Trial Outcomes & Findings for Human Papilloma Virus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Bio's Novel HPV Vaccine. (NCT NCT00231413)
NCT ID: NCT00231413
Last Updated: 2019-12-12
Results Overview
Seroconversion was defined as the appearance of anti-HPV-16 antibodies \[i.e. antibody titer greater than or equal to (≥) the cut-off value\] in the serum of subjects seronegative before vaccination. The cut-off value was 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
383 participants
Primary outcome timeframe
At Month 7
Results posted on
2019-12-12
Participant Flow
Participant milestones
| Measure |
HPV-16/18 Group
Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA A Group
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA B Group
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA C Group
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA D Group
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA E Group
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA F Group
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
|---|---|---|---|---|---|---|---|
|
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 |
HPV-16/18 Group
Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA A Group
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA B Group
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA C Group
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA D Group
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA E Group
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA F Group
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Non-serious AE
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
4
|
2
|
2
|
0
|
3
|
|
Overall Study
Migrated/moved from study area
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
4
|
1
|
1
|
1
|
4
|
0
|
|
Overall Study
Pregnancy
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Human Papilloma Virus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Bio's Novel HPV Vaccine.
Baseline characteristics by cohort
| Measure |
HPV-16/18 Group
n=88 Participants
Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA A Group
n=50 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA B Group
n=49 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA C Group
n=48 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA D Group
n=48 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA E Group
n=50 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA F Group
n=50 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
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 2.10 • 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
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
White/caucasian
|
80 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
44 Participants
n=8 Participants
|
47 Participants
n=8 Participants
|
355 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Arabic/north african
|
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
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
East/south east asian
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
South asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
American hispanic
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Other, not specified
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: At Month 7Population: The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures, seronegative before vaccination 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 anti-HPV-16 antibodies \[i.e. antibody titer greater than or equal to (≥) the cut-off value\] in the serum of subjects seronegative before vaccination. The cut-off value was 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Outcome measures
| Measure |
HPV-16/18 Group
n=62 Participants
Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA A Group
n=32 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA B Group
n=31 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA C Group
n=23 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA D Group
n=33 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA E Group
n=28 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA F Group
n=33 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
|---|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects for Anti-Human Papillomavirus (Anti-HPV)-16 at Month 7
|
62 Participants
|
27 Participants
|
31 Participants
|
23 Participants
|
33 Participants
|
28 Participants
|
33 Participants
|
PRIMARY outcome
Timeframe: At Month 7Population: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures, who were seronegative before vaccination 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 anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 7 EL.U/mL.
Outcome measures
| Measure |
HPV-16/18 Group
n=59 Participants
Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA A Group
n=30 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA B Group
n=37 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA C Group
n=34 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA D Group
n=27 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA E Group
n=33 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA F Group
n=36 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
|---|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects for Anti-HPV-18 at Month 7
|
59 Participants
|
30 Participants
|
37 Participants
|
34 Participants
|
27 Participants
|
33 Participants
|
36 Participants
|
PRIMARY outcome
Timeframe: At Month 7Population: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures, who were seronegative before vaccination and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Anti-HPV-16 antibody titers were presented as Geometric Mean Titers (GMT) and expressed in EL.U/mL.
Outcome measures
| Measure |
HPV-16/18 Group
n=62 Participants
Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA A Group
n=27 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA B Group
n=31 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA C Group
n=23 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA D Group
n=33 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA E Group
n=28 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA F Group
n=33 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
|---|---|---|---|---|---|---|---|
|
Anti-HPV-16 Antibody Titers Assessed by ELISA at Month 7
|
9086.1 EL.U/mL
Interval 7231.1 to 11417.1
|
5757.4 EL.U/mL
Interval 4283.9 to 7737.8
|
7897.7 EL.U/mL
Interval 5825.2 to 10707.6
|
7524.1 EL.U/mL
Interval 5678.1 to 9970.2
|
5986.4 EL.U/mL
Interval 4485.2 to 7990.2
|
8483.5 EL.U/mL
Interval 6257.6 to 11501.1
|
7605.0 EL.U/mL
Interval 5818.7 to 9939.6
|
PRIMARY outcome
Timeframe: At Month 7Population: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures, who were seronegative before vaccination and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Anti-HPV-18 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.
Outcome measures
| Measure |
HPV-16/18 Group
n=59 Participants
Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA A Group
n=30 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA B Group
n=37 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA C Group
n=34 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA D Group
n=27 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA E Group
n=33 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA F Group
n=36 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
|---|---|---|---|---|---|---|---|
|
Anti-HPV-18 Antibody Titers Assessed by ELISA at Month 7
|
5184.5 EL.U/mL
Interval 4211.1 to 6382.8
|
3061.3 EL.U/mL
Interval 2231.7 to 4199.4
|
3640.2 EL.U/mL
Interval 2590.4 to 5115.6
|
3268.6 EL.U/mL
Interval 2650.4 to 4031.1
|
2998.5 EL.U/mL
Interval 2109.5 to 4262.1
|
3296.2 EL.U/mL
Interval 2402.8 to 4521.8
|
3056.0 EL.U/mL
Interval 2364.5 to 3949.5
|
SECONDARY outcome
Timeframe: At Month 2Population: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures, who were seronegative before vaccination 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 anti-HPV-16 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 8 EL.U/mL.
Outcome measures
| Measure |
HPV-16/18 Group
n=62 Participants
Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA A Group
n=27 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA B Group
n=31 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA C Group
n=23 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA D Group
n=33 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA E Group
n=28 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA F Group
n=33 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
|---|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects for Anti-HPV-16 at Month 2
|
62 Participants
|
27 Participants
|
31 Participants
|
23 Participants
|
33 Participants
|
28 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: At Month 2Population: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures, who were seronegative before vaccination 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 anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 7 EL.U/mL.
Outcome measures
| Measure |
HPV-16/18 Group
n=59 Participants
Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA A Group
n=30 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA B Group
n=37 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA C Group
n=34 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA D Group
n=27 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA E Group
n=33 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA F Group
n=36 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
|---|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects for Anti-HPV-18 at Month 2
|
59 Participants
|
30 Participants
|
37 Participants
|
34 Participants
|
27 Participants
|
33 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: At Month 2Population: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures, who were seronegative before vaccination and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Anti-HPV-16 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.
Outcome measures
| Measure |
HPV-16/18 Group
n=62 Participants
Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA A Group
n=27 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA B Group
n=31 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA C Group
n=23 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA D Group
n=33 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA E Group
n=28 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA F Group
n=33 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
|---|---|---|---|---|---|---|---|
|
Anti-HPV-16 Antibody Titers Assessed by ELISA at Month 2
|
3256.7 EL.U/mL
Interval 2613.6 to 4058.0
|
2718.9 EL.U/mL
Interval 2207.9 to 3348.1
|
2779.4 EL.U/mL
Interval 2139.2 to 3611.2
|
2915.5 EL.U/mL
Interval 2346.9 to 3621.9
|
2353.5 EL.U/mL
Interval 1782.0 to 3108.2
|
3202.3 EL.U/mL
Interval 2539.5 to 4038.0
|
2720.9 EL.U/mL
Interval 2226.8 to 3324.6
|
SECONDARY outcome
Timeframe: At Month 2Population: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures, who were seronegative before vaccination and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Anti-HPV-18 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.
Outcome measures
| Measure |
HPV-16/18 Group
n=59 Participants
Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA A Group
n=30 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA B Group
n=37 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA C Group
n=34 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA D Group
n=27 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA E Group
n=33 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA F Group
n=36 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
|---|---|---|---|---|---|---|---|
|
Anti-HPV-18 Antibody Titers Assessed by ELISA at Month 2
|
2530.1 EL.U/mL
Interval 2007.0 to 3189.5
|
1731.5 EL.U/mL
Interval 1311.6 to 2285.9
|
1875.9 EL.U/mL
Interval 1464.0 to 2403.7
|
2082.2 EL.U/mL
Interval 1682.3 to 2577.2
|
2048.8 EL.U/mL
Interval 1566.9 to 2678.8
|
2003.1 EL.U/mL
Interval 1575.4 to 2547.0
|
1820.0 EL.U/mL
Interval 1412.2 to 2345.6
|
SECONDARY outcome
Timeframe: At Month 2 and Month 7Population: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures, who were seronegative before vaccination 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 anti-HPV-31 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 59 EL.U/mL.
Outcome measures
| Measure |
HPV-16/18 Group
n=61 Participants
Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA A Group
n=32 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA B Group
n=37 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA C Group
n=29 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA D Group
n=31 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA E Group
n=30 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA F Group
n=36 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
|---|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects for Anti-HPV-31 at Months 2 and 7
Month 2
|
54 Participants
|
32 Participants
|
37 Participants
|
29 Participants
|
31 Participants
|
30 Participants
|
36 Participants
|
|
Number of Seroconverted Subjects for Anti-HPV-31 at Months 2 and 7
Month 7
|
61 Participants
|
32 Participants
|
37 Participants
|
29 Participants
|
31 Participants
|
30 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: At Month 2 and Month 7Population: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures, who were seronegative before vaccination 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 anti-HPV-45 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 59 EL.U/mL.
Outcome measures
| Measure |
HPV-16/18 Group
n=56 Participants
Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA A Group
n=33 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA B Group
n=31 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA C Group
n=27 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA D Group
n=32 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA E Group
n=34 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA F Group
n=35 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
|---|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects for Anti-HPV-45 at Months 2 and 7
Month 2
|
54 Participants
|
33 Participants
|
31 Participants
|
27 Participants
|
32 Participants
|
34 Participants
|
35 Participants
|
|
Number of Seroconverted Subjects for Anti-HPV-45 at Months 2 and 7
Month 7
|
56 Participants
|
33 Participants
|
31 Participants
|
27 Participants
|
32 Participants
|
34 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: At Month 2 and Month 7Population: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures, who were seronegative before vaccination and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Anti-HPV-31 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.
Outcome measures
| Measure |
HPV-16/18 Group
n=61 Participants
Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA A Group
n=32 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA B Group
n=37 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA C Group
n=29 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA D Group
n=31 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA E Group
n=30 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA F Group
n=36 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
|---|---|---|---|---|---|---|---|
|
Anti-HPV-31 Antibody Titers Assessed by ELISA at Months 2 and 7
Month 2
|
232.8 EL.U/mL
Interval 178.0 to 304.5
|
3694.6 EL.U/mL
Interval 2720.2 to 5018.0
|
6271.3 EL.U/mL
Interval 4762.4 to 8258.3
|
4570.7 EL.U/mL
Interval 3636.0 to 5745.6
|
5114.8 EL.U/mL
Interval 3967.7 to 6593.5
|
4846.7 EL.U/mL
Interval 3817.6 to 6153.3
|
5627.6 EL.U/mL
Interval 4650.8 to 6809.6
|
|
Anti-HPV-31 Antibody Titers Assessed by ELISA at Months 2 and 7
Month 7
|
920.5 EL.U/mL
Interval 705.8 to 1200.6
|
7909.0 EL.U/mL
Interval 5712.3 to 10950.4
|
14957.8 EL.U/mL
Interval 11096.1 to 20163.5
|
9688.5 EL.U/mL
Interval 7660.9 to 12252.7
|
11768.3 EL.U/mL
Interval 8598.0 to 16107.6
|
9139.9 EL.U/mL
Interval 6334.9 to 13186.9
|
12652.0 EL.U/mL
Interval 10052.5 to 15923.6
|
SECONDARY outcome
Timeframe: At Month 2 and Month 7Population: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures, who were seronegative before vaccination and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Anti-HPV-45 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.
Outcome measures
| Measure |
HPV-16/18 Group
n=56 Participants
Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA A Group
n=33 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA B Group
n=31 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA C Group
n=27 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA D Group
n=32 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA E Group
n=34 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA F Group
n=35 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
|---|---|---|---|---|---|---|---|
|
Anti-HPV-45 Antibody Titers Assessed by ELISA at Months 2 and 7
Month 2
|
317.4 EL.U/mL
Interval 246.2 to 409.2
|
1550.7 EL.U/mL
Interval 1158.1 to 2076.5
|
2613.9 EL.U/mL
Interval 1980.7 to 3449.5
|
1893.7 EL.U/mL
Interval 1513.2 to 2369.8
|
2113.3 EL.U/mL
Interval 1602.9 to 2786.4
|
2217.4 EL.U/mL
Interval 1763.8 to 2787.7
|
2208.9 EL.U/mL
Interval 1718.5 to 2839.4
|
|
Anti-HPV-45 Antibody Titers Assessed by ELISA at Months 2 and 7
Month 7
|
915.7 EL.U/mL
Interval 732.1 to 1145.3
|
4719.4 EL.U/mL
Interval 3631.1 to 6133.9
|
7923.1 EL.U/mL
Interval 5902.7 to 10635.0
|
5851.8 EL.U/mL
Interval 4400.7 to 7781.4
|
6027.6 EL.U/mL
Interval 4463.6 to 8139.4
|
6266.4 EL.U/mL
Interval 4514.6 to 8698.1
|
6149.5 EL.U/mL
Interval 4805.2 to 7869.8
|
SECONDARY outcome
Timeframe: During the 7 day post-vaccination period following each dose and across dosesPopulation: The analysis was based on the Total Vaccinated Cohort (TVC), which included all subjects with at least one vaccine administration documented, for whom data were available at the specified time point and had symptom sheets completed.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptom regardless of their intensity grade. Grade 3 pain = significant pain at rest, that prevented normal every day activity. Grade 3 redness/swelling = redness/swelling above 50 millimeters (mm). All the reported local symptoms are considered related to the vaccination in the study.
Outcome measures
| Measure |
HPV-16/18 Group
n=86 Participants
Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA A Group
n=49 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA B Group
n=47 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA C Group
n=46 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA D Group
n=46 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA E Group
n=50 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA F Group
n=48 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain - Dose 1
|
81 Participants
|
45 Participants
|
44 Participants
|
45 Participants
|
44 Participants
|
49 Participants
|
46 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain - Dose 1
|
6 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
5 Participants
|
5 Participants
|
7 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain - Dose 2
|
70 Participants
|
42 Participants
|
40 Participants
|
42 Participants
|
40 Participants
|
43 Participants
|
45 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain - Dose 2
|
2 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain - Dose 3
|
68 Participants
|
40 Participants
|
33 Participants
|
40 Participants
|
37 Participants
|
40 Participants
|
39 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain - Dose 3
|
7 Participants
|
6 Participants
|
3 Participants
|
10 Participants
|
7 Participants
|
6 Participants
|
7 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain - Across doses
|
81 Participants
|
48 Participants
|
46 Participants
|
45 Participants
|
44 Participants
|
50 Participants
|
47 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain - Across doses
|
10 Participants
|
12 Participants
|
7 Participants
|
14 Participants
|
11 Participants
|
12 Participants
|
12 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness - Dose 1
|
20 Participants
|
10 Participants
|
8 Participants
|
12 Participants
|
15 Participants
|
18 Participants
|
11 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness - Dose 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness - Dose 2
|
21 Participants
|
18 Participants
|
9 Participants
|
10 Participants
|
14 Participants
|
15 Participants
|
13 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness - Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness - Dose 3
|
22 Participants
|
17 Participants
|
12 Participants
|
15 Participants
|
13 Participants
|
13 Participants
|
13 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness - Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness - Across doses
|
36 Participants
|
28 Participants
|
15 Participants
|
22 Participants
|
24 Participants
|
22 Participants
|
25 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness - Across doses
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling - Dose 1
|
17 Participants
|
10 Participants
|
6 Participants
|
8 Participants
|
6 Participants
|
14 Participants
|
9 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling - Dose 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling - Dose 2
|
17 Participants
|
11 Participants
|
3 Participants
|
6 Participants
|
16 Participants
|
18 Participants
|
6 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling - Dose 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling - Dose 3
|
23 Participants
|
14 Participants
|
8 Participants
|
11 Participants
|
15 Participants
|
16 Participants
|
11 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling - Dose 3
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling - Across doses
|
33 Participants
|
22 Participants
|
12 Participants
|
18 Participants
|
21 Participants
|
27 Participants
|
19 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling - Across doses
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 7 day post-vaccination period following each dose and across dosesPopulation: The analysis was based on the TVC, which included all subjects with at least one vaccine administration documented, for whom data were available at the specified time point and had symptom sheets completed.
Assessed solicited general symptoms were arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash and urticaria. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Any Fever = axillary temperature greater than or equal to (≥) 37.5 degrees Celsius (°C). Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever greater than (\>) 39.0°C. Related = general symptom assessed by the investigator as causally related to the vaccination.
Outcome measures
| Measure |
HPV-16/18 Group
n=86 Participants
Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA A Group
n=49 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA B Group
n=47 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA C Group
n=46 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA D Group
n=46 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA E Group
n=50 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA F Group
n=48 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Artharlgia - Dose 1
|
6 Participants
|
6 Participants
|
4 Participants
|
6 Participants
|
10 Participants
|
5 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Arthralgia - Dose 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Arthralgia - Dose 1
|
2 Participants
|
5 Participants
|
2 Participants
|
4 Participants
|
7 Participants
|
3 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Artharlgia - Dose 2
|
4 Participants
|
11 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Arthralgia - Dose 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Arthralgia - Dose 2
|
2 Participants
|
10 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Artharlgia - Dose 3
|
3 Participants
|
4 Participants
|
7 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Arthralgia - Dose 3
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Arthralgia - Dose 3
|
2 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Artharlgia - Across doses
|
11 Participants
|
13 Participants
|
9 Participants
|
11 Participants
|
11 Participants
|
9 Participants
|
11 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Arthralgia - Across doses
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Arthralgia - Across doses
|
5 Participants
|
12 Participants
|
7 Participants
|
9 Participants
|
9 Participants
|
5 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue - Dose 1
|
37 Participants
|
23 Participants
|
24 Participants
|
19 Participants
|
20 Participants
|
27 Participants
|
25 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue - Dose 1
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue - Dose 1
|
26 Participants
|
13 Participants
|
16 Participants
|
8 Participants
|
15 Participants
|
22 Participants
|
20 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue - Dose 2
|
32 Participants
|
19 Participants
|
13 Participants
|
18 Participants
|
19 Participants
|
21 Participants
|
16 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue - Dose 2
|
1 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue - Dose 2
|
22 Participants
|
14 Participants
|
10 Participants
|
10 Participants
|
14 Participants
|
16 Participants
|
11 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue - Dose 3
|
28 Participants
|
16 Participants
|
15 Participants
|
18 Participants
|
14 Participants
|
22 Participants
|
20 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue - Dose 3
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue - Dose 3
|
18 Participants
|
15 Participants
|
11 Participants
|
14 Participants
|
12 Participants
|
16 Participants
|
14 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue - Across doses
|
54 Participants
|
33 Participants
|
30 Participants
|
32 Participants
|
25 Participants
|
34 Participants
|
31 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue - Across doses
|
1 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue - Across doses
|
42 Participants
|
28 Participants
|
24 Participants
|
22 Participants
|
22 Participants
|
27 Participants
|
27 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever - Dose 1
|
4 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever - Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever - Dose 1
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever - Dose 2
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever - Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever - Dose 2
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever - Dose 3
|
7 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever - Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever - Dose 3
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever - Across doses
|
10 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
9 Participants
|
4 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever - Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever - Across doses
|
5 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
9 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal - Dose 1
|
25 Participants
|
10 Participants
|
13 Participants
|
10 Participants
|
9 Participants
|
10 Participants
|
13 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal - Dose 1
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal - Dose 1
|
14 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
8 Participants
|
5 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal - Dose 2
|
16 Participants
|
10 Participants
|
8 Participants
|
6 Participants
|
6 Participants
|
10 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal - Dose 2
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal - Dose 2
|
7 Participants
|
6 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
8 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal - Dose 3
|
17 Participants
|
5 Participants
|
7 Participants
|
6 Participants
|
8 Participants
|
7 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal - Dose 3
|
5 Participants
|
1 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal - Dose 3
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Urticaria - Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Urticaria - Dose 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Urticaria - Dose 3
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Urticaria - Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Urticaria - Dose 3
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Urticaria - Across doses
|
3 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Urticaria - Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Urticaria - Across doses
|
3 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal - Across doses
|
18 Participants
|
8 Participants
|
12 Participants
|
8 Participants
|
10 Participants
|
10 Participants
|
11 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache - Dose 1
|
32 Participants
|
11 Participants
|
16 Participants
|
24 Participants
|
17 Participants
|
29 Participants
|
13 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache - Dose 1
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache - Dose 1
|
19 Participants
|
8 Participants
|
6 Participants
|
9 Participants
|
13 Participants
|
18 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache - Dose 2
|
21 Participants
|
17 Participants
|
9 Participants
|
14 Participants
|
12 Participants
|
19 Participants
|
19 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache - Dose 2
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache - Dose 2
|
15 Participants
|
12 Participants
|
7 Participants
|
8 Participants
|
9 Participants
|
14 Participants
|
11 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache - Dose 3
|
24 Participants
|
12 Participants
|
8 Participants
|
14 Participants
|
9 Participants
|
18 Participants
|
18 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache - Dose 3
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache - Dose 3
|
14 Participants
|
10 Participants
|
5 Participants
|
6 Participants
|
6 Participants
|
15 Participants
|
13 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal - Across doses
|
36 Participants
|
15 Participants
|
18 Participants
|
20 Participants
|
17 Participants
|
17 Participants
|
18 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal - Across doses
|
4 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache - Across doses
|
45 Participants
|
24 Participants
|
23 Participants
|
31 Participants
|
22 Participants
|
33 Participants
|
27 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache - Across doses
|
5 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache - Across doses
|
32 Participants
|
17 Participants
|
15 Participants
|
16 Participants
|
19 Participants
|
25 Participants
|
21 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia - Dose 1
|
20 Participants
|
14 Participants
|
11 Participants
|
8 Participants
|
11 Participants
|
14 Participants
|
10 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia - Dose 1
|
0 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia - Dose 1
|
14 Participants
|
11 Participants
|
9 Participants
|
5 Participants
|
11 Participants
|
10 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia - Dose 2
|
12 Participants
|
11 Participants
|
7 Participants
|
9 Participants
|
9 Participants
|
5 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia - Dose 2
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia - Dose 2
|
8 Participants
|
11 Participants
|
7 Participants
|
5 Participants
|
8 Participants
|
4 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia - Dose 3
|
10 Participants
|
11 Participants
|
11 Participants
|
7 Participants
|
8 Participants
|
7 Participants
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia - Dose 3
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia - Dose 3
|
8 Participants
|
11 Participants
|
9 Participants
|
5 Participants
|
6 Participants
|
6 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia - Across doses
|
25 Participants
|
18 Participants
|
19 Participants
|
16 Participants
|
17 Participants
|
19 Participants
|
15 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia - Across doses
|
2 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia - Across doses
|
20 Participants
|
16 Participants
|
16 Participants
|
13 Participants
|
15 Participants
|
14 Participants
|
13 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Rash - Dose 1
|
4 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Rash - Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Rash - Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Rash - Dose 2
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Rash - Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Rash - Dose 2
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Rash - Dose 3
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Rash - Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Rash - Dose 3
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Rash - Across doses
|
6 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Rash - Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Rash - Across doses
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Urticaria - Dose 1
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Urticaria - Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Urticaria - Dose 1
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Urticaria - Dose 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 30-day post-vaccination periodPopulation: The analysis was based on the TVC, which included all subjects with at least one vaccine administration documented for whom data were available.
An unsolicited adverse event (AE) was defined as any AE reported in addition to those solicited during the clinical study. Also, any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Any is defined as the occurrence of any unsolicited AE irrespective of its intensity grade and relationship to vaccination. Grade 3 unsolicited AE = an AE that prevented normal, everyday activities. Related AE = an AE assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
HPV-16/18 Group
n=88 Participants
Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA A Group
n=50 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA B Group
n=49 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA C Group
n=48 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA D Group
n=48 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA E Group
n=50 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA F Group
n=50 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Any AEs
|
60 Participants
|
31 Participants
|
34 Participants
|
25 Participants
|
32 Participants
|
36 Participants
|
29 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Grade 3 AEs
|
14 Participants
|
5 Participants
|
8 Participants
|
3 Participants
|
5 Participants
|
6 Participants
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Related AEs
|
17 Participants
|
16 Participants
|
7 Participants
|
6 Participants
|
9 Participants
|
8 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Month 7Population: The analysis was based on the TVC, which included all subjects with at least one vaccine administration documented for whom data were available.
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
HPV-16/18 Group
n=88 Participants
Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA A Group
n=50 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA B Group
n=49 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA C Group
n=48 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA D Group
n=48 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA E Group
n=50 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA F Group
n=50 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With Any Serious Adverse Events (SAEs)
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Month 12Population: The analysis was based on the TVC, which included all subjects with at least one vaccine administration documented for whom data were available.
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
HPV-16/18 Group
n=88 Participants
Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA A Group
n=50 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA B Group
n=49 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA C Group
n=48 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA D Group
n=48 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA E Group
n=50 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA F Group
n=50 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With Any SAEs During the Extended Safety Follow-up
|
2 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Month 12Population: The analysis was based on the TVC, which included all subjects with at least one vaccine administration documented for whom data were available.
Outcomes of reported pregnancies were: Healthy baby, Spontaneous abortion, Elective abortion.
Outcome measures
| Measure |
HPV-16/18 Group
n=88 Participants
Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA A Group
n=50 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA B Group
n=49 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA C Group
n=48 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA D Group
n=48 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA E Group
n=50 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA F Group
n=50 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Healthy baby
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Spontaneous abortion
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Elective abortion
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 0 up to Month 12Population: The analysis was based on the TVC, which included all subjects with at least one vaccine administration documented for whom data were available.
NOCDs assessed include chronic diseases such as autoimmune disorders, diabetes, allergies also asthma and pathognomic signs/symptoms of these diseases.
Outcome measures
| Measure |
HPV-16/18 Group
n=88 Participants
Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA A Group
n=50 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA B Group
n=49 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA C Group
n=48 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA D Group
n=48 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA E Group
n=50 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA F Group
n=50 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs)
|
5 Participants
|
1 Participants
|
6 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From Day 0 up to Month 12Population: The analysis was based on the TVC, which included all subjects with at least one vaccine administration documented for whom data were available.
Medically significant conditions are AEs prompting emergency room or physician visits that were not related to common diseases or routine visits for physical examination or vaccination, or SAEs that were not related to common diseases.
Outcome measures
| Measure |
HPV-16/18 Group
n=88 Participants
Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA A Group
n=50 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA B Group
n=49 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA C Group
n=48 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA D Group
n=48 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA E Group
n=50 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA F Group
n=50 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Medically Significant Conditions
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Month 2 and Month 7Population: The analysis was based on the TVC, which included all subjects with at least one vaccine administration documented for whom data were available at the specified time points.
The parameters assessed were both biochemical (alanine aminotransferase = ALAT, creatinine = CREA, blood urea nitrogen = BUN) and haematological \[basophils = BAS, eosinophils = EOS, red blood cells = RBC, hematocrit = HCT, hemoglobin = HGB, leukocytes (white blood cells) = WBC, lymphocytes = LYM, monocytes = MONO, neutrophils = NEU and platelets = PLA\]. Abnormal values of a parameter at Months 2 and 7 are defined as below and above the normal ranges, as compared to the baseline status of the same parameter.
Outcome measures
| Measure |
HPV-16/18 Group
n=83 Participants
Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA A Group
n=45 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA B Group
n=43 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA C Group
n=45 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA D Group
n=45 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA E Group
n=49 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA F Group
n=46 Participants
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
CREA, Above (pre-vacc) - Below (Month 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
ALAT, Normal (pre-vacc) - Normal (Month 2)
|
78 Participants
|
43 Participants
|
42 Participants
|
44 Participants
|
42 Participants
|
47 Participants
|
46 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
ALAT, Normal (pre-vacc) - Below (Month 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
ALAT, Normal (pre-vacc) - Above (Month 2)
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
ALAT, Normal (pre-vacc) - Missing (Month 2)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
ALAT, Normal (pre-vacc) - Normal (Month 7)
|
78 Participants
|
44 Participants
|
40 Participants
|
44 Participants
|
41 Participants
|
41 Participants
|
45 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
ALAT, Normal (pre-vacc) - Below (Month 7)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
ALAT, Normal (pre-vacc) - Above (Month 7)
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
ALAT, Normal (pre-vacc) - Missing (Month 7)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
ALAT, Above (pre-vacc) - Normal (Month 2)
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
ALAT, Above (pre-vacc) - Below (Month 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
ALAT, Above (pre-vacc) - Above (Month 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
ALAT, Above (pre-vacc) - Normal (Month 7)
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
ALAT, Above (pre-vacc) - Below (Month 7)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
ALAT, Above (pre-vacc) - Above (Month 7)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
BAS, Normal (pre-vacc) - Normal (Month 2)
|
80 Participants
|
43 Participants
|
42 Participants
|
42 Participants
|
43 Participants
|
48 Participants
|
45 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
BAS, Normal (pre-vacc) - Below (Month 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
BAS, Normal (pre-vacc) - Above (Month 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
BAS, Normal (pre-vacc) - Missing (Month 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
BAS, Normal (pre-vacc) - Normal (Month 7)
|
76 Participants
|
40 Participants
|
40 Participants
|
41 Participants
|
43 Participants
|
43 Participants
|
44 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
BAS, Normal (pre-vacc) - Below (Month 7)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
BAS, Normal (pre-vacc) - Above (Month 7)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
BAS, Normal (pre-vacc) - Missing (Month 7)
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
CREA, Normal (pre-vacc) - Normal (Month 2)
|
78 Participants
|
43 Participants
|
42 Participants
|
43 Participants
|
43 Participants
|
47 Participants
|
43 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
CREA, Normal (pre-vacc) - Below (Month 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
CREA, Normal (pre-vacc) - Above (Month 2)
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
CREA, Normal (pre-vacc) - Missing (Month 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
CREA, Normal (pre-vacc) - Normal (Month 7)
|
73 Participants
|
43 Participants
|
42 Participants
|
43 Participants
|
41 Participants
|
44 Participants
|
43 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
CREA, Normal (pre-vacc) - Below (Month 7)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
CREA, Normal (pre-vacc) - Above (Month 7)
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
CREA, Above (pre-vacc) - Normal (Month 2)
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
CREA, Above (pre-vacc) - Above (Month 2)
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
CREA, Above (pre-vacc) - Normal (Month 7)
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
CREA, Above (pre-vacc) - Below (Month 7)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
CREA, Above (pre-vacc) - Above (Month 7)
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
EOS, Normal (pre-vacc) - Normal (Month 2)
|
67 Participants
|
40 Participants
|
42 Participants
|
38 Participants
|
39 Participants
|
45 Participants
|
41 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
EOS, Normal (pre-vacc) - Below (Month 2)
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
EOS, Normal (pre-vacc) - Above (Month 2)
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
EOS, Normal (pre-vacc) - Missing (Month 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
EOS, Normal (pre-vacc) - Normal (Month 7)
|
63 Participants
|
38 Participants
|
40 Participants
|
38 Participants
|
40 Participants
|
38 Participants
|
43 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
EOS, Normal (pre-vacc) - Below (Month 7)
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
EOS, Normal (pre-vacc) - Above (Month 7)
|
4 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
EOS, Normal (pre-vacc) - Missing (Month 7)
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
EOS, Above (pre-vacc) - Normal (Month 2)
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
EOS, Above (pre-vacc) - Below (Month 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
EOS, Above (pre-vacc) - Above (Month 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
EOS, Above (pre-vacc) - Normal (Month 7)
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
EOS, Above (pre-vacc) - Below (Month 7)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
EOS, Above (pre-vacc) - Above (Month 7)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
EOS, Below (pre-vacc) - Normal (Month 2)
|
3 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
EOS, Below (pre-vacc) - Below (Month 2)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
EOS, Below (pre-vacc) - Above (Month 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
EOS, Below (pre-vacc) - Normal (Month 7)
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
EOS, Below (pre-vacc) - Below (Month 7)
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
EOS, Below (pre-vacc) - Above (Month 7)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
HCT, Normal (pre-vacc) - Normal (Month 2)
|
73 Participants
|
39 Participants
|
41 Participants
|
40 Participants
|
39 Participants
|
45 Participants
|
41 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
HCT, Normal (pre-vacc) - Below (Month 2)
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
HCT, Normal (pre-vacc) - Above (Month 2)
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
HCT, Normal (pre-vacc) - Missing (Month 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
HCT, Normal (pre-vacc) - Normal (Month 7)
|
71 Participants
|
38 Participants
|
40 Participants
|
40 Participants
|
41 Participants
|
43 Participants
|
39 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
HCT, Normal (pre-vacc) - Below (Month 7)
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
HCT, Normal (pre-vacc) - Above (Month 7)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
HCT, Normal (pre-vacc) - Missing (Month 7)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
HCT, Above (pre-vacc) - Normal (Month 2)
|
4 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
HCT, Above (pre-vacc) - Below (Month 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
HCT, Above (pre-vacc) - Above (Month 2)
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
HCT, Above (pre-vacc) - Normal (Month 7)
|
5 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
HCT, Above (pre-vacc) - Below (Month 7)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
HCT, Above (pre-vacc) - Above (Month 7)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
HCT, Below (pre-vacc) - Normal (Month 2)
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
HCT, Below (pre-vacc) - Below (Month 2)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
HCT, Below (pre-vacc) - Above (Month 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
HCT, Below (pre-vacc) - Normal (Month 7)
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
HCT, Below (pre-vacc) - Below (Month 7)
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
HCT, Below (pre-vacc) - Above (Month 7)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
LYM, Normal (pre-vacc) - Normal (Month 2)
|
70 Participants
|
38 Participants
|
36 Participants
|
39 Participants
|
38 Participants
|
40 Participants
|
40 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
LYM, Normal (pre-vacc) - Below (Month 2)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
LYM, Normal (pre-vacc) - Above (Month 2)
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
LYM, Normal (pre-vacc) - Missing (Month 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
LYM, Normal (pre-vacc) - Normal (Month 7)
|
65 Participants
|
35 Participants
|
34 Participants
|
38 Participants
|
39 Participants
|
37 Participants
|
39 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
LYM, Normal (pre-vacc) - Below (Month 7)
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
LYM, Normal (pre-vacc) - Above (Month 7)
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
LYM, Normal (pre-vacc) - Missing (Month 7)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
LYM, Above (pre-vacc) - Normal (Month 2)
|
3 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
LYM, Above (pre-vacc) - Below (Month 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
LYM, Above (pre-vacc) - Above (Month 2)
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
LYM, Above (pre-vacc) - Normal (Month 7)
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
LYM, Above (pre-vacc) - Below (Month 7)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
LYM, Above (pre-vacc) - Above (Month 7)
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
LYM, Below (pre-vacc) - Normal (Month 2)
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
LYM, Below (pre-vacc) - Below (Month 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
LYM, Below (pre-vacc) - Above (Month 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
LYM, Below (pre-vacc) - Normal (Month 7)
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
LYM, Below (pre-vacc) - Below (Month 7)
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
LYM, Below (pre-vacc) - Above (Month 7)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
MONO, Normal (pre-vacc) - Normal (Month 2)
|
68 Participants
|
34 Participants
|
36 Participants
|
31 Participants
|
36 Participants
|
40 Participants
|
37 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
MONO, Normal (pre-vacc) - Below (Month 2)
|
6 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
MONO, Normal (pre-vacc) - Above (Month 2)
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
MONO, Normal (pre-vacc) - Missing (Month 2)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
MONO, Normal (pre-vacc) - Normal (Month 7)
|
69 Participants
|
35 Participants
|
34 Participants
|
32 Participants
|
35 Participants
|
35 Participants
|
39 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
MONO, Normal (pre-vacc) - Below (Month 7)
|
3 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
MONO, Normal (pre-vacc) - Above (Month 7)
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
MONO, Normal (pre-vacc) - Missing (Month 7)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
MONO, Above (pre-vacc) - Normal (Month 2)
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
MONO, Above (pre-vacc) - Below (Month 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
MONO, Above (pre-vacc) - Above (Month 2)
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
MONO, Above (pre-vacc) - Normal (Month 7)
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
MONO, Above (pre-vacc) - Below (Month 7)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
MONO, Above (pre-vacc) - Above (Month 7)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
MONO, Below (pre-vacc) - Normal (Month 2)
|
1 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
MONO, Below (pre-vacc) - Below (Month 2)
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
MONO, Below (pre-vacc) - Above (Month 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
MONO, Below (pre-vacc) - Normal (Month 7)
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
MONO, Below (pre-vacc) - Below (Month 7)
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
MONO, Below (pre-vacc) - Above (Month 7)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
NEU, Normal (pre-vacc) - Normal (Month 2)
|
63 Participants
|
39 Participants
|
39 Participants
|
36 Participants
|
40 Participants
|
42 Participants
|
41 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
NEU, Normal (pre-vacc) - Below (Month 2)
|
7 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
NEU, Normal (pre-vacc) - Above (Month 2)
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
NEU, Normal (pre-vacc) - Missing (Month 2)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
NEU, Normal (pre-vacc) - Normal (Month 7)
|
69 Participants
|
35 Participants
|
38 Participants
|
37 Participants
|
40 Participants
|
38 Participants
|
39 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
NEU, Normal (pre-vacc) - Below (Month 7)
|
2 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
NEU, Normal (pre-vacc) - Above (Month 7)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
NEU, Normal (pre-vacc) - Missing (Month 7)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
NEU, Above (pre-vacc) - Normal (Month 2)
|
3 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
NEU, Above (pre-vacc) - Below (Month 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
NEU, Above (pre-vacc) - Above (Month 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
NEU, Above (pre-vacc) - Normal (Month 7)
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
NEU, Above (pre-vacc) - Below (Month 7)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
NEU, Above (pre-vacc) - Above (Month 7)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
NEU, Below (pre-vacc) - Normal (Month 2)
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
NEU, Below (pre-vacc) - Below (Month 2)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
NEU, Below (pre-vacc) - Above (Month 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
NEU, Below (pre-vacc) - Normal (Month 7)
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
NEU, Below (pre-vacc) - Below (Month 7)
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
NEU, Below (pre-vacc) - Above (Month 7)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
PLA, Normal (pre-vacc) - Normal (Month 2)
|
74 Participants
|
43 Participants
|
40 Participants
|
41 Participants
|
43 Participants
|
46 Participants
|
43 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
PLA, Normal (pre-vacc) - Below (Month 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
PLA, Normal (pre-vacc) - Above (Month 2)
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
PLA, Normal (pre-vacc) - Missing (Month 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
PLA, Normal (pre-vacc) - Normal (Month 7)
|
70 Participants
|
42 Participants
|
39 Participants
|
41 Participants
|
43 Participants
|
40 Participants
|
42 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
PLA, Normal (pre-vacc) - Below (Month 7)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
PLA, Normal (pre-vacc) - Above (Month 7)
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
PLA, Normal (pre-vacc) - Missing (Month 7)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
PLA, Above (pre-vacc) - Normal (Month 2)
|
4 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
PLA, Above (pre-vacc) - Below (Month 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
PLA, Above (pre-vacc) - Above (Month 2)
|
3 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
PLA, Above (pre-vacc) - Normal (Month 7)
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
PLA, Above (pre-vacc) - Below (Month 7)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
PLA, Above (pre-vacc) - Above (Month 7)
|
5 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
PLA, Below (pre-vacc) - Normal (Month 2)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
PLA, Below (pre-vacc) - Below (Month 2)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
PLA, Below (pre-vacc) - Above (Month 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
PLA, Below (pre-vacc) - Normal (Month 7)
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
PLA, Below (pre-vacc) - Below (Month 7)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
PLA, Below (pre-vacc) - Above (Month 7)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
RBC, Normal (pre-vacc) - Normal (Month 2)
|
83 Participants
|
41 Participants
|
42 Participants
|
41 Participants
|
41 Participants
|
47 Participants
|
41 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
RBC, Normal (pre-vacc) - Below (Month 2)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
RBC, Normal (pre-vacc) - Above (Month 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
RBC, Normal (pre-vacc) - Missing (Month 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
RBC, Normal (pre-vacc) - Normal (Month 7)
|
78 Participants
|
42 Participants
|
41 Participants
|
41 Participants
|
41 Participants
|
43 Participants
|
42 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
RBC, Normal (pre-vacc) - Below (Month 7)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
RBC, Normal (pre-vacc) - Above (Month 7)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
RBC, Above (pre-vacc) - Normal (Month 2)
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
RBC, Above (pre-vacc) - Below (Month 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
RBC, Above (pre-vacc) - Above (Month 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
RBC, Above (pre-vacc) - Normal (Month 7)
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
RBC, Above (pre-vacc) - Below (Month 7)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
RBC, Above (pre-vacc) - Above (Month 7)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
RBC, Below (pre-vacc) - Normal (Month 2)
|
0 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
RBC, Below (pre-vacc) - Below (Month 2)
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
RBC, Below (pre-vacc) - Above (Month 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
RBC, Below (pre-vacc) - Normal (Month 7)
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
RBC, Below (pre-vacc) - Below (Month 7)
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
RBC, Below (pre-vacc) - Above (Month 7)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
WBC, Normal (pre-vacc) - Normal (Month 2)
|
71 Participants
|
37 Participants
|
39 Participants
|
40 Participants
|
41 Participants
|
42 Participants
|
40 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
WBC, Normal (pre-vacc) - Below (Month 2)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
WBC, Normal (pre-vacc) - Above (Month 2)
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
WBC, Normal (pre-vacc) - Missing (Month 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
WBC, Normal (pre-vacc) - Normal (Month 7)
|
69 Participants
|
36 Participants
|
38 Participants
|
41 Participants
|
38 Participants
|
37 Participants
|
37 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
WBC, Normal (pre-vacc) - Below (Month 7)
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
WBC, Normal (pre-vacc) - Above (Month 7)
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
WBC, Normal (pre-vacc) - Missing (Month 7)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
WBC, Above (pre-vacc) - Normal (Month 2)
|
3 Participants
|
6 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
WBC, Above (pre-vacc) - Below (Month 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
WBC, Above (pre-vacc) - Above (Month 2)
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
WBC, Above (pre-vacc) - Normal (Month 7)
|
3 Participants
|
6 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
WBC, Above (pre-vacc) - Below (Month 7)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
WBC, Above (pre-vacc) - Above (Month 7)
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
WBC, Below (pre-vacc) - Above (Month 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
WBC, Below (pre-vacc) - Normal (Month 7)
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
WBC, Below (pre-vacc) - Below (Month 7)
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
WBC, Below (pre-vacc) - Normal (Month 2)
|
4 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
WBC, Below (pre-vacc) - Below (Month 2)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
WBC, Below (pre-vacc) - Above (Month 7)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
HPV-16/18 Group
Serious events: 2 serious events
Other events: 81 other events
Deaths: 0 deaths
HPV-TETRA A Group
Serious events: 2 serious events
Other events: 48 other events
Deaths: 0 deaths
HPV-TETRA B Group
Serious events: 1 serious events
Other events: 46 other events
Deaths: 0 deaths
HPV-TETRA C Group
Serious events: 3 serious events
Other events: 45 other events
Deaths: 0 deaths
HPV-TETRA D Group
Serious events: 2 serious events
Other events: 44 other events
Deaths: 0 deaths
HPV-TETRA E Group
Serious events: 0 serious events
Other events: 50 other events
Deaths: 0 deaths
HPV-TETRA F Group
Serious events: 0 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HPV-16/18 Group
n=88 participants at risk
Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA A Group
n=50 participants at risk
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA B Group
n=49 participants at risk
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA C Group
n=48 participants at risk
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA D Group
n=48 participants at risk
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA E Group
n=50 participants at risk
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA F Group
n=50 participants at risk
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
|---|---|---|---|---|---|---|---|
|
General disorders
Asthenia
|
0.00%
0/88 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
2.0%
1/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/49 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/88 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
2.0%
1/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/49 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
2.1%
1/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
|
Nervous system disorders
Headache
|
1.1%
1/88 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/49 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
|
Nervous system disorders
Myelitis
|
0.00%
0/88 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/49 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
2.1%
1/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/88 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/49 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
2.1%
1/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/88 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/49 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
2.1%
1/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
0.00%
0/88 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
2.0%
1/49 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
|
Pregnancy, puerperium and perinatal conditions
Premature labour
|
0.00%
0/88 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
2.0%
1/49 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
|
Psychiatric disorders
Major depression
|
1.1%
1/88 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/49 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
1.1%
1/88 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/49 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/88 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/49 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
2.1%
1/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
Other adverse events
| Measure |
HPV-16/18 Group
n=88 participants at risk
Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA A Group
n=50 participants at risk
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA B Group
n=49 participants at risk
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA C Group
n=48 participants at risk
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA D Group
n=48 participants at risk
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA E Group
n=50 participants at risk
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
HPV-TETRA F Group
n=50 participants at risk
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
|
|---|---|---|---|---|---|---|---|
|
General disorders
Pain*
|
94.2%
81/86 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
98.0%
48/49 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
97.9%
46/47 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
97.8%
45/46 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
95.7%
44/46 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
100.0%
50/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
97.9%
47/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
|
General disorders
Redness*
|
41.9%
36/86 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
57.1%
28/49 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
31.9%
15/47 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
47.8%
22/46 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
52.2%
24/46 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
44.0%
22/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
52.1%
25/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
|
General disorders
Swelling*
|
38.4%
33/86 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
44.9%
22/49 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
25.5%
12/47 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
39.1%
18/46 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
45.7%
21/46 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
54.0%
27/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
39.6%
19/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
|
General disorders
Arthralgia*
|
12.8%
11/86 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
26.5%
13/49 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
19.1%
9/47 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
23.9%
11/46 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
23.9%
11/46 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
18.0%
9/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
22.9%
11/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
|
General disorders
Fatigue*
|
62.8%
54/86 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
67.3%
33/49 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
63.8%
30/47 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
69.6%
32/46 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
54.3%
25/46 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
68.0%
34/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
64.6%
31/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
|
General disorders
Fever*
|
11.6%
10/86 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
8.2%
4/49 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
8.5%
4/47 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
6.5%
3/46 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
19.6%
9/46 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
8.0%
4/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
4.2%
2/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
|
General disorders
Gastrointestinal*
|
41.9%
36/86 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
30.6%
15/49 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
38.3%
18/47 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
43.5%
20/46 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
37.0%
17/46 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
34.0%
17/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
37.5%
18/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
|
General disorders
Headache (solicited)*
|
52.3%
45/86 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
49.0%
24/49 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
48.9%
23/47 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
67.4%
31/46 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
47.8%
22/46 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
66.0%
33/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
56.2%
27/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
|
General disorders
Myalgia*
|
29.1%
25/86 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
36.7%
18/49 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
40.4%
19/47 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
34.8%
16/46 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
37.0%
17/46 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
38.0%
19/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
31.2%
15/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
|
General disorders
Rash*
|
7.0%
6/86 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
8.2%
4/49 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
4.3%
2/47 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
4.3%
2/46 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
8.7%
4/46 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
6.0%
3/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
4.2%
2/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
|
General disorders
Urticaria*
|
3.5%
3/86 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
4.1%
2/49 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
6.4%
3/47 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/46 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/46 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
2.0%
1/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
6.2%
3/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
|
Gastrointestinal disorders
Diarrhea**
|
3.4%
3/88 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
2.0%
1/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
2.0%
1/49 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
8.3%
4/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
6.2%
3/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
|
Gastrointestinal disorders
Nausea**
|
3.4%
3/88 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
6.0%
3/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
2.0%
1/49 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
6.2%
3/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
2.0%
1/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
|
Gastrointestinal disorders
Toothache**
|
1.1%
1/88 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
6.1%
3/49 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
2.1%
1/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
8.0%
4/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
|
General disorders
Injection site pruritus**
|
1.1%
1/88 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
6.0%
3/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/49 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
2.1%
1/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
|
General disorders
Injection site reaction**
|
1.1%
1/88 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
6.0%
3/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
2.0%
1/49 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
2.1%
1/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
2.1%
1/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
2.0%
1/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
4.0%
2/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
|
Infections and infestations
Cystitis**
|
1.1%
1/88 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
2.0%
1/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
6.1%
3/49 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
2.1%
1/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
4.0%
2/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
|
Infections and infestations
Influenza**
|
0.00%
0/88 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/49 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
2.1%
1/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
6.2%
3/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
6.0%
3/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
|
Infections and infestations
Nasopharyngitis**
|
10.2%
9/88 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
6.0%
3/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
10.2%
5/49 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
4.2%
2/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
6.2%
3/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
10.0%
5/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
12.0%
6/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
|
Infections and infestations
Upper respiratory tract infection**
|
4.5%
4/88 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
8.0%
4/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
18.4%
9/49 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
8.3%
4/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
12.5%
6/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
14.0%
7/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
10.0%
5/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
|
Nervous system disorders
Dizziness**
|
2.3%
2/88 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
6.0%
3/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
2.0%
1/49 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
2.1%
1/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
2.0%
1/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
4.0%
2/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
|
Nervous system disorders
Headache (unsolicited)**
|
14.8%
13/88 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
16.0%
8/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
14.3%
7/49 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
8.3%
4/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
14.6%
7/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
10.0%
5/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
12.0%
6/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
|
Reproductive system and breast disorders
Dysmenorhoea**
|
1.1%
1/88 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
6.0%
3/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
6.1%
3/49 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
2.1%
1/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
4.2%
2/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
2.0%
1/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain**
|
12.5%
11/88 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
2.0%
1/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
4.1%
2/49 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
6.2%
3/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
8.0%
4/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
8.0%
4/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
|
Infections and infestations
Rhinitis**
|
3.4%
3/88 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
2.0%
1/49 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/48 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
0.00%
0/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
6.0%
3/50 • Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 30-day period after vaccination. SAEs: From Day 0 up to Month 12.
The Total Number of Participants Affected by Other AEs was analyzed separately for solicited AEs and unsolicited AEs. An analysis of all AEs was not possible, and the relevant data are no longer available. The Total Number of Participants Affected in Other AEs table is populated with the highest number of participants affected in the Other AEs table.
|
Additional Information
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