinal symptoms
172
  32.7%
139
  26.5%
Any Headache
250
  47.5%
220
  41.9%
Any Myalgia
145
  27.6%
103
  19.6%
Any Rash
25
   4.8%
18
   3.4%
Any Urticaria
26
   4.9%
21
   4.0%
Grade 3 Arthralgia
13
   2.5%
3
   0.6%
Grade 3 Fatigue
30
   5.7%
12
   2.3%
Grade 3 Fever
2
   0.4%
0
   0.0%
Grade 3 Gastrointestinal symptoms
10
   1.9%
12
   2.3%
Grade 3 Headache
19
   3.6%
20
   3.8%
Grade 3 Myalgia
10
   1.9%
8
   1.5%
Grade 3 Rash
0
   0.0%
1
   0.2%
Grade 3 Urticaria
1
   0.2%
2
   0.4%
Related Arthralgia
102
  19.4%
74
  14.1%
Related Fatigue
230
  43.7%
181
  34.5%
Related Fever
59
  11.2%
46
   8.8%
Related Gastrointestinal symptoms
134
  25.5%
106
  20.2%
Related Headache
209
  39.7%
187
  35.6%
Related Myalgia
132
  25.1%
90
  17.1%
Related Rash
19
   3.6%
11
   2.1%
Related Urticaria
24
   4.6%
15
   2.9%
17.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Hide Description Unsolicited AE covers any AE 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.Grade 3 AE = AE that prevented normal activity. Related AE = AE assessed by the investigator as causally related to the study vaccination.
Time Frame During the 30-day period (Day 0-29) following vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
Arm/Group Title Cervarix Group Gardasil Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Overall Number of Participants Analyzed 553 553
Measure Type: Count of Participants
Unit of Measure: Participants
Any AEs
235
  42.5%
202
  36.5%
Grade 3 AEs
41
   7.4%
37
   6.7%
Related AEs
70
  12.7%
63
  11.4%
18.Secondary Outcome
Title Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)
Hide Description NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSCs 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 Up to Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
Arm/Group Title Cervarix Group Gardasil Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Overall Number of Participants Analyzed 553 553
Measure Type: Count of Participants
Unit of Measure: Participants
NOCD(s)
14
   2.5%
13
   2.4%
MSC(s)
164
  29.7%
148
  26.8%
19.Secondary Outcome
Title Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)
Hide Description NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. 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 Up To Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
Arm/Group Title Cervarix Group Gardasil Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Gardasil Group Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Overall Number of Participants Analyzed 553 553
Measure Type: Count of Participants
Unit of Measure: Participants
NOCD(s)
14
   2.5%
17
   3.1%
MSC(s)
181
  32.7%
168
  30.4%
20.Secondary Outcome
Title Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)
Hide Description NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. 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 Up To Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
Arm/Group Title Cervarix Group Gardasil Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Overall Number of Participants Analyzed 553 553
Measure Type: Count of Participants
Unit of Measure: Participants
NOCD(s)
20
   3.6%
21
   3.8%
MSC(s)
210
  38.0%
185
  33.5%
21.Secondary Outcome
Title Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)
Hide Description NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. 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 Up To Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
Arm/Group Title Cervarix Group Gardasil Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Overall Number of Participants Analyzed 553 553
Measure Type: Count of Participants
Unit of Measure: Participants
NOCD(s)
20
   3.6%
21
   3.8%
MSC(s)
221
  40.0%
192
  34.7%
22.Secondary Outcome
Title Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)
Hide Description NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. 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 Up To Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
Arm/Group Title Cervarix Group Gardasil Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Overall Number of Participants Analyzed 553 553
Measure Type: Count of Participants
Unit of Measure: Participants
NOCD(s)
27
   4.9%
29
   5.2%
MSC(s)
239
  43.2%
205
  37.1%
23.Secondary Outcome
Title Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)
Hide Description NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSCs 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 Up to Month 48
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
Arm/Group Title Cervarix Group Gardasil Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Overall Number of Participants Analyzed 553 553
Measure Type: Count of Participants
Unit of Measure: Participants
NOCDs
33
   6.0%
33
   6.0%
MSCs
251
  45.4%
216
  39.1%
24.Secondary Outcome
Title Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)
Hide Description

NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSCs 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.

Note: NOCD and MSC cases were unblinded at the Month 60 analysis.

Time Frame Up to Month 60
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Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
Arm/Group Title Cervarix Group Gardasil Group
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Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Overall Number of Participants Analyzed 553 553
Measure Type: Count of Participants
Unit of Measure: Participants
Any NOCD(s)
39
   7.1%
43
   7.8%
Any MSC(s)
259
  46.8%
226
  40.9%
25.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)
Hide Description SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAEs was not assessed.
Time Frame Up to Month 7
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Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
Arm/Group Title Cervarix Group Gardasil Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Overall Number of Participants Analyzed 553 553
Measure Type: Count of Participants
Unit of Measure: Participants
Any SAE(s)
6
   1.1%
7
   1.3%
Related SAE(s)
1
   0.2%
1
   0.2%
26.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)
Hide Description SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAEs was not assessed.
Time Frame Up to Month 12
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Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
Arm/Group Title Cervarix Group Gardasil Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Overall Number of Participants Analyzed 553 553
Measure Type: Count of Participants
Unit of Measure: Participants
Any SAE(s)
12
   2.2%
20
   3.6%
Related SAE(s)
1
   0.2%
1
   0.2%
27.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)
Hide Description SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAEs was not assessed.
Time Frame Up to Month 18
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Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
Arm/Group Title Cervarix Group Gardasil Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Overall Number of Participants Analyzed 553 553
Measure Type: Count of Participants
Unit of Measure: Participants
Any SAE(s)
14
   2.5%
20
   3.6%
Related SAE(s)
1
   0.2%
1
   0.2%
28.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)
Hide Description SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAEs was not assessed.
Time Frame Up to Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
Arm/Group Title Cervarix Group Gardasil Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Overall Number of Participants Analyzed 553 553
Measure Type: Count of Participants
Unit of Measure: Participants
Any SAE(s)
23
   4.2%
22
   4.0%
Related SAE(s)
1
   0.2%
1
   0.2%
29.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)
Hide Description SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAEs was not assessed.
Time Frame Up to Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
Arm/Group Title Cervarix Group Gardasil Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Overall Number of Participants Analyzed 553 553
Measure Type: Count of Participants
Unit of Measure: Participants
Any SAE(s)
30
   5.4%
28
   5.1%
Related SAE(s)
1
   0.2%
1
   0.2%
30.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)
Hide Description SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAEs was not assessed.
Time Frame Up to Month 48
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
Arm/Group Title Cervarix Group Gardasil Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Overall Number of Participants Analyzed 553 553
Measure Type: Count of Participants
Unit of Measure: Participants
Any SAE(s)
37
   6.7%
34
   6.1%
Related SAE(s)
1
   0.2%
1
   0.2%
31.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)
Hide Description

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAE(s) was not assessed.

Note: SAEs were unblinded at the Month 60 analysis.

Time Frame Up to Month 60
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
Arm/Group Title Cervarix Group Gardasil Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
Overall Number of Participants Analyzed 553 553
Measure Type: Count of Participants
Unit of Measure: Participants
Any SAE(s)
44
   8.0%
37
   6.7%
Related SAE(s)
1
   0.2%
1
   0.2%
Time Frame SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
Adverse Event Reporting Description AEs collected by systematic assessment are reported for subjects with a symptom diary card available. AEs collected non-systematically are reported for the Total Vaccinated Cohort.
 
Arm/Group Title Cervarix Group Gardasil Group
Hide Arm/Group Description Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm. Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
All-Cause Mortality
Cervarix Group Gardasil Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Cervarix Group Gardasil Group
Affected / at Risk (%) Affected / at Risk (%)
Total   44/553 (7.96%)   37/553 (6.69%) 
Cardiac disorders     
Postural orthostatic tachycardia syndrome * 1  0/553 (0.00%)  1/553 (0.18%) 
Supraventricular tachycardia * 1  0/553 (0.00%)  1/553 (0.18%) 
Congenital, familial and genetic disorders     
Arnold-Chiari malformation * 1  1/553 (0.18%)  0/553 (0.00%) 
Pyloric stenosis * 1  1/553 (0.18%)  0/553 (0.00%) 
Ear and labyrinth disorders     
Tinnitus * 1  1/553 (0.18%)  0/553 (0.00%) 
Gastrointestinal disorders     
Vomiting * 1  2/553 (0.36%)  0/553 (0.00%) 
Cyclic vomiting syndrome * 1  1/553 (0.18%)  0/553 (0.00%) 
Gastritis * 1  1/553 (0.18%)  0/553 (0.00%) 
Gastrooesophageal reflux disease * 1  1/553 (0.18%)  0/553 (0.00%) 
Haemorrhoids * 1  1/553 (0.18%)  0/553 (0.00%) 
Ileitis * 1  0/553 (0.00%)  1/553 (0.18%) 
Nausea * 1  1/553 (0.18%)  0/553 (0.00%) 
Pancreatitis * 1  1/553 (0.18%)  0/553 (0.00%) 
General disorders     
Chest pain * 1  1/553 (0.18%)  0/553 (0.00%) 
Non-cardiac chest pain * 1  1/553 (0.18%)  0/553 (0.00%) 
Hepatobiliary disorders     
Cholelithiasis * 1  2/553 (0.36%)  1/553 (0.18%) 
Cholecystitis acute * 1  3/553 (0.54%)  1/553 (0.18%) 
Cholecystitis * 1  1/553 (0.18%)  0/553 (0.00%) 
Hepatitis * 1  1/553 (0.18%)  0/553 (0.00%) 
Infections and infestations     
Appendicitis * 1  1/553 (0.18%)  2/553 (0.36%) 
Pneumonia * 1  2/553 (0.36%)  0/553 (0.00%) 
Cellulitis * 1  0/553 (0.00%)  1/553 (0.18%) 
Endometritis * 1  1/553 (0.18%)  0/553 (0.00%) 
Escherichia infection * 1  1/553 (0.18%)  0/553 (0.00%) 
Postoperative wound infection * 1  0/553 (0.00%)  1/553 (0.18%) 
Sepsis * 1  1/553 (0.18%)  0/553 (0.00%) 
Urinary tract infection * 1  1/553 (0.18%)  0/553 (0.00%) 
Injury, poisoning and procedural complications     
Ankle fracture * 1  1/553 (0.18%)  0/553 (0.00%) 
Fibula fracture * 1  0/553 (0.00%)  1/553 (0.18%) 
Intentional overdose * 1  1/553 (0.18%)  0/553 (0.00%) 
Road traffic accident * 1  0/553 (0.00%)  1/553 (0.18%) 
Spinal shock * 1  1/553 (0.18%)  0/553 (0.00%) 
Tibia fracture * 1  0/553 (0.00%)  1/553 (0.18%) 
Metabolism and nutrition disorders     
Dehydration * 1  1/553 (0.18%)  0/553 (0.00%) 
Hyperglycaemia * 1  0/553 (0.00%)  1/553 (0.18%) 
Hyponatraemia * 1  1/553 (0.18%)  0/553 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Uterine leiomyoma * 1  4/553 (0.72%)  3/553 (0.54%) 
Breast cancer in situ * 1  0/553 (0.00%)  1/553 (0.18%) 
Cervix carcinoma stage 0 * 1  0/553 (0.00%)  1/553 (0.18%) 
Malignant melanoma * 1  0/553 (0.00%)  1/553 (0.18%) 
Metastatic renal cell carcinoma * 1  1/553 (0.18%)  0/553 (0.00%) 
Thyroid cancer * 1  0/553 (0.00%)  1/553 (0.18%) 
Nervous system disorders     
Convulsion * 1  0/553 (0.00%)  1/553 (0.18%) 
Embolic cerebral infarction * 1  0/553 (0.00%)  1/553 (0.18%) 
Grand mal convulsion * 1  1/553 (0.18%)  0/553 (0.00%) 
Multiple sclerosis * 1  0/553 (0.00%)  1/553 (0.18%) 
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous complete * 1  1/553 (0.18%)  2/553 (0.36%) 
Abortion spontaneous * 1  7/553 (1.27%)  4/553 (0.72%) 
Abortion missed * 1  3/553 (0.54%)  2/553 (0.36%) 
Abortion spontaneous incomplete * 1  3/553 (0.54%)  2/553 (0.36%) 
Premature labour * 1  1/553 (0.18%)  1/553 (0.18%) 
Abortion incomplete * 1  1/553 (0.18%)  0/553 (0.00%) 
Ectopic pregnancy * 1  1/553 (0.18%)  0/553 (0.00%) 
Foetal death * 1  1/553 (0.18%)  0/553 (0.00%) 
Psychiatric disorders     
Anxiety * 1  1/553 (0.18%)  1/553 (0.18%) 
Major depression * 1  2/553 (0.36%)  0/553 (0.00%) 
Anorexia nervosa * 1  0/553 (0.00%)  1/553 (0.18%) 
Bipolar I disorder * 1  1/553 (0.18%)  0/553 (0.00%) 
Reproductive system and breast disorders     
Menorrhagia * 1  2/553 (0.36%)  1/553 (0.18%) 
Ovarian cyst * 1  1/553 (0.18%)  1/553 (0.18%) 
Adenomyosis * 1  0/553 (0.00%)  1/553 (0.18%) 
Breast hyperplasia * 1  0/553 (0.00%)  1/553 (0.18%) 
Endometriosis * 1  0/553 (0.00%)  1/553 (0.18%) 
Pelvic pain * 1  1/553 (0.18%)  0/553 (0.00%) 
Uterine enlargement * 1  1/553 (0.18%)  0/553 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Bronchospasm * 1  0/553 (0.00%)  1/553 (0.18%) 
Status asthmaticus * 1  0/553 (0.00%)  1/553 (0.18%) 
Skin and subcutaneous tissue disorders     
Angioedema * 1  0/553 (0.00%)  1/553 (0.18%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cervarix Group Gardasil Group
Affected / at Risk (%) Affected / at Risk (%)
Total   500/553 (90.42%)   462/553 (83.54%) 
General disorders     
Pain  1  487/553 (88.07%)  375/553 (67.81%) 
Redness  1  232/553 (41.95%)  134/553 (24.23%) 
Swelling  1  191/553 (34.54%)  114/553 (20.61%) 
Arthralgia  1  114/553 (20.61%)  81/553 (14.65%) 
Fatigue  1  262/553 (47.38%)  209/553 (37.79%) 
Fever  1  76/553 (13.74%)  58/553 (10.49%) 
Gastrointestinal  1  172/553 (31.10%)  139/553 (25.14%) 
Headache  1  250/553 (45.21%)  220/553 (39.78%) 
Myalgia  1  145/553 (26.22%)  103/553 (18.63%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Publications:
Coursaget P et al. (2011) Priming as a basis for long-term protection and implications for HPV vaccination. Gynecologic Oncology. 121:S1-S9.
Coursaget P et al. (2011) Priming as a basis for long-term protection and implications for HPV vaccination. Gynecologic Oncology . 121:S1-S9.
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00423046    
Other Study ID Numbers: 108933
First Submitted: January 16, 2007
First Posted: January 17, 2007
Results First Submitted: November 12, 2009
Results First Posted: August 25, 2010
Last Update Posted: January 2, 2020