Trial Outcomes & Findings for Evaluation of Safety and Immunogenicity of Co-administering HPV Vaccine With Other Vaccines in Healthy Female Subjects (NCT NCT00369824)
NCT ID: NCT00369824
Last Updated: 2018-07-20
Results Overview
Anti-D and anti-T antibodies cut-off values assessed include 1.0 international unit per milliliter (IU/mL)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1330 participants
Primary outcome timeframe
Before and one month after vaccination with Boostrix
Results posted on
2018-07-20
Participant Flow
Participant milestones
| Measure |
Cervarix + Boostrix/Menactra Group
Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
|
Cervarix + Menactra/Boostrix Group
Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
|
Cervarix + Boostrix + Menactra Group
Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
|
Boostrix/Cervarix Group
Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
|
Menactra/Cervarix Group
Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
|
Cervarix Group
Subjects received Cervarix at Months 0, 1 and 6.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
212
|
214
|
214
|
214
|
214
|
215
|
|
Overall Study
COMPLETED
|
197
|
195
|
202
|
199
|
196
|
204
|
|
Overall Study
NOT COMPLETED
|
15
|
19
|
12
|
15
|
18
|
11
|
Reasons for withdrawal
| Measure |
Cervarix + Boostrix/Menactra Group
Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
|
Cervarix + Menactra/Boostrix Group
Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
|
Cervarix + Boostrix + Menactra Group
Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
|
Boostrix/Cervarix Group
Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
|
Menactra/Cervarix Group
Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
|
Cervarix Group
Subjects received Cervarix at Months 0, 1 and 6.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
0
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
9
|
5
|
5
|
4
|
6
|
2
|
|
Overall Study
Lost to Follow-up
|
6
|
11
|
7
|
8
|
9
|
6
|
|
Overall Study
Other
|
0
|
0
|
0
|
2
|
1
|
3
|
Baseline Characteristics
Evaluation of Safety and Immunogenicity of Co-administering HPV Vaccine With Other Vaccines in Healthy Female Subjects
Baseline characteristics by cohort
| Measure |
Cervarix + Boostrix/Menactra Group
n=212 Participants
Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
|
Cervarix + Menactra/Boostrix Group
n=214 Participants
Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
|
Cervarix + Boostrix + Menactra Group
n=214 Participants
Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
|
Boostrix/Cervarix Group
n=214 Participants
Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
|
Menactra/Cervarix Group
n=214 Participants
Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
|
Cervarix Group
n=215 Participants
Subjects received Cervarix at Months 0, 1 and 6.
|
Total
n=1283 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
13.5 years
STANDARD_DEVIATION 2.27 • n=5 Participants
|
13.3 years
STANDARD_DEVIATION 2.28 • n=7 Participants
|
13.5 years
STANDARD_DEVIATION 2.26 • n=5 Participants
|
13.5 years
STANDARD_DEVIATION 2.33 • n=4 Participants
|
13.3 years
STANDARD_DEVIATION 2.35 • n=21 Participants
|
13.4 years
STANDARD_DEVIATION 2.34 • n=8 Participants
|
13.4 years
STANDARD_DEVIATION 2.3 • n=8 Participants
|
|
Sex: Female, Male
Female
|
212 Participants
n=5 Participants
|
214 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
214 Participants
n=4 Participants
|
214 Participants
n=21 Participants
|
215 Participants
n=8 Participants
|
1283 Participants
n=8 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
|
PRIMARY outcome
Timeframe: Before and one month after vaccination with BoostrixPopulation: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, Month 1 and only for Cervarix + Boostrix/Menactra, Cervarix + Boostrix + Menactra and Boostrix/Cervarix groups.
Anti-D and anti-T antibodies cut-off values assessed include 1.0 international unit per milliliter (IU/mL)
Outcome measures
| Measure |
Cervarix + Boostrix/Menactra Group
n=194 Participants
Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
|
Cervarix + Menactra/Boostrix Group
Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
|
Cervarix + Boostrix + Menactra Group
n=201 Participants
Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
|
Boostrix/Cervarix Group
n=199 Participants
Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
|
Menactra/Cervarix Group
Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
|
Cervarix Group
Subjects received Cervarix at Months 0, 1 and 6.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 1.0 International Unit Per Milliliter (IU/mL)
Anti-T (1 month after vaccination)
|
194 Participants
|
—
|
201 Participants
|
198 Participants
|
—
|
—
|
|
Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 1.0 International Unit Per Milliliter (IU/mL)
Anti-D (Before vaccination)
|
38 Participants
|
—
|
33 Participants
|
39 Participants
|
—
|
—
|
|
Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 1.0 International Unit Per Milliliter (IU/mL)
Anti-D (1 month after vaccination)
|
193 Participants
|
—
|
200 Participants
|
190 Participants
|
—
|
—
|
|
Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 1.0 International Unit Per Milliliter (IU/mL)
Anti-T (Before vaccination)
|
75 Participants
|
—
|
75 Participants
|
72 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Before and one month after vaccination with BoostrixPopulation: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity Month 1, and only for Cervarix + Boostrix/Menactra, Cervarix + Boostrix + Menactra and Boostrix/Cervarix groups.
Concentrations given as Geometric Means Concentrations (GMCs)
Outcome measures
| Measure |
Cervarix + Boostrix/Menactra Group
n=194 Participants
Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
|
Cervarix + Menactra/Boostrix Group
Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
|
Cervarix + Boostrix + Menactra Group
n=201 Participants
Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
|
Boostrix/Cervarix Group
n=199 Participants
Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
|
Menactra/Cervarix Group
Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
|
Cervarix Group
Subjects received Cervarix at Months 0, 1 and 6.
|
|---|---|---|---|---|---|---|
|
Concentration of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies
Anti-PRN (Before vaccination)
|
12.978 International Units per Milliliter
Interval 10.781 to 15.622
|
—
|
16.040 International Units per Milliliter
Interval 13.479 to 19.087
|
15.871 International Units per Milliliter
Interval 13.033 to 19.327
|
—
|
—
|
|
Concentration of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies
Anti-PT (Before vaccination)
|
9.515 International Units per Milliliter
Interval 8.078 to 11.207
|
—
|
10.356 International Units per Milliliter
Interval 8.733 to 12.28
|
11.164 International Units per Milliliter
Interval 9.319 to 13.375
|
—
|
—
|
|
Concentration of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies
Anti-PT (1month after vaccination)
|
74.682 International Units per Milliliter
Interval 66.001 to 84.504
|
—
|
70.908 International Units per Milliliter
Interval 61.763 to 81.408
|
78.807 International Units per Milliliter
Interval 69.035 to 89.962
|
—
|
—
|
|
Concentration of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies
Anti-FHA (Before vaccination)
|
32.472 International Units per Milliliter
Interval 27.019 to 39.026
|
—
|
37.671 International Units per Milliliter
Interval 31.572 to 44.947
|
38.819 International Units per Milliliter
Interval 32.467 to 46.413
|
—
|
—
|
|
Concentration of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies
Anti-FHA (1month after vaccination)
|
648.018 International Units per Milliliter
Interval 577.051 to 727.714
|
—
|
544.665 International Units per Milliliter
Interval 481.612 to 615.974
|
676.765 International Units per Milliliter
Interval 596.493 to 767.84
|
—
|
—
|
|
Concentration of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies
Anti-PRN(1month after vaccination)
|
416.049 International Units per Milliliter
Interval 345.557 to 500.921
|
—
|
323.205 International Units per Milliliter
Interval 268.389 to 389.217
|
379.467 International Units per Milliliter
Interval 311.05 to 462.933
|
—
|
—
|
PRIMARY outcome
Timeframe: Before and one month after vaccination with MenactraPopulation: Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity Month1 and only for Cervarix + Menactra/Boostrix, Cervarix + Boostrix + Menactra and Menactra/Cervarix groups.
Titers given as Geometric Mean Titers (GMTs)
Outcome measures
| Measure |
Cervarix + Boostrix/Menactra Group
Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
|
Cervarix + Menactra/Boostrix Group
n=200 Participants
Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
|
Cervarix + Boostrix + Menactra Group
n=200 Participants
Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
|
Boostrix/Cervarix Group
Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
|
Menactra/Cervarix Group
n=203 Participants
Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
|
Cervarix Group
Subjects received Cervarix at Months 0, 1 and 6.
|
|---|---|---|---|---|---|---|
|
Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies
Anti-C (Before vaccination)
|
—
|
37.738 Titer
Interval 27.249 to 52.264
|
35.827 Titer
Interval 26.004 to 49.36
|
—
|
30.696 Titer
Interval 21.974 to 42.879
|
—
|
|
Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies
Anti-C (1month after vaccination)
|
—
|
2497.463 Titer
Interval 1985.199 to 3141.912
|
2112.366 Titer
Interval 1708.155 to 2612.228
|
—
|
2375.963 Titer
Interval 1938.868 to 2911.595
|
—
|
|
Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies
Anti-W135(1month after vaccination)
|
—
|
4564.037 Titer
Interval 3990.523 to 5219.977
|
3856.584 Titer
Interval 3298.787 to 4508.7
|
—
|
5056.182 Titer
Interval 4401.292 to 5808.516
|
—
|
|
Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies
Anti-A (Before vaccination)
|
—
|
898.650 Titer
Interval 780.476 to 1034.717
|
829.508 Titer
Interval 716.806 to 959.931
|
—
|
763.324 Titer
Interval 648.325 to 898.721
|
—
|
|
Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies
Anti-A (1month after vaccination)
|
—
|
7570.228 Titer
Interval 6701.054 to 8556.14
|
6919.419 Titer
Interval 6197.308 to 7725.67
|
—
|
8352.685 Titer
Interval 7435.325 to 9383.226
|
—
|
|
Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies
Anti-Y (Before vaccination)
|
—
|
87.356 Titer
Interval 63.239 to 120.67
|
72.756 Titer
Interval 52.881 to 100.101
|
—
|
110.911 Titer
Interval 81.291 to 151.322
|
—
|
|
Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies
Anti-Y (1month after vaccination)
|
—
|
4787.556 Titer
Interval 4079.87 to 5617.996
|
3947.330 Titer
Interval 3292.007 to 4733.105
|
—
|
4335.380 Titer
Interval 3688.566 to 5095.617
|
—
|
|
Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies
Anti-W135 (Before vaccination)
|
—
|
33.946 Titer
Interval 24.902 to 46.274
|
28.750 Titer
Interval 21.338 to 38.737
|
—
|
34.206 Titer
Interval 25.374 to 46.111
|
—
|
SECONDARY outcome
Timeframe: Before vaccination (PRE), one month post Dose 2 (Mth2) and one and six months post Dose 3 (Mth 7 and Mth 12)Population: Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity at Month 12/13
Cut-off values assessed include 8 enzyme-linked immunosorbent assay units Per Milliliter (EL.U/mL) for anti-HPV16 antibodies and 7 EL.U/mL for anti-HPV18 antibodies.
Outcome measures
| Measure |
Cervarix + Boostrix/Menactra Group
n=163 Participants
Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
|
Cervarix + Menactra/Boostrix Group
n=158 Participants
Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
|
Cervarix + Boostrix + Menactra Group
n=165 Participants
Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
|
Boostrix/Cervarix Group
n=156 Participants
Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
|
Menactra/Cervarix Group
n=147 Participants
Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
|
Cervarix Group
n=166 Participants
Subjects received Cervarix at Months 0, 1 and 6.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values
Anti-HPV16 PRE
|
19 Participants
|
8 Participants
|
9 Participants
|
5 Participants
|
11 Participants
|
11 Participants
|
|
Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values
Anti-HPV16 Mth7
|
161 Participants
|
158 Participants
|
164 Participants
|
156 Participants
|
142 Participants
|
164 Participants
|
|
Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values
Anti-HPV16 Mth2
|
163 Participants
|
158 Participants
|
163 Participants
|
156 Participants
|
145 Participants
|
166 Participants
|
|
Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values
Anti-HPV16 Mth12
|
163 Participants
|
158 Participants
|
164 Participants
|
156 Participants
|
146 Participants
|
166 Participants
|
|
Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values
Anti-HPV18 PRE
|
14 Participants
|
10 Participants
|
13 Participants
|
8 Participants
|
6 Participants
|
11 Participants
|
|
Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values
Anti-HPV18 Mth2
|
163 Participants
|
157 Participants
|
164 Participants
|
152 Participants
|
146 Participants
|
165 Participants
|
|
Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values
Anti-HPV18 Mth7
|
161 Participants
|
157 Participants
|
165 Participants
|
152 Participants
|
143 Participants
|
163 Participants
|
|
Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values
Anti-HPV18 Mth12
|
163 Participants
|
157 Participants
|
165 Participants
|
152 Participants
|
147 Participants
|
165 Participants
|
SECONDARY outcome
Timeframe: Before and one month after vaccination with BoostrixPopulation: Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity Month 1, and only for Cervarix + Boostrix/Menactra, Cervarix + Boostrix + Menactra and Boostrix/Cervarix groups
Anti-D and anti-T antibodies cut-off values assessed include 0.1 international unit per milliliter (IU/mL)
Outcome measures
| Measure |
Cervarix + Boostrix/Menactra Group
n=194 Participants
Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
|
Cervarix + Menactra/Boostrix Group
Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
|
Cervarix + Boostrix + Menactra Group
n=201 Participants
Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
|
Boostrix/Cervarix Group
n=199 Participants
Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
|
Menactra/Cervarix Group
Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
|
Cervarix Group
Subjects received Cervarix at Months 0, 1 and 6.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 0.1 International Unit Per Milliliter (IU/mL)
Anti-T (1month after vaccination)
|
194 Participants
|
—
|
201 Participants
|
199 Participants
|
—
|
—
|
|
Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 0.1 International Unit Per Milliliter (IU/mL)
Anti-D (Before vaccination)
|
170 Participants
|
—
|
181 Participants
|
167 Participants
|
—
|
—
|
|
Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 0.1 International Unit Per Milliliter (IU/mL)
Anti-D (1month after vaccination)
|
194 Participants
|
—
|
201 Participants
|
199 Participants
|
—
|
—
|
|
Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 0.1 International Unit Per Milliliter (IU/mL)
Anti-T (Before vaccination)
|
188 Participants
|
—
|
199 Participants
|
195 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Before and one month after vaccination with BoostrixPopulation: Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity Month 1, and only for Cervarix + Boostrix/Menactra, Cervarix + Boostrix + Menactra and Boostrix/Cervarix groups.
Concentrations given as Geometric Mean Concentrations (GMCs)
Outcome measures
| Measure |
Cervarix + Boostrix/Menactra Group
n=194 Participants
Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
|
Cervarix + Menactra/Boostrix Group
Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
|
Cervarix + Boostrix + Menactra Group
n=201 Participants
Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
|
Boostrix/Cervarix Group
n=199 Participants
Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
|
Menactra/Cervarix Group
Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
|
Cervarix Group
Subjects received Cervarix at Months 0, 1 and 6.
|
|---|---|---|---|---|---|---|
|
Concentration of Anti-D and Anti-T Antibodies
Anti-D (Before vaccination)
|
0.362 International Unit per Milliliter
Interval 0.305 to 0.431
|
—
|
0.368 International Unit per Milliliter
Interval 0.315 to 0.43
|
0.331 International Unit per Milliliter
Interval 0.28 to 0.39
|
—
|
—
|
|
Concentration of Anti-D and Anti-T Antibodies
Anti-D (1month after vaccination)
|
8.928 International Unit per Milliliter
Interval 7.821 to 10.192
|
—
|
27.438 International Unit per Milliliter
Interval 24.297 to 30.984
|
7.527 International Unit per Milliliter
Interval 6.492 to 8.727
|
—
|
—
|
|
Concentration of Anti-D and Anti-T Antibodies
Anti-T (Before vaccination)
|
0.811 International Unit per Milliliter
Interval 0.686 to 0.96
|
—
|
0.895 International Unit per Milliliter
Interval 0.765 to 1.046
|
0.700 International Unit per Milliliter
Interval 0.602 to 0.814
|
—
|
—
|
|
Concentration of Anti-D and Anti-T Antibodies
Anti-T (1month after vaccination)
|
15.584 International Unit per Milliliter
Interval 13.923 to 17.443
|
—
|
12.415 International Unit per Milliliter
Interval 11.184 to 13.781
|
14.524 International Unit per Milliliter
Interval 12.814 to 16.462
|
—
|
—
|
SECONDARY outcome
Timeframe: One month after vaccination with BoostrixPopulation: Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity Month 1, and only for Cervarix + Boostrix/Menactra, Cervarix + Boostrix + Menactra and Boostrix/Cervarix groups.
Booster responses for anti-D and anti-T defined as: * For initially seronegative subjects (pre-vaccination titer below cut-off: \< 0.1 IU/mL): antibody titer at least 4 times the cut-off (post-vaccination titer ≥ 0.4 IU/mL) * For initially seropositive subjects (pre-vaccination titer above 0.1 IU/mL): an increase in antibody titer of at least 4 times the pre-vaccination titer
Outcome measures
| Measure |
Cervarix + Boostrix/Menactra Group
n=194 Participants
Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
|
Cervarix + Menactra/Boostrix Group
Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
|
Cervarix + Boostrix + Menactra Group
n=199 Participants
Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
|
Boostrix/Cervarix Group
n=199 Participants
Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
|
Menactra/Cervarix Group
Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
|
Cervarix Group
Subjects received Cervarix at Months 0, 1 and 6.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Booster Response for Anti-D and Anti-T
Anti-D
|
175 Participants
|
—
|
196 Participants
|
182 Participants
|
—
|
—
|
|
Number of Subjects With Booster Response for Anti-D and Anti-T
Anti-T
|
157 Participants
|
—
|
162 Participants
|
168 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: One month after vaccination with BoostrixPopulation: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity Month 1, and only for Cervarix + Boostrix/Menactra, Cervarix + Boostrix + Menactra and Boostrix + Cervarix groups.
Booster responses defined as: * For initially seronegative subjects (pre-vaccination titer below cut-off: \< 5 EL.U/mL): antibody titers at least 4 times the cut-off, * For initially seropositive subjects with pre-vaccination titer above 5 EL.U/mL and \< 20 EL.U/mL: an increase in antibody titers of at least 4 times the pre-vaccination titer, * For initially seropositive subjects with pre-vaccination titer ≥ 20 EL.U/mL: an increase in antibody titers of at least two times the pre-vaccination titer
Outcome measures
| Measure |
Cervarix + Boostrix/Menactra Group
n=194 Participants
Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
|
Cervarix + Menactra/Boostrix Group
Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
|
Cervarix + Boostrix + Menactra Group
n=197 Participants
Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
|
Boostrix/Cervarix Group
n=198 Participants
Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
|
Menactra/Cervarix Group
Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
|
Cervarix Group
Subjects received Cervarix at Months 0, 1 and 6.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Booster Response for Anti-PT, Anti-FHA and Anti-PRN
Anti-FHA
|
167 Participants
|
—
|
163 Participants
|
165 Participants
|
—
|
—
|
|
Number of Subjects With Booster Response for Anti-PT, Anti-FHA and Anti-PRN
Anti-PT
|
138 Participants
|
—
|
116 Participants
|
133 Participants
|
—
|
—
|
|
Number of Subjects With Booster Response for Anti-PT, Anti-FHA and Anti-PRN
Anti-PRN
|
183 Participants
|
—
|
180 Participants
|
177 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: One month after vaccination with MenactraPopulation: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity Month 1, and only for Cervarix + Menactra/Boostrix, Cervarix + Boostrix + Menactra and Menactra/Cervarix groups
Vaccine responses for anti-A, C, Y and W-135 defined as: * For initially seronegative subjects (pre-vaccination titer below cut-off of 8): antibody titers at least 4 times the cut-off (post vaccination titer ≥ 32) * For initially seropositive subjects (pre-vaccination titer above 8): antibody titers at least 4 times the pre-vaccination antibody titer
Outcome measures
| Measure |
Cervarix + Boostrix/Menactra Group
Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
|
Cervarix + Menactra/Boostrix Group
n=185 Participants
Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
|
Cervarix + Boostrix + Menactra Group
n=189 Participants
Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
|
Boostrix/Cervarix Group
Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
|
Menactra/Cervarix Group
n=192 Participants
Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
|
Cervarix Group
Subjects received Cervarix at Months 0, 1 and 6.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Anti-A, Anti-C, Anti-Y and Anti-W135 Vaccine Response
Anti-A
|
—
|
127 Participants
|
112 Participants
|
—
|
139 Participants
|
—
|
|
Number of Subjects With Anti-A, Anti-C, Anti-Y and Anti-W135 Vaccine Response
Anti-C
|
—
|
162 Participants
|
163 Participants
|
—
|
161 Participants
|
—
|
|
Number of Subjects With Anti-A, Anti-C, Anti-Y and Anti-W135 Vaccine Response
Anti-Y
|
—
|
169 Participants
|
166 Participants
|
—
|
171 Participants
|
—
|
|
Number of Subjects With Anti-A, Anti-C, Anti-Y and Anti-W135 Vaccine Response
Anti-W135
|
—
|
176 Participants
|
183 Participants
|
—
|
181 Participants
|
—
|
SECONDARY outcome
Timeframe: During the 7-day period following each vaccinationPopulation: Analysis was performed on the Total Vaccinated cohort including all vaccinated subjects receiving one dose at least
Solicited local symptoms assessed include pain, redness and swelling.
Outcome measures
| Measure |
Cervarix + Boostrix/Menactra Group
n=209 Participants
Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
|
Cervarix + Menactra/Boostrix Group
n=208 Participants
Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
|
Cervarix + Boostrix + Menactra Group
n=209 Participants
Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
|
Boostrix/Cervarix Group
n=211 Participants
Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
|
Menactra/Cervarix Group
n=209 Participants
Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
|
Cervarix Group
n=210 Participants
Subjects received Cervarix at Months 0, 1 and 6.
|
|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Solicited Local Symptoms
Pain
|
197 Participants
|
204 Participants
|
204 Participants
|
203 Participants
|
193 Participants
|
201 Participants
|
|
Number of Subjects Reporting Solicited Local Symptoms
Redness
|
97 Participants
|
93 Participants
|
103 Participants
|
103 Participants
|
99 Participants
|
93 Participants
|
|
Number of Subjects Reporting Solicited Local Symptoms
Swelling
|
94 Participants
|
90 Participants
|
102 Participants
|
100 Participants
|
74 Participants
|
86 Participants
|
SECONDARY outcome
Timeframe: During the 7-day period following each vaccinationPopulation: Analysis was performed on the Total Vaccinated cohort including all vaccinated subjects receiving one dose at least
Solicited general symptoms assessed include Arthralgia, fatigue, fever, gastrointestinal, headache, myalgia, rash and urticaria
Outcome measures
| Measure |
Cervarix + Boostrix/Menactra Group
n=209 Participants
Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
|
Cervarix + Menactra/Boostrix Group
n=208 Participants
Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
|
Cervarix + Boostrix + Menactra Group
n=210 Participants
Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
|
Boostrix/Cervarix Group
n=211 Participants
Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
|
Menactra/Cervarix Group
n=209 Participants
Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
|
Cervarix Group
n=210 Participants
Subjects received Cervarix at Months 0, 1 and 6.
|
|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Solicited General Symptoms
Urticaria
|
7 Participants
|
5 Participants
|
12 Participants
|
7 Participants
|
4 Participants
|
6 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Arthralgia
|
37 Participants
|
42 Participants
|
34 Participants
|
48 Participants
|
33 Participants
|
47 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Fatigue
|
94 Participants
|
100 Participants
|
111 Participants
|
118 Participants
|
99 Participants
|
98 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Fever
|
31 Participants
|
32 Participants
|
24 Participants
|
28 Participants
|
35 Participants
|
23 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Gastrointestinal
|
59 Participants
|
62 Participants
|
70 Participants
|
65 Participants
|
65 Participants
|
69 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Headache
|
107 Participants
|
118 Participants
|
124 Participants
|
133 Participants
|
122 Participants
|
112 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Myalgia
|
80 Participants
|
89 Participants
|
101 Participants
|
96 Participants
|
66 Participants
|
89 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Rash
|
11 Participants
|
12 Participants
|
19 Participants
|
15 Participants
|
13 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: During the 30-day period following each vaccinationUnsolicited adverse event = Any adverse event (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.
Outcome measures
| Measure |
Cervarix + Boostrix/Menactra Group
n=212 Participants
Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
|
Cervarix + Menactra/Boostrix Group
n=214 Participants
Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
|
Cervarix + Boostrix + Menactra Group
n=214 Participants
Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
|
Boostrix/Cervarix Group
n=214 Participants
Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
|
Menactra/Cervarix Group
n=214 Participants
Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
|
Cervarix Group
n=215 Participants
Subjects received Cervarix at Months 0, 1 and 6.
|
|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
|
108 Participants
|
121 Participants
|
119 Participants
|
122 Participants
|
127 Participants
|
118 Participants
|
SECONDARY outcome
Timeframe: During the active phase of the study (up to Month 7 or Month 8) and throughout the entire study (up to Month 12 or Month 13)Serious adverse events assessed include medical occurrences that results in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Outcome measures
| Measure |
Cervarix + Boostrix/Menactra Group
n=212 Participants
Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
|
Cervarix + Menactra/Boostrix Group
n=214 Participants
Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
|
Cervarix + Boostrix + Menactra Group
n=214 Participants
Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
|
Boostrix/Cervarix Group
n=214 Participants
Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
|
Menactra/Cervarix Group
n=214 Participants
Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
|
Cervarix Group
n=215 Participants
Subjects received Cervarix at Months 0, 1 and 6.
|
|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events
During the active phase
|
0 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
5 Participants
|
4 Participants
|
|
Number of Subjects Reporting Serious Adverse Events
During the entire study
|
1 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
7 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: During the active phase of the study (up to Month 7 or Month 8) and throughout the entire study period (up to Month 12 or Month 13)NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes
Outcome measures
| Measure |
Cervarix + Boostrix/Menactra Group
n=212 Participants
Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
|
Cervarix + Menactra/Boostrix Group
n=214 Participants
Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
|
Cervarix + Boostrix + Menactra Group
n=214 Participants
Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
|
Boostrix/Cervarix Group
n=214 Participants
Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
|
Menactra/Cervarix Group
n=214 Participants
Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
|
Cervarix Group
n=215 Participants
Subjects received Cervarix at Months 0, 1 and 6.
|
|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs)
During the entire study
|
3 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
|
Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs)
During the active phase
|
3 Participants
|
6 Participants
|
6 Participants
|
5 Participants
|
11 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: During the active phase (up to Month 7 or Month 8) and throughout the entire study (up to Month 12 or Month 13)Medically significant AEs assessed include AEs prompting emergency room or physician visits that are not related to common diseases or SAEs that are not related to common diseases.
Outcome measures
| Measure |
Cervarix + Boostrix/Menactra Group
n=212 Participants
Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
|
Cervarix + Menactra/Boostrix Group
n=214 Participants
Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
|
Cervarix + Boostrix + Menactra Group
n=214 Participants
Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
|
Boostrix/Cervarix Group
n=214 Participants
Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
|
Menactra/Cervarix Group
n=214 Participants
Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
|
Cervarix Group
n=215 Participants
Subjects received Cervarix at Months 0, 1 and 6.
|
|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Medically Significant Adverse Events (AEs)
During the entire study
|
43 Participants
|
46 Participants
|
54 Participants
|
59 Participants
|
64 Participants
|
64 Participants
|
|
Number of Subjects Reporting Medically Significant Adverse Events (AEs)
During the active phase
|
40 Participants
|
43 Participants
|
51 Participants
|
56 Participants
|
62 Participants
|
59 Participants
|
Adverse Events
Cervarix + Boostrix/Menactra Group
Serious events: 1 serious events
Other events: 202 other events
Deaths: 0 deaths
Cervarix + Menactra/Boostrix Group
Serious events: 3 serious events
Other events: 207 other events
Deaths: 0 deaths
Cervarix + Boostrix + Menactra Group
Serious events: 4 serious events
Other events: 205 other events
Deaths: 0 deaths
Boostrix/Cervarix Group
Serious events: 0 serious events
Other events: 208 other events
Deaths: 0 deaths
Menactra/Cervarix Group
Serious events: 7 serious events
Other events: 202 other events
Deaths: 0 deaths
Cervarix Group
Serious events: 4 serious events
Other events: 203 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cervarix + Boostrix/Menactra Group
n=212 participants at risk
Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
|
Cervarix + Menactra/Boostrix Group
n=214 participants at risk
Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
|
Cervarix + Boostrix + Menactra Group
n=214 participants at risk
Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
|
Boostrix/Cervarix Group
n=214 participants at risk
Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
|
Menactra/Cervarix Group
n=214 participants at risk
Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
|
Cervarix Group
n=215 participants at risk
Subjects received Cervarix at Months 0, 1 and 6.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/212
|
0.47%
1/214
|
0.00%
0/214
|
0.00%
0/214
|
0.93%
2/214
|
0.00%
0/215
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/212
|
0.00%
0/214
|
0.00%
0/214
|
0.00%
0/214
|
0.47%
1/214
|
0.00%
0/215
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous complete
|
0.00%
0/212
|
0.00%
0/214
|
0.00%
0/214
|
0.00%
0/214
|
0.47%
1/214
|
0.00%
0/215
|
|
Psychiatric disorders
Adjustment disorder
|
0.00%
0/212
|
0.00%
0/214
|
0.00%
0/214
|
0.00%
0/214
|
0.00%
0/214
|
0.47%
1/215
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/212
|
0.00%
0/214
|
0.00%
0/214
|
0.00%
0/214
|
0.47%
1/214
|
0.00%
0/215
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/212
|
0.00%
0/214
|
0.00%
0/214
|
0.00%
0/214
|
0.00%
0/214
|
0.47%
1/215
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/212
|
0.00%
0/214
|
0.00%
0/214
|
0.00%
0/214
|
0.47%
1/214
|
0.00%
0/215
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/212
|
0.00%
0/214
|
0.00%
0/214
|
0.00%
0/214
|
0.00%
0/214
|
0.47%
1/215
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/212
|
0.00%
0/214
|
0.00%
0/214
|
0.00%
0/214
|
0.00%
0/214
|
0.47%
1/215
|
|
Eye disorders
Hyphaema
|
0.00%
0/212
|
0.00%
0/214
|
0.47%
1/214
|
0.00%
0/214
|
0.00%
0/214
|
0.00%
0/215
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/212
|
0.00%
0/214
|
0.47%
1/214
|
0.00%
0/214
|
0.00%
0/214
|
0.00%
0/215
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/212
|
0.00%
0/214
|
0.00%
0/214
|
0.00%
0/214
|
0.47%
1/214
|
0.00%
0/215
|
|
General disorders
Pyrexia
|
0.00%
0/212
|
0.00%
0/214
|
0.00%
0/214
|
0.00%
0/214
|
0.47%
1/214
|
0.00%
0/215
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/212
|
0.00%
0/214
|
0.00%
0/214
|
0.00%
0/214
|
0.47%
1/214
|
0.00%
0/215
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/212
|
0.00%
0/214
|
0.00%
0/214
|
0.00%
0/214
|
0.47%
1/214
|
0.00%
0/215
|
|
Skin and subcutaneous tissue disorders
Stevens-johnson syndrome
|
0.00%
0/212
|
0.47%
1/214
|
0.00%
0/214
|
0.00%
0/214
|
0.00%
0/214
|
0.00%
0/215
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/212
|
0.00%
0/214
|
0.00%
0/214
|
0.00%
0/214
|
0.47%
1/214
|
0.00%
0/215
|
|
Infections and infestations
Viral infection
|
0.00%
0/212
|
0.00%
0/214
|
0.47%
1/214
|
0.00%
0/214
|
0.00%
0/214
|
0.00%
0/215
|
|
Psychiatric disorders
Conversion disorder
|
0.00%
0/212
|
0.00%
0/214
|
0.47%
1/214
|
0.00%
0/214
|
0.00%
0/214
|
0.00%
0/215
|
|
Psychiatric disorders
Depression
|
0.00%
0/212
|
0.47%
1/214
|
0.00%
0/214
|
0.00%
0/214
|
0.00%
0/214
|
0.00%
0/215
|
|
Nervous system disorders
Facial palsy
|
0.47%
1/212
|
0.00%
0/214
|
0.00%
0/214
|
0.00%
0/214
|
0.00%
0/214
|
0.00%
0/215
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/212
|
0.00%
0/214
|
0.00%
0/214
|
0.00%
0/214
|
0.47%
1/214
|
0.00%
0/215
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/212
|
0.47%
1/214
|
0.00%
0/214
|
0.00%
0/214
|
0.00%
0/214
|
0.00%
0/215
|
Other adverse events
| Measure |
Cervarix + Boostrix/Menactra Group
n=212 participants at risk
Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
|
Cervarix + Menactra/Boostrix Group
n=214 participants at risk
Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
|
Cervarix + Boostrix + Menactra Group
n=214 participants at risk
Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
|
Boostrix/Cervarix Group
n=214 participants at risk
Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
|
Menactra/Cervarix Group
n=214 participants at risk
Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
|
Cervarix Group
n=215 participants at risk
Subjects received Cervarix at Months 0, 1 and 6.
|
|---|---|---|---|---|---|---|
|
General disorders
Pain
|
92.9%
197/212
|
95.3%
204/214
|
95.3%
204/214
|
94.9%
203/214
|
90.2%
193/214
|
93.5%
201/215
|
|
General disorders
Redness
|
45.8%
97/212
|
43.5%
93/214
|
48.1%
103/214
|
48.1%
103/214
|
46.3%
99/214
|
43.3%
93/215
|
|
General disorders
Swelling
|
44.3%
94/212
|
42.1%
90/214
|
47.7%
102/214
|
46.7%
100/214
|
34.6%
74/214
|
40.0%
86/215
|
|
General disorders
Arthralgia
|
17.5%
37/212
|
19.6%
42/214
|
15.9%
34/214
|
22.4%
48/214
|
15.4%
33/214
|
21.9%
47/215
|
|
General disorders
Fatigue
|
44.3%
94/212
|
46.7%
100/214
|
51.9%
111/214
|
55.1%
118/214
|
46.3%
99/214
|
45.6%
98/215
|
|
General disorders
Fever
|
14.6%
31/212
|
15.0%
32/214
|
11.2%
24/214
|
13.1%
28/214
|
16.4%
35/214
|
10.7%
23/215
|
|
General disorders
Gastrointestinal
|
27.8%
59/212
|
29.0%
62/214
|
32.7%
70/214
|
30.4%
65/214
|
30.4%
65/214
|
32.1%
69/215
|
|
General disorders
Headache
|
50.5%
107/212
|
55.1%
118/214
|
57.9%
124/214
|
62.1%
133/214
|
57.0%
122/214
|
52.1%
112/215
|
|
General disorders
Myalgia
|
37.7%
80/212
|
41.6%
89/214
|
47.2%
101/214
|
44.9%
96/214
|
30.8%
66/214
|
41.4%
89/215
|
|
General disorders
Rash
|
5.2%
11/212
|
5.6%
12/214
|
8.9%
19/214
|
7.0%
15/214
|
6.1%
13/214
|
6.0%
13/215
|
|
General disorders
Urticaria
|
3.3%
7/212
|
2.3%
5/214
|
5.6%
12/214
|
3.3%
7/214
|
1.9%
4/214
|
2.8%
6/215
|
|
General disorders
Injection site haematoma
|
17.5%
37/212
|
16.4%
35/214
|
13.6%
29/214
|
14.5%
31/214
|
10.3%
22/214
|
7.9%
17/215
|
|
Nervous system disorders
Headache
|
6.1%
13/212
|
7.5%
16/214
|
6.1%
13/214
|
6.1%
13/214
|
9.8%
21/214
|
8.4%
18/215
|
|
Infections and infestations
Nasopharynigitis
|
5.2%
11/212
|
6.1%
13/214
|
6.1%
13/214
|
4.7%
10/214
|
7.5%
16/214
|
8.4%
18/215
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.8%
8/212
|
3.7%
8/214
|
0.00%
0/214
|
4.7%
10/214
|
6.1%
13/214
|
7.0%
15/215
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/212
|
4.7%
10/214
|
5.6%
12/214
|
6.5%
14/214
|
0.00%
0/214
|
0.00%
0/215
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
4.2%
9/212
|
0.00%
0/214
|
6.1%
13/214
|
4.7%
10/214
|
0.00%
0/214
|
0.00%
0/215
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/212
|
0.00%
0/214
|
0.00%
0/214
|
4.7%
10/214
|
0.00%
0/214
|
5.1%
11/215
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/212
|
0.00%
0/214
|
0.00%
0/214
|
0.00%
0/214
|
5.1%
11/214
|
0.00%
0/215
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER