Trial Outcomes & Findings for Immunogenicity of GlaxoSmithKline Biological's Human Papillomavirus (HPV) Vaccine (580299) Versus Merck's Gardasil® in Healthy Females 18-45 Years of Age (NCT NCT00423046)
NCT ID: NCT00423046
Last Updated: 2020-01-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1106 participants
Primary outcome timeframe
At Month 7
Results posted on
2020-01-02
Participant Flow
Subjects who missed Month 7 visit and/or one or more follow-up visits were permitted to attend the next scheduled follow-up visits.
Participant milestones
| Measure |
Cervarix Group
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 Study
STARTED
|
553
|
553
|
|
Overall Study
COMPLETED
|
213
|
208
|
|
Overall Study
NOT COMPLETED
|
340
|
345
|
Reasons for withdrawal
| Measure |
Cervarix Group
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 Study
Other
|
340
|
345
|
Baseline Characteristics
Immunogenicity of GlaxoSmithKline Biological's Human Papillomavirus (HPV) Vaccine (580299) Versus Merck's Gardasil® in Healthy Females 18-45 Years of Age
Baseline characteristics by cohort
| Measure |
Cervarix Group
n=553 Participants
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
n=553 Participants
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
n=1106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.3 years
STANDARD_DEVIATION 8.02 • n=5 Participants
|
30.2 years
STANDARD_DEVIATION 7.78 • n=7 Participants
|
30.25 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
553 Participants
n=5 Participants
|
553 Participants
n=7 Participants
|
1106 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Month 7Population: 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.
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.
Outcome measures
| Measure |
Cervarix Group
n=118 Participants
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
n=131 Participants
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.
|
|---|---|---|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-16
|
36791.8 titer
Interval 29265.6 to 46253.6
|
10053.1 titer
Interval 8135.8 to 12422.1
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-18
|
16486.9 titer
Interval 13383.4 to 20310.1
|
2257.9 titer
Interval 1809.4 to 2817.7
|
SECONDARY outcome
Timeframe: At Month 6, 7, 12, 18, 24, 36, 48 and 60Population: 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.
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.
Outcome measures
| Measure |
Cervarix Group
n=118 Participants
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
n=130 Participants
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.
|
|---|---|---|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-18, 27-35-year, Month 18
|
1302.2 Titer
Interval 1011.3 to 1677.0
|
133.3 Titer
Interval 100.8 to 176.3
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-18, 27-35-year, Month 24
|
1028.4 Titer
Interval 801.4 to 1319.8
|
116.2 Titer
Interval 87.4 to 154.5
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-18, 27-35-year, Month 36
|
942.8 Titer
Interval 712.6 to 1247.3
|
101.9 Titer
Interval 69.6 to 149.2
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-18, 36-45-year, Month 6
|
618.8 Titer
Interval 446.6 to 857.4
|
168.7 Titer
Interval 126.9 to 224.3
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-18, 36-45-year, Month 7
|
9845.5 Titer
Interval 7834.7 to 12372.3
|
1438.8 Titer
Interval 1105.0 to 1873.4
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-18, 36-45-year, Month 12
|
3032.4 Titer
Interval 2320.8 to 3962.3
|
433.9 Titer
Interval 325.2 to 579.0
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-18, 36-45-year, Month 18
|
1426.7 Titer
Interval 1083.9 to 1877.9
|
181.5 Titer
Interval 136.8 to 240.8
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-18, 27-35-year, Month 48
|
982.4 Titer
Interval 741.4 to 1301.7
|
76.9 Titer
Interval 52.7 to 112.3
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-18, 27-35-year, Month 60
|
967.2 Titer
Interval 701.2 to 1334.1
|
74.4 Titer
Interval 46.8 to 118.2
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-18, 36-45-year, Month 24
|
1040.0 Titer
Interval 785.7 to 1376.6
|
135.8 Titer
Interval 99.0 to 186.2
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-18, 36-45-year, Month 36
|
903.5 Titer
Interval 625.1 to 1305.8
|
103.2 Titer
Interval 74.6 to 142.8
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-18, 36-45-year, Month 48
|
784.5 Titer
Interval 528.7 to 1164.2
|
91.5 Titer
Interval 67.0 to 125.0
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-18, 36-45-year, Month 60
|
816.6 Titer
Interval 554.7 to 1202.1
|
105.3 Titer
Interval 71.8 to 154.3
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-18, 18-26-year, Month 60
|
1522.9 Titer
Interval 968.2 to 2395.4
|
126.2 Titer
Interval 84.0 to 189.5
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-18, 27-35-year, Month 6
|
429.2 Titer
Interval 326.4 to 564.4
|
175.8 Titer
Interval 132.8 to 232.6
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-18, 27-35-year, Month 7
|
9501.6 Titer
Interval 7518.5 to 12007.7
|
1043.0 Titer
Interval 789.6 to 1377.7
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-18, 27-35-year, Month 12
|
2266.3 Titer
Interval 1764.8 to 2910.1
|
280.3 Titer
Interval 209.2 to 375.5
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-16, 18-26-year, Month 6
|
1627.9 Titer
Interval 1304.0 to 2032.3
|
1592.4 Titer
Interval 1204.3 to 2105.7
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-16, 18-26-year, Month 12
|
14524.7 Titer
Interval 11069.7 to 19058.0
|
3265.2 Titer
Interval 2544.7 to 4189.7
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-16, 18-26-year, Month 18
|
6000.3 Titer
Interval 4681.2 to 7691.0
|
1182.7 Titer
Interval 882.7 to 1584.8
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-16, 18-26-year, Month 24
|
5184.2 Titer
Interval 4015.0 to 6693.8
|
893.5 Titer
Interval 672.2 to 1187.9
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-16, 18-26-year, Month 36
|
3844.7 Titer
Interval 2803.6 to 5272.3
|
653.2 Titer
Interval 460.4 to 926.7
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-16, 18-26-year, Month 48
|
3900.9 Titer
Interval 2745.4 to 5542.6
|
750.4 Titer
Interval 505.1 to 1114.8
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-16, 18-26-year, Month 60
|
4117.8 Titer
Interval 2742.1 to 6183.7
|
529.8 Titer
Interval 343.2 to 817.9
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-16, 27-35-year, Month 6
|
1263.1 Titer
Interval 892.7 to 1787.2
|
1014.1 Titer
Interval 737.6 to 1394.1
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-16, 27-35-year, Month 7
|
23907.9 Titer
Interval 18912.7 to 30222.4
|
4958.4 Titer
Interval 3895.6 to 6311.2
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-16, 27-35-year, Month 12
|
7419.2 Titer
Interval 5592.1 to 9843.3
|
1755.9 Titer
Interval 1290.3 to 2389.7
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-16, 27-35-year, Month 18
|
2907.9 Titer
Interval 2229.2 to 3793.1
|
689.8 Titer
Interval 505.8 to 940.8
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-16, 27-35-year, Month 24
|
2269.2 Titer
Interval 1765.8 to 2916.2
|
618.8 Titer
Interval 447.4 to 856.0
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-16, 27-35-year, Month 36
|
1897.6 Titer
Interval 1418.9 to 2537.8
|
501.7 Titer
Interval 346.7 to 726.0
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-16, 27-35-year, Month 48
|
2046.3 Titer
Interval 1469.4 to 2849.8
|
677.6 Titer
Interval 433.0 to 1060.2
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-16, 27-35-year, Month 60
|
1925.3 Titer
Interval 1301.9 to 2847.4
|
346.4 Titer
Interval 214.9 to 558.4
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-16, 36-45-year, Month 6
|
1729.8 Titer
Interval 1214.8 to 2463.1
|
1916.5 Titer
Interval 1361.3 to 2698.2
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-16, 36-45-year, Month 7
|
17301.5 Titer
Interval 13605.3 to 22001.9
|
7634.4 Titer
Interval 5915.7 to 9852.5
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-16, 36-45-year, Month 12
|
7110.4 Titer
Interval 5386.3 to 9386.4
|
2678.2 Titer
Interval 1986.8 to 3610.2
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-16, 36-45-year, Month 18
|
2344.0 Titer
Interval 1807.7 to 3039.4
|
994.8 Titer
Interval 732.9 to 1350.4
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-16, 36-45-year, Month 24
|
2058.5 Titer
Interval 1592.2 to 2661.3
|
874.7 Titer
Interval 636.9 to 1201.3
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-16, 36-45-year, Month 36
|
1794.2 Titer
Interval 1278.1 to 2518.8
|
823.7 Titer
Interval 567.2 to 1196.1
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-16, 36-45-year, Month 48
|
2081.4 Titer
Interval 1378.1 to 3143.6
|
1018.7 Titer
Interval 645.3 to 1608.0
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-16, 36-45-year, Month 60
|
1784.5 Titer
Interval 1233.1 to 2582.6
|
764.9 Titer
Interval 468.3 to 1249.4
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-18, 18-26-year, Month 6
|
686.2 Titer
Interval 549.1 to 857.6
|
234.1 Titer
Interval 186.6 to 293.5
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-18, 18-26-year, Month 12
|
4472.4 Titer
Interval 3528.1 to 5669.3
|
595.8 Titer
Interval 469.0 to 756.9
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-18, 18-26-year, Month 18
|
2256.1 Titer
Interval 1761.5 to 2889.6
|
249.3 Titer
Interval 195.2 to 318.3
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-18, 18-26-year, Month 24
|
1652.0 Titer
Interval 1296.3 to 2105.4
|
175.1 Titer
Interval 132.8 to 230.8
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-18, 18-26-year, Month 36
|
1593.7 Titer
Interval 1177.2 to 2157.6
|
127.8 Titer
Interval 92.6 to 176.6
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies
Anti-HPV-18, 18-26-year, Month 48
|
1710.9 Titer
Interval 1179.5 to 2481.8
|
139.0 Titer
Interval 98.7 to 195.8
|
SECONDARY outcome
Timeframe: At Month 7Population: 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.
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.
Outcome measures
| Measure |
Cervarix Group
n=128 Participants
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
n=131 Participants
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.
|
|---|---|---|
|
Number of Subjects With Antibody Titers (Neutralizing Assay) Against Other Oncongenic HPV Types Greater Than or Equal to the Cut-off Value
Anti-HPV-45, 27-35-year
|
21 Participants
|
7 Participants
|
|
Number of Subjects With Antibody Titers (Neutralizing Assay) Against Other Oncongenic HPV Types Greater Than or Equal to the Cut-off Value
Anti-HPV-45, 36-45-year
|
28 Participants
|
10 Participants
|
|
Number of Subjects With Antibody Titers (Neutralizing Assay) Against Other Oncongenic HPV Types Greater Than or Equal to the Cut-off Value
Anti-HPV-31, 18-26-year
|
90 Participants
|
60 Participants
|
|
Number of Subjects With Antibody Titers (Neutralizing Assay) Against Other Oncongenic HPV Types Greater Than or Equal to the Cut-off Value
Anti-HPV-31, 27-35-year
|
59 Participants
|
32 Participants
|
|
Number of Subjects With Antibody Titers (Neutralizing Assay) Against Other Oncongenic HPV Types Greater Than or Equal to the Cut-off Value
Anti-HPV-31, 36-45-year
|
68 Participants
|
39 Participants
|
|
Number of Subjects With Antibody Titers (Neutralizing Assay) Against Other Oncongenic HPV Types Greater Than or Equal to the Cut-off Value
Anti-HPV-45, 18-26-year
|
35 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: At Month 7Population: 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.
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
Outcome measures
| Measure |
Cervarix Group
n=128 Participants
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
n=131 Participants
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.
|
|---|---|---|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Neutralization Assay
Anti-HPV-31, 18-26-year
|
387.3 titer
Interval 288.1 to 520.7
|
143.2 titer
Interval 110.4 to 185.8
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Neutralization Assay
Anti-HPV-31, 27-35-year
|
369.6 titer
Interval 271.0 to 504.2
|
191.8 titer
Interval 122.9 to 299.5
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Neutralization Assay
Anti-HPV-31, 36-45-year
|
231.0 titer
Interval 165.5 to 322.3
|
198.5 titer
Interval 142.5 to 276.6
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Neutralization Assay
Anti-HPV-45, 18-26-year
|
129.7 titer
Interval 87.7 to 191.7
|
86.5 titer
Interval 11.4 to 655.1
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Neutralization Assay
Anti-HPV-45, 27-35-year
|
144.1 titer
Interval 84.0 to 247.3
|
379.9 titer
Interval 90.4 to 1595.7
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Neutralization Assay
Anti-HPV-45, 36-45-year
|
157.6 titer
Interval 103.0 to 241.1
|
79.0 titer
Interval 56.3 to 110.9
|
SECONDARY outcome
Timeframe: At Month 6, 7, 12, 18, 24, 36, 48 and 60Population: 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.
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.
Outcome measures
| Measure |
Cervarix Group
n=118 Participants
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
n=131 Participants
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.
|
|---|---|---|
|
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
Anti-HPV-16, 18-26-year, Month 6
|
104 Participants
|
101 Participants
|
|
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
Anti-HPV-16, 18-26-year, Month 7
|
104 Participants
|
103 Participants
|
|
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
Anti-HPV-16, 18-26-year, Month 12
|
101 Participants
|
99 Participants
|
|
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
Anti-HPV-16, 18-26-year, Month 18
|
100 Participants
|
91 Participants
|
|
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
Anti-HPV-16, 18-26-year, Month 24
|
97 Participants
|
87 Participants
|
|
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
Anti-HPV-16, 18-26-year, Month 36
|
60 Participants
|
61 Participants
|
|
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
Anti-HPV-16, 18-26-year, Month 48
|
54 Participants
|
56 Participants
|
|
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
Anti-HPV-16, 18-26-year, Month 60
|
35 Participants
|
39 Participants
|
|
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
Anti-HPV-16, 27-35-year, Month 6
|
90 Participants
|
83 Participants
|
|
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
Anti-HPV-16, 27-35-year, Month 7
|
90 Participants
|
85 Participants
|
|
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
Anti-HPV-16, 27-35-year, Month 12
|
91 Participants
|
84 Participants
|
|
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
Anti-HPV-16, 27-35-year, Month 18
|
87 Participants
|
82 Participants
|
|
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
Anti-HPV-16, 27-35-year, Month 24
|
84 Participants
|
77 Participants
|
|
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
Anti-HPV-16, 27-35-year, Month 36
|
63 Participants
|
49 Participants
|
|
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
Anti-HPV-16, 27-35-year, Month 48
|
54 Participants
|
49 Participants
|
|
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
Anti-HPV-16, 27-35-year, Month 60
|
43 Participants
|
28 Participants
|
|
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
Anti-HPV-16, 36-45-year, Month 6
|
95 Participants
|
81 Participants
|
|
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
Anti-HPV-16, 36-45-year, Month 7
|
96 Participants
|
83 Participants
|
|
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
Anti-HPV-16, 36-45-year, Month 12
|
89 Participants
|
83 Participants
|
|
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
Anti-HPV-16, 36-45-year, Month 18
|
90 Participants
|
82 Participants
|
|
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
Anti-HPV-16, 36-45-year, Month 24
|
87 Participants
|
80 Participants
|
|
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
Anti-HPV-16, 36-45-year, Month 36
|
61 Participants
|
57 Participants
|
|
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
Anti-HPV-16, 36-45-year, Month 48
|
50 Participants
|
53 Participants
|
|
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
Anti-HPV-16, 36-45-year, Month 60
|
46 Participants
|
45 Participants
|
|
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
Anti-HPV-18, 18-26-year, Month 6
|
117 Participants
|
121 Participants
|
|
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
Anti-HPV-18, 18-26-year, Month 7
|
118 Participants
|
131 Participants
|
|
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
Anti-HPV-18, 18-26-year, Month 12
|
112 Participants
|
122 Participants
|
|
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
Anti-HPV-18, 18-26-year, Month 18
|
109 Participants
|
106 Participants
|
|
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
Anti-HPV-18, 18-26-year, Month 24
|
106 Participants
|
92 Participants
|
|
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
Anti-HPV-18, 18-26-year, Month 36
|
64 Participants
|
60 Participants
|
|
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
Anti-HPV-18, 18-26-year, Month 48
|
59 Participants
|
57 Participants
|
|
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
Anti-HPV-18, 18-26-year, Month 60
|
39 Participants
|
40 Participants
|
|
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
Anti-HPV-18, 27-35-year, Month 6
|
99 Participants
|
84 Participants
|
|
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
Anti-HPV-18, 27-35-year, Month 7
|
102 Participants
|
99 Participants
|
|
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
Anti-HPV-18, 27-35-year, Month 12
|
104 Participants
|
92 Participants
|
|
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
Anti-HPV-18, 27-35-year, Month 18
|
101 Participants
|
74 Participants
|
|
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
Anti-HPV-18, 27-35-year, Month 24
|
98 Participants
|
68 Participants
|
|
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
Anti-HPV-18, 27-35-year, Month 36
|
75 Participants
|
43 Participants
|
|
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
Anti-HPV-18, 27-35-year, Month 48
|
66 Participants
|
34 Participants
|
|
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
Anti-HPV-18, 27-35-year, Month 60
|
53 Participants
|
22 Participants
|
|
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
Anti-HPV-18, 36-45-year, Month 6
|
107 Participants
|
78 Participants
|
|
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
Anti-HPV-18, 36-45-year, Month 7
|
110 Participants
|
91 Participants
|
|
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
Anti-HPV-18, 36-45-year, Month 12
|
104 Participants
|
90 Participants
|
|
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
Anti-HPV-18, 36-45-year, Month 18
|
102 Participants
|
79 Participants
|
|
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
Anti-HPV-18, 36-45-year, Month 24
|
99 Participants
|
68 Participants
|
|
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
Anti-HPV-18, 36-45-year, Month 36
|
69 Participants
|
45 Participants
|
|
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
Anti-HPV-18, 36-45-year, Month 48
|
59 Participants
|
44 Participants
|
|
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
Anti-HPV-18, 36-45-year, Month 60
|
55 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: At Month 6, 7, 12, 18, 24, 36, 48 and 60Population: 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.
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.
Outcome measures
| Measure |
Cervarix Group
n=95 Participants
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
n=100 Participants
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.
|
|---|---|---|
|
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)
Anti-HPV-18, 27-35-year, Month 12
|
72 Participants
|
68 Participants
|
|
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)
Anti-HPV-18, 27-35-year, Month 18
|
69 Participants
|
64 Participants
|
|
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)
Anti-HPV-18, 27-35-year, Month 24
|
68 Participants
|
61 Participants
|
|
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)
Anti-HPV-18, 27-35-year, Month 36
|
54 Participants
|
41 Participants
|
|
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)
Anti-HPV-18, 27-35-year, Month 48
|
50 Participants
|
36 Participants
|
|
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)
Anti-HPV-18, 27-35-year, Month 60
|
39 Participants
|
23 Participants
|
|
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)
Anti-HPV-18, 36-45-year, Month 6
|
74 Participants
|
67 Participants
|
|
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)
Anti-HPV-18, 36-45-year, Month 7
|
74 Participants
|
68 Participants
|
|
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)
Anti-HPV-18, 36-45-year, Month 12
|
69 Participants
|
70 Participants
|
|
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)
Anti-HPV-18, 36-45-year, Month 18
|
69 Participants
|
71 Participants
|
|
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)
Anti-HPV-18, 36-45-year, Month 24
|
67 Participants
|
67 Participants
|
|
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)
Anti-HPV-18, 36-45-year, Month 36
|
51 Participants
|
51 Participants
|
|
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)
Anti-HPV-18, 36-45-year, Month 48
|
43 Participants
|
51 Participants
|
|
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)
Anti-HPV-18 36-45-year, Month 60
|
39 Participants
|
41 Participants
|
|
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)
Anti-HPV-16, 18-26-year, Month 6
|
91 Participants
|
85 Participants
|
|
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)
Anti-HPV-16, 18-26-year, Month 7
|
91 Participants
|
86 Participants
|
|
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)
Anti-HPV-16, 18-26-year, Month 12
|
87 Participants
|
81 Participants
|
|
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)
Anti-HPV-16, 18-26-year, Month 18
|
84 Participants
|
76 Participants
|
|
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)
Anti-HPV-16, 18-26-year, Month 24
|
81 Participants
|
73 Participants
|
|
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)
Anti-HPV-16, 18-26-year, Month 36
|
50 Participants
|
53 Participants
|
|
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)
Anti-HPV-16, 18-26-year, Month 48
|
46 Participants
|
47 Participants
|
|
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)
Anti-HPV-16, 18-26-year, Month 60
|
31 Participants
|
35 Participants
|
|
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)
Anti-HPV-16, 27-35-year, Month 6
|
57 Participants
|
55 Participants
|
|
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)
Anti-HPV-16, 27-35-year, Month 7
|
57 Participants
|
56 Participants
|
|
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)
Anti-HPV-16, 27-35-year, Month 12
|
57 Participants
|
57 Participants
|
|
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)
Anti-HPV-16, 27-35-year, Month 18
|
54 Participants
|
53 Participants
|
|
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)
Anti-HPV-16, 27-35-year, Month 24
|
52 Participants
|
51 Participants
|
|
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)
Anti-HPV-16, 27-35-year, Month 36
|
41 Participants
|
35 Participants
|
|
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)
Anti-HPV-16, 27-35-year, Month 48
|
37 Participants
|
36 Participants
|
|
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)
Anti-HPV-16, 27-35-year, Month 60
|
28 Participants
|
20 Participants
|
|
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)
Anti-HPV-16, 36-45-year, Month 6
|
64 Participants
|
52 Participants
|
|
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)
Anti-HPV-16, 36-45-year, Month 7
|
64 Participants
|
52 Participants
|
|
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)
Anti-HPV-16, 36-45-year, Month 12
|
59 Participants
|
53 Participants
|
|
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)
Anti-HPV-16, 36-45-year, Month 18
|
61 Participants
|
52 Participants
|
|
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)
Anti-HPV-16, 36-45-year, Month 24
|
58 Participants
|
50 Participants
|
|
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)
Anti-HPV-16, 36-45-year, Month 36
|
42 Participants
|
36 Participants
|
|
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)
Anti-HPV-16, 36-45-year, Month 48
|
35 Participants
|
36 Participants
|
|
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)
Anti-HPV-16, 36-45-year, Month 60
|
31 Participants
|
31 Participants
|
|
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)
Anti-HPV-18, 18-26-year, Month 6
|
95 Participants
|
99 Participants
|
|
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)
Anti-HPV-18, 18-26-year, Month 7
|
95 Participants
|
100 Participants
|
|
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)
Anti-HPV-18, 18-26-year, Month 12
|
92 Participants
|
97 Participants
|
|
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)
Anti-HPV-18, 18-26-year, Month 18
|
90 Participants
|
87 Participants
|
|
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)
Anti-HPV-18, 18-26-year, Month 24
|
87 Participants
|
82 Participants
|
|
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)
Anti-HPV-18, 18-26-year, Month 36
|
49 Participants
|
59 Participants
|
|
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)
Anti-HPV-18, 18-26-year, Month 48
|
47 Participants
|
52 Participants
|
|
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)
Anti-HPV-18, 18-26-year, Month 60
|
31 Participants
|
38 Participants
|
|
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)
Anti-HPV-18, 27-35-year, Month 6
|
71 Participants
|
66 Participants
|
|
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)
Anti-HPV-18, 27-35-year, Month 7
|
71 Participants
|
67 Participants
|
SECONDARY outcome
Timeframe: At Month 6, 7, 12, 18, 24, 36, 48 and 60Population: 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.
Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
Outcome measures
| Measure |
Cervarix Group
n=95 Participants
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
n=100 Participants
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.
|
|---|---|---|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-16, 18-26-year, Month 6
|
827.7 EL.U/mL
Interval 697.4 to 982.4
|
889.3 EL.U/mL
Interval 710.1 to 1113.9
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-16, 18-26-year, Month 7
|
8864.0 EL.U/mL
Interval 7251.6 to 10834.9
|
3248.8 EL.U/mL
Interval 2742.3 to 3848.8
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-16, 18-26-year, Month 12
|
3332.8 EL.U/mL
Interval 2645.1 to 4199.2
|
1137.3 EL.U/mL
Interval 924.6 to 1398.8
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-16, 18-26-year, Month 18
|
2266.3 EL.U/mL
Interval 1813.2 to 2832.6
|
560.1 EL.U/mL
Interval 434.3 to 722.3
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-16, 18-26-year, Month 24
|
1771.9 EL.U/mL
Interval 1424.4 to 2204.3
|
419.7 EL.U/mL
Interval 320.6 to 549.5
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-16, 18-26-year, Month 36
|
1373.2 EL.U/mL
Interval 1026.0 to 1837.8
|
297.7 EL.U/mL
Interval 214.9 to 412.3
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-16, 18-26-year, Month 48
|
1169.1 EL.U/mL
Interval 872.6 to 1566.4
|
247.1 EL.U/mL
Interval 174.0 to 350.9
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-16, 18-26-year, Month 60
|
1196.8 EL.U/mL
Interval 830.3 to 1725.1
|
231.9 EL.U/mL
Interval 153.7 to 349.9
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-16, 27-35-year, Month 6
|
414.0 EL.U/mL
Interval 313.1 to 547.4
|
715.8 EL.U/mL
Interval 551.0 to 930.1
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-16, 27-35-year, Month 7
|
5076.9 EL.U/mL
Interval 3998.4 to 6446.3
|
2203.1 EL.U/mL
Interval 1754.3 to 2766.8
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-16, 27-35-year, Month 12
|
1978.0 EL.U/mL
Interval 1513.8 to 2584.4
|
769.2 EL.U/mL
Interval 596.8 to 991.4
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-16, 27-35-year, Month 18
|
1177.3 EL.U/mL
Interval 892.3 to 1553.3
|
384.0 EL.U/mL
Interval 281.1 to 524.6
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-16, 27-35-year, Month 24
|
932.8 EL.U/mL
Interval 713.3 to 1219.8
|
300.6 EL.U/mL
Interval 217.1 to 416.3
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-16, 27-35-year, Month 36
|
746.3 EL.U/mL
Interval 559.1 to 996.3
|
201.9 EL.U/mL
Interval 141.6 to 287.9
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-16, 27-35-year, Month 48
|
608.2 EL.U/mL
Interval 453.8 to 815.0
|
188.7 EL.U/mL
Interval 131.8 to 270.1
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-16, 27-35-year, Month 60
|
602.7 EL.U/mL
Interval 427.6 to 849.4
|
155.7 EL.U/mL
Interval 100.4 to 241.6
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-16, 36-45-year, Month 6
|
536.2 EL.U/mL
Interval 401.8 to 715.5
|
690.4 EL.U/mL
Interval 531.9 to 896.0
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-16, 36-45-year, Month 7
|
3789.2 EL.U/mL
Interval 2996.7 to 4791.4
|
2064.7 EL.U/mL
Interval 1705.2 to 2500.0
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-16, 36-45-year, Month 12
|
1521.7 EL.U/mL
Interval 1169.1 to 1980.7
|
722.2 EL.U/mL
Interval 586.4 to 889.6
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-16, 36-45-year, Month 18
|
905.0 EL.U/mL
Interval 696.9 to 1175.4
|
382.7 EL.U/mL
Interval 294.5 to 497.4
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-16, 36-45-year, Month 24
|
713.9 EL.U/mL
Interval 543.9 to 936.9
|
308.4 EL.U/mL
Interval 242.2 to 392.7
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-16, 36-45-year, Month 36
|
540.0 EL.U/mL
Interval 369.2 to 789.8
|
237.1 EL.U/mL
Interval 175.0 to 321.2
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-16, 36-45-year, Month 48
|
462.2 EL.U/mL
Interval 311.4 to 685.8
|
225.9 EL.U/mL
Interval 169.6 to 301.0
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-16, 36-45-year, Month 60
|
430.3 EL.U/mL
Interval 300.1 to 617.1
|
199.0 EL.U/mL
Interval 145.6 to 272.0
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-18, 18-26-year, Month 6
|
538.7 EL.U/mL
Interval 442.6 to 655.9
|
155.4 EL.U/mL
Interval 128.5 to 188.0
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-18, 18-26-year, Month 7
|
4246.6 EL.U/mL
Interval 3537.2 to 5098.2
|
756.8 EL.U/mL
Interval 625.8 to 915.2
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-18, 18-26-year, Month 12
|
1477.9 EL.U/mL
Interval 1189.9 to 1835.6
|
194.0 EL.U/mL
Interval 157.3 to 239.4
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-18, 18-26-year, Month 18
|
825.0 EL.U/mL
Interval 650.3 to 1046.8
|
89.6 EL.U/mL
Interval 70.1 to 114.6
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-18, 18-26-year, Month 24
|
649.2 EL.U/mL
Interval 512.5 to 822.5
|
70.1 EL.U/mL
Interval 53.6 to 91.6
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-18, 18-26-year, Month 36
|
582.1 EL.U/mL
Interval 418.1 to 810.4
|
61.5 EL.U/mL
Interval 44.7 to 84.7
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-18, 18-26-year, Month 48
|
449.7 EL.U/mL
Interval 319.0 to 633.8
|
55.1 EL.U/mL
Interval 39.9 to 75.9
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-18, 18-26-year, Month 60
|
451.8 EL.U/mL
Interval 281.7 to 724.6
|
49.6 EL.U/mL
Interval 33.0 to 74.6
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-18, 27-35-year, Month 6
|
314.6 EL.U/mL
Interval 245.7 to 403.0
|
128.6 EL.U/mL
Interval 100.1 to 165.2
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-18, 27-35-year, Month 7
|
2726.3 EL.U/mL
Interval 2232.7 to 3329.0
|
503.4 EL.U/mL
Interval 395.4 to 640.9
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-18, 27-35-year, Month 12
|
892.4 EL.U/mL
Interval 716.1 to 1112.0
|
130.4 EL.U/mL
Interval 101.1 to 168.1
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-18, 27-35-year, Month 18
|
501.2 EL.U/mL
Interval 397.6 to 631.9
|
55.0 EL.U/mL
Interval 41.8 to 72.4
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-18, 27-35-year, Month 24
|
390.5 EL.U/mL
Interval 311.0 to 490.4
|
46.4 EL.U/mL
Interval 35.6 to 60.6
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-18, 27-35-year, Month 36
|
341.7 EL.U/mL
Interval 265.0 to 440.5
|
39.2 EL.U/mL
Interval 27.3 to 56.2
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-18, 27-35-year, Month 48
|
304.7 EL.U/mL
Interval 232.4 to 399.5
|
30.6 EL.U/mL
Interval 21.1 to 44.4
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-18, 27-35-year, Month 60
|
231.8 EL.U/mL
Interval 183.6 to 292.7
|
30.9 EL.U/mL
Interval 19.0 to 50.3
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-18, 36-45-year, Month 6
|
331.1 EL.U/mL
Interval 253.0 to 433.2
|
131.3 EL.U/mL
Interval 104.1 to 165.6
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-18, 36-45-year, Month 7
|
2709.6 EL.U/mL
Interval 2188.3 to 3355.1
|
636.2 EL.U/mL
Interval 511.5 to 791.2
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-18, 36-45-year, Month 12
|
838.8 EL.U/mL
Interval 650.5 to 1081.7
|
185.0 EL.U/mL
Interval 148.0 to 231.3
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-18, 36-45-year, Month 18
|
454.8 EL.U/mL
Interval 355.6 to 581.7
|
85.8 EL.U/mL
Interval 68.8 to 107.1
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-18, 36-45-year, Month 24
|
345.2 EL.U/mL
Interval 266.4 to 447.2
|
66.9 EL.U/mL
Interval 51.5 to 86.9
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-18, 36-45-year, Month 36
|
276.8 EL.U/mL
Interval 199.8 to 383.3
|
53.5 EL.U/mL
Interval 40.2 to 71.3
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-18, 36-45-year, Month 48
|
231.2 EL.U/mL
Interval 167.9 to 318.4
|
47.8 EL.U/mL
Interval 37.2 to 61.3
|
|
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-18, 36-45-year, Month 60
|
242.2 EL.U/mL
Interval 170.3 to 344.6
|
41.0 EL.U/mL
Interval 30.5 to 55.0
|
SECONDARY outcome
Timeframe: At Month 6, 7, 12, 18, 24, 36 and 48Population: 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.
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.
Outcome measures
| Measure |
Cervarix Group
n=109 Participants
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
n=111 Participants
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.
|
|---|---|---|
|
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)
Anti-HPV-31, 18-26-year, Month 6
|
75 Participants
|
104 Participants
|
|
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)
Anti-HPV-31, 18-26-year, Month 7
|
98 Participants
|
111 Participants
|
|
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)
Anti-HPV-31, 18-26-year, Month 12
|
89 Participants
|
103 Participants
|
|
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)
Anti-HPV-31, 18-26-year, Month 18
|
80 Participants
|
71 Participants
|
|
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)
Anti-HPV-31, 18-26-year, Month 24
|
77 Participants
|
62 Participants
|
|
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)
Anti-HPV-31, 18-26-year, Month 36
|
44 Participants
|
42 Participants
|
|
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)
Anti-HPV-31, 18-26-year, Month 48
|
37 Participants
|
32 Participants
|
|
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)
Anti-HPV-31, 27-35-year, Month 6
|
42 Participants
|
76 Participants
|
|
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)
Anti-HPV-31, 27-35-year, Month 7
|
80 Participants
|
81 Participants
|
|
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)
Anti-HPV-31, 27-35-year, Month 12
|
72 Participants
|
80 Participants
|
|
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)
Anti-HPV-31, 36-45-year, Month 12
|
69 Participants
|
75 Participants
|
|
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)
Anti-HPV-31, 36-45-year, Month 24
|
49 Participants
|
51 Participants
|
|
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)
Anti-HPV-31, 36-45-year, Month 36
|
33 Participants
|
38 Participants
|
|
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)
Anti-HPV-31, 36-45-year, Month 48
|
20 Participants
|
32 Participants
|
|
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)
Anti-HPV-45, 18-26-year, Month 6
|
95 Participants
|
104 Participants
|
|
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)
Anti-HPV-45, 18-26-year, Month 7
|
109 Participants
|
109 Participants
|
|
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)
Anti-HPV-45, 18-26-year, Month 12
|
101 Participants
|
105 Participants
|
|
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)
Anti-HPV-45, 18-26-year, Month 18
|
90 Participants
|
77 Participants
|
|
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)
Anti-HPV-45, 18-26-year, Month 24
|
89 Participants
|
68 Participants
|
|
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)
Anti-HPV-45, 18-26-year, Month 36
|
50 Participants
|
46 Participants
|
|
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)
Anti-HPV-45, 18-26-year, Month 48
|
37 Participants
|
34 Participants
|
|
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)
Anti-HPV-45, 27-35-year, Month 6
|
62 Participants
|
83 Participants
|
|
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)
Anti-HPV-45, 27-35-year, Month 7
|
85 Participants
|
86 Participants
|
|
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)
Anti-HPV-45, 27-35-year, Month 12
|
81 Participants
|
84 Participants
|
|
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)
Anti-HPV-45, 27-35-year, Month 18
|
68 Participants
|
64 Participants
|
|
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)
Anti-HPV-45, 27-35-year, Month 24
|
68 Participants
|
56 Participants
|
|
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)
Anti-HPV-45, 27-35-year, Month 36
|
45 Participants
|
29 Participants
|
|
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)
Anti-HPV-45, 27-35-year, Month 48
|
36 Participants
|
21 Participants
|
|
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)
Anti-HPV-45, 36-45-year, Month 6
|
58 Participants
|
76 Participants
|
|
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)
Anti-HPV-45, 36-45-year, Month 7
|
83 Participants
|
80 Participants
|
|
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)
Anti-HPV-45, 36-45-year, Month 12
|
73 Participants
|
80 Participants
|
|
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)
Anti-HPV-45, 36-45-year, Month 18
|
56 Participants
|
67 Participants
|
|
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)
Anti-HPV-45, 36-45-year, Month 24
|
51 Participants
|
61 Participants
|
|
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)
Anti-HPV-45, 36-45-year, Month 36
|
31 Participants
|
41 Participants
|
|
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)
Anti-HPV-45, 36-45-year, Month 48
|
28 Participants
|
32 Participants
|
|
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)
Anti-HPV-31, 27-35-year, Month 18
|
52 Participants
|
53 Participants
|
|
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)
Anti-HPV-31, 27-35-year, Month 24
|
50 Participants
|
48 Participants
|
|
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)
Anti-HPV-31, 27-35-year, Month 36
|
30 Participants
|
29 Participants
|
|
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)
Anti-HPV-31, 27-35-year, Month 48
|
22 Participants
|
23 Participants
|
|
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)
Anti-HPV-31, 36-45-year, Month 6
|
45 Participants
|
70 Participants
|
|
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)
Anti-HPV-31, 36-45-year, Month 7
|
76 Participants
|
78 Participants
|
|
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)
Anti-HPV-31, 36-45-year, Month 18
|
48 Participants
|
56 Participants
|
SECONDARY outcome
Timeframe: At Month 6, 7, 12, 18, 24, 36 and 48Population: 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.
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).
Outcome measures
| Measure |
Cervarix Group
n=109 Participants
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
n=111 Participants
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.
|
|---|---|---|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-31, 18-26-year, Month 6
|
108.5 EL.U/mL
Interval 89.0 to 132.2
|
230.0 EL.U/mL
Interval 191.7 to 276.0
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-31, 18-26-year, Month 7
|
1245.8 EL.U/mL
Interval 1013.0 to 1532.1
|
865.9 EL.U/mL
Interval 734.9 to 1020.2
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-31, 18-26-year, Month 12
|
357.0 EL.U/mL
Interval 280.6 to 454.3
|
265.0 EL.U/mL
Interval 221.9 to 316.4
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-31, 18-26-year, Month 18
|
231.3 EL.U/mL
Interval 180.8 to 295.8
|
115.1 EL.U/mL
Interval 93.4 to 141.9
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-31, 18-26-year, Month 24
|
214.8 EL.U/mL
Interval 167.5 to 275.3
|
108.6 EL.U/mL
Interval 86.0 to 137.1
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-31, 18-26-year, Month 36
|
169.2 EL.U/mL
Interval 125.4 to 228.3
|
94.0 EL.U/mL
Interval 73.5 to 120.4
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-31, 18-26-year, Month 48
|
124.7 EL.U/mL
Interval 91.8 to 169.4
|
75.7 EL.U/mL
Interval 58.2 to 98.4
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-31, 27-35-year, Month 6
|
69.1 EL.U/mL
Interval 55.1 to 86.8
|
235.9 EL.U/mL
Interval 188.0 to 296.0
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-31, 27-35-year, Month 7
|
588.5 EL.U/mL
Interval 462.7 to 748.4
|
602.7 EL.U/mL
Interval 500.0 to 726.4
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-31, 27-35-year, Month 12
|
166.5 EL.U/mL
Interval 130.3 to 212.8
|
217.8 EL.U/mL
Interval 180.4 to 262.9
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-31, 27-35-year, Month 18
|
106.0 EL.U/mL
Interval 81.4 to 138.0
|
95.6 EL.U/mL
Interval 75.8 to 120.7
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-31, 27-35-year, Month 24
|
99.1 EL.U/mL
Interval 76.7 to 128.1
|
86.7 EL.U/mL
Interval 67.7 to 111.1
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-31, 27-35-year, Month 36
|
74.5 EL.U/mL
Interval 56.0 to 99.1
|
69.2 EL.U/mL
Interval 52.4 to 91.4
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-31, 27-35-year, Month 48
|
64.4 EL.U/mL
Interval 48.4 to 85.8
|
59.8 EL.U/mL
Interval 46.0 to 77.7
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-31, 36-45-year, Month 6
|
88.4 EL.U/mL
Interval 67.0 to 116.7
|
223.8 EL.U/mL
Interval 169.4 to 295.6
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-31, 36-45-year, Month 7
|
687.5 EL.U/mL
Interval 551.2 to 857.4
|
649.6 EL.U/mL
Interval 519.6 to 811.9
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-31, 36-45-year, Month 12
|
197.1 EL.U/mL
Interval 154.5 to 251.5
|
243.5 EL.U/mL
Interval 191.6 to 309.4
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-31, 36-45-year, Month 18
|
109.5 EL.U/mL
Interval 83.1 to 144.4
|
122.9 EL.U/mL
Interval 93.2 to 162.1
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-31, 36-45-year, Month 24
|
108.8 EL.U/mL
Interval 83.5 to 141.7
|
110.6 EL.U/mL
Interval 83.2 to 147.0
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-31, 36-45-year, Month 36
|
94.4 EL.U/mL
Interval 69.6 to 128.1
|
92.8 EL.U/mL
Interval 69.5 to 124.0
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-31, 36-45-year, Month 48
|
67.4 EL.U/mL
Interval 49.3 to 92.1
|
71.8 EL.U/mL
Interval 54.8 to 94.0
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-45, 18-26-year, Month 6
|
155.4 EL.U/mL
Interval 130.2 to 185.5
|
242.6 EL.U/mL
Interval 203.3 to 289.6
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-45, 18-26-year, Month 7
|
1248.1 EL.U/mL
Interval 1040.8 to 1496.6
|
1103.5 EL.U/mL
Interval 938.9 to 1296.9
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-45, 18-26-year, Month 12
|
348.0 EL.U/mL
Interval 283.2 to 427.7
|
277.8 EL.U/mL
Interval 235.3 to 328.0
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-45, 18-26-year, Month 18
|
216.2 EL.U/mL
Interval 170.6 to 273.9
|
127.1 EL.U/mL
Interval 103.6 to 155.9
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-45, 18-26-year, Month 24
|
192.9 EL.U/mL
Interval 154.4 to 240.8
|
114.0 EL.U/mL
Interval 91.7 to 141.7
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-45, 18-26-year, Month 36
|
140.5 EL.U/mL
Interval 106.7 to 184.9
|
95.2 EL.U/mL
Interval 76.5 to 118.6
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-45, 18-26-year, Month 48
|
99.8 EL.U/mL
Interval 74.3 to 134.0
|
75.6 EL.U/mL
Interval 57.6 to 99.4
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-45, 27-35-year, Month 6
|
103.3 EL.U/mL
Interval 82.1 to 130.0
|
260.7 EL.U/mL
Interval 212.4 to 319.9
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-45, 27-35-year, Month 7
|
720.6 EL.U/mL
Interval 579.2 to 896.6
|
828.8 EL.U/mL
Interval 695.6 to 987.3
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-45, 27-35-year, Month 12
|
212.1 EL.U/mL
Interval 168.9 to 266.3
|
242.3 EL.U/mL
Interval 201.2 to 291.8
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-45, 27-35-year, Month 18
|
135.3 EL.U/mL
Interval 106.5 to 171.9
|
102.0 EL.U/mL
Interval 84.0 to 123.9
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-45, 27-35-year, Month 24
|
125.9 EL.U/mL
Interval 101.3 to 156.5
|
100.6 EL.U/mL
Interval 79.1 to 127.9
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-45, 27-35-year, Month 36
|
94.3 EL.U/mL
Interval 73.9 to 120.5
|
73.5 EL.U/mL
Interval 56.0 to 96.5
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-45, 27-35-year, Month 48
|
79.1 EL.U/mL
Interval 61.3 to 102.0
|
60.2 EL.U/mL
Interval 45.9 to 78.9
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-45, 36-45-year, Month 6
|
103.0 EL.U/mL
Interval 80.8 to 131.4
|
258.8 EL.U/mL
Interval 204.7 to 327.3
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-45, 36-45-year, Month 7
|
634.3 EL.U/mL
Interval 506.1 to 795.0
|
985.1 EL.U/mL
Interval 803.8 to 1207.4
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-45, 36-45-year, Month 12
|
196.3 EL.U/mL
Interval 154.8 to 248.8
|
298.2 EL.U/mL
Interval 243.1 to 365.8
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-45, 36-45-year, Month 18
|
121.7 EL.U/mL
Interval 93.5 to 158.5
|
141.6 EL.U/mL
Interval 113.3 to 177.0
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-45, 36-45-year, Month 24
|
114.1 EL.U/mL
Interval 87.6 to 148.8
|
122.7 EL.U/mL
Interval 97.2 to 155.0
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-45, 36-45-year, Month 36
|
85.5 EL.U/mL
Interval 63.9 to 114.5
|
94.7 EL.U/mL
Interval 73.6 to 121.8
|
|
Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Anti-HPV-45, 36-45-year, Month 48
|
82.8 EL.U/mL
Interval 61.8 to 111.0
|
74.3 EL.U/mL
Interval 57.8 to 95.5
|
SECONDARY outcome
Timeframe: At Month 7, 12, 18, 24, 36 and 48Population: 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.
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.
Outcome measures
| Measure |
Cervarix Group
n=17 Participants
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
n=18 Participants
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.
|
|---|---|---|
|
Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells
HPV-16, 18-26-year, Month 7
|
1285.6 cells per million CD4 T-cells
Interval 695.0 to 3040.0
|
729.1 cells per million CD4 T-cells
Interval 277.0 to 2515.0
|
|
Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells
HPV-16, 18-26-year, Month 12
|
1087.6 cells per million CD4 T-cells
Interval 400.0 to 3203.0
|
421.3 cells per million CD4 T-cells
Interval 187.0 to 1239.0
|
|
Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells
HPV-16, 18-26-year, Month 18
|
1194.4 cells per million CD4 T-cells
Interval 508.0 to 3902.0
|
309.0 cells per million CD4 T-cells
Interval 26.0 to 1281.0
|
|
Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells
HPV-16, 18-26-year, Month 24
|
1195.9 cells per million CD4 T-cells
Interval 632.0 to 2979.0
|
323.5 cells per million CD4 T-cells
Interval 72.0 to 919.0
|
|
Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells
HPV-16, 18-26-year, Month 36
|
838.3 cells per million CD4 T-cells
Interval 379.0 to 1309.0
|
399.9 cells per million CD4 T-cells
Interval 175.0 to 789.0
|
|
Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells
HPV-16, 18-26-year, Month 48
|
1272.4 cells per million CD4 T-cells
Interval 994.0 to 1658.0
|
388.6 cells per million CD4 T-cells
Interval 208.0 to 958.0
|
|
Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells
HPV-16, 27-35-year, Month 7
|
990.7 cells per million CD4 T-cells
Interval 54.0 to 4231.0
|
637.1 cells per million CD4 T-cells
Interval 172.0 to 1990.0
|
|
Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells
HPV-16, 27-35-year, Month 12
|
664.1 cells per million CD4 T-cells
Interval 112.0 to 1762.0
|
493.3 cells per million CD4 T-cells
Interval 227.0 to 1230.0
|
|
Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells
HPV-16, 27-35-year, Month 18
|
1134.4 cells per million CD4 T-cells
Interval 425.0 to 2158.0
|
448.0 cells per million CD4 T-cells
Interval 127.0 to 1478.0
|
|
Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells
HPV-16, 27-35-year, Month 24
|
919.8 cells per million CD4 T-cells
Interval 120.0 to 2341.0
|
373.0 cells per million CD4 T-cells
Interval 81.0 to 853.0
|
|
Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells
HPV-16, 27-35-year, Month 36
|
431.0 cells per million CD4 T-cells
Interval 1.0 to 2912.0
|
85.9 cells per million CD4 T-cells
Interval 1.0 to 607.0
|
|
Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells
HPV-16, 27-35-year, Month 48
|
307.7 cells per million CD4 T-cells
Interval 1.0 to 1930.0
|
560.8 cells per million CD4 T-cells
Interval 285.0 to 1482.0
|
|
Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells
HPV-16, 36-45-year, Month 7
|
979.7 cells per million CD4 T-cells
Interval 227.0 to 2773.0
|
609.8 cells per million CD4 T-cells
Interval 347.0 to 1320.0
|
|
Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells
HPV-16, 36-45-year, Month 12
|
707.7 cells per million CD4 T-cells
Interval 200.0 to 1495.0
|
431.3 cells per million CD4 T-cells
Interval 120.0 to 936.0
|
|
Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells
HPV-16, 36-45-year, Month 18
|
1116.8 cells per million CD4 T-cells
Interval 266.0 to 2840.0
|
446.1 cells per million CD4 T-cells
Interval 41.0 to 1610.0
|
|
Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells
HPV-16, 36-45-year, Month 24
|
1118.9 cells per million CD4 T-cells
Interval 447.0 to 1940.0
|
789.3 cells per million CD4 T-cells
Interval 570.0 to 1090.0
|
|
Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells
HPV-16, 36-45-year, Month 36
|
710.5 cells per million CD4 T-cells
Interval 71.0 to 1698.0
|
494.2 cells per million CD4 T-cells
Interval 336.0 to 1105.0
|
|
Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells
HPV-16, 36-45-year, Month 48
|
1247.9 cells per million CD4 T-cells
Interval 597.0 to 2503.0
|
642.4 cells per million CD4 T-cells
Interval 367.0 to 1422.0
|
|
Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells
HPV-18, 18-26-year, Month 7
|
998.8 cells per million CD4 T-cells
Interval 439.0 to 2344.0
|
594.9 cells per million CD4 T-cells
Interval 122.0 to 1783.0
|
|
Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells
HPV-18, 18-26-year, Month 12
|
716.4 cells per million CD4 T-cells
Interval 238.0 to 1413.0
|
192.3 cells per million CD4 T-cells
Interval 1.0 to 906.0
|
|
Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells
HPV-18, 18-26-year, Month 18
|
844.3 cells per million CD4 T-cells
Interval 346.0 to 2492.0
|
264.2 cells per million CD4 T-cells
Interval 1.0 to 1214.0
|
|
Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells
HPV-18, 18-26-year, Month 24
|
793.0 cells per million CD4 T-cells
Interval 296.0 to 2051.0
|
197.4 cells per million CD4 T-cells
Interval 1.0 to 625.0
|
|
Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells
HPV-18, 18-26-year, Month 36
|
622.6 cells per million CD4 T-cells
Interval 311.0 to 920.0
|
211.4 cells per million CD4 T-cells
Interval 68.0 to 557.0
|
|
Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells
HPV-18, 18-26-year, Month 48
|
927.7 cells per million CD4 T-cells
Interval 819.0 to 1055.0
|
162.1 cells per million CD4 T-cells
Interval 13.0 to 676.0
|
|
Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells
HPV-18, 27-35-year, Month 7
|
924.3 cells per million CD4 T-cells
Interval 217.0 to 2589.0
|
680.7 cells per million CD4 T-cells
Interval 133.0 to 2427.0
|
|
Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells
HPV-18, 27-35-year, Month 12
|
416.5 cells per million CD4 T-cells
Interval 1.0 to 2239.0
|
471.2 cells per million CD4 T-cells
Interval 133.0 to 1134.0
|
|
Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells
HPV-18, 27-35-year, Month 18
|
710.8 cells per million CD4 T-cells
Interval 102.0 to 1879.0
|
568.4 cells per million CD4 T-cells
Interval 106.0 to 1919.0
|
|
Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells
HPV-18, 27-35-year, Month 24
|
575.6 cells per million CD4 T-cells
Interval 67.0 to 2113.0
|
355.8 cells per million CD4 T-cells
Interval 114.0 to 826.0
|
|
Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells
HPV-18, 27-35-year, Month 36
|
265.4 cells per million CD4 T-cells
Interval 1.0 to 1646.0
|
206.2 cells per million CD4 T-cells
Interval 27.0 to 748.0
|
|
Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells
HPV-18, 27-35-year, Month 48
|
643.7 cells per million CD4 T-cells
Interval 119.0 to 2032.0
|
426.7 cells per million CD4 T-cells
Interval 242.0 to 1198.0
|
|
Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells
HPV-18, 36-45-year, Month 7
|
815.6 cells per million CD4 T-cells
Interval 147.0 to 2983.0
|
212.2 cells per million CD4 T-cells
Interval 1.0 to 1424.0
|
|
Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells
HPV-18, 36-45-year, Month 12
|
384.3 cells per million CD4 T-cells
Interval 1.0 to 1521.0
|
405.0 cells per million CD4 T-cells
Interval 123.0 to 1044.0
|
|
Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells
HPV-18, 36-45-year, Month 18
|
949.0 cells per million CD4 T-cells
Interval 106.0 to 2746.0
|
195.4 cells per million CD4 T-cells
Interval 1.0 to 1204.0
|
|
Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells
HPV-18, 36-45-year, Month 24
|
807.2 cells per million CD4 T-cells
Interval 327.0 to 1616.0
|
520.5 cells per million CD4 T-cells
Interval 220.0 to 717.0
|
|
Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells
HPV-18, 36-45-year, Month 36
|
337.4 cells per million CD4 T-cells
Interval 7.0 to 1293.0
|
392.1 cells per million CD4 T-cells
Interval 203.0 to 772.0
|
|
Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells
HPV-18, 36-45-year, Month 48
|
764.0 cells per million CD4 T-cells
Interval 231.0 to 2068.0
|
612.2 cells per million CD4 T-cells
Interval 389.0 to 778.0
|
SECONDARY outcome
Timeframe: At Month 7, 12 and 18Population: 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.
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.
Outcome measures
| Measure |
Cervarix Group
n=24 Participants
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
n=23 Participants
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.
|
|---|---|---|
|
Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells
HPV-16, 18-26-year, Month 7
|
5.3 cells per million CD8 T-cells
Interval 1.0 to 258.0
|
3.2 cells per million CD8 T-cells
Interval 1.0 to 107.0
|
|
Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells
HPV-16, 18-26-year, Month 12
|
4.0 cells per million CD8 T-cells
Interval 1.0 to 96.0
|
2.8 cells per million CD8 T-cells
Interval 1.0 to 102.0
|
|
Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells
HPV-16, 18-26-year, Month 18
|
3.5 cells per million CD8 T-cells
Interval 1.0 to 336.0
|
4.5 cells per million CD8 T-cells
Interval 1.0 to 73.0
|
|
Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells
HPV-16, 27-35-year, Month 7
|
2.5 cells per million CD8 T-cells
Interval 1.0 to 89.0
|
5.1 cells per million CD8 T-cells
Interval 1.0 to 302.0
|
|
Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells
HPV-16, 27-35-year, Month 12
|
5.0 cells per million CD8 T-cells
Interval 1.0 to 133.0
|
3.8 cells per million CD8 T-cells
Interval 1.0 to 205.0
|
|
Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells
HPV-16, 27-35-year, Month 18
|
2.4 cells per million CD8 T-cells
Interval 1.0 to 76.0
|
8.6 cells per million CD8 T-cells
Interval 1.0 to 112.0
|
|
Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells
HPV-16, 36-45-year, Month 7
|
3.0 cells per million CD8 T-cells
Interval 1.0 to 422.0
|
6.1 cells per million CD8 T-cells
Interval 1.0 to 222.0
|
|
Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells
HPV-16, 36-45-year, Month 12
|
4.6 cells per million CD8 T-cells
Interval 1.0 to 123.0
|
4.0 cells per million CD8 T-cells
Interval 1.0 to 247.0
|
|
Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells
HPV-16, 36-45-year, Month 18
|
4.1 cells per million CD8 T-cells
Interval 1.0 to 111.0
|
8.9 cells per million CD8 T-cells
Interval 1.0 to 412.0
|
|
Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells
HPV-18, 36-45-year, Month 18
|
6.3 cells per million CD8 T-cells
Interval 1.0 to 161.0
|
4.5 cells per million CD8 T-cells
Interval 1.0 to 668.0
|
|
Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells
HPV-18, 18-26-year, Month 7
|
9.3 cells per million CD8 T-cells
Interval 1.0 to 148.0
|
3.0 cells per million CD8 T-cells
Interval 1.0 to 426.0
|
|
Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells
HPV-18, 18-26-year, Month 12
|
4.6 cells per million CD8 T-cells
Interval 1.0 to 197.0
|
3.4 cells per million CD8 T-cells
Interval 1.0 to 104.0
|
|
Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells
HPV-18, 18-26-year, Month 18
|
4.1 cells per million CD8 T-cells
Interval 1.0 to 533.0
|
4.3 cells per million CD8 T-cells
Interval 1.0 to 94.0
|
|
Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells
HPV-18, 27-35-year, Month 7
|
2.6 cells per million CD8 T-cells
Interval 1.0 to 131.0
|
3.6 cells per million CD8 T-cells
Interval 1.0 to 173.0
|
|
Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells
HPV-18, 27-35-year, Month 12
|
3.5 cells per million CD8 T-cells
Interval 1.0 to 251.0
|
4.6 cells per million CD8 T-cells
Interval 1.0 to 78.0
|
|
Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells
HPV-18, 27-35-year, Month 18
|
3.1 cells per million CD8 T-cells
Interval 1.0 to 476.0
|
7.1 cells per million CD8 T-cells
Interval 1.0 to 790.0
|
|
Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells
HPV-18, 36-45-year, Month 7
|
9.2 cells per million CD8 T-cells
Interval 1.0 to 202.0
|
3.4 cells per million CD8 T-cells
Interval 1.0 to 220.0
|
|
Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells
HPV-18, 36-45-year, Month 12
|
2.4 cells per million CD8 T-cells
Interval 1.0 to 111.0
|
6.8 cells per million CD8 T-cells
Interval 1.0 to 261.0
|
SECONDARY outcome
Timeframe: At Month 7, 12, 18, 24, 36 and 48Population: 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.
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.
Outcome measures
| Measure |
Cervarix Group
n=19 Participants
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
n=15 Participants
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.
|
|---|---|---|
|
Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells
HPV-16, 18-26-year, Month 7
|
700.7 cells per million B-cells
Interval 223.0 to 3515.0
|
358.5 cells per million B-cells
Interval 22.0 to 2802.0
|
|
Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells
HPV-16, 18-26-year, Month 12
|
344.1 cells per million B-cells
Interval 93.0 to 1068.0
|
192.3 cells per million B-cells
Interval 77.0 to 463.0
|
|
Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells
HPV-16, 18-26-year, Month 18
|
262.1 cells per million B-cells
Interval 51.0 to 1067.0
|
325.2 cells per million B-cells
Interval 35.0 to 1868.0
|
|
Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells
HPV-16, 18-26-year, Month 24
|
233.5 cells per million B-cells
Interval 59.0 to 1777.0
|
440.0 cells per million B-cells
Interval 30.0 to 1751.0
|
|
Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells
HPV-16, 18-26-year, Month 36
|
207.7 cells per million B-cells
Interval 39.0 to 586.0
|
505.4 cells per million B-cells
Interval 445.0 to 574.0
|
|
Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells
HPV-16, 18-26-year, Month 48
|
219.7 cells per million B-cells
Interval 60.0 to 657.0
|
130.0 cells per million B-cells
Interval 54.0 to 515.0
|
|
Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells
HPV-16, 27-35-year, Month 7
|
898.0 cells per million B-cells
Interval 111.0 to 5058.0
|
253.5 cells per million B-cells
Interval 62.0 to 767.0
|
|
Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells
HPV-16, 27-35-year, Month 12
|
237.6 cells per million B-cells
Interval 27.0 to 2910.0
|
202.8 cells per million B-cells
Interval 38.0 to 655.0
|
|
Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells
HPV-16, 27-35-year, Month 18
|
216.5 cells per million B-cells
Interval 47.0 to 1846.0
|
194.3 cells per million B-cells
Interval 94.0 to 816.0
|
|
Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells
HPV-16, 27-35-year, Month 24
|
279.1 cells per million B-cells
Interval 49.0 to 962.0
|
141.2 cells per million B-cells
Interval 29.0 to 715.0
|
|
Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells
HPV-16, 27-35-year, Month 36
|
506.5 cells per million B-cells
Interval 270.0 to 1438.0
|
142.1 cells per million B-cells
Interval 43.0 to 290.0
|
|
Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells
HPV-16, 27-35-year, Month 48
|
354.3 cells per million B-cells
Interval 72.0 to 3847.0
|
358.0 cells per million B-cells
Interval 251.0 to 456.0
|
|
Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells
HPV-16, 36-45-year, Month 7
|
1476.0 cells per million B-cells
Interval 349.0 to 19927.0
|
539.3 cells per million B-cells
Interval 114.0 to 7359.0
|
|
Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells
HPV-16, 36-45-year, Month 12
|
363.7 cells per million B-cells
Interval 69.0 to 1549.0
|
270.8 cells per million B-cells
Interval 37.0 to 2238.0
|
|
Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells
HPV-16, 36-45-year, Month 18
|
301.3 cells per million B-cells
Interval 43.0 to 2053.0
|
210.2 cells per million B-cells
Interval 156.0 to 264.0
|
|
Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells
HPV-16, 36-45-year, Month 24
|
492.1 cells per million B-cells
Interval 133.0 to 1708.0
|
338.0 cells per million B-cells
Interval 77.0 to 808.0
|
|
Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells
HPV-18, 36-45-year, Month 12
|
459.8 cells per million B-cells
Interval 110.0 to 2653.0
|
242.8 cells per million B-cells
Interval 116.0 to 664.0
|
|
Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells
HPV-16, 36-45-year, Month 36
|
503.9 cells per million B-cells
Interval 190.0 to 1052.0
|
192.9 cells per million B-cells
Interval 118.0 to 468.0
|
|
Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells
HPV-16, 36-45-year, Month 48
|
364.8 cells per million B-cells
Interval 127.0 to 741.0
|
738.0 cells per million B-cells
Interval 738.0 to 738.0
|
|
Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells
HPV-18, 18-26-year, Month 7
|
313.2 cells per million B-cells
Interval 41.0 to 792.0
|
163.9 cells per million B-cells
Interval 22.0 to 630.0
|
|
Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells
HPV-18, 18-26-year, Month 12
|
152.5 cells per million B-cells
Interval 30.0 to 918.0
|
63.8 cells per million B-cells
Interval 28.0 to 181.0
|
|
Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells
HPV-18, 18-26-year, Month 18
|
137.3 cells per million B-cells
Interval 31.0 to 1677.0
|
76.4 cells per million B-cells
Interval 19.0 to 479.0
|
|
Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells
HPV-18, 18-26-year, Month 24
|
255.5 cells per million B-cells
Interval 36.0 to 1456.0
|
101.0 cells per million B-cells
Interval 34.0 to 668.0
|
|
Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells
HPV-18, 18-26-year, Month 36
|
391.0 cells per million B-cells
Interval 87.0 to 2781.0
|
114.1 cells per million B-cells
Interval 36.0 to 779.0
|
|
Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells
HPV-18, 18-26-year, Month 48
|
124.7 cells per million B-cells
Interval 46.0 to 214.0
|
118.0 cells per million B-cells
Interval 46.0 to 347.0
|
|
Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells
HPV-18, 27-35-year, Month 7
|
433.4 cells per million B-cells
Interval 32.0 to 3375.0
|
153.7 cells per million B-cells
Interval 42.0 to 530.0
|
|
Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells
HPV-18, 27-35-year, Month 12
|
172.4 cells per million B-cells
Interval 10.0 to 972.0
|
130.4 cells per million B-cells
Interval 20.0 to 409.0
|
|
Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells
HPV-18, 27-35-year, Month 18
|
202.5 cells per million B-cells
Interval 28.0 to 869.0
|
74.7 cells per million B-cells
Interval 15.0 to 710.0
|
|
Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells
HPV-18, 27-35-year, Month 24
|
151.6 cells per million B-cells
Interval 14.0 to 606.0
|
97.0 cells per million B-cells
Interval 45.0 to 226.0
|
|
Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells
HPV-18, 27-35-year, Month 36
|
161.9 cells per million B-cells
Interval 53.0 to 629.0
|
224.2 cells per million B-cells
Interval 47.0 to 829.0
|
|
Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells
HPV-18, 27-35-year, Month 48
|
366.4 cells per million B-cells
Interval 13.0 to 2167.0
|
134.2 cells per million B-cells
Interval 104.0 to 157.0
|
|
Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells
HPV-18, 36-45-year, Month 7
|
785.7 cells per million B-cells
Interval 85.0 to 7635.0
|
192.5 cells per million B-cells
Interval 76.0 to 517.0
|
|
Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells
HPV-18, 36-45-year, Month 18
|
436.9 cells per million B-cells
Interval 93.0 to 1753.0
|
91.5 cells per million B-cells
Interval 23.0 to 349.0
|
|
Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells
HPV-18, 36-45-year, Month 24
|
576.8 cells per million B-cells
Interval 154.0 to 1873.0
|
106.6 cells per million B-cells
Interval 61.0 to 171.0
|
|
Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells
HPV-18, 36-45-year, Month 36
|
376.6 cells per million B-cells
Interval 95.0 to 1161.0
|
23.0 cells per million B-cells
Interval 23.0 to 23.0
|
|
Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells
HPV-18, 36-45-year, Month 48
|
302.4 cells per million B-cells
Interval 190.0 to 543.0
|
91.7 cells per million B-cells
Interval 69.0 to 122.0
|
SECONDARY outcome
Timeframe: At Month 7, 12, 18, 24, 36 and 48Population: 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.
Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
Outcome measures
| Measure |
Cervarix Group
n=51 Participants
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
n=57 Participants
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.
|
|---|---|---|
|
Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS)
Anti-HPV-16, Month 7
|
168.9 EL.U/mL
Interval 114.4 to 249.4
|
90.7 EL.U/mL
Interval 62.6 to 131.6
|
|
Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS)
Anti-HPV-16, Month 12
|
129.7 EL.U/mL
Interval 89.6 to 187.8
|
46.8 EL.U/mL
Interval 33.0 to 66.5
|
|
Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS)
Anti-HPV-16, Month 18
|
96.0 EL.U/mL
Interval 64.8 to 142.3
|
52.8 EL.U/mL
Interval 35.6 to 78.3
|
|
Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS)
Anti-HPV-16, Month 24
|
85.0 EL.U/mL
Interval 57.9 to 124.8
|
45.1 EL.U/mL
Interval 27.0 to 75.2
|
|
Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS)
Anti-HPV-16, Month 36
|
57.1 EL.U/mL
Interval 39.6 to 82.4
|
48.8 EL.U/mL
Interval 30.8 to 77.4
|
|
Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS)
Anti-HPV-16, Month 48
|
32.7 EL.U/mL
Interval 22.7 to 47.1
|
72.2 EL.U/mL
Interval 34.4 to 151.3
|
|
Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS)
Anti-HPV-18, Month 7
|
88.6 EL.U/mL
Interval 65.0 to 120.8
|
43.4 EL.U/mL
Interval 30.1 to 62.6
|
|
Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS)
Anti-HPV-18, Month 12
|
59.0 EL.U/mL
Interval 42.5 to 81.9
|
29.1 EL.U/mL
Interval 18.6 to 45.3
|
|
Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS)
Anti-HPV-18, Month 18
|
33.2 EL.U/mL
Interval 21.3 to 51.8
|
16.4 EL.U/mL
Interval 10.4 to 25.9
|
|
Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS)
Anti-HPV-18, Month 24
|
43.9 EL.U/mL
Interval 28.1 to 68.8
|
21.5 EL.U/mL
Interval 10.5 to 44.3
|
|
Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS)
Anti-HPV-18, Month 36
|
24.3 EL.U/mL
Interval 18.0 to 32.8
|
23.3 EL.U/mL
Interval 12.3 to 44.0
|
|
Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS)
Anti-HPV-18, Month 48
|
16.6 EL.U/mL
Interval 10.3 to 26.7
|
20.2 EL.U/mL
Interval 12.5 to 32.8
|
SECONDARY outcome
Timeframe: Up to Month 7Population: 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).
Outcome measures
| Measure |
Cervarix Group
n=553 Participants
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
n=553 Participants
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.
|
|---|---|---|
|
Number of Subjects Completing the 3-dose Vaccination Schedule
|
468 Participants
|
467 Participants
|
SECONDARY outcome
Timeframe: During the 7-day period (Day 0-6) following vaccinationPopulation: Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
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.
Outcome measures
| Measure |
Cervarix Group
n=524 Participants
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
n=524 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms
Any Pain
|
487 Participants
|
375 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms
Any Redness
|
232 Participants
|
134 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms
Any Swelling
|
191 Participants
|
114 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms
Grade 3 Pain
|
91 Participants
|
18 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms
Grade 3 Redness
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms
Grade 3 Swelling
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: During the 7-day period (Day 0-6) following vaccinationPopulation: Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
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.
Outcome measures
| Measure |
Cervarix Group
n=526 Participants
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
n=525 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Urticaria
|
1 Participants
|
2 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Arthralgia
|
114 Participants
|
81 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue
|
262 Participants
|
209 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Fever
|
76 Participants
|
58 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal symptoms
|
172 Participants
|
139 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Headache
|
250 Participants
|
220 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia
|
145 Participants
|
103 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Rash
|
25 Participants
|
18 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Urticaria
|
26 Participants
|
21 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Arthralgia
|
13 Participants
|
3 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue
|
30 Participants
|
12 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal symptoms
|
10 Participants
|
12 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache
|
19 Participants
|
20 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia
|
10 Participants
|
8 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Rash
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Arthralgia
|
102 Participants
|
74 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue
|
230 Participants
|
181 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Fever
|
59 Participants
|
46 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal symptoms
|
134 Participants
|
106 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Headache
|
209 Participants
|
187 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia
|
132 Participants
|
90 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Rash
|
19 Participants
|
11 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Urticaria
|
24 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: During the 30-day period (Day 0-29) following vaccinationPopulation: Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
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.
Outcome measures
| Measure |
Cervarix Group
n=553 Participants
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
n=553 Participants
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.
|
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Any AEs
|
235 Participants
|
202 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Grade 3 AEs
|
41 Participants
|
37 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Related AEs
|
70 Participants
|
63 Participants
|
SECONDARY outcome
Timeframe: Up to Month 7Population: Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
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.
Outcome measures
| Measure |
Cervarix Group
n=553 Participants
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
n=553 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)
NOCD(s)
|
14 Participants
|
13 Participants
|
|
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)
MSC(s)
|
164 Participants
|
148 Participants
|
SECONDARY outcome
Timeframe: Up To Month 12Population: Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
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.
Outcome measures
| Measure |
Cervarix Group
n=553 Participants
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
n=553 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)
NOCD(s)
|
14 Participants
|
17 Participants
|
|
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)
MSC(s)
|
181 Participants
|
168 Participants
|
SECONDARY outcome
Timeframe: Up To Month 18Population: Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
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.
Outcome measures
| Measure |
Cervarix Group
n=553 Participants
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
n=553 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)
NOCD(s)
|
20 Participants
|
21 Participants
|
|
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)
MSC(s)
|
210 Participants
|
185 Participants
|
SECONDARY outcome
Timeframe: Up To Month 24Population: Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
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.
Outcome measures
| Measure |
Cervarix Group
n=553 Participants
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
n=553 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)
NOCD(s)
|
20 Participants
|
21 Participants
|
|
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)
MSC(s)
|
221 Participants
|
192 Participants
|
SECONDARY outcome
Timeframe: Up To Month 36Population: Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
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.
Outcome measures
| Measure |
Cervarix Group
n=553 Participants
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
n=553 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)
NOCD(s)
|
27 Participants
|
29 Participants
|
|
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)
MSC(s)
|
239 Participants
|
205 Participants
|
SECONDARY outcome
Timeframe: Up to Month 48Population: Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
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.
Outcome measures
| Measure |
Cervarix Group
n=553 Participants
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
n=553 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)
NOCDs
|
33 Participants
|
33 Participants
|
|
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)
MSCs
|
251 Participants
|
216 Participants
|
SECONDARY outcome
Timeframe: Up to Month 60Population: Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
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.
Outcome measures
| Measure |
Cervarix Group
n=553 Participants
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
n=553 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)
Any NOCD(s)
|
39 Participants
|
43 Participants
|
|
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)
Any MSC(s)
|
259 Participants
|
226 Participants
|
SECONDARY outcome
Timeframe: Up to Month 7Population: Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
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.
Outcome measures
| Measure |
Cervarix Group
n=553 Participants
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
n=553 Participants
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.
|
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)
Any SAE(s)
|
6 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)
Related SAE(s)
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
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.
Outcome measures
| Measure |
Cervarix Group
n=553 Participants
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
n=553 Participants
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.
|
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)
Related SAE(s)
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)
Any SAE(s)
|
12 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Up to Month 18Population: Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
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.
Outcome measures
| Measure |
Cervarix Group
n=553 Participants
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
n=553 Participants
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.
|
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)
Any SAE(s)
|
14 Participants
|
20 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)
Related SAE(s)
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Month 24Population: Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
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.
Outcome measures
| Measure |
Cervarix Group
n=553 Participants
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
n=553 Participants
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.
|
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)
Related SAE(s)
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)
Any SAE(s)
|
23 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Up to Month 36Population: Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
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.
Outcome measures
| Measure |
Cervarix Group
n=553 Participants
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
n=553 Participants
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.
|
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)
Any SAE(s)
|
30 Participants
|
28 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)
Related SAE(s)
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Month 48Population: Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
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.
Outcome measures
| Measure |
Cervarix Group
n=553 Participants
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
n=553 Participants
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.
|
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)
Any SAE(s)
|
37 Participants
|
34 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)
Related SAE(s)
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Month 60Population: Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.
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.
Outcome measures
| Measure |
Cervarix Group
n=553 Participants
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
n=553 Participants
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.
|
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)
Any SAE(s)
|
44 Participants
|
37 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)
Related SAE(s)
|
1 Participants
|
1 Participants
|
Adverse Events
Cervarix Group
Serious events: 44 serious events
Other events: 500 other events
Deaths: 0 deaths
Gardasil Group
Serious events: 37 serious events
Other events: 462 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cervarix Group
n=553 participants at risk
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
n=553 participants at risk
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.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous complete
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.36%
2/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Infections and infestations
Appendicitis
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.36%
2/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.36%
2/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.36%
2/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
1.3%
7/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.72%
4/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.72%
4/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.54%
3/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.54%
3/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.36%
2/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous incomplete
|
0.54%
3/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.36%
2/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.54%
3/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Psychiatric disorders
Anxiety
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Psychiatric disorders
Major depression
|
0.36%
2/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Infections and infestations
Pneumonia
|
0.36%
2/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Pregnancy, puerperium and perinatal conditions
Premature labour
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Gastrointestinal disorders
Vomiting
|
0.36%
2/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion incomplete
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Psychiatric disorders
Anorexia nervosa
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Congenital, familial and genetic disorders
Arnold-Chiari malformation
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Psychiatric disorders
Bipolar I disorder
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Reproductive system and breast disorders
Breast hyperplasia
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage 0
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
General disorders
Chest pain
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Gastrointestinal disorders
Cyclic vomiting syndrome
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Nervous system disorders
Embolic cerebral infarction
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Infections and infestations
Endometritis
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Infections and infestations
Escherichia infection
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal death
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Gastrointestinal disorders
Gastritis
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Nervous system disorders
Grand mal convulsion
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Hepatobiliary disorders
Hepatitis
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Gastrointestinal disorders
Ileitis
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Nervous system disorders
Multiple sclerosis
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Gastrointestinal disorders
Nausea
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
General disorders
Non-cardiac chest pain
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Cardiac disorders
Postural orthostatic tachycardia syndrome
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Congenital, familial and genetic disorders
Pyloric stenosis
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Infections and infestations
Sepsis
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Injury, poisoning and procedural complications
Spinal shock
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Infections and infestations
Urinary tract infection
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
Reproductive system and breast disorders
Uterine enlargement
|
0.18%
1/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
0.00%
0/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
Other adverse events
| Measure |
Cervarix Group
n=553 participants at risk
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
n=553 participants at risk
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.
|
|---|---|---|
|
General disorders
Pain
|
88.1%
487/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
67.8%
375/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
General disorders
Redness
|
42.0%
232/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
24.2%
134/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
General disorders
Swelling
|
34.5%
191/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
20.6%
114/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
General disorders
Arthralgia
|
20.6%
114/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
14.6%
81/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
General disorders
Fatigue
|
47.4%
262/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
37.8%
209/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
General disorders
Fever
|
13.7%
76/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
10.5%
58/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
General disorders
Gastrointestinal
|
31.1%
172/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
25.1%
139/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
General disorders
Headache
|
45.2%
250/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
39.8%
220/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
|
General disorders
Myalgia
|
26.2%
145/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
18.6%
103/553 • SAEs: From Day 0 up to Month 60. Solicited symptoms: During the 7-day (Days 0-6) post-vaccination period.
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.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER