Trial Outcomes & Findings for Human Papillomavirus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Biologicals Novel HPV Vaccine (NCT NCT00359619)
NCT ID: NCT00359619
Last Updated: 2020-01-02
Results Overview
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 8 ELISA units per milliliter (EL.U/mL).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
383 participants
Primary outcome timeframe
At Months 18, 24, 36 and 48.
Results posted on
2020-01-02
Participant Flow
The study is a safety follow-up of the primary study NCT00231413, starting from Month 18 post-vaccination.
A total number of 383 subjects were enrolled in the primary study. A total of 193, 216, 182 and 166 subjects attended Month 18, Month 24, Month 36 and Month 48 visits, respectively. No separate demography data was tabulated for these intermediate timepoints, as statistics were computed only after the last study visit at Month 48.
Participant milestones
| Measure |
Cervarix Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 1 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 2 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 3 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 4 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 5 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 6 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
88
|
50
|
49
|
48
|
48
|
50
|
50
|
|
Overall Study
COMPLETED
|
80
|
45
|
42
|
45
|
45
|
45
|
46
|
|
Overall Study
NOT COMPLETED
|
8
|
5
|
7
|
3
|
3
|
5
|
4
|
Reasons for withdrawal
| Measure |
Cervarix Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 1 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 2 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 3 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 4 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 5 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 6 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
4
|
2
|
2
|
0
|
3
|
|
Overall Study
Other
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
4
|
2
|
1
|
1
|
5
|
0
|
Baseline Characteristics
Human Papillomavirus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Biologicals Novel HPV Vaccine
Baseline characteristics by cohort
| Measure |
Cervarix Group
n=88 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 1 Group
n=50 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 2 Group
n=49 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 3 Group
n=48 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 4 Group
n=48 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 5 Group
n=50 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 6 Group
n=50 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Total
n=383 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
20.9 Years
STANDARD_DEVIATION 2.03 • n=5 Participants
|
21.5 Years
STANDARD_DEVIATION 2.18 • n=7 Participants
|
21.2 Years
STANDARD_DEVIATION 2.07 • n=5 Participants
|
21.1 Years
STANDARD_DEVIATION 2.09 • n=4 Participants
|
21.4 Years
STANDARD_DEVIATION 2.27 • n=21 Participants
|
21.2 Years
STANDARD_DEVIATION 2.26 • n=8 Participants
|
20.7 Years
STANDARD_DEVIATION 1.91 • n=8 Participants
|
21.1 Years
STANDARD_DEVIATION 2.11 • n=24 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
50 Participants
n=8 Participants
|
50 Participants
n=8 Participants
|
383 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: At Months 18, 24, 36 and 48.Population: The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 8 ELISA units per milliliter (EL.U/mL).
Outcome measures
| Measure |
Cervarix Group
n=28 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 1 Group
n=12 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 2 Group
n=11 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 3 Group
n=9 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 4 Group
n=16 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 5 Group
n=15 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 6 Group
n=15 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.
Anti-HPV-16, Month 36 (N=28,12,11,9,16,15,15)
|
28 subjects
|
12 subjects
|
11 subjects
|
9 subjects
|
16 subjects
|
15 subjects
|
15 subjects
|
|
Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.
Anti-HPV-16, Month 48 (N=28,12,11,9,16,15,15)
|
28 subjects
|
12 subjects
|
11 subjects
|
9 subjects
|
16 subjects
|
15 subjects
|
15 subjects
|
|
Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.
Anti-HPV-16, Month 18 (N=27,10,9,8,14,13,13)
|
27 subjects
|
10 subjects
|
9 subjects
|
8 subjects
|
14 subjects
|
13 subjects
|
13 subjects
|
|
Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.
Anti-HPV-16, Month 24 (N=28,12,11,9,16,15,15)
|
28 subjects
|
12 subjects
|
11 subjects
|
9 subjects
|
16 subjects
|
15 subjects
|
15 subjects
|
PRIMARY outcome
Timeframe: At Months 18, 24, 36 and 48.Population: The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 8 EL.U/mL.
Outcome measures
| Measure |
Cervarix Group
n=28 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 1 Group
n=12 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 2 Group
n=11 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 3 Group
n=9 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 4 Group
n=16 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 5 Group
n=15 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 6 Group
n=15 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.
Anti-HPV-16 Month 18 (N=27,10,9,8,14,13,13)
|
1933.9 EL.U/mL
Interval 1318.0 to 2837.5
|
1868.3 EL.U/mL
Interval 1263.0 to 2763.8
|
1902.3 EL.U/mL
Interval 603.5 to 5996.7
|
1996.4 EL.U/mL
Interval 1017.8 to 3915.8
|
1437.1 EL.U/mL
Interval 777.3 to 2657.0
|
2200.3 EL.U/mL
Interval 1284.4 to 3769.4
|
1769.8 EL.U/mL
Interval 914.9 to 3423.7
|
|
Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.
Anti-HPV-16 Month 24 (N=28,12,11,9,16,15,15)
|
1477.1 EL.U/mL
Interval 1039.3 to 2099.3
|
1381.6 EL.U/mL
Interval 942.1 to 2026.4
|
1339.9 EL.U/mL
Interval 553.1 to 3246.1
|
1520.6 EL.U/mL
Interval 916.6 to 2522.5
|
1264.4 EL.U/mL
Interval 718.8 to 2224.0
|
1817.8 EL.U/mL
Interval 1194.5 to 2766.4
|
1585.6 EL.U/mL
Interval 952.0 to 2640.9
|
|
Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.
Anti-HPV-16 Month 36 (N=28,12,11,9,16,15,15)
|
1296.8 EL.U/mL
Interval 917.1 to 1833.6
|
1200.5 EL.U/mL
Interval 814.8 to 1768.9
|
1023.1 EL.U/mL
Interval 389.2 to 2689.8
|
1275.3 EL.U/mL
Interval 780.2 to 2084.7
|
960.6 EL.U/mL
Interval 555.6 to 1660.7
|
1521.8 EL.U/mL
Interval 943.4 to 2454.8
|
1076.9 EL.U/mL
Interval 619.0 to 1873.6
|
|
Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.
Anti-HPV-16 Month 48 (N=28,12,11,9,16,15,15)
|
1300.9 EL.U/mL
Interval 952.3 to 1777.1
|
1115.4 EL.U/mL
Interval 780.3 to 1594.3
|
1007.5 EL.U/mL
Interval 361.3 to 2809.6
|
1337.7 EL.U/mL
Interval 755.4 to 2368.9
|
1070.8 EL.U/mL
Interval 614.6 to 1865.7
|
1417.8 EL.U/mL
Interval 882.0 to 2279.0
|
1105.5 EL.U/mL
Interval 620.6 to 1969.3
|
PRIMARY outcome
Timeframe: At Months 18, 24, 36 and 48.Population: The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 8 EL.U/mL.
Outcome measures
| Measure |
Cervarix Group
n=33 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 1 Group
n=18 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 2 Group
n=16 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 3 Group
n=18 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 4 Group
n=18 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 5 Group
n=20 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 6 Group
n=19 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies
Anti-HPV-16 Month 18 (N=32,15,13,16,16,17,17)
|
1902.6 Titers
Interval 1309.3 to 2764.7
|
1558.5 Titers
Interval 1122.9 to 2163.2
|
1791.7 Titers
Interval 823.6 to 3897.7
|
1552.9 Titers
Interval 981.6 to 2456.5
|
1242.8 Titers
Interval 687.3 to 2247.4
|
1869.6 Titers
Interval 1161.1 to 3010.5
|
1764.4 Titers
Interval 1073.8 to 2899.2
|
|
Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies
Anti-HPV-16 Month 24 (N=33,18,16,18,18,20,19)
|
1472.8 Titers
Interval 1046.2 to 2073.3
|
1223.4 Titers
Interval 911.2 to 1642.6
|
1347.4 Titers
Interval 740.7 to 2451.1
|
1579.5 Titers
Interval 1053.9 to 2367.2
|
1092.8 Titers
Interval 626.2 to 1907.2
|
1672.2 Titers
Interval 1130.2 to 2474.1
|
1130.2 Titers
Interval 1130.2 to 2367.2
|
|
Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies
Anti-HPV-16 Month 36 (N=33,18,16,18,18,20,19)
|
1291.7 Titers
Interval 928.4 to 1797.1
|
1031.2 Titers
Interval 764.2 to 1391.5
|
1032.9 Titers
Interval 538.9 to 1979.5
|
1107.7 Titers
Interval 776.4 to 1580.3
|
841.4 Titers
Interval 495.4 to 1428.9
|
1381.9 Titers
Interval 901.0 to 2119.3
|
1128.6 Titers
Interval 728.5 to 1748.3
|
|
Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies
Anti-HPV-16 Month 48 (N=33,18,16,18,18,20,19)
|
1248.8 Titers
Interval 907.1 to 1719.1
|
955.5 Titers
Interval 722.7 to 1263.1
|
1104.9 Titers
Interval 556.9 to 2192.1
|
1097.4 Titers
Interval 737.8 to 1632.4
|
911.3 Titers
Interval 526.5 to 1577.4
|
1310.1 Titers
Interval 862.8 to 1989.2
|
1150.4 Titers
Interval 727.8 to 1818.3
|
PRIMARY outcome
Timeframe: At Months 18, 24, 36 and 48.Population: The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 7 EL.U/mL.
Outcome measures
| Measure |
Cervarix Group
n=26 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 1 Group
n=13 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 2 Group
n=14 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 3 Group
n=18 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 4 Group
n=12 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 5 Group
n=18 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 6 Group
n=17 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.
Anti-HPV-18 Month 18 (N=26,10,12,16,11,15,15)
|
26 subjects
|
10 subjects
|
12 subjects
|
16 subjects
|
11 subjects
|
15 subjects
|
15 subjects
|
|
Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.
Anti-HPV-18 Month 24 (N=26,13,14,18,12,18,17)
|
26 subjects
|
13 subjects
|
14 subjects
|
18 subjects
|
12 subjects
|
18 subjects
|
17 subjects
|
|
Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.
Anti-HPV-18 Month 36 (N=26,13,14,18,12,18,17)
|
26 subjects
|
13 subjects
|
14 subjects
|
18 subjects
|
12 subjects
|
18 subjects
|
17 subjects
|
|
Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.
Anti-HPV-18 Month 48 (N=26,13,14,18,12,18,17)
|
26 subjects
|
13 subjects
|
14 subjects
|
18 subjects
|
12 subjects
|
18 subjects
|
17 subjects
|
PRIMARY outcome
Timeframe: At Months 18, 24, 36 and 48.Population: The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 7 EL.U/mL.
Outcome measures
| Measure |
Cervarix Group
n=26 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 1 Group
n=13 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 2 Group
n=14 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 3 Group
n=18 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 4 Group
n=12 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 5 Group
n=18 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 6 Group
n=17 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.
Anti-HPV-18 Month 48 (N=26,13,14,18,12,18,17)
|
729.3 EL.U/mL
Interval 516.0 to 1030.8
|
248.6 EL.U/mL
Interval 149.7 to 412.8
|
278.3 EL.U/mL
Interval 125.6 to 616.6
|
443.3 EL.U/mL
Interval 252.6 to 778.0
|
382.0 EL.U/mL
Interval 170.8 to 854.0
|
440.7 EL.U/mL
Interval 290.2 to 669.2
|
320.9 EL.U/mL
Interval 206.2 to 499.2
|
|
Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.
Anti-HPV-18 Month 18 (N=26,10,12,16,11,15,15)
|
1060.9 EL.U/mL
Interval 720.1 to 1562.9
|
469.3 EL.U/mL
Interval 247.6 to 889.4
|
532.5 EL.U/mL
Interval 211.2 to 1342.7
|
536.7 EL.U/mL
Interval 296.0 to 973.0
|
563.7 EL.U/mL
Interval 262.0 to 1212.5
|
637.9 EL.U/mL
Interval 394.8 to 1030.8
|
572.2 EL.U/mL
Interval 342.7 to 955.3
|
|
Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.
Anti-HPV-18 Month 24 (N=26,13,14,18,12,18,17)
|
781.7 EL.U/mL
Interval 538.5 to 1134.9
|
321.2 EL.U/mL
Interval 192.8 to 535.2
|
387.0 EL.U/mL
Interval 185.7 to 806.6
|
465.1 EL.U/mL
Interval 267.6 to 808.5
|
502.4 EL.U/mL
Interval 225.1 to 1121.5
|
536.5 EL.U/mL
Interval 358.9 to 802.0
|
419.7 EL.U/mL
Interval 269.1 to 654.5
|
|
Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.
Anti-HPV-18 Month 36 (N=26,13,14,18,12,18,17)
|
733.6 EL.U/mL
Interval 487.2 to 1104.6
|
286.1 EL.U/mL
Interval 179.4 to 456.1
|
333.4 EL.U/mL
Interval 151.0 to 736.0
|
424.6 EL.U/mL
Interval 254.4 to 708.5
|
381.7 EL.U/mL
Interval 165.1 to 882.7
|
456.5 EL.U/mL
Interval 299.8 to 695.2
|
356.7 EL.U/mL
Interval 232.3 to 547.8
|
PRIMARY outcome
Timeframe: At Months 18, 24, 36 and 48.Population: The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 7 EL.U/mL.
Outcome measures
| Measure |
Cervarix Group
n=33 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 1 Group
n=18 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 2 Group
n=16 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 3 Group
n=18 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 4 Group
n=18 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 5 Group
n=20 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 6 Group
n=19 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies
Anti-HPV-16 Month 24 (N=33,18,16,18,18,20,19)
|
739.5 Titers
Interval 526.6 to 1038.3
|
355.2 Titers
Interval 236.2 to 534.3
|
410.5 Titers
Interval 217.0 to 776.6
|
465.1 Titers
Interval 267.6 to 808.5
|
442.1 Titers
Interval 251.9 to 775.8
|
497.7 Titers
Interval 329.4 to 752.1
|
425.4 Titers
Interval 287.1 to 630.5
|
|
Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies
Anti-HPV-16 Month 36 (N=33,18,16,18,18,20,19)
|
683.5 Titers
Interval 475.4 to 982.7
|
320.5 Titers
Interval 220.4 to 466.1
|
349.8 Titers
Interval 175.7 to 696.5
|
424.6 Titers
Interval 254.4 to 708.5
|
348.1 Titers
Interval 193.0 to 628.1
|
426.1 Titers
Interval 281.7 to 644.4
|
364.9 Titers
Interval 249.2 to 534.4
|
|
Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies
Anti-HPV-16 Month 48 (N=33,18,16,18,18,20,19)
|
666.3 Titers
Interval 477.9 to 929.2
|
284.6 Titers
Interval 190.8 to 424.7
|
297.7 Titers
Interval 148.9 to 595.3
|
443.3 Titers
Interval 252.6 to 778.0
|
329.7 Titers
Interval 184.8 to 588.2
|
412.0 Titers
Interval 273.3 to 621.0
|
330.2 Titers
Interval 222.3 to 490.4
|
|
Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies
Anti-HPV-16 Month 18 (N=32,15,13,16,16,17,17)
|
994.4 Titers
Interval 699.5 to 1413.5
|
525.5 Titers
Interval 328.2 to 841.6
|
524.1 Titers
Interval 225.6 to 1217.5
|
536.7 Titers
Interval 296.0 to 973.0
|
551.1 Titers
Interval 312.4 to 972.2
|
574.9 Titers
Interval 355.3 to 930.2
|
570.5 Titers
Interval 365.6 to 890.4
|
SECONDARY outcome
Timeframe: At Months 18, 24, 36 and 48.Population: The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 59 EL.U/mL.
Outcome measures
| Measure |
Cervarix Group
n=28 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 1 Group
n=16 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 2 Group
n=15 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 3 Group
n=15 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 4 Group
n=16 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 5 Group
n=18 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 6 Group
n=19 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.
Anti-HPV-31 Month 18 (N=27,13,12,13,14,15,17)
|
25 subjects
|
13 subjects
|
12 subjects
|
13 subjects
|
14 subjects
|
15 subjects
|
17 subjects
|
|
Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.
Anti-HPV-31 Month 24 (N=28,16,15,15,16,17,19)
|
22 subjects
|
16 subjects
|
15 subjects
|
15 subjects
|
16 subjects
|
17 subjects
|
19 subjects
|
|
Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.
Anti-HPV-31 Month 36 (N=28,16,15,15,16,18,19)
|
23 subjects
|
16 subjects
|
15 subjects
|
15 subjects
|
16 subjects
|
18 subjects
|
19 subjects
|
|
Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.
Anti-HPV-31 Month 48 (N=28,16,15,15,16,18,19)
|
23 subjects
|
16 subjects
|
15 subjects
|
15 subjects
|
16 subjects
|
18 subjects
|
19 subjects
|
SECONDARY outcome
Timeframe: At Months 18, 24, 36 and 48.Population: The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 59 EL.U/mL.
Outcome measures
| Measure |
Cervarix Group
n=28 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 1 Group
n=16 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 2 Group
n=15 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 3 Group
n=15 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 4 Group
n=16 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 5 Group
n=18 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 6 Group
n=19 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.
Anti-HPV-31 Month 18 (N=27,13,12,13,14,15,17)
|
187.7 EL.U/mL.
Interval 124.2 to 283.8
|
1776.8 EL.U/mL.
Interval 1086.4 to 2906.1
|
2685.9 EL.U/mL.
Interval 1157.8 to 6230.9
|
2388.8 EL.U/mL.
Interval 1352.0 to 4220.8
|
2714.9 EL.U/mL.
Interval 1312.1 to 5617.3
|
1952.4 EL.U/mL.
Interval 1226.4 to 3108.2
|
3466.4 EL.U/mL.
Interval 2077.8 to 5782.9
|
|
Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.
Anti-HPV-31 Month 24 (N=28,16,15,15,16,17,19)
|
125.3 EL.U/mL.
Interval 80.6 to 194.8
|
1336.1 EL.U/mL.
Interval 891.6 to 2002.2
|
2076.2 EL.U/mL.
Interval 1168.0 to 3690.7
|
1966.7 EL.U/mL.
Interval 1221.9 to 3165.5
|
2298.0 EL.U/mL.
Interval 1214.8 to 4347.0
|
1911.8 EL.U/mL.
Interval 1162.0 to 3145.5
|
2518.3 EL.U/mL.
Interval 1648.7 to 3846.7
|
|
Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.
Anti-HPV-31 Month 36 (N=28,16,15,15,16,18,19)
|
164.6 EL.U/mL.
Interval 107.7 to 251.7
|
1346.7 EL.U/mL.
Interval 941.1 to 1927.0
|
1776.6 EL.U/mL.
Interval 976.5 to 3232.1
|
1644.0 EL.U/mL.
Interval 993.6 to 2720.2
|
1825.1 EL.U/mL.
Interval 984.1 to 3384.7
|
1584.1 EL.U/mL.
Interval 982.1 to 2555.2
|
2080.0 EL.U/mL.
Interval 1400.9 to 3088.3
|
|
Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.
Anti-HPV-31 Month 48 (N=28,16,15,15,16,18,19)
|
174.7 EL.U/mL.
Interval 114.4 to 266.7
|
1284.5 EL.U/mL.
Interval 878.4 to 1878.3
|
2105.3 EL.U/mL.
Interval 1155.1 to 3837.3
|
1744.2 EL.U/mL.
Interval 966.3 to 3148.3
|
2126.9 EL.U/mL.
Interval 1159.6 to 3901.1
|
1434.2 EL.U/mL.
Interval 892.0 to 2306.0
|
2118.1 EL.U/mL.
Interval 1536.6 to 2919.7
|
SECONDARY outcome
Timeframe: At Months 18, 24, 36 and 48.Population: The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 59 EL.U/mL.
Outcome measures
| Measure |
Cervarix Group
n=24 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 1 Group
n=17 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 2 Group
n=12 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 3 Group
n=13 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 4 Group
n=16 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 5 Group
n=18 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 6 Group
n=16 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.
Anti-HPV-45 Month 18 (N=20,14,10,11,14,15,15)
|
20 subjects
|
14 subjects
|
10 subjects
|
11 subjects
|
14 subjects
|
15 subjects
|
15 subjects
|
|
Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.
Anti-HPV-45 Month 48 (N=19,17,12,13,16,18,16)
|
19 subjects
|
17 subjects
|
12 subjects
|
13 subjects
|
16 subjects
|
18 subjects
|
16 subjects
|
|
Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.
Anti-HPV-45 Month 24 (N=19,17,12,13,16,17,16)
|
19 subjects
|
17 subjects
|
12 subjects
|
13 subjects
|
16 subjects
|
17 subjects
|
16 subjects
|
|
Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.
Anti-HPV-45 Month 36 (N=18,17,12,13,16,18,16)
|
18 subjects
|
17 subjects
|
12 subjects
|
13 subjects
|
16 subjects
|
18 subjects
|
16 subjects
|
SECONDARY outcome
Timeframe: At Months 18, 24, 36 and 48.Population: The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 59 EL.U/mL.
Outcome measures
| Measure |
Cervarix Group
n=24 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 1 Group
n=17 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 2 Group
n=12 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 3 Group
n=13 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 4 Group
n=16 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 5 Group
n=18 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 6 Group
n=16 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.
Anti-HPV-45 Month 18 (N=20,14,10,11,14,15,15)
|
184.8 EL.U/mL
Interval 111.9 to 305.1
|
919.8 EL.U/mL
Interval 510.9 to 1655.9
|
1731.0 EL.U/mL
Interval 591.8 to 5063.3
|
959.1 EL.U/mL
Interval 557.9 to 1648.9
|
1086.6 EL.U/mL
Interval 528.7 to 2233.2
|
1235.8 EL.U/mL
Interval 757.9 to 2014.8
|
1094.9 EL.U/mL
Interval 613.1 to 1955.4
|
|
Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.
Anti-HPV-45 Month 24 (N=19,17,12,13,16,17,16)
|
138.3 EL.U/mL
Interval 86.4 to 221.4
|
713.0 EL.U/mL
Interval 440.6 to 1153.9
|
1274.5 EL.U/mL
Interval 590.1 to 2752.5
|
904.9 EL.U/mL
Interval 546.7 to 1497.8
|
948.1 EL.U/mL
Interval 515.2 to 1744.6
|
1106.5 EL.U/mL
Interval 680.1 to 1800.4
|
848.2 EL.U/mL
Interval 494.1 to 1456.0
|
|
Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.
Anti-HPV-45 Month 36 (N=18,17,12,13,16,18,16)
|
165.4 EL.U/mL
Interval 97.9 to 279.4
|
707.8 EL.U/mL
Interval 451.9 to 1108.6
|
1103.9 EL.U/mL
Interval 521.0 to 2338.8
|
810.7 EL.U/mL
Interval 492.6 to 1334.2
|
825.2 EL.U/mL
Interval 450.2 to 1512.4
|
1015.6 EL.U/mL
Interval 660.2 to 1562.4
|
774.7 EL.U/mL
Interval 486.2 to 1234.3
|
|
Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.
Anti-HPV-45 Month 48 (N=19,17,12,13,16,18,16)
|
190.7 EL.U/mL
Interval 115.8 to 314.1
|
659.0 EL.U/mL
Interval 415.4 to 1045.6
|
1036.2 EL.U/mL
Interval 477.2 to 2249.9
|
806.9 EL.U/mL
Interval 447.5 to 1454.7
|
815.1 EL.U/mL
Interval 453.3 to 1465.7
|
914.6 EL.U/mL
Interval 600.7 to 1392.5
|
750.0 EL.U/mL
Interval 448.0 to 1255.5
|
SECONDARY outcome
Timeframe: From Month 0 to Months 18, 24, 36 and 48Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
NOCDs include conditions such as diabetes, autoimmune disease, asthma, allergies etc. At least one NOCD = At least one NOCD experienced (regardless of the Medical Dictionary for Regulatory Activities \[MedDRA\] Preferred Term)
Outcome measures
| Measure |
Cervarix Group
n=88 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 1 Group
n=50 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 2 Group
n=49 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 3 Group
n=48 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 4 Group
n=48 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 5 Group
n=50 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 6 Group
n=50 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)
NOCD(s) at Month 24
|
6 subjects
|
1 subjects
|
6 subjects
|
2 subjects
|
3 subjects
|
1 subjects
|
2 subjects
|
|
Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)
NOCD(s) at Month 18
|
6 subjects
|
1 subjects
|
6 subjects
|
2 subjects
|
3 subjects
|
1 subjects
|
2 subjects
|
|
Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)
NOCD(s) at Month 36
|
7 subjects
|
1 subjects
|
6 subjects
|
2 subjects
|
3 subjects
|
1 subjects
|
3 subjects
|
|
Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)
NOCD(s) at Month 48
|
7 subjects
|
1 subjects
|
7 subjects
|
3 subjects
|
4 subjects
|
1 subjects
|
4 subjects
|
SECONDARY outcome
Timeframe: From Month 0 to Months 18, 24, 36 and 48Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
MAEs were defined as adverse events (AEs) prompting emergency room or physician visits that were not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, and injury. At least one MAE = At least one medically significant AE experienced (regardless of the MedDRA Preferred Term).
Outcome measures
| Measure |
Cervarix Group
n=88 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 1 Group
n=50 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 2 Group
n=49 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 3 Group
n=48 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 4 Group
n=48 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 5 Group
n=50 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 6 Group
n=50 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With at Least One Medically Significant Condition (MAEs).
MAE(s) at Month 18
|
4 subjects
|
3 subjects
|
2 subjects
|
4 subjects
|
5 subjects
|
1 subjects
|
1 subjects
|
|
Number of Subjects With at Least One Medically Significant Condition (MAEs).
MAE(s) at Month 24
|
6 subjects
|
3 subjects
|
3 subjects
|
7 subjects
|
8 subjects
|
5 subjects
|
1 subjects
|
|
Number of Subjects With at Least One Medically Significant Condition (MAEs).
MAE(s) at Month 36
|
9 subjects
|
4 subjects
|
3 subjects
|
7 subjects
|
9 subjects
|
5 subjects
|
2 subjects
|
|
Number of Subjects With at Least One Medically Significant Condition (MAEs).
MAE(s) at Month 48
|
14 subjects
|
7 subjects
|
5 subjects
|
9 subjects
|
12 subjects
|
5 subjects
|
3 subjects
|
SECONDARY outcome
Timeframe: From Month 0 to Months 18, 24, 36 and 48Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
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. Any = Occurrence of any symptom regardless of intensity grade.
Outcome measures
| Measure |
Cervarix Group
n=88 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 1 Group
n=50 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 2 Group
n=49 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 3 Group
n=48 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 4 Group
n=48 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 5 Group
n=50 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 6 Group
n=50 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With Any Serious Adverse Events (SAEs).
Any SAE(s) at Month 24
|
2 subjects
|
3 subjects
|
1 subjects
|
3 subjects
|
3 subjects
|
1 subjects
|
1 subjects
|
|
Number of Subjects With Any Serious Adverse Events (SAEs).
Any SAE(s) at Month 18
|
2 subjects
|
3 subjects
|
1 subjects
|
3 subjects
|
2 subjects
|
0 subjects
|
1 subjects
|
|
Number of Subjects With Any Serious Adverse Events (SAEs).
Any SAE(s) at Month 36
|
2 subjects
|
3 subjects
|
2 subjects
|
4 subjects
|
3 subjects
|
1 subjects
|
1 subjects
|
|
Number of Subjects With Any Serious Adverse Events (SAEs).
Any SAE(s) at Month 48
|
6 subjects
|
4 subjects
|
2 subjects
|
6 subjects
|
3 subjects
|
1 subjects
|
1 subjects
|
SECONDARY outcome
Timeframe: From Month 0 to Month 18Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Pregnancy outcomes were healthy baby, spontaneous abortion and elective abortion.
Outcome measures
| Measure |
Cervarix Group
n=88 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 1 Group
n=50 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 2 Group
n=49 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 3 Group
n=48 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 4 Group
n=48 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 5 Group
n=50 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 6 Group
n=50 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With Pregnancy Outcomes.
Spontaneous abortion
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
1 subjects
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Pregnancy Outcomes.
Elective abortion
|
1 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Pregnancy Outcomes.
Healthy baby
|
3 subjects
|
0 subjects
|
2 subjects
|
1 subjects
|
0 subjects
|
1 subjects
|
3 subjects
|
SECONDARY outcome
Timeframe: From Month 0 to Month 24Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Pregnancy outcomes were healthy baby, spontaneous abortion, elective abortion and ongoing pregnancy.
Outcome measures
| Measure |
Cervarix Group
n=88 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 1 Group
n=50 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 2 Group
n=49 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 3 Group
n=48 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 4 Group
n=48 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 5 Group
n=50 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 6 Group
n=50 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With Pregnancy Outcomes.
Elective abortion
|
1 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Pregnancy Outcomes.
Ongoing pregnancy
|
0 subjects
|
0 subjects
|
0 subjects
|
1 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Pregnancy Outcomes.
Healthy baby
|
4 subjects
|
1 subjects
|
2 subjects
|
2 subjects
|
0 subjects
|
1 subjects
|
3 subjects
|
|
Number of Subjects With Pregnancy Outcomes.
Spontaneous abortion
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
1 subjects
|
0 subjects
|
0 subjects
|
SECONDARY outcome
Timeframe: From Month 0 to Month 36Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Pregnancy outcomes were healthy baby, abnormal infant/congenital anomaly, spontaneous abortion and elective abortion.
Outcome measures
| Measure |
Cervarix Group
n=88 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 1 Group
n=50 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 2 Group
n=49 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 3 Group
n=48 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 4 Group
n=48 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 5 Group
n=50 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 6 Group
n=50 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With Pregnancy Outcomes.
Healthy baby
|
4 subjects
|
4 subjects
|
3 subjects
|
2 subjects
|
0 subjects
|
1 subjects
|
3 subjects
|
|
Number of Subjects With Pregnancy Outcomes.
Abnormal infant/congenital anomaly
|
1 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Pregnancy Outcomes.
Spontaneous abortion
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
1 subjects
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Pregnancy Outcomes.
Elective abortion
|
1 subjects
|
0 subjects
|
0 subjects
|
1 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
SECONDARY outcome
Timeframe: From Month 0 to Month 48Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Pregnancy outcomes were normal infant, abnormal infant/congenital anomaly, spontaneous abortion and elective termination.
Outcome measures
| Measure |
Cervarix Group
n=88 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 1 Group
n=50 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 2 Group
n=49 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 3 Group
n=48 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 4 Group
n=48 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 5 Group
n=50 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 6 Group
n=50 Participants
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With Pregnancy Outcomes.
Normal infant
|
9 subjects
|
6 subjects
|
3 subjects
|
2 subjects
|
0 subjects
|
1 subjects
|
4 subjects
|
|
Number of Subjects With Pregnancy Outcomes.
Elective termination
|
1 subjects
|
0 subjects
|
0 subjects
|
1 subjects
|
1 subjects
|
1 subjects
|
0 subjects
|
|
Number of Subjects With Pregnancy Outcomes.
Abnormal infant/congenital anomaly
|
1 subjects
|
1 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Pregnancy Outcomes.
Spontaneous abortion
|
0 subjects
|
0 subjects
|
0 subjects
|
1 subjects
|
1 subjects
|
0 subjects
|
0 subjects
|
Adverse Events
Cervarix Group
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Cervarix 1 Group
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Cervarix 2 Group
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Cervarix 3 Group
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Cervarix 4 Group
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Cervarix 5 Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Cervarix 6 Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cervarix Group
n=88 participants at risk
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 1 Group
n=50 participants at risk
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 2 Group
n=49 participants at risk
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 3 Group
n=48 participants at risk
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 4 Group
n=48 participants at risk
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 5 Group
n=50 participants at risk
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
Cervarix 6 Group
n=50 participants at risk
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/88 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/49 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
2.0%
1/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
|
General disorders
Asthenia
|
0.00%
0/88 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
2.0%
1/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/49 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
|
Infections and infestations
Appendicitis
|
1.1%
1/88 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
2.0%
1/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
2.0%
1/49 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
2.1%
1/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
2.1%
1/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/88 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/49 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
2.1%
1/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/88 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/49 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
2.0%
1/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/88 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
2.0%
1/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/49 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
|
Infections and infestations
Post procedural infection
|
1.1%
1/88 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/49 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
|
Infections and infestations
Pyelonephritis
|
1.1%
1/88 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/49 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
|
Infections and infestations
Tonsillitis streptococcal
|
0.00%
0/88 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/49 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
2.1%
1/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/88 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
2.0%
1/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/49 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
|
Musculoskeletal and connective tissue disorders
Patellofemoral pain syndrome
|
0.00%
0/88 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/49 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
2.0%
1/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/88 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/49 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
2.0%
1/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
|
Nervous system disorders
Headache
|
1.1%
1/88 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/49 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
|
Nervous system disorders
Myelitis
|
0.00%
0/88 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/49 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
2.1%
1/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/88 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/49 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
2.1%
1/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous complete
|
0.00%
0/88 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/49 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
2.1%
1/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal distress syndrome
|
1.1%
1/88 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/49 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
0.00%
0/88 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
2.0%
1/49 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
|
Pregnancy, puerperium and perinatal conditions
Premature labour
|
0.00%
0/88 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
2.0%
1/49 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
|
Psychiatric disorders
Bulimia nervosa
|
0.00%
0/88 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/49 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
2.1%
1/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
|
Psychiatric disorders
Major depression
|
1.1%
1/88 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/49 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
1.1%
1/88 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/49 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/88 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/49 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
2.1%
1/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/48 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
0.00%
0/50 • SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
|
Other adverse events
Adverse event data not reported
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