Trial Outcomes & Findings for Study on a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared to a Meningococcal Reference Vaccine, and When Given Alone or With Two Other Vaccines in Healthy Adolescents (NCT NCT04490018)
NCT ID: NCT04490018
Last Updated: 2025-09-12
Results Overview
Antibody titers against meningococcal serogroups A, C, W, and Y were measured by serum bactericidal assay using human complement (hSBA). Non-inferiority data analysis for this outcome measure was planned to be conducted only for Groups 1 and 2, not for Group 3. Group 3 data is reported separately.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
463 participants
Primary outcome timeframe
Day 31 (post-vaccination)
Results posted on
2025-09-12
Participant Flow
The study was conducted at 21 active centers in Hungary, Italy, Spain and Singapore between 16 March 2021 to 11 May 2022.
A total of 463 participants were enrolled and randomized in this study.
Participant milestones
| Measure |
Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)
Participants received 0.5 milliliters (mL) intramuscular injection of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate vaccine (MenACYW Conjugate vaccine) on Day 01 and 0.5-mL intramuscular injection of 9-valent human papilloma virus (9vHPV) + tetanus, diphtheria, and acellular pertussis - inactivated polio vaccines (Tdap-IPV) (sequentially after MenACYW vaccine) at Day 31.
|
Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)
Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
|---|---|---|---|
|
Overall Study
STARTED
|
173
|
173
|
117
|
|
Overall Study
Safety Analysis Set
|
171
|
171
|
116
|
|
Overall Study
Vaccinated at Day 01
|
170
|
172
|
116
|
|
Overall Study
Vaccinated at Day 31
|
168
|
169
|
0
|
|
Overall Study
COMPLETED
|
167
|
165
|
116
|
|
Overall Study
NOT COMPLETED
|
6
|
8
|
1
|
Reasons for withdrawal
| Measure |
Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)
Participants received 0.5 milliliters (mL) intramuscular injection of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate vaccine (MenACYW Conjugate vaccine) on Day 01 and 0.5-mL intramuscular injection of 9-valent human papilloma virus (9vHPV) + tetanus, diphtheria, and acellular pertussis - inactivated polio vaccines (Tdap-IPV) (sequentially after MenACYW vaccine) at Day 31.
|
Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)
Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
0
|
|
Overall Study
Withdrawal by parent/guardian
|
2
|
3
|
0
|
Baseline Characteristics
Study on a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared to a Meningococcal Reference Vaccine, and When Given Alone or With Two Other Vaccines in Healthy Adolescents
Baseline characteristics by cohort
| Measure |
Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)
n=173 Participants
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31.
|
Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)
n=173 Participants
Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
n=117 Participants
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
Total
n=463 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
12.4 years
STANDARD_DEVIATION 2.32 • n=93 Participants
|
12.8 years
STANDARD_DEVIATION 2.38 • n=4 Participants
|
12.5 years
STANDARD_DEVIATION 2.47 • n=27 Participants
|
12.6 years
STANDARD_DEVIATION 2.38 • n=483 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=93 Participants
|
57 Participants
n=4 Participants
|
45 Participants
n=27 Participants
|
151 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
124 Participants
n=93 Participants
|
116 Participants
n=4 Participants
|
72 Participants
n=27 Participants
|
312 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
165 Participants
n=93 Participants
|
169 Participants
n=4 Participants
|
115 Participants
n=27 Participants
|
449 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Day 31 (post-vaccination)Population: Analysis was performed on hSBA Per-Protocol Analysis Set for meningococcal vaccines (PPASM) which was a subset that included all participants who received a dose of the study vaccine and had a valid post-vaccination serology result. The participants who presented protocol deviations were excluded from PPASM. Here, 'number analyzed'=participants with available data for each specified category.
Antibody titers against meningococcal serogroups A, C, W, and Y were measured by serum bactericidal assay using human complement (hSBA). Non-inferiority data analysis for this outcome measure was planned to be conducted only for Groups 1 and 2, not for Group 3. Group 3 data is reported separately.
Outcome measures
| Measure |
Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)
n=161 Participants
Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
n=159 Participants
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
|---|---|---|---|
|
Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® Vaccine (Non-inferiority Analysis): Groups 1 and 2
Serogroup A
|
92.5 percentage of participants
Interval 87.3 to 96.1
|
97.5 percentage of participants
Interval 93.7 to 99.3
|
—
|
|
Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® Vaccine (Non-inferiority Analysis): Groups 1 and 2
Serogroup C
|
95.0 percentage of participants
Interval 90.4 to 97.8
|
100 percentage of participants
Interval 97.7 to 100.0
|
—
|
|
Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® Vaccine (Non-inferiority Analysis): Groups 1 and 2
Serogroup W
|
98.8 percentage of participants
Interval 95.6 to 99.8
|
100 percentage of participants
Interval 97.7 to 100.0
|
—
|
|
Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® Vaccine (Non-inferiority Analysis): Groups 1 and 2
Serogroup Y
|
98.1 percentage of participants
Interval 94.6 to 99.6
|
99.4 percentage of participants
Interval 96.5 to 100.0
|
—
|
SECONDARY outcome
Timeframe: Day 01 (pre-vaccination) and Day 31 (post-vaccination)Population: Analysis was performed on hSBA PPASM. Here, 'number analyzed'=participants with available data for each specified category.
GMTs against Meningococcal Serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.
Outcome measures
| Measure |
Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)
n=161 Participants
Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
n=159 Participants
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
n=113 Participants
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W
Serogroup A: Day 01
|
6.41 titers
Interval 5.67 to 7.26
|
6.95 titers
Interval 6.18 to 7.83
|
7.38 titers
Interval 6.23 to 8.75
|
|
Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W
Serogroup A: Day 31
|
56.0 titers
Interval 44.0 to 71.2
|
78.2 titers
Interval 64.6 to 94.7
|
42.2 titers
Interval 32.5 to 54.7
|
|
Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W
Serogroup C: Day 01
|
5.51 titers
Interval 4.59 to 6.62
|
6.40 titers
Interval 5.17 to 7.92
|
5.67 titers
Interval 4.51 to 7.14
|
|
Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W
Serogroup C: Day 31
|
619 titers
Interval 411.0 to 931.0
|
2294 titers
Interval 1675.0 to 3142.0
|
1938 titers
Interval 1365.0 to 2752.0
|
|
Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W
Serogroup Y: Day 01
|
3.14 titers
Interval 2.63 to 3.75
|
2.56 titers
Interval 2.27 to 2.89
|
2.43 titers
Interval 2.09 to 2.84
|
|
Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W
Serogroup Y: Day 31
|
84.8 titers
Interval 68.3 to 105.0
|
169 titers
Interval 141.0 to 202.0
|
171 titers
Interval 138.0 to 211.0
|
|
Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W
Serogroup W: Day 01
|
4.36 titers
Interval 3.68 to 5.17
|
3.76 titers
Interval 3.22 to 4.4
|
3.98 titers
Interval 3.18 to 4.96
|
|
Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W
Serogroup W: Day 31
|
64.6 titers
Interval 52.5 to 79.4
|
134 titers
Interval 109.0 to 164.0
|
74.6 titers
Interval 61.8 to 90.1
|
SECONDARY outcome
Timeframe: Day 01 (pre-vaccination) and Day 31 (post-vaccination)Population: Analysis was performed on hSBA PPASM. Here, 'number analyzed'=participants with available data for each specified category.
Antibody titers against Meningococcal Serogroups A, C, Y and W were measured by hSBA. Percentage of participants With hSBA antibody titers \>=1:4 and \>=1:8 for serogroups A, C, Y, and W were reported in the outcome measure.
Outcome measures
| Measure |
Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)
n=161 Participants
Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
n=159 Participants
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
n=113 Participants
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
|---|---|---|---|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W
Serogroup C: >= 1:8: Day 01
|
35.6 percentage of participants
Interval 28.2 to 43.6
|
41.1 percentage of participants
Interval 33.4 to 49.2
|
41.6 percentage of participants
Interval 32.4 to 51.2
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W
Serogroup C: >= 1:4: Day 31
|
96.3 percentage of participants
Interval 92.1 to 98.6
|
100 percentage of participants
Interval 97.7 to 100.0
|
99.1 percentage of participants
Interval 95.2 to 100.0
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W
Serogroup C: >= 1:8: Day 31
|
95.0 percentage of participants
Interval 90.4 to 97.8
|
100 percentage of participants
Interval 97.7 to 100.0
|
99.1 percentage of participants
Interval 95.2 to 100.0
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W
Serogroup Y: >= 1:4: Day 01
|
17.4 percentage of participants
Interval 11.9 to 24.1
|
14.5 percentage of participants
Interval 9.4 to 20.9
|
8.8 percentage of participants
Interval 4.3 to 15.7
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W
Serogroup Y: >= 1:8: Day 01
|
15.5 percentage of participants
Interval 10.3 to 22.1
|
9.4 percentage of participants
Interval 5.4 to 15.1
|
6.2 percentage of participants
Interval 2.5 to 12.3
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W
Serogroup Y: >= 1:4: Day 31
|
98.8 percentage of participants
Interval 95.6 to 99.8
|
99.4 percentage of participants
Interval 96.5 to 100.0
|
100 percentage of participants
Interval 96.8 to 100.0
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W
Serogroup Y: >= 1:8: Day 31
|
98.1 percentage of participants
Interval 94.6 to 99.6
|
99.4 percentage of participants
Interval 96.5 to 100.0
|
100 percentage of participants
Interval 96.8 to 100.0
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W
Serogroup W: >= 1:4: Day 01
|
46.6 percentage of participants
Interval 38.7 to 54.6
|
39.6 percentage of participants
Interval 32.0 to 47.7
|
30.4 percentage of participants
Interval 22.0 to 39.8
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W
Serogroup W: >= 1:8: Day 01
|
28.6 percentage of participants
Interval 21.7 to 36.2
|
22.6 percentage of participants
Interval 16.4 to 29.9
|
26.8 percentage of participants
Interval 18.9 to 36.0
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W
Serogroup W: >= 1:4: Day 31
|
98.8 percentage of participants
Interval 95.6 to 99.8
|
100 percentage of participants
Interval 97.7 to 100.0
|
100 percentage of participants
Interval 96.8 to 100.0
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W
Serogroup W: >= 1:8: Day 31
|
98.8 percentage of participants
Interval 95.6 to 99.8
|
100 percentage of participants
Interval 97.7 to 100.0
|
99.1 percentage of participants
Interval 95.2 to 100.0
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W
Serogroup A: >= 1:4: Day 01
|
88.1 percentage of participants
Interval 82.1 to 92.7
|
94.3 percentage of participants
Interval 89.5 to 97.4
|
83.9 percentage of participants
Interval 75.8 to 90.2
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W
Serogroup A: >= 1:8: Day 01
|
50.6 percentage of participants
Interval 42.6 to 58.6
|
56.3 percentage of participants
Interval 48.2 to 64.2
|
58.9 percentage of participants
Interval 49.2 to 68.1
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W
Serogroup A: >= 1:4: Day 31
|
95.0 percentage of participants
Interval 90.4 to 97.8
|
98.7 percentage of participants
Interval 95.5 to 99.8
|
96.5 percentage of participants
Interval 91.2 to 99.0
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W
Serogroup A: >= 1:8: Day 31
|
92.5 percentage of participants
Interval 87.3 to 96.1
|
97.5 percentage of participants
Interval 93.7 to 99.3
|
91.2 percentage of participants
Interval 84.3 to 95.7
|
|
Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W
Serogroup C: >= 1:4: Day 01
|
61.3 percentage of participants
Interval 53.2 to 68.8
|
61.4 percentage of participants
Interval 53.3 to 69.0
|
57.5 percentage of participants
Interval 47.9 to 66.8
|
SECONDARY outcome
Timeframe: From Baseline (Day 01) to Day 31 (post-vaccination)Population: Analysis was performed on hSBA PPASM. Here, 'number analyzed'=participants with available data for each specified category.
Antibody titers against Meningococcal Serogroups A, C, Y and W were measured by hSBA. Fold-rise was calculated as ratio of post-dose titer on Day 31 to pre-dose titer on Day 01.
Outcome measures
| Measure |
Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)
n=161 Participants
Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
n=159 Participants
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
n=113 Participants
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
|---|---|---|---|
|
Percentage of Participants With >= 4-Fold Rise In hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W
Serogroup A
|
76.1 percentage of participants
Interval 68.7 to 82.5
|
88.0 percentage of participants
Interval 81.9 to 92.6
|
65.2 percentage of participants
Interval 55.6 to 73.9
|
|
Percentage of Participants With >= 4-Fold Rise In hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W
Serogroup C
|
91.9 percentage of participants
Interval 86.5 to 95.6
|
99.4 percentage of participants
Interval 96.5 to 100.0
|
97.3 percentage of participants
Interval 92.4 to 99.4
|
|
Percentage of Participants With >= 4-Fold Rise In hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W
Serogroup Y
|
92.5 percentage of participants
Interval 87.3 to 96.1
|
98.7 percentage of participants
Interval 95.5 to 99.8
|
99.1 percentage of participants
Interval 95.2 to 100.0
|
|
Percentage of Participants With >= 4-Fold Rise In hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W
Serogroup W
|
88.2 percentage of participants
Interval 82.2 to 92.7
|
94.3 percentage of participants
Interval 89.5 to 97.4
|
86.6 percentage of participants
Interval 78.9 to 92.3
|
SECONDARY outcome
Timeframe: Day 31 (post-vaccination)Population: Analysis was performed on hSBA PPASM. Here, 'number analyzed'=participants with available data for each specified category.
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The vaccine seroresponse was defined as a post-vaccination hSBA titer greater than or equal to (\>=) 1:16 for participants with pre-vaccination hSBA titer less than (\<) 1:8, or a \>= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>= 1:8.
Outcome measures
| Measure |
Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)
n=161 Participants
Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
n=159 Participants
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
n=113 Participants
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
|---|---|---|---|
|
Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W
Serogroup A
|
75.5 percentage of participants
Interval 68.0 to 81.9
|
88.0 percentage of participants
Interval 81.9 to 92.6
|
63.4 percentage of participants
Interval 53.8 to 72.3
|
|
Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W
Serogroup C
|
88.8 percentage of participants
Interval 82.8 to 93.2
|
99.4 percentage of participants
Interval 96.5 to 100.0
|
97.3 percentage of participants
Interval 92.4 to 99.4
|
|
Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W
Serogroup Y
|
88.1 percentage of participants
Interval 82.1 to 92.7
|
98.7 percentage of participants
Interval 95.5 to 99.8
|
99.1 percentage of participants
Interval 95.2 to 100.0
|
|
Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W
Serogroup W
|
81.4 percentage of participants
Interval 74.5 to 87.1
|
93.1 percentage of participants
Interval 88.0 to 96.5
|
85.7 percentage of participants
Interval 77.8 to 91.6
|
SECONDARY outcome
Timeframe: Day 01 (pre-vaccination) and Day 31 (post-vaccination)Population: Analysis was performed on participants who were MenC primed, received a dose of the study vaccine and had a valid post-vaccination serology result. The participants who presented protocol deviations were excluded. Here, 'number analyzed' = participants with available data for specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
GMTs against meningococcal Serogroup C in MenC primed participants (participants who received monovalent MenC priming in infancy \< 2 years of age) were measured by hSBA. Titers were expressed in terms of 1/dilution.
Outcome measures
| Measure |
Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)
n=112 Participants
Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
n=114 Participants
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroup C: Meningococcal Serogroup C Conjugate Vaccine (MenC) Primed Participants in Groups 1 and 2
Day 01
|
7.06 titers
Interval 5.57 to 8.95
|
7.30 titers
Interval 5.64 to 9.45
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroup C: Meningococcal Serogroup C Conjugate Vaccine (MenC) Primed Participants in Groups 1 and 2
Day 31
|
2361 titers
Interval 1740.0 to 3204.0
|
4222 titers
Interval 3166.0 to 5632.0
|
—
|
SECONDARY outcome
Timeframe: Day 01 (pre-vaccination) and Day 31 (post-vaccination)Population: Analysis was performed on participants who were MenC primed. Here, "overall number of participants analyzed" signifies participants with available data for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
GMTs against Serogroup C in MenC primed participants (participants who received monovalent MenC priming in infancy \< 2 years of age) were measured by rSBA. Titers were expressed in terms of 1/dilution.
Outcome measures
| Measure |
Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)
n=37 Participants
Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
n=37 Participants
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Antibodies Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups C: Meningococcal Serogroup C Conjugate Vaccine (MenC) Primed Participants in Groups 1 and 2
Day 01
|
3.32 titers
Interval 2.24 to 4.91
|
6.51 titers
Interval 3.56 to 11.9
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups C: Meningococcal Serogroup C Conjugate Vaccine (MenC) Primed Participants in Groups 1 and 2
Day 31
|
7052 titers
Interval 4706.0 to 10567.0
|
19760 titers
Interval 13308.0 to 29338.0
|
—
|
SECONDARY outcome
Timeframe: Day 31 (post-vaccination) and Day 61 (post-vaccination)Population: Analysis performed on Per-Protocol Analysis Set for concomitant vaccines (PPASC) which was a subset that included all participants who received a dose of study vaccine and had a valid post-vaccination serology result. Participants who presented protocol deviations and who did not produce a valid test result were excluded from PPASC. Here, 'number analyzed'=participants with available data for each specified category.
Geometric mean concentrations of anti-Diphtheria, and tetanus antibodies were measured by electro chemiluminescent method. Blood samples were assessed for participants at Day 31 and at Day 61, respectively.
Outcome measures
| Measure |
Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)
n=147 Participants
Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
n=149 Participants
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
|---|---|---|---|
|
Geometric Mean Concentrations (GMCs) of Anti-Diphtheria, Tetanus Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2
Anti-Tetanus: Day 31
|
18.4 International units/milliliter (IU/mL)
Interval 15.8 to 21.5
|
25.5 International units/milliliter (IU/mL)
Interval 22.0 to 29.5
|
—
|
|
Geometric Mean Concentrations (GMCs) of Anti-Diphtheria, Tetanus Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2
Anti-Tetanus: Day 61
|
16.1 International units/milliliter (IU/mL)
Interval 14.1 to 18.5
|
17.3 International units/milliliter (IU/mL)
Interval 14.9 to 20.1
|
—
|
|
Geometric Mean Concentrations (GMCs) of Anti-Diphtheria, Tetanus Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2
Anti-Diphteria: Day 31
|
0.215 International units/milliliter (IU/mL)
Interval 0.181 to 0.254
|
0.200 International units/milliliter (IU/mL)
Interval 0.169 to 0.238
|
—
|
|
Geometric Mean Concentrations (GMCs) of Anti-Diphtheria, Tetanus Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2
Anti-Diphteria: Day 61
|
3.88 International units/milliliter (IU/mL)
Interval 3.37 to 4.47
|
3.75 International units/milliliter (IU/mL)
Interval 3.24 to 4.35
|
—
|
SECONDARY outcome
Timeframe: Day 31 (post-vaccination) and Day 61 (post-vaccination)Population: Analysis was performed on PPASC. Here, 'number analyzed'=participants with available data for each specified category.
GMCs of anti-poliovirus types 1, 2, and 3 were measured by neutralization assay. Concentrations were expressed in terms of titers (1/dilution). Blood samples were assessed for participants at Day 31 and at Day 61, respectively.
Outcome measures
| Measure |
Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)
n=147 Participants
Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
n=149 Participants
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
|---|---|---|---|
|
Geometric Mean Concentrations (GMCs) of Anti-Polio Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2
Anti-Polio type 1: Day 31
|
109 titers
Interval 86.0 to 138.0
|
94.7 titers
Interval 75.5 to 119.0
|
—
|
|
Geometric Mean Concentrations (GMCs) of Anti-Polio Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2
Anti-Polio type 1: Day 61
|
3266 titers
Interval 2778.0 to 3840.0
|
3135 titers
Interval 2692.0 to 3650.0
|
—
|
|
Geometric Mean Concentrations (GMCs) of Anti-Polio Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2
Anti-Polio type 2: Day 31
|
234 titers
Interval 188.0 to 292.0
|
227 titers
Interval 184.0 to 281.0
|
—
|
|
Geometric Mean Concentrations (GMCs) of Anti-Polio Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2
Anti-Polio type 2: Day 61
|
2648 titers
Interval 2074.0 to 3381.0
|
3344 titers
Interval 2635.0 to 4245.0
|
—
|
|
Geometric Mean Concentrations (GMCs) of Anti-Polio Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2
Anti-Polio type 3: Day 31
|
155 titers
Interval 120.0 to 200.0
|
135 titers
Interval 105.0 to 174.0
|
—
|
|
Geometric Mean Concentrations (GMCs) of Anti-Polio Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2
Anti-Polio type 3: Day 61
|
5591 titers
Interval 4647.0 to 6728.0
|
7059 titers
Interval 5861.0 to 8502.0
|
—
|
SECONDARY outcome
Timeframe: Day 31 (post-vaccination) and Day 61 (post-vaccination)Population: Analysis was performed on PPASC. Here, 'number analyzed'=participants with available data for each specified category.
GMCs of anti-pertussis antibodies (pertussis toxoid \[PT\], filamentous hemagglutinin \[FHA\], pertactin \[PRN\]) and fimbriae types 2 and 3 \[FIM\], were measured by electro chemiluminescent method. Blood samples were assessed for participants at Day 31 and at Day 61, respectively.
Outcome measures
| Measure |
Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)
n=147 Participants
Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
n=149 Participants
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
|---|---|---|---|
|
Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2
Anti-PT: Day 31
|
12.3 Endotoxin units per milliliter (EU/mL)
Interval 10.5 to 14.4
|
11.9 Endotoxin units per milliliter (EU/mL)
Interval 10.2 to 13.8
|
—
|
|
Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2
Anti-PT: Day 61
|
59.3 Endotoxin units per milliliter (EU/mL)
Interval 51.1 to 68.8
|
58.4 Endotoxin units per milliliter (EU/mL)
Interval 50.6 to 67.4
|
—
|
|
Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2
Anti-FHA: Day 31
|
58.3 Endotoxin units per milliliter (EU/mL)
Interval 51.4 to 66.1
|
47.3 Endotoxin units per milliliter (EU/mL)
Interval 40.9 to 54.7
|
—
|
|
Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2
Anti-FHA: Day 61
|
210 Endotoxin units per milliliter (EU/mL)
Interval 187.0 to 236.0
|
177 Endotoxin units per milliliter (EU/mL)
Interval 156.0 to 200.0
|
—
|
|
Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2
Anti-PRN: Day 31
|
18.2 Endotoxin units per milliliter (EU/mL)
Interval 14.0 to 23.7
|
14.5 Endotoxin units per milliliter (EU/mL)
Interval 11.2 to 18.8
|
—
|
|
Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2
Anti-PRN: Day 61
|
394 Endotoxin units per milliliter (EU/mL)
Interval 316.0 to 491.0
|
331 Endotoxin units per milliliter (EU/mL)
Interval 265.0 to 414.0
|
—
|
|
Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2
Anti-FIM: Day 31
|
3.18 Endotoxin units per milliliter (EU/mL)
Interval 2.56 to 3.95
|
2.74 Endotoxin units per milliliter (EU/mL)
Interval 2.23 to 3.37
|
—
|
|
Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2
Anti-FIM: Day 61
|
194 Endotoxin units per milliliter (EU/mL)
Interval 140.0 to 271.0
|
152 Endotoxin units per milliliter (EU/mL)
Interval 112.0 to 207.0
|
—
|
SECONDARY outcome
Timeframe: Day 01 (pre-vaccination) and Day 31 (post-vaccination)Population: Analysis was performed on PPASC.
GMCs of anti-diphtheria, and tetanus antibodies were measured by electro chemiluminescent method. Blood samples were assessed for participants at Day 01 and at Day 31, respectively.
Outcome measures
| Measure |
Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)
Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
n=113 Participants
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
|---|---|---|---|
|
Geometric Mean Concentrations (GMCs) of Anti-Diphtheria, Tetanus Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3
Anti-Tetanus: Day 01
|
—
|
0.708 IU/mL
Interval 0.574 to 0.874
|
—
|
|
Geometric Mean Concentrations (GMCs) of Anti-Diphtheria, Tetanus Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3
Anti-Tetanus: Day 31
|
—
|
34.5 IU/mL
Interval 30.1 to 39.6
|
—
|
|
Geometric Mean Concentrations (GMCs) of Anti-Diphtheria, Tetanus Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3
Anti-Diphtheria: Day 01
|
—
|
0.256 IU/mL
Interval 0.208 to 0.316
|
—
|
|
Geometric Mean Concentrations (GMCs) of Anti-Diphtheria, Tetanus Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3
Anti-Diphtheria: Day 31
|
—
|
2.91 IU/mL
Interval 2.46 to 3.44
|
—
|
SECONDARY outcome
Timeframe: Day 01 (pre-vaccination) and Day 31 (post-vaccination)Population: Analysis was performed on PPASC.
GMCs of anti-poliovirus types 1, 2, and 3 were measured by neutralization assay. Concentrations were expressed in terms of titers (1/dilution). Blood samples were assessed for participants at Day 01 and at Day 31, respectively.
Outcome measures
| Measure |
Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)
Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
n=113 Participants
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
|---|---|---|---|
|
Geometric Mean Concentrations (GMCs) of Anti-Polio Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3
Anti-Polio type 1: Day 01
|
—
|
146 titers
Interval 112.0 to 190.0
|
—
|
|
Geometric Mean Concentrations (GMCs) of Anti-Polio Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3
Anti-Polio type 1: Day 31
|
—
|
1593 titers
Interval 1306.0 to 1943.0
|
—
|
|
Geometric Mean Concentrations (GMCs) of Anti-Polio Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3
Anti-Polio type 2: Day 01
|
—
|
225 titers
Interval 178.0 to 285.0
|
—
|
|
Geometric Mean Concentrations (GMCs) of Anti-Polio Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3
Anti-Polio type 2: Day 31
|
—
|
2950 titers
Interval 2409.0 to 3613.0
|
—
|
|
Geometric Mean Concentrations (GMCs) of Anti-Polio Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3
Anti-Polio type 3: Day 01
|
—
|
221 titers
Interval 162.0 to 302.0
|
—
|
|
Geometric Mean Concentrations (GMCs) of Anti-Polio Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3
Anti-Polio type 3: Day 31
|
—
|
3166 titers
Interval 2553.0 to 3926.0
|
—
|
SECONDARY outcome
Timeframe: Day 01 (pre-vaccination) and Day 31 (post-vaccination)Population: Analysis was performed on PPASC.
GMCs of anti-pertussis antibodies (PT, FHA, FIM, and PRN) antibodies were measured by electro chemiluminescent method. Blood samples were assessed for participants at Day 01 and at Day 31, respectively.
Outcome measures
| Measure |
Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)
Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
n=113 Participants
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
|---|---|---|---|
|
Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3
Anti-PT: Day 01
|
—
|
8.77 EU/mL
Interval 7.07 to 10.9
|
—
|
|
Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3
Anti-PT: Day 31
|
—
|
41.4 EU/mL
Interval 36.1 to 47.4
|
—
|
|
Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3
Anti-FHA: Day 01
|
—
|
44.5 EU/mL
Interval 37.5 to 52.9
|
—
|
|
Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3
Anti-FHA: Day 31
|
—
|
146 EU/mL
Interval 128.0 to 166.0
|
—
|
|
Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3
Anti-PRN: Day 01
|
—
|
11.4 EU/mL
Interval 8.4 to 15.6
|
—
|
|
Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3
Anti-PRN: Day 31
|
—
|
236 EU/mL
Interval 184.0 to 303.0
|
—
|
|
Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3
Anti-FIM: Day 01
|
—
|
2.32 EU/mL
Interval 1.84 to 2.94
|
—
|
|
Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3
Anti-FIM: Day 31
|
—
|
106 EU/mL
Interval 75.3 to 149.0
|
—
|
SECONDARY outcome
Timeframe: Day 31 (post-vaccination) and Day 61 (post-vaccination)Population: Analysis was performed on PPASC. Here, 'number analyzed' = participants with available data for specified category.
Anti-Diphtheria, Tetanus, and Pertussis (PT, FHA, FIM, and PRN) antibodies were measured by electro chemiluminescent method. Anti-poliovirus types 1, 2, and 3 were measured by neutralization assay. GMCRs were calculated as the ratio of GMCs at Day 61 and Day 31. Blood samples were assessed for participants at Day 31 and at Day 61, respectively.
Outcome measures
| Measure |
Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)
n=147 Participants
Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
n=149 Participants
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
|---|---|---|---|
|
Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2
Anti-Tetanus
|
0.876 ratio
Interval 0.824 to 0.931
|
0.677 ratio
Interval 0.646 to 0.71
|
—
|
|
Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2
Anti-Diphtheria
|
18.1 ratio
Interval 15.1 to 21.7
|
18.5 ratio
Interval 15.3 to 22.5
|
—
|
|
Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2
Anti-Polio type 1
|
29.5 ratio
Interval 22.1 to 39.4
|
32.9 ratio
Interval 24.5 to 44.2
|
—
|
|
Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2
Anti-Polio type 2
|
11.3 ratio
Interval 8.09 to 15.8
|
14.9 ratio
Interval 10.8 to 20.5
|
—
|
|
Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2
Anti-Polio type 3
|
36.1 ratio
Interval 26.7 to 48.8
|
51.8 ratio
Interval 38.0 to 70.5
|
—
|
|
Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2
Anti-PT
|
4.83 ratio
Interval 4.33 to 5.38
|
4.90 ratio
Interval 4.36 to 5.51
|
—
|
|
Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2
Anti-FHA
|
3.61 ratio
Interval 3.18 to 4.09
|
3.76 ratio
Interval 3.24 to 4.35
|
—
|
|
Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2
Anti-PRN
|
21.6 ratio
Interval 16.9 to 27.7
|
22.4 ratio
Interval 17.9 to 27.9
|
—
|
|
Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2
Anti-FIM
|
61.2 ratio
Interval 49.4 to 75.8
|
55.3 ratio
Interval 44.4 to 68.9
|
—
|
SECONDARY outcome
Timeframe: Day 01 (pre-vaccination) and Day 31 (post-vaccination)Population: Analysis was performed on PPASC.
Anti-Diphtheria, Tetanus, and Pertussis (PT, FHA, FIM, and PRN) antibodies were measured by electro chemiluminescent method. Anti-poliovirus types 1, 2, and 3 were measured by neutralization assay. GMCRs were calculated as the ratio of GMCs at Day 31/Day 01. Blood samples were assessed for participants at Day 01 and at Day 31, respectively.
Outcome measures
| Measure |
Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)
Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
n=113 Participants
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
|---|---|---|---|
|
Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3
Anti-Tetanus
|
—
|
48.7 ratio
Interval 40.1 to 59.3
|
—
|
|
Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3
Anti-Diphtheria
|
—
|
11.4 ratio
Interval 9.17 to 14.1
|
—
|
|
Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3
Anti-Polio type 1
|
—
|
10.9 ratio
Interval 7.77 to 15.4
|
—
|
|
Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3
Anti-Polio type 2
|
—
|
13.1 ratio
Interval 9.66 to 17.8
|
—
|
|
Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3
Anti-Polio type 3
|
—
|
14.3 ratio
Interval 10.1 to 20.3
|
—
|
|
Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3
Anti-PT
|
—
|
4.72 ratio
Interval 4.05 to 5.49
|
—
|
|
Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3
Anti-FHA
|
—
|
3.27 ratio
Interval 2.82 to 3.8
|
—
|
|
Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3
Anti-PRN
|
—
|
20.6 ratio
Interval 15.7 to 27.1
|
—
|
|
Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3
Anti-FIM
|
—
|
45.7 ratio
Interval 35.7 to 58.5
|
—
|
SECONDARY outcome
Timeframe: Day 31 (post-vaccination) and Day 61 (post-vaccination)Population: Analysis was performed on PPASC. Here, 'number analyzed' = participants with available data for specified category.
Antibody titers above predefined thresholds against Tdap-IPV vaccine antigens were defined as: Anti-D Ab titers and Anti-T Ab titers \>= 0.1 IU/mL, and \>= 1.0 IU/mL; Anti-Polio 1, 2, and 3 Ab titers \>= 8 (1/dilution). Blood samples were assessed for participants at Day 31 and at Day 61, respectively.
Outcome measures
| Measure |
Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)
n=147 Participants
Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
n=149 Participants
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
|---|---|---|---|
|
Percentage of Participants With Antibody Titers Above Predefined Thresholds Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2
Anti-T: Day 31: >=0.1
|
100 percentage of participants
Interval 97.5 to 100.0
|
100 percentage of participants
Interval 97.5 to 100.0
|
—
|
|
Percentage of Participants With Antibody Titers Above Predefined Thresholds Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2
Anti-T: Day 31: >=1.0
|
98.0 percentage of participants
Interval 94.2 to 99.6
|
100 percentage of participants
Interval 97.5 to 100.0
|
—
|
|
Percentage of Participants With Antibody Titers Above Predefined Thresholds Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2
Anti-T: Day 61: >=0.1
|
100 percentage of participants
Interval 97.5 to 100.0
|
100 percentage of participants
Interval 97.6 to 100.0
|
—
|
|
Percentage of Participants With Antibody Titers Above Predefined Thresholds Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2
Anti-T: Day 61: >=1.0
|
100 percentage of participants
Interval 97.5 to 100.0
|
99.3 percentage of participants
Interval 96.3 to 100.0
|
—
|
|
Percentage of Participants With Antibody Titers Above Predefined Thresholds Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2
Anti-D: Day 31: >=0.1
|
79.6 percentage of participants
Interval 72.2 to 85.8
|
76.9 percentage of participants
Interval 69.2 to 83.4
|
—
|
|
Percentage of Participants With Antibody Titers Above Predefined Thresholds Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2
Anti-D: Day 31: >=1.0
|
4.8 percentage of participants
Interval 1.9 to 9.6
|
4.8 percentage of participants
Interval 1.9 to 9.6
|
—
|
|
Percentage of Participants With Antibody Titers Above Predefined Thresholds Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2
Anti-D: Day 61: >=0.1
|
100 percentage of participants
Interval 97.5 to 100.0
|
100 percentage of participants
Interval 97.6 to 100.0
|
—
|
|
Percentage of Participants With Antibody Titers Above Predefined Thresholds Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2
Anti-D: Day 61: >=1.0
|
92.5 percentage of participants
Interval 87.0 to 96.2
|
93.3 percentage of participants
Interval 88.0 to 96.7
|
—
|
|
Percentage of Participants With Antibody Titers Above Predefined Thresholds Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2
Anti-Polio 1: Day 31: >=8
|
95.2 percentage of participants
Interval 90.4 to 98.1
|
95.2 percentage of participants
Interval 90.4 to 98.1
|
—
|
|
Percentage of Participants With Antibody Titers Above Predefined Thresholds Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2
Anti-Polio 1: Day 61: >=8
|
100 percentage of participants
Interval 97.5 to 100.0
|
100 percentage of participants
Interval 97.6 to 100.0
|
—
|
|
Percentage of Participants With Antibody Titers Above Predefined Thresholds Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2
Anti-Polio 2: Day 31: >=8
|
100 percentage of participants
Interval 97.5 to 100.0
|
99.3 percentage of participants
Interval 96.3 to 100.0
|
—
|
|
Percentage of Participants With Antibody Titers Above Predefined Thresholds Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2
Anti-Polio 2: Day 61: >=8
|
100 percentage of participants
Interval 97.5 to 100.0
|
100 percentage of participants
Interval 97.5 to 100.0
|
—
|
|
Percentage of Participants With Antibody Titers Above Predefined Thresholds Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2
Anti-Polio 3: Day 31: >=8
|
96.6 percentage of participants
Interval 92.2 to 98.9
|
95.9 percentage of participants
Interval 91.3 to 98.5
|
—
|
|
Percentage of Participants With Antibody Titers Above Predefined Thresholds Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2
Anti-Polio 3: Day 61: >=8
|
100 percentage of participants
Interval 97.5 to 100.0
|
100 percentage of participants
Interval 97.6 to 100.0
|
—
|
SECONDARY outcome
Timeframe: Day 01 (pre-vaccination) and Day 31 (post-vaccination)Population: Analysis was performed on PPASC.
Antibody titers above predefined thresholds against Tdap-IPV vaccine antigens were defined as: Anti-D Ab titers and Anti-T Ab titers \>= 0.1 IU/mL, and \>= 1.0 IU/mL; Anti-Polio 1, 2, and 3 Ab titers \>= 8 (1/dilution). Blood samples were assessed for participants at Day 01 and at Day 31, respectively.
Outcome measures
| Measure |
Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)
Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
n=113 Participants
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
|---|---|---|---|
|
Percentage of Participants With Antibody Titers Above Predefined Thresholds Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3
Anti-T: Day 01: >=0.1
|
—
|
96.5 percentage of participants
Interval 91.2 to 99.0
|
—
|
|
Percentage of Participants With Antibody Titers Above Predefined Thresholds Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3
Anti-T: Day 01: >=1.0
|
—
|
38.9 percentage of participants
Interval 29.9 to 48.6
|
—
|
|
Percentage of Participants With Antibody Titers Above Predefined Thresholds Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3
Anti-T: Day 31: >=0.1
|
—
|
100 percentage of participants
Interval 96.8 to 100.0
|
—
|
|
Percentage of Participants With Antibody Titers Above Predefined Thresholds Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3
Anti-T: Day 31: >=1.0
|
—
|
100 percentage of participants
Interval 96.8 to 100.0
|
—
|
|
Percentage of Participants With Antibody Titers Above Predefined Thresholds Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3
Anti-D: Day 01: >=0.1
|
—
|
85.0 percentage of participants
Interval 77.0 to 91.0
|
—
|
|
Percentage of Participants With Antibody Titers Above Predefined Thresholds Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3
Anti-D: Day 01: >=1.0
|
—
|
9.7 percentage of participants
Interval 5.0 to 16.8
|
—
|
|
Percentage of Participants With Antibody Titers Above Predefined Thresholds Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3
Anti-D: Day 31: >=0.1
|
—
|
99.1 percentage of participants
Interval 95.2 to 100.0
|
—
|
|
Percentage of Participants With Antibody Titers Above Predefined Thresholds Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3
Anti-D: Day 31: >=1.0
|
—
|
90.3 percentage of participants
Interval 83.2 to 95.0
|
—
|
|
Percentage of Participants With Antibody Titers Above Predefined Thresholds Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3
Anti-Polio 1: Day 01: >=8
|
—
|
99.1 percentage of participants
Interval 95.2 to 100.0
|
—
|
|
Percentage of Participants With Antibody Titers Above Predefined Thresholds Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3
Anti-Polio 1: Day 31: >=8
|
—
|
100 percentage of participants
Interval 96.8 to 100.0
|
—
|
|
Percentage of Participants With Antibody Titers Above Predefined Thresholds Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3
Anti-Polio 2: Day 01: >=8
|
—
|
100 percentage of participants
Interval 96.8 to 100.0
|
—
|
|
Percentage of Participants With Antibody Titers Above Predefined Thresholds Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3
Anti-Polio 2: Day 31: >=8
|
—
|
100 percentage of participants
Interval 96.8 to 100.0
|
—
|
|
Percentage of Participants With Antibody Titers Above Predefined Thresholds Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3
Anti-Polio 3: Day 01: >=8
|
—
|
96.5 percentage of participants
Interval 91.2 to 99.0
|
—
|
|
Percentage of Participants With Antibody Titers Above Predefined Thresholds Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3
Anti-Polio 3: Day 31: >=8
|
—
|
100 percentage of participants
Interval 96.8 to 100.0
|
—
|
SECONDARY outcome
Timeframe: Day 61 (post-vaccination for Groups 1 and 2) and Day 31 (post-vaccination for Group 3)Population: Analysis was performed on PPASC. Here, 'number analyzed'=participants with available data for each specified category.
Vaccine seroresponse was defined as post-vaccination concentration \>= 4 \* Baseline concentration, if the anti-pertussis antibody concentration at Baseline was \< 4\*lower limit of quantification (LLOQ), or \>= 2\*Baseline concentration, if the anti-pertussis antibody concentration at Baseline was \>= 4\*LLOQ. Post vaccine seroresponse for anti-pertussis antigens was Day 31 for Group 3 and Day 61 for Groups 1 and 2.
Outcome measures
| Measure |
Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)
n=147 Participants
Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
n=149 Participants
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
n=113 Participants
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
|---|---|---|---|
|
Percentage of Participants With Vaccine Seroresponse Against Pertussis Antigens
Anti-PT
|
83.0 percentage of participants
Interval 75.9 to 88.7
|
81.4 percentage of participants
Interval 74.1 to 87.4
|
76.1 percentage of participants
Interval 67.2 to 83.6
|
|
Percentage of Participants With Vaccine Seroresponse Against Pertussis Antigens
Anti-FHA
|
76.2 percentage of participants
Interval 68.5 to 82.8
|
74.8 percentage of participants
Interval 67.0 to 81.6
|
70.8 percentage of participants
Interval 61.5 to 79.0
|
|
Percentage of Participants With Vaccine Seroresponse Against Pertussis Antigens
Anti-PRN
|
94.6 percentage of participants
Interval 89.6 to 97.6
|
98.0 percentage of participants
Interval 94.2 to 99.6
|
91.2 percentage of participants
Interval 84.3 to 95.7
|
|
Percentage of Participants With Vaccine Seroresponse Against Pertussis Antigens
Anti-FIM
|
97.3 percentage of participants
Interval 93.2 to 99.3
|
93.9 percentage of participants
Interval 88.7 to 97.2
|
95.6 percentage of participants
Interval 90.0 to 98.5
|
SECONDARY outcome
Timeframe: Day 31 (post-vaccination) and Day 61 (post-vaccination)Population: Analysis was performed on PPASC. Here, 'number analyzed'=participants with available data for each specified category.
Anti-HPV antibodies were measured by the direct virus-like particle (VLP) electrochemiluminescence multi-plex immunoassay for detection of antibodies towards HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. Titers were expressed in terms of 1/dilution. Blood samples were assessed for participants at Day 31 and at Day 61, respectively.
Outcome measures
| Measure |
Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)
n=147 Participants
Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
n=149 Participants
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2
Anti-HPV type-6: Day 31
|
2.03 titers
Interval 1.74 to 2.37
|
2.30 titers
Interval 1.94 to 2.73
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2
Anti-HPV type-6: Day 61
|
64.8 titers
Interval 55.8 to 75.4
|
73.9 titers
Interval 64.3 to 85.0
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2
Anti-HPV type-11: Day 31
|
1.08 titers
Interval 1.03 to 1.13
|
1.11 titers
Interval 1.05 to 1.18
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2
Anti-HPV type-11: Day 61
|
39.3 titers
Interval 33.9 to 45.5
|
43.9 titers
Interval 38.9 to 49.5
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2
Anti-HPV type-16: Day 31
|
2.08 titers
Interval 1.97 to 2.19
|
2.06 titers
Interval 1.95 to 2.17
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2
Anti-HPV type-16: Day 61
|
168 titers
Interval 142.0 to 199.0
|
199 titers
Interval 171.0 to 231.0
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2
Anti-HPV type-18: Day 31
|
1.52 titers
Interval 1.49 to 1.54
|
1.59 titers
Interval 1.5 to 1.7
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2
Anti-HPV type-18: Day 61
|
38.5 titers
Interval 31.3 to 47.4
|
46.5 titers
Interval 38.4 to 56.4
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2
Anti-HPV type-31: Day 31
|
1.05 titers
Interval 1.01 to 1.1
|
1.08 titers
Interval 0.995 to 1.18
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2
Anti-HPV type-31: Day 61
|
28.9 titers
Interval 24.0 to 34.9
|
31.7 titers
Interval 26.5 to 38.1
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2
Anti-HPV type-33: Day 31
|
1.02 titers
Interval 0.997 to 1.04
|
1.01 titers
Interval 0.987 to 1.04
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2
Anti-HPV type-33: Day 61
|
19.1 titers
Interval 16.1 to 22.7
|
21.1 titers
Interval 17.8 to 24.9
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2
Anti-HPV type-45: Day 31
|
0.509 titers
Interval 0.492 to 0.527
|
0.520 titers
Interval 0.499 to 0.543
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2
Anti-HPV type-45: Day 61
|
9.54 titers
Interval 7.68 to 11.9
|
11.5 titers
Interval 9.35 to 14.1
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2
Anti-HPV type-52: Day 31
|
0.514 titers
Interval 0.498 to 0.53
|
0.535 titers
Interval 0.503 to 0.569
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2
Anti-HPV type-52: Day 61
|
39.3 titers
Interval 33.5 to 46.1
|
47.4 titers
Interval 41.1 to 54.7
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2
Anti-HPV type-58: Day 31
|
1.05 titers
Interval 1.0 to 1.1
|
1.09 titers
Interval 1.02 to 1.16
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2
Anti-HPV type-58: Day 61
|
26.0 titers
Interval 22.2 to 30.4
|
29.6 titers
Interval 25.5 to 34.3
|
—
|
SECONDARY outcome
Timeframe: Day 01 (pre-vaccination) and Day 31 (post-vaccination)Population: Analysis was performed on PPASC.
Anti-HPV antibodies were measured by the direct VLP electrochemiluminescence multi-plex immunoassay for detection of antibodies towards HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. Titers were expressed in terms of 1/dilution. Blood samples were assessed for participants at Day 01 and at Day 31, respectively.
Outcome measures
| Measure |
Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)
Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
n=113 Participants
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3
Anti-HPV type-6: Day 01
|
—
|
2.12 titers
Interval 1.76 to 2.55
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3
Anti-HPV type-6: Day 31
|
—
|
50.6 titers
Interval 42.0 to 60.9
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3
Anti-HPV type-11: Day 01
|
—
|
1.07 titers
Interval 1.02 to 1.13
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3
Anti-HPV type-11: Day 31
|
—
|
36.3 titers
Interval 30.8 to 42.8
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3
Anti-HPV type-16: Day 01
|
—
|
2.02 titers
Interval 1.98 to 2.07
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3
Anti-HPV type-16: Day 31
|
—
|
146 titers
Interval 118.0 to 179.0
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3
Anti-HPV type-18: Day 01
|
—
|
1.50 titers
The 95% CI was not computable as the standard deviation of the sample was 0, since all participants had the same value.
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3
Anti-HPV type-18: Day 31
|
—
|
31.2 titers
Interval 24.0 to 40.6
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3
Anti-HPV type-31: Day 01
|
—
|
1.07 titers
Interval 1.02 to 1.13
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3
Anti-HPV type-31: Day 31
|
—
|
24.7 titers
Interval 19.2 to 31.8
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3
Anti-HPV type-33: Day 01
|
—
|
1.01 titers
Interval 0.989 to 1.03
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3
Anti-HPV type-33: Day 31
|
—
|
15.0 titers
Interval 12.2 to 18.6
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3
Anti-HPV type-45: Day 01
|
—
|
0.524 titers
Interval 0.493 to 0.556
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3
Anti-HPV type-45: Day 31
|
—
|
8.24 titers
Interval 6.3 to 10.8
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3
Anti-HPV type-52: Day 01
|
—
|
0.521 titers
Interval 0.5 to 0.544
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3
Anti-HPV type-52: Day 31
|
—
|
40.9 titers
Interval 33.5 to 49.8
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3
Anti-HPV type-58: Day 01
|
—
|
1.08 titers
Interval 1.02 to 1.14
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3
Anti-HPV type-58: Day 31
|
—
|
20.6 titers
Interval 16.9 to 25.1
|
—
|
SECONDARY outcome
Timeframe: Day 31 (post-vaccination) and Day 61 (post-vaccination)Population: Analysis was performed on PPASC. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Anti-HPV antibodies were measured by the direct virus-like particle (VLP) electrochemiluminescence multi-plex immunoassay for detection of antibodies towards HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. GMTRs were calculated as the ratio of GMTs at Day 61/Day 31. Blood samples were assessed for participants at Day 31 and at Day 61, respectively.
Outcome measures
| Measure |
Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)
n=147 Participants
Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
n=147 Participants
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
|---|---|---|---|
|
Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2
Anti-HPV type-6
|
31.9 ratio
Interval 26.5 to 38.5
|
32.0 ratio
Interval 26.5 to 38.6
|
—
|
|
Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2
Anti-HPV type-11
|
36.5 ratio
Interval 31.3 to 42.7
|
39.0 ratio
Interval 34.2 to 44.5
|
—
|
|
Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2
Anti-HPV type-16
|
80.8 ratio
Interval 68.1 to 95.8
|
96.6 ratio
Interval 83.4 to 112.0
|
—
|
|
Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2
Anti-HPV type-18
|
25.4 ratio
Interval 20.6 to 31.2
|
29.7 ratio
Interval 24.4 to 36.2
|
—
|
|
Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2
Anti-HPV type-31
|
27.5 ratio
Interval 22.8 to 33.2
|
29.8 ratio
Interval 25.1 to 35.4
|
—
|
|
Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2
Anti-HPV type-33
|
18.7 ratio
Interval 15.8 to 22.2
|
20.8 ratio
Interval 17.7 to 24.4
|
—
|
|
Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2
Anti-HPV type-45
|
18.8 ratio
Interval 15.1 to 23.3
|
21.9 ratio
Interval 17.9 to 26.9
|
—
|
|
Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2
Anti-HPV type-52
|
76.5 ratio
Interval 65.0 to 90.1
|
88.0 ratio
Interval 77.1 to 100.0
|
—
|
|
Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2
Anti-HPV type-58
|
24.8 ratio
Interval 21.2 to 29.0
|
27.1 ratio
Interval 23.3 to 31.4
|
—
|
SECONDARY outcome
Timeframe: Day 01 (pre-vaccination) and Day 31 (post-vaccination)Population: Analysis was performed on PPASC.
Anti-HPV antibodies were measured by the direct VLP electrochemiluminescence multi-plex immunoassay for detection of antibodies towards HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. GMTRs were calculated as the ratio of GMTs at Day 31/Day 01. Blood samples were assessed for participants at Day 01 and at Day 31, respectively.
Outcome measures
| Measure |
Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)
Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
n=113 Participants
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
|---|---|---|---|
|
Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3
Anti-HPV type-6
|
—
|
23.9 ratio
Interval 19.4 to 29.3
|
—
|
|
Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3
Anti-HPV type-11
|
—
|
33.9 ratio
Interval 28.6 to 40.1
|
—
|
|
Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3
Anti-HPV type-16
|
—
|
71.9 ratio
Interval 58.6 to 88.2
|
—
|
|
Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3
Anti-HPV type-18
|
—
|
20.8 ratio
Interval 16.0 to 27.1
|
—
|
|
Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3
Anti-HPV type-31
|
—
|
23.1 ratio
Interval 17.9 to 29.6
|
—
|
|
Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3
Anti-HPV type-33
|
—
|
14.9 ratio
Interval 12.0 to 18.4
|
—
|
|
Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3
Anti-HPV type-45
|
—
|
15.7 ratio
Interval 12.0 to 20.7
|
—
|
|
Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3
Anti-HPV type-52
|
—
|
78.4 ratio
Interval 64.3 to 95.5
|
—
|
|
Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3
Anti-HPV type-58
|
—
|
19.1 ratio
Interval 15.8 to 23.2
|
—
|
SECONDARY outcome
Timeframe: Day 61 (post-vaccination for Groups 1 and 2) and Day 31 (post-vaccination for Group 3)Population: Analysis was performed on PPASC. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
Vaccine Seroconversion was defined as changing serostatus from seronegative (participants with a titer inferior to the serostatus cut-off value) at Baseline to seropositive after vaccination. A participant with a titer at or above the serostatus cut-off for a given HPV type was considered seropositive for that type. The serostatus cut-offs for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were 9, 6, 5, 5, 3, 4, 3, 5 and 5 milli-Merck units (mMU)/mL, respectively. Post vaccine seroconversion for antigens contained in HPV vaccine was Day 31 for Group 3 and Day 61 for Groups 1 and 2.
Outcome measures
| Measure |
Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)
n=147 Participants
Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
n=147 Participants
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
n=113 Participants
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
|---|---|---|---|
|
Percentage of Participants With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine
Anti-HPV type-6
|
88.4 percentage of participants
Interval 82.1 to 93.1
|
87.8 percentage of participants
Interval 81.3 to 92.6
|
85.0 percentage of participants
Interval 77.0 to 91.0
|
|
Percentage of Participants With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine
Anti-HPV type-11
|
97.3 percentage of participants
Interval 93.2 to 99.3
|
99.3 percentage of participants
Interval 96.3 to 100.0
|
97.3 percentage of participants
Interval 92.4 to 99.4
|
|
Percentage of Participants With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine
Anti-HPV type-16
|
96.6 percentage of participants
Interval 92.2 to 98.9
|
99.3 percentage of participants
Interval 96.3 to 100.0
|
98.2 percentage of participants
Interval 93.8 to 99.8
|
|
Percentage of Participants With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine
Anti-HPV type-18
|
92.5 percentage of participants
Interval 87.0 to 96.2
|
94.6 percentage of participants
Interval 89.6 to 97.6
|
88.5 percentage of participants
Interval 81.1 to 93.7
|
|
Percentage of Participants With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine
Anti-HPV type-31
|
93.2 percentage of participants
Interval 87.8 to 96.7
|
96.6 percentage of participants
Interval 92.2 to 98.9
|
88.5 percentage of participants
Interval 81.1 to 93.7
|
|
Percentage of Participants With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine
Anti-HPV type-33
|
91.8 percentage of participants
Interval 86.2 to 95.7
|
95.2 percentage of participants
Interval 90.4 to 98.1
|
87.6 percentage of participants
Interval 80.1 to 93.1
|
|
Percentage of Participants With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine
Anti-HPV type-45
|
83.0 percentage of participants
Interval 75.9 to 88.7
|
81.6 percentage of participants
Interval 74.4 to 87.5
|
75.2 percentage of participants
Interval 66.2 to 82.9
|
|
Percentage of Participants With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine
Anti-HPV type-52
|
98.0 percentage of participants
Interval 94.2 to 99.6
|
99.3 percentage of participants
Interval 96.3 to 100.0
|
96.5 percentage of participants
Interval 91.2 to 99.0
|
|
Percentage of Participants With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine
Anti-HPV type-58
|
92.5 percentage of participants
Interval 87.0 to 96.2
|
95.2 percentage of participants
Interval 90.4 to 98.1
|
92.0 percentage of participants
Interval 85.4 to 96.3
|
SECONDARY outcome
Timeframe: Within 30 minutes post-any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 31])Population: Analysis was performed on safety analysis set that included all participants who had received at least one dose of the study vaccines and had any safety data available. Here, 'number analyzed' = participants with available data for each specified category and "0" in the number analyzed field signifies that at Day 31, participants of Group 3 received no vaccination and thus data were not collected and analyzed.
An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not had any casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report form (CRF) in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB. Reported AEs for each arm were presented as pre-specified in the study protocol.
Outcome measures
| Measure |
Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)
n=171 Participants
Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
n=171 Participants
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
n=116 Participants
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
|---|---|---|---|
|
Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs)
Post-any vaccination
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs)
Post-vaccination 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs)
Post-vaccination 2
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post-any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 31])Population: Analysis was performed on safety analysis set. Here, 'Number analyzed'=participants with available data for specified category. The assessment of injection site reactions (pain, swelling and erythema) after the MenACYW Conjugate vaccines (MenQuadfi and Nimenrix) and 2 other adolescent vaccines allowed in the assessment of local reactogenicity and helped in identifying injection site reaction per vaccine received. Reported AEs for each arm were presented as pre-specified in the study protocol.
SR: expected AR (sign or symptom) observed \& reported under conditions (nature \& onset) prelisted (i.e., solicited) in CRF \& considered as related to product. Injection site reactions: pain, erythema, \& swelling. Here, "0" in number analyzed for MenACYW categories signifies no participant were evaluable as in Group (Gps.) 2 MenACYW vaccine was not administered; for Gps.1\& 3: "0" in number analyzed for Nimenrix signifies no participant were evaluable as in Gps. 1 \& 3 Nimenrix was not administered. At Vaccination (vacc.)1 (Gps.1 \& 2): "0" in number analyzed for 9vHPV \& Tadp-IPV signifies no participant were evaluable as these vaccines were not administered at vacc.1 (Day01). At Vacc. 2 (Gps.1, 2 \& 3): "0" in number analyzed for MenACYW and Nimenrix signifies no participant were evaluable as these vaccines were not administered at vacc. 2 (Day 31); \& for Gps. 3 "0" in number analyzed for 9vHPV and Tadp-IPV signifies no participant were evaluable as these vaccines were not administered.
Outcome measures
| Measure |
Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)
n=171 Participants
Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
n=171 Participants
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
n=116 Participants
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
|---|---|---|---|
|
Number of Participants Reporting Solicited Injection Site Reactions
MenACYW Conjugate vaccine: Pain: Post-any vaccination
|
—
|
91 Participants
|
69 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reactions
MenACYW Conjugate vaccine: Erythema: Post-any vaccination
|
—
|
19 Participants
|
11 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reactions
MenACYW Conjugate vaccine: Swelling: Post-any vaccination
|
—
|
17 Participants
|
12 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reactions
Nimenrix vaccine: Pain: Post-any vaccination
|
87 Participants
|
—
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactions
Nimenrix vaccine: Erythema: Post-any vaccination
|
3 Participants
|
—
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactions
Nimenrix vaccine: Swelling: Post-any vaccination
|
7 Participants
|
—
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactions
9vHPV: Pain: Post-any vaccination
|
125 Participants
|
113 Participants
|
97 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reactions
9vHPV: Erythema: Post-any vaccination
|
3 Participants
|
7 Participants
|
6 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reactions
9vHPV: Swelling: Post-any vaccination
|
3 Participants
|
4 Participants
|
7 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reactions
Tdap-IPV: Pain: Post-any vaccination
|
117 Participants
|
116 Participants
|
95 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reactions
Tdap-IPV: Erythema: Post-any vaccination
|
5 Participants
|
9 Participants
|
13 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reactions
Tdap-IPV: Swelling: Post-any vaccination
|
3 Participants
|
9 Participants
|
10 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reactions
MenACYW Conjugate vaccine: Pain: Post-vaccination 1
|
—
|
91 Participants
|
69 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reactions
MenACYW Conjugate vaccine: Erythema: Post-vaccination 1
|
—
|
19 Participants
|
11 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reactions
MenACYW Conjugate vaccine: Swelling: Post-vaccination 1
|
—
|
17 Participants
|
12 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reactions
Nimenrix vaccine: Pain: Post-vaccination 1
|
87 Participants
|
—
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactions
Nimenrix vaccine: Erythema: Post-vaccination 1
|
3 Participants
|
—
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactions
Nimenrix vaccine: Swelling: Post-vaccination 1
|
7 Participants
|
—
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactions
9vHPV: Pain: Post-vaccination 1
|
—
|
—
|
97 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reactions
9vHPV: Erythema: Post-vaccination 1
|
—
|
—
|
6 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reactions
9vHPV: Swelling: Post-vaccination 1
|
—
|
—
|
7 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reactions
Tdap-IPV: Pain: Post-vaccination 1
|
—
|
—
|
95 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reactions
Tdap-IPV: Erythema: Post-vaccination 1
|
—
|
—
|
13 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reactions
Tdap-IPV: Swelling: Post-vaccination 1
|
—
|
—
|
10 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reactions
9vHPV: Pain: Post-vaccination 2
|
125 Participants
|
113 Participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactions
9vHPV: Erythema: Post-vaccination 2
|
3 Participants
|
7 Participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactions
9vHPV: Swelling: Post-vaccination 2
|
3 Participants
|
4 Participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactions
Tdap-IPV: Pain: Post-vaccination 2
|
117 Participants
|
116 Participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactions
Tdap-IPV: Erythema: Post-vaccination 2
|
5 Participants
|
9 Participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site Reactions
Tdap-IPV: Swelling: Post-vaccination 2
|
3 Participants
|
9 Participants
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post-any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 31])Population: Analysis was performed on safety analysis set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category and "0" in the number analyzed field signifies that at Day 31, participants of Group 3 received no vaccination and thus data were not collected and analyzed.
A solicited reaction (SR) was an expected adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRF and considered as related to the product administered. Solicited systemic reactions included fever, headache, malaise, and myalgia. Reported AEs for each arm were presented as pre-specified in the study protocol.
Outcome measures
| Measure |
Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)
n=170 Participants
Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
n=169 Participants
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
n=116 Participants
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
|---|---|---|---|
|
Number of Participants Reporting Solicited Systemic Reactions
Fever: Post-any vaccination
|
11 Participants
|
12 Participants
|
6 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactions
Headache: Post-any vaccination
|
64 Participants
|
75 Participants
|
52 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactions
Malaise: Post-any vaccination
|
48 Participants
|
65 Participants
|
42 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactions
Myalgia: Post-any vaccination
|
81 Participants
|
84 Participants
|
67 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactions
Fever: Post-vaccination 1
|
4 Participants
|
7 Participants
|
6 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactions
Headache: Post-vaccination 1
|
44 Participants
|
59 Participants
|
52 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactions
Malaise: Post-vaccination 1
|
32 Participants
|
46 Participants
|
42 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactions
Myalgia: Post-vaccination 1
|
53 Participants
|
51 Participants
|
67 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactions
Fever: Post-vaccination 2
|
7 Participants
|
6 Participants
|
—
|
|
Number of Participants Reporting Solicited Systemic Reactions
Headache: Post-vaccination 2
|
40 Participants
|
37 Participants
|
—
|
|
Number of Participants Reporting Solicited Systemic Reactions
Malaise: Post-vaccination 2
|
26 Participants
|
40 Participants
|
—
|
|
Number of Participants Reporting Solicited Systemic Reactions
Myalgia: Post-vaccination 2
|
61 Participants
|
67 Participants
|
—
|
SECONDARY outcome
Timeframe: From Day 01 up to Day 31 post-any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 31])Population: Analysis was performed on safety analysis set. Here, 'Number analyzed' = participants with available data for each specified category and "0" in the number analyzed field signifies that at Day 31, participants of Group 3 received no vaccination and thus data were not collected and analyzed.
An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not had any casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. Reported AEs for each arm were presented as pre-specified in the study protocol.
Outcome measures
| Measure |
Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)
n=171 Participants
Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
n=171 Participants
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
n=116 Participants
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
|---|---|---|---|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs)
Post-any vaccination
|
49 Participants
|
69 Participants
|
37 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs)
Post-vaccination 1
|
31 Participants
|
49 Participants
|
37 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs)
Post-vaccination 2
|
27 Participants
|
34 Participants
|
—
|
SECONDARY outcome
Timeframe: From Day 01 up to the last study day (i.e., Day 61 for Groups 1 and 2 and Day 31 for Group 3)Population: Analysis was performed on safety analysis set.
A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. A SAE which caused death of the participant was considered as fatal SAE. Adverse events of special interest (AESIs) were defined as event for which ongoing monitoring and rapid communication by the investigator to the sponsor was done. Reported AEs for each arm were presented as pre-specified in the study protocol.
Outcome measures
| Measure |
Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)
n=171 Participants
Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
n=171 Participants
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
n=116 Participants
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
|---|---|---|---|
|
Number of Participants Reporting Serious Adverse Events (SAEs) Including Adverse Events of Special Interest (AESI)
AESI
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Serious Adverse Events (SAEs) Including Adverse Events of Special Interest (AESI)
SAE
|
1 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)
Serious events: 0 serious events
Other events: 153 other events
Deaths: 0 deaths
Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)
Serious events: 1 serious events
Other events: 151 other events
Deaths: 0 deaths
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
Serious events: 0 serious events
Other events: 112 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)
n=171 participants at risk
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31.
|
Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)
n=171 participants at risk
Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
n=116 participants at risk
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Type 1 Diabetes Mellitus
|
0.00%
0/171 • Unsolicited AE data were collected from Day 01 up to Day 31 post-any vaccination. Solicited reaction data were collected from Day 01 up to Day 7 post-any vaccination. The SAEs were collected up to the last study day i.e., Day 61 for Groups 1 and 2 and Day 31 for Group 3
SR was an expected AR that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set. In AE section, solicited reaction Fever is reported under Pyrexia. Reported AEs for each arm were presented as pre-specified in study protocol.
|
0.58%
1/171 • Number of events 1 • Unsolicited AE data were collected from Day 01 up to Day 31 post-any vaccination. Solicited reaction data were collected from Day 01 up to Day 7 post-any vaccination. The SAEs were collected up to the last study day i.e., Day 61 for Groups 1 and 2 and Day 31 for Group 3
SR was an expected AR that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set. In AE section, solicited reaction Fever is reported under Pyrexia. Reported AEs for each arm were presented as pre-specified in study protocol.
|
0.00%
0/116 • Unsolicited AE data were collected from Day 01 up to Day 31 post-any vaccination. Solicited reaction data were collected from Day 01 up to Day 7 post-any vaccination. The SAEs were collected up to the last study day i.e., Day 61 for Groups 1 and 2 and Day 31 for Group 3
SR was an expected AR that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set. In AE section, solicited reaction Fever is reported under Pyrexia. Reported AEs for each arm were presented as pre-specified in study protocol.
|
Other adverse events
| Measure |
Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)
n=171 participants at risk
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31.
|
Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)
n=171 participants at risk
Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.
|
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
n=116 participants at risk
Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
|
|---|---|---|---|
|
General disorders
Injection Site Bruising
|
4.1%
7/171 • Number of events 8 • Unsolicited AE data were collected from Day 01 up to Day 31 post-any vaccination. Solicited reaction data were collected from Day 01 up to Day 7 post-any vaccination. The SAEs were collected up to the last study day i.e., Day 61 for Groups 1 and 2 and Day 31 for Group 3
SR was an expected AR that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set. In AE section, solicited reaction Fever is reported under Pyrexia. Reported AEs for each arm were presented as pre-specified in study protocol.
|
5.3%
9/171 • Number of events 10 • Unsolicited AE data were collected from Day 01 up to Day 31 post-any vaccination. Solicited reaction data were collected from Day 01 up to Day 7 post-any vaccination. The SAEs were collected up to the last study day i.e., Day 61 for Groups 1 and 2 and Day 31 for Group 3
SR was an expected AR that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set. In AE section, solicited reaction Fever is reported under Pyrexia. Reported AEs for each arm were presented as pre-specified in study protocol.
|
2.6%
3/116 • Number of events 3 • Unsolicited AE data were collected from Day 01 up to Day 31 post-any vaccination. Solicited reaction data were collected from Day 01 up to Day 7 post-any vaccination. The SAEs were collected up to the last study day i.e., Day 61 for Groups 1 and 2 and Day 31 for Group 3
SR was an expected AR that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set. In AE section, solicited reaction Fever is reported under Pyrexia. Reported AEs for each arm were presented as pre-specified in study protocol.
|
|
General disorders
Injection Site Erythema
|
15.8%
27/171 • Number of events 35 • Unsolicited AE data were collected from Day 01 up to Day 31 post-any vaccination. Solicited reaction data were collected from Day 01 up to Day 7 post-any vaccination. The SAEs were collected up to the last study day i.e., Day 61 for Groups 1 and 2 and Day 31 for Group 3
SR was an expected AR that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set. In AE section, solicited reaction Fever is reported under Pyrexia. Reported AEs for each arm were presented as pre-specified in study protocol.
|
5.3%
9/171 • Number of events 11 • Unsolicited AE data were collected from Day 01 up to Day 31 post-any vaccination. Solicited reaction data were collected from Day 01 up to Day 7 post-any vaccination. The SAEs were collected up to the last study day i.e., Day 61 for Groups 1 and 2 and Day 31 for Group 3
SR was an expected AR that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set. In AE section, solicited reaction Fever is reported under Pyrexia. Reported AEs for each arm were presented as pre-specified in study protocol.
|
15.5%
18/116 • Number of events 30 • Unsolicited AE data were collected from Day 01 up to Day 31 post-any vaccination. Solicited reaction data were collected from Day 01 up to Day 7 post-any vaccination. The SAEs were collected up to the last study day i.e., Day 61 for Groups 1 and 2 and Day 31 for Group 3
SR was an expected AR that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set. In AE section, solicited reaction Fever is reported under Pyrexia. Reported AEs for each arm were presented as pre-specified in study protocol.
|
|
General disorders
Injection Site Pain
|
84.2%
144/171 • Number of events 320 • Unsolicited AE data were collected from Day 01 up to Day 31 post-any vaccination. Solicited reaction data were collected from Day 01 up to Day 7 post-any vaccination. The SAEs were collected up to the last study day i.e., Day 61 for Groups 1 and 2 and Day 31 for Group 3
SR was an expected AR that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set. In AE section, solicited reaction Fever is reported under Pyrexia. Reported AEs for each arm were presented as pre-specified in study protocol.
|
81.9%
140/171 • Number of events 329 • Unsolicited AE data were collected from Day 01 up to Day 31 post-any vaccination. Solicited reaction data were collected from Day 01 up to Day 7 post-any vaccination. The SAEs were collected up to the last study day i.e., Day 61 for Groups 1 and 2 and Day 31 for Group 3
SR was an expected AR that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set. In AE section, solicited reaction Fever is reported under Pyrexia. Reported AEs for each arm were presented as pre-specified in study protocol.
|
92.2%
107/116 • Number of events 261 • Unsolicited AE data were collected from Day 01 up to Day 31 post-any vaccination. Solicited reaction data were collected from Day 01 up to Day 7 post-any vaccination. The SAEs were collected up to the last study day i.e., Day 61 for Groups 1 and 2 and Day 31 for Group 3
SR was an expected AR that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set. In AE section, solicited reaction Fever is reported under Pyrexia. Reported AEs for each arm were presented as pre-specified in study protocol.
|
|
General disorders
Injection Site Swelling
|
14.6%
25/171 • Number of events 30 • Unsolicited AE data were collected from Day 01 up to Day 31 post-any vaccination. Solicited reaction data were collected from Day 01 up to Day 7 post-any vaccination. The SAEs were collected up to the last study day i.e., Day 61 for Groups 1 and 2 and Day 31 for Group 3
SR was an expected AR that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set. In AE section, solicited reaction Fever is reported under Pyrexia. Reported AEs for each arm were presented as pre-specified in study protocol.
|
7.6%
13/171 • Number of events 13 • Unsolicited AE data were collected from Day 01 up to Day 31 post-any vaccination. Solicited reaction data were collected from Day 01 up to Day 7 post-any vaccination. The SAEs were collected up to the last study day i.e., Day 61 for Groups 1 and 2 and Day 31 for Group 3
SR was an expected AR that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set. In AE section, solicited reaction Fever is reported under Pyrexia. Reported AEs for each arm were presented as pre-specified in study protocol.
|
12.9%
15/116 • Number of events 30 • Unsolicited AE data were collected from Day 01 up to Day 31 post-any vaccination. Solicited reaction data were collected from Day 01 up to Day 7 post-any vaccination. The SAEs were collected up to the last study day i.e., Day 61 for Groups 1 and 2 and Day 31 for Group 3
SR was an expected AR that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set. In AE section, solicited reaction Fever is reported under Pyrexia. Reported AEs for each arm were presented as pre-specified in study protocol.
|
|
General disorders
Malaise
|
38.0%
65/171 • Number of events 86 • Unsolicited AE data were collected from Day 01 up to Day 31 post-any vaccination. Solicited reaction data were collected from Day 01 up to Day 7 post-any vaccination. The SAEs were collected up to the last study day i.e., Day 61 for Groups 1 and 2 and Day 31 for Group 3
SR was an expected AR that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set. In AE section, solicited reaction Fever is reported under Pyrexia. Reported AEs for each arm were presented as pre-specified in study protocol.
|
28.1%
48/171 • Number of events 58 • Unsolicited AE data were collected from Day 01 up to Day 31 post-any vaccination. Solicited reaction data were collected from Day 01 up to Day 7 post-any vaccination. The SAEs were collected up to the last study day i.e., Day 61 for Groups 1 and 2 and Day 31 for Group 3
SR was an expected AR that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set. In AE section, solicited reaction Fever is reported under Pyrexia. Reported AEs for each arm were presented as pre-specified in study protocol.
|
36.2%
42/116 • Number of events 42 • Unsolicited AE data were collected from Day 01 up to Day 31 post-any vaccination. Solicited reaction data were collected from Day 01 up to Day 7 post-any vaccination. The SAEs were collected up to the last study day i.e., Day 61 for Groups 1 and 2 and Day 31 for Group 3
SR was an expected AR that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set. In AE section, solicited reaction Fever is reported under Pyrexia. Reported AEs for each arm were presented as pre-specified in study protocol.
|
|
General disorders
Pyrexia
|
8.2%
14/171 • Number of events 15 • Unsolicited AE data were collected from Day 01 up to Day 31 post-any vaccination. Solicited reaction data were collected from Day 01 up to Day 7 post-any vaccination. The SAEs were collected up to the last study day i.e., Day 61 for Groups 1 and 2 and Day 31 for Group 3
SR was an expected AR that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set. In AE section, solicited reaction Fever is reported under Pyrexia. Reported AEs for each arm were presented as pre-specified in study protocol.
|
6.4%
11/171 • Number of events 11 • Unsolicited AE data were collected from Day 01 up to Day 31 post-any vaccination. Solicited reaction data were collected from Day 01 up to Day 7 post-any vaccination. The SAEs were collected up to the last study day i.e., Day 61 for Groups 1 and 2 and Day 31 for Group 3
SR was an expected AR that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set. In AE section, solicited reaction Fever is reported under Pyrexia. Reported AEs for each arm were presented as pre-specified in study protocol.
|
5.2%
6/116 • Number of events 6 • Unsolicited AE data were collected from Day 01 up to Day 31 post-any vaccination. Solicited reaction data were collected from Day 01 up to Day 7 post-any vaccination. The SAEs were collected up to the last study day i.e., Day 61 for Groups 1 and 2 and Day 31 for Group 3
SR was an expected AR that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set. In AE section, solicited reaction Fever is reported under Pyrexia. Reported AEs for each arm were presented as pre-specified in study protocol.
|
|
Infections and infestations
Covid-19
|
5.3%
9/171 • Number of events 9 • Unsolicited AE data were collected from Day 01 up to Day 31 post-any vaccination. Solicited reaction data were collected from Day 01 up to Day 7 post-any vaccination. The SAEs were collected up to the last study day i.e., Day 61 for Groups 1 and 2 and Day 31 for Group 3
SR was an expected AR that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set. In AE section, solicited reaction Fever is reported under Pyrexia. Reported AEs for each arm were presented as pre-specified in study protocol.
|
0.58%
1/171 • Number of events 1 • Unsolicited AE data were collected from Day 01 up to Day 31 post-any vaccination. Solicited reaction data were collected from Day 01 up to Day 7 post-any vaccination. The SAEs were collected up to the last study day i.e., Day 61 for Groups 1 and 2 and Day 31 for Group 3
SR was an expected AR that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set. In AE section, solicited reaction Fever is reported under Pyrexia. Reported AEs for each arm were presented as pre-specified in study protocol.
|
1.7%
2/116 • Number of events 2 • Unsolicited AE data were collected from Day 01 up to Day 31 post-any vaccination. Solicited reaction data were collected from Day 01 up to Day 7 post-any vaccination. The SAEs were collected up to the last study day i.e., Day 61 for Groups 1 and 2 and Day 31 for Group 3
SR was an expected AR that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set. In AE section, solicited reaction Fever is reported under Pyrexia. Reported AEs for each arm were presented as pre-specified in study protocol.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
49.1%
84/171 • Number of events 118 • Unsolicited AE data were collected from Day 01 up to Day 31 post-any vaccination. Solicited reaction data were collected from Day 01 up to Day 7 post-any vaccination. The SAEs were collected up to the last study day i.e., Day 61 for Groups 1 and 2 and Day 31 for Group 3
SR was an expected AR that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set. In AE section, solicited reaction Fever is reported under Pyrexia. Reported AEs for each arm were presented as pre-specified in study protocol.
|
47.4%
81/171 • Number of events 114 • Unsolicited AE data were collected from Day 01 up to Day 31 post-any vaccination. Solicited reaction data were collected from Day 01 up to Day 7 post-any vaccination. The SAEs were collected up to the last study day i.e., Day 61 for Groups 1 and 2 and Day 31 for Group 3
SR was an expected AR that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set. In AE section, solicited reaction Fever is reported under Pyrexia. Reported AEs for each arm were presented as pre-specified in study protocol.
|
57.8%
67/116 • Number of events 67 • Unsolicited AE data were collected from Day 01 up to Day 31 post-any vaccination. Solicited reaction data were collected from Day 01 up to Day 7 post-any vaccination. The SAEs were collected up to the last study day i.e., Day 61 for Groups 1 and 2 and Day 31 for Group 3
SR was an expected AR that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set. In AE section, solicited reaction Fever is reported under Pyrexia. Reported AEs for each arm were presented as pre-specified in study protocol.
|
|
Nervous system disorders
Headache
|
44.4%
76/171 • Number of events 98 • Unsolicited AE data were collected from Day 01 up to Day 31 post-any vaccination. Solicited reaction data were collected from Day 01 up to Day 7 post-any vaccination. The SAEs were collected up to the last study day i.e., Day 61 for Groups 1 and 2 and Day 31 for Group 3
SR was an expected AR that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set. In AE section, solicited reaction Fever is reported under Pyrexia. Reported AEs for each arm were presented as pre-specified in study protocol.
|
38.6%
66/171 • Number of events 87 • Unsolicited AE data were collected from Day 01 up to Day 31 post-any vaccination. Solicited reaction data were collected from Day 01 up to Day 7 post-any vaccination. The SAEs were collected up to the last study day i.e., Day 61 for Groups 1 and 2 and Day 31 for Group 3
SR was an expected AR that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set. In AE section, solicited reaction Fever is reported under Pyrexia. Reported AEs for each arm were presented as pre-specified in study protocol.
|
44.8%
52/116 • Number of events 52 • Unsolicited AE data were collected from Day 01 up to Day 31 post-any vaccination. Solicited reaction data were collected from Day 01 up to Day 7 post-any vaccination. The SAEs were collected up to the last study day i.e., Day 61 for Groups 1 and 2 and Day 31 for Group 3
SR was an expected AR that was prelisted (i.e., solicited) in the CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set. In AE section, solicited reaction Fever is reported under Pyrexia. Reported AEs for each arm were presented as pre-specified in study protocol.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable participant matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
- Publication restrictions are in place
Restriction type: OTHER