Trial Outcomes & Findings for A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adolescents (NCT NCT00518180)
NCT ID: NCT00518180
Last Updated: 2016-05-18
Results Overview
Immune responses to MenACWY, as measured by the percentage of hSBA seroresponders, when given: (a) alone; (b) concomitantly with a Tetanus diphtheria acellular pertussis (Tdap) vaccine and a Human Papillomavirus Recombinant (HPV) vaccine; and (c) when given one month after a Tdap vaccine. Seroresponse to MenACWY: For a subject with baseline hSBA titer \<1:4, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with baseline hSBA titer ≥ 1:4, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1620 participants
Primary outcome timeframe
1 month post MenACWY vaccination
Results posted on
2016-05-18
Participant Flow
Participants were enrolled at a single center in Costa Rica.
All enrolled subjects were randomized at a 1:1:1 ratio to receive the MenACWY vaccine when given alone and concomitantly with the Tdap vaccine and the HPV vaccine at different schedules.
Participant milestones
| Measure |
MenACWY+Tdap+HPV
The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
|
MenACWY→Tdap→HPV
The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
|
Tdap →MenACWY → HPV
Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
|
|---|---|---|---|
|
Overall Study
STARTED
|
540
|
541
|
539
|
|
Overall Study
COMPLETED
|
475
|
472
|
457
|
|
Overall Study
NOT COMPLETED
|
65
|
69
|
82
|
Reasons for withdrawal
| Measure |
MenACWY+Tdap+HPV
The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
|
MenACWY→Tdap→HPV
The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
|
Tdap →MenACWY → HPV
Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
29
|
30
|
42
|
|
Overall Study
Lost to Follow-up
|
30
|
28
|
34
|
|
Overall Study
Administrative reason
|
0
|
2
|
2
|
|
Overall Study
Protocol Violation
|
5
|
7
|
4
|
|
Overall Study
Unable to classify
|
0
|
2
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adolescents
Baseline characteristics by cohort
| Measure |
MenACWY+Tdap+HPV
n=540 Participants
The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
|
MenACWY→Tdap→HPV
n=541 Participants
The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
|
Tdap →MenACWY → HPV
n=539 Participants
Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
|
Total
n=1620 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
13.9 years
STANDARD_DEVIATION 2.1 • n=99 Participants
|
13.9 years
STANDARD_DEVIATION 2.2 • n=107 Participants
|
13.8 years
STANDARD_DEVIATION 2.2 • n=206 Participants
|
13.9 years
STANDARD_DEVIATION 2.1 • n=7 Participants
|
|
Sex: Female, Male
Female
|
308 Participants
n=99 Participants
|
309 Participants
n=107 Participants
|
307 Participants
n=206 Participants
|
924 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
232 Participants
n=99 Participants
|
232 Participants
n=107 Participants
|
232 Participants
n=206 Participants
|
696 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
539 participants
n=99 Participants
|
541 participants
n=107 Participants
|
539 participants
n=206 Participants
|
1619 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 1 month post MenACWY vaccinationPopulation: The analysis was performed on the per-protocol (PP) population. A total of 182 subjects were excluded from the PP population due to protocol deviations. The most common protocol deviations were blood draw performed outside the protocol-specified window.
Immune responses to MenACWY, as measured by the percentage of hSBA seroresponders, when given: (a) alone; (b) concomitantly with a Tetanus diphtheria acellular pertussis (Tdap) vaccine and a Human Papillomavirus Recombinant (HPV) vaccine; and (c) when given one month after a Tdap vaccine. Seroresponse to MenACWY: For a subject with baseline hSBA titer \<1:4, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with baseline hSBA titer ≥ 1:4, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Outcome measures
| Measure |
MenACWY+Tdap+HPV
n=494 Participants
The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
|
MenACWY→Tdap→HPV
n=487 Participants
The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
|
Tdap →MenACWY → HPV
n=458 Participants
Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
|
|---|---|---|---|
|
Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse
Serogroup A (N=494, 486, 458)
|
80 Percentage of participants
Interval 76.0 to 84.0
|
82 Percentage of participants
Interval 78.0 to 85.0
|
87 Percentage of participants
Interval 83.0 to 90.0
|
|
Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse
Serogroup C (N=476, 472, 457)
|
83 Percentage of participants
Interval 79.0 to 86.0
|
84 Percentage of participants
Interval 81.0 to 88.0
|
84 Percentage of participants
Interval 80.0 to 87.0
|
|
Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse
Serogroup W (N=487, 474, 458)
|
77 Percentage of participants
Interval 73.0 to 80.0
|
81 Percentage of participants
Interval 77.0 to 84.0
|
65 Percentage of participants
Interval 61.0 to 70.0
|
|
Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse
Serogroup Y (N=493, 487, 460)
|
83 Percentage of participants
Interval 79.0 to 86.0
|
82 Percentage of participants
Interval 79.0 to 86.0
|
78 Percentage of participants
Interval 74.0 to 82.0
|
PRIMARY outcome
Timeframe: 1 month post Tdap vaccinationPopulation: The analysis was performed on the per-protocol (PP) population. A total of 183 subjects were excluded from the PP population due to protocol deviations. The most common protocol deviations were blood draw performed outside the protocol-specified window.
To compare the immune response to Tdap given concomitantly with MenACWY and HPV vaccine with the immune response to Tdap when administered alone
Outcome measures
| Measure |
MenACWY+Tdap+HPV
n=492 Participants
The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
|
MenACWY→Tdap→HPV
n=458 Participants
The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
|
Tdap →MenACWY → HPV
n=487 Participants
Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
|
|---|---|---|---|
|
Percentage of Subjects With Antidiphtheria and Antitetanus Toxin ≥1.0 IU/mL
Diphtheria
|
100 Percentage of subjects
Interval 99.0 to 100.0
|
100 Percentage of subjects
Interval 99.0 to 100.0
|
98 Percentage of subjects
Interval 96.0 to 99.0
|
|
Percentage of Subjects With Antidiphtheria and Antitetanus Toxin ≥1.0 IU/mL
Tetanus
|
100 Percentage of subjects
Interval 99.0 to 100.0
|
100 Percentage of subjects
Interval 99.0 to 100.0
|
100 Percentage of subjects
Interval 99.0 to 100.0
|
PRIMARY outcome
Timeframe: 1 month post Tdap vaccinationPopulation: The analysis was performed on the per-protocol (PP) population.
To compare the immune response of Tdap given concomitantly with MenACWY and HPV vaccine with the immune response of Tdap when administered alone
Outcome measures
| Measure |
MenACWY+Tdap+HPV
n=492 Participants
The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
|
MenACWY→Tdap→HPV
n=458 Participants
The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
|
Tdap →MenACWY → HPV
n=487 Participants
Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
|
|---|---|---|---|
|
Geometric Mean Concentrations (GMC) of Antipertussis Toxin (Anti-PT), Antifilamentous Hemagglutinin (Anti-FHA), and Antipertactin (Anti-PRN)
Anti-PT (N=479, 451, 477)
|
51 IU/mL
Interval 47.0 to 55.0
|
79 IU/mL
Interval 72.0 to 87.0
|
63 IU/mL
Interval 58.0 to 69.0
|
|
Geometric Mean Concentrations (GMC) of Antipertussis Toxin (Anti-PT), Antifilamentous Hemagglutinin (Anti-FHA), and Antipertactin (Anti-PRN)
Anti-FHA (N=489, 457, 485)
|
342 IU/mL
Interval 310.0 to 376.0
|
1106 IU/mL
Interval 989.0 to 1238.0
|
511 IU/mL
Interval 464.0 to 563.0
|
|
Geometric Mean Concentrations (GMC) of Antipertussis Toxin (Anti-PT), Antifilamentous Hemagglutinin (Anti-FHA), and Antipertactin (Anti-PRN)
Anti-PRN (N=492, 458, 487)
|
819 IU/mL
Interval 727.0 to 923.0
|
1563 IU/mL
Interval 1390.0 to 1758.0
|
1197 IU/mL
Interval 1061.0 to 1350.0
|
SECONDARY outcome
Timeframe: 1 month post MenACWY vaccinationPopulation: The analysis was performed on the per-protocol (PP) population.
The immune responses to the MenACWY conjugate vaccine, as measured by the hSBA Geometric Mean Titers (GMTs) when given: (a) alone, (b) concomitantly with the Tdap vaccine and the HPV vaccine, and (c) when given one month after the Tdap vaccine.
Outcome measures
| Measure |
MenACWY+Tdap+HPV
n=494 Participants
The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
|
MenACWY→Tdap→HPV
n=487 Participants
The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
|
Tdap →MenACWY → HPV
n=460 Participants
Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
|
|---|---|---|---|
|
Effect of Concomitant and Sequential Vaccination on hSBA Geometric Mean Titers (GMTs) for A, C, W, and Y Serogroups
Serogroup A (N=494, 486, 458)
|
62 Titers
Interval 52.0 to 74.0
|
67 Titers
Interval 56.0 to 80.0
|
95 Titers
Interval 79.0 to 113.0
|
|
Effect of Concomitant and Sequential Vaccination on hSBA Geometric Mean Titers (GMTs) for A, C, W, and Y Serogroups
Serogroup C (N=476, 472, 457)
|
66 Titers
Interval 56.0 to 77.0
|
70 Titers
Interval 60.0 to 83.0
|
68 Titers
Interval 58.0 to 79.0
|
|
Effect of Concomitant and Sequential Vaccination on hSBA Geometric Mean Titers (GMTs) for A, C, W, and Y Serogroups
Serogroup W (N=487, 474, 458)
|
146 Titers
Interval 129.0 to 165.0
|
159 Titers
Interval 140.0 to 181.0
|
104 Titers
Interval 91.0 to 119.0
|
|
Effect of Concomitant and Sequential Vaccination on hSBA Geometric Mean Titers (GMTs) for A, C, W, and Y Serogroups
Serogroup Y (N=493, 487, 460)
|
72 Titers
Interval 62.0 to 84.0
|
81 Titers
Interval 70.0 to 95.0
|
57 Titers
Interval 49.0 to 67.0
|
SECONDARY outcome
Timeframe: 1 month post third HPV vaccinationPopulation: The analysis was performed on the per-protocol (PP) population.
To compare the immune response of HPV vaccine given concomitantly with MenACWY and Tdap to the response when HPV vaccine is given alone. (Immune response against HPV virus-like particles (VLPs) for types 6, 11, 16, and 18 was measured at one month after the third HPV vaccination.) Anti-HPV Seroconversion (SC): SC was defined as negative (baseline HPV titer \< type-specific cut-off) for anti-HPV and anti-HPV ≥ an HPV type-specific cut-off at one month after the third HPV injection.
Outcome measures
| Measure |
MenACWY+Tdap+HPV
n=364 Participants
The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
|
MenACWY→Tdap→HPV
n=744 Participants
The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
|
Tdap →MenACWY → HPV
Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
|
|---|---|---|---|
|
Percentage of Subjects With Anti-HPV Seroconversion
HPV 6 (N=361, 737)
|
99 Percentage of subjects
Interval 98.0 to 100.0
|
100 Percentage of subjects
Interval 99.0 to 100.0
|
—
|
|
Percentage of Subjects With Anti-HPV Seroconversion
HPV 11 (N=362, 744)
|
100 Percentage of subjects
Interval 99.0 to 100.0
|
100 Percentage of subjects
Interval 99.0 to 100.0
|
—
|
|
Percentage of Subjects With Anti-HPV Seroconversion
HPV 16 (N=360, 744)
|
100 Percentage of subjects
Interval 99.0 to 100.0
|
100 Percentage of subjects
Interval 99.0 to 100.0
|
—
|
|
Percentage of Subjects With Anti-HPV Seroconversion
HPV 18 (N=364, 743)
|
100 Percentage of subjects
Interval 98.0 to 100.0
|
99 Percentage of subjects
Interval 99.0 to 100.0
|
—
|
SECONDARY outcome
Timeframe: 1 month post third HPV vaccinationPopulation: The analysis was performed on the per-protocol (PP) population.
To compare the immune response of HPV vaccine given concomitantly with MenACWY and Tdap to the response when HPV vaccine is given alone. (Immune response against HPV virus-like particles (VLPs) for types 6, 11, 16, and 18 was measured at one month after the third HPV vaccine vaccination.)
Outcome measures
| Measure |
MenACWY+Tdap+HPV
n=364 Participants
The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
|
MenACWY→Tdap→HPV
n=745 Participants
The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
|
Tdap →MenACWY → HPV
Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
|
|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Anti-HPV by Competitive Luminex Immunoassay
HPV 6 (N=361, 737)
|
1059 Titers
Interval 926.0 to 1212.0
|
1461 Titers
Interval 1327.0 to 1608.0
|
—
|
|
Geometric Mean Titers (GMTs) of Anti-HPV by Competitive Luminex Immunoassay
HPV 11 (N=362, 744)
|
1264 Titers
Interval 1134.0 to 1408.0
|
1701 Titers
Interval 1575.0 to 1837.0
|
—
|
|
Geometric Mean Titers (GMTs) of Anti-HPV by Competitive Luminex Immunoassay
HPV 16 (N=360, 744)
|
5286 Titers
Interval 4705.0 to 5939.0
|
6590 Titers
Interval 6068.0 to 7158.0
|
—
|
|
Geometric Mean Titers (GMTs) of Anti-HPV by Competitive Luminex Immunoassay
HPV 18 (N=364, 743)
|
908 Titers
Interval 798.0 to 1032.0
|
1117 Titers
Interval 1019.0 to 1224.0
|
—
|
SECONDARY outcome
Timeframe: 1 month post MenACWY vaccinationPopulation: The analysis was performed on the per-protocol (PP) population.
The immune responses to MenACWY, as measured by the percentage of subjects with hSBA titer ≥ 1:8, hSBA titer ≥ 1:4, when given: (a) alone, (b) concomitantly with Tdap and HPV vaccine; and (c) when given one month after Tdap.
Outcome measures
| Measure |
MenACWY+Tdap+HPV
n=475 Participants
The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
|
MenACWY→Tdap→HPV
n=472 Participants
The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
|
Tdap →MenACWY → HPV
n=457 Participants
Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
|
|---|---|---|---|
|
Percentage of Subjects With hSBA ≥ 1:8, hSBA Titer ≥ 1:4, for A, C, W, and Y Serogroups
Serogroup Y hSBA ≥ 1:8 (N=493, 487, 460)
|
93 Percentage of subjects
Interval 90.0 to 95.0
|
93 Percentage of subjects
Interval 90.0 to 95.0
|
92 Percentage of subjects
Interval 90.0 to 95.0
|
|
Percentage of Subjects With hSBA ≥ 1:8, hSBA Titer ≥ 1:4, for A, C, W, and Y Serogroups
Serogroup A hSBA ≥ 1:4 (N=408, 404, 412)
|
83 Percentage of subjects
Interval 79.0 to 86.0
|
83 Percentage of subjects
Interval 79.0 to 86.0
|
90 Percentage of subjects
Interval 87.0 to 93.0
|
|
Percentage of Subjects With hSBA ≥ 1:8, hSBA Titer ≥ 1:4, for A, C, W, and Y Serogroups
Serogroup C hSBA ≥ 1:4 (N=456, 447, 430)
|
92 Percentage of subjects
Interval 90.0 to 94.0
|
92 Percentage of subjects
Interval 89.0 to 94.0
|
94 Percentage of subjects
Interval 92.0 to 96.0
|
|
Percentage of Subjects With hSBA ≥ 1:8, hSBA Titer ≥ 1:4, for A, C, W, and Y Serogroups
Serogroup W hSBA ≥ 1:4 (N=478, 471, 443)
|
98 Percentage of subjects
Interval 97.0 to 99.0
|
99 Percentage of subjects
Interval 98.0 to 100.0
|
97 Percentage of subjects
Interval 95.0 to 98.0
|
|
Percentage of Subjects With hSBA ≥ 1:8, hSBA Titer ≥ 1:4, for A, C, W, and Y Serogroups
Serogroup Y hSBA ≥ 1:4 (N=465, 456, 438)
|
94 Percentage of subjects
Interval 92.0 to 96.0
|
94 Percentage of subjects
Interval 91.0 to 96.0
|
95 Percentage of subjects
Interval 93.0 to 97.0
|
|
Percentage of Subjects With hSBA ≥ 1:8, hSBA Titer ≥ 1:4, for A, C, W, and Y Serogroups
Serogroup A hSBA ≥ 1:8 (N=494, 486, 458)
|
81 Percentage of subjects
Interval 78.0 to 85.0
|
82 Percentage of subjects
Interval 79.0 to 86.0
|
89 Percentage of subjects
Interval 85.0 to 91.0
|
|
Percentage of Subjects With hSBA ≥ 1:8, hSBA Titer ≥ 1:4, for A, C, W, and Y Serogroups
Serogroup C hSBA ≥ 1:8 (N=476, 472, 457)
|
92 Percentage of subjects
Interval 89.0 to 94.0
|
90 Percentage of subjects
Interval 87.0 to 93.0
|
93 Percentage of subjects
Interval 90.0 to 95.0
|
|
Percentage of Subjects With hSBA ≥ 1:8, hSBA Titer ≥ 1:4, for A, C, W, and Y Serogroups
Serogroup W hSBA ≥ 1:8 (N=487, 474, 458)
|
98 Percentage of subjects
Interval 96.0 to 99.0
|
99 Percentage of subjects
Interval 98.0 to 100.0
|
95 Percentage of subjects
Interval 93.0 to 97.0
|
SECONDARY outcome
Timeframe: 1 month post Tdap vaccinationPopulation: The analysis was performed on the per-protocol (PP) population.
The immune response to the Tdap vaccine, as measured by the percentage of subjects with antidiphtheria and antitetanus toxin ≥1.0 IU/mL.
Outcome measures
| Measure |
MenACWY+Tdap+HPV
n=492 Participants
The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
|
MenACWY→Tdap→HPV
n=458 Participants
The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
|
Tdap →MenACWY → HPV
n=487 Participants
Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
|
|---|---|---|---|
|
The Effect of Sequential Vaccination on Immunogenicity for Diphtheria and Tetanus
Diphtheria (% ≥1.0 IU/mL)
|
100 Percentages of subjects
Interval 99.0 to 100.0
|
100 Percentages of subjects
Interval 99.0 to 100.0
|
98 Percentages of subjects
Interval 96.0 to 99.0
|
|
The Effect of Sequential Vaccination on Immunogenicity for Diphtheria and Tetanus
Tetanus (% ≥1.0 IU/mL)
|
100 Percentages of subjects
Interval 99.0 to 100.0
|
100 Percentages of subjects
Interval 99.0 to 100.0
|
100 Percentages of subjects
Interval 99.0 to 100.0
|
SECONDARY outcome
Timeframe: 1 month post Tdap vaccinationPopulation: The analysis was performed on the per-protocol (PP) population.
To compare the immune response of Tdap, as measured by the antidiphtheria and antitetanus GMCs, when administered one month after the MenACWY vaccine with the immune response of the Tdap vaccine when administered alone.
Outcome measures
| Measure |
MenACWY+Tdap+HPV
n=492 Participants
The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
|
MenACWY→Tdap→HPV
n=458 Participants
The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
|
Tdap →MenACWY → HPV
n=487 Participants
Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
|
|---|---|---|---|
|
Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus
Tetanus
|
8.75 IU/mL
Interval 8.23 to 9.3
|
12 IU/mL
Interval 11.0 to 13.0
|
10 IU/mL
Interval 9.46 to 11.0
|
|
Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus
Diphtheria
|
37 IU/mL
Interval 34.0 to 41.0
|
10 IU/mL
Interval 9.12 to 12.0
|
10 IU/mL
Interval 9.38 to 11.0
|
SECONDARY outcome
Timeframe: 1 month post Tdap vaccinationPopulation: The analysis was performed on the per-protocol (PP) population.
To compare the immune response to Tdap administered one month after MenACWY with the immune response to Tdap administered alone.
Outcome measures
| Measure |
MenACWY+Tdap+HPV
n=492 Participants
The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
|
MenACWY→Tdap→HPV
n=458 Participants
The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
|
Tdap →MenACWY → HPV
n=487 Participants
Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
|
|---|---|---|---|
|
Geometric Mean Titers (GMT) of Pertussis Antigens
Anti-PT (N=479, 451, 477)
|
51 Titers
Interval 47.0 to 55.0
|
79 Titers
Interval 72.0 to 87.0
|
63 Titers
Interval 58.0 to 69.0
|
|
Geometric Mean Titers (GMT) of Pertussis Antigens
Anti-FHA (N=489, 457, 485)
|
342 Titers
Interval 310.0 to 376.0
|
1106 Titers
Interval 989.0 to 1238.0
|
511 Titers
Interval 464.0 to 563.0
|
|
Geometric Mean Titers (GMT) of Pertussis Antigens
Anti-PRN (N=492, 458, 487)
|
819 Titers
Interval 727.0 to 923.0
|
1563 Titers
Interval 1390.0 to 1758.0
|
1197 Titers
Interval 1061.0 to 1350.0
|
SECONDARY outcome
Timeframe: 1 month post Tdap vaccinationPopulation: The analysis was performed on the per-protocol (PP) population.
To compare the immune response of Tdap, defined by the percentage of subjects with a 4-fold rise in antibody titer over baseline against PT, FHA, PRN, when administered one month after the MenACWY with the immune response of Tdap when administered alone.
Outcome measures
| Measure |
MenACWY+Tdap+HPV
n=492 Participants
The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
|
MenACWY→Tdap→HPV
n=458 Participants
The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
|
Tdap →MenACWY → HPV
n=487 Participants
Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
|
|---|---|---|---|
|
Percentages of Subjects With at Least a 4-fold Rise for PT, FHA, and PRN
Anti-PT (N=479, 451, 477)
|
83 Percentages of subjects
Interval 79.0 to 86.0
|
89 Percentages of subjects
Interval 86.0 to 92.0
|
86 Percentages of subjects
Interval 83.0 to 89.0
|
|
Percentages of Subjects With at Least a 4-fold Rise for PT, FHA, and PRN
Anti-FHA (N=489, 457, 485)
|
67 Percentages of subjects
Interval 63.0 to 71.0
|
90 Percentages of subjects
Interval 87.0 to 93.0
|
78 Percentages of subjects
Interval 74.0 to 82.0
|
|
Percentages of Subjects With at Least a 4-fold Rise for PT, FHA, and PRN
Anti-PRN (N=492, 458, 487)
|
86 Percentages of subjects
Interval 83.0 to 89.0
|
95 Percentages of subjects
Interval 92.0 to 97.0
|
89 Percentages of subjects
Interval 85.0 to 91.0
|
SECONDARY outcome
Timeframe: Days 1 to 7Population: The analysis was performed on the safety set.
Number of subjects with specified local and systemic reactions were assessed when MenACWY was given alone, one month after Tdap, and concomitantly with Tdap and HPV vaccine.
Outcome measures
| Measure |
MenACWY+Tdap+HPV
n=540 Participants
The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
|
MenACWY→Tdap→HPV
n=541 Participants
The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
|
Tdap →MenACWY → HPV
n=539 Participants
Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
|
|---|---|---|---|
|
Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.
Analgesic/Antipyretic Med. Used post-vaccination 1
|
110 Subjects
|
83 Subjects
|
96 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.
Injection site pain MenACWY
|
263 Subjects
|
246 Subjects
|
239 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.
Injection site pain Tdap
|
367 Subjects
|
310 Subjects
|
383 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.
Injection site erythema MenACWY
|
68 Subjects
|
66 Subjects
|
64 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.
Injection site erythema Tdap
|
78 Subjects
|
38 Subjects
|
70 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.
Injection site induration MenACWY
|
68 Subjects
|
70 Subjects
|
63 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.
Injection site induration Tdap
|
90 Subjects
|
64 Subjects
|
110 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.
Chills post-vaccination 1
|
77 Subjects
|
66 Subjects
|
70 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.
Chills post-vaccination 2
|
0 Subjects
|
42 Subjects
|
45 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.
Nausea post-vaccination 1
|
88 Subjects
|
72 Subjects
|
82 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.
Nausea post-vaccination 2
|
0 Subjects
|
42 Subjects
|
64 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.
Malaise post-vaccination 1
|
133 Subjects
|
110 Subjects
|
115 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.
Malaise post-vaccination 2
|
0 Subjects
|
91 Subjects
|
88 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.
Myalgia post-vaccination 1
|
146 Subjects
|
104 Subjects
|
142 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.
Myalgia post-vaccination 2
|
0 Subjects
|
81 Subjects
|
82 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.
Arthralgia post-vaccination 1
|
94 Subjects
|
62 Subjects
|
76 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.
Arthralgia post-vaccination 2
|
0 Subjects
|
52 Subjects
|
52 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.
Headache post-vaccination 1
|
217 Subjects
|
194 Subjects
|
200 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.
Headache post-vaccination 2
|
0 Subjects
|
125 Subjects
|
138 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.
Rash post-vaccination 1
|
21 Subjects
|
17 Subjects
|
20 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.
Rash post-vaccination 2
|
0 Subjects
|
15 Subjects
|
13 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.
Fever ≥ 38°Celsius post-vaccination 1
|
27 Subjects
|
19 Subjects
|
17 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.
Fever ≥ 38°Celsius post-vaccination 2
|
0 Subjects
|
25 Subjects
|
30 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.
Analgesic/Antipyretic Med. Used post-vaccination 2
|
0 Subjects
|
58 Subjects
|
49 Subjects
|
SECONDARY outcome
Timeframe: Days 1 to 7Population: The analysis was performed on the safety population.
Number of subjects with specified local and systemic reactions were solicited for 7 days after the HPV vaccination.
Outcome measures
| Measure |
MenACWY+Tdap+HPV
n=540 Participants
The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
|
MenACWY→Tdap→HPV
n=494 Participants
The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
|
Tdap →MenACWY → HPV
n=486 Participants
Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
|
|---|---|---|---|
|
Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
Injection site pain postvaccination 1
|
265 Subjects
|
180 Subjects
|
204 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
Injection site erythema postvaccination 1
|
74 Subjects
|
36 Subjects
|
42 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
Injection site induration postvaccination 1
|
54 Subjects
|
27 Subjects
|
26 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
Injection site pain (N=498, 483, 468) postvac 2
|
208 Subjects
|
208 Subjects
|
189 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
Injection site erythema postvaccination 2
|
62 Subjects
|
48 Subjects
|
57 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
Injection site induration postvaccination 2
|
46 Subjects
|
37 Subjects
|
50 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
Injection site pain postvaccination 3
|
229 Subjects
|
227 Subjects
|
208 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
Injection site erythema postvaccination 3
|
60 Subjects
|
56 Subjects
|
55 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
Injection site induration postvaccination 3
|
60 Subjects
|
47 Subjects
|
48 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
Chills postvaccination 1
|
77 Subjects
|
27 Subjects
|
30 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
Nausea postvaccination 1
|
88 Subjects
|
39 Subjects
|
32 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
Malaise postvaccination 1
|
133 Subjects
|
49 Subjects
|
55 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
Myalgia postvaccination 1
|
146 Subjects
|
32 Subjects
|
56 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
Arthralgia postvaccination 1
|
94 Subjects
|
33 Subjects
|
28 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
Headache postvaccination 1
|
217 Subjects
|
93 Subjects
|
97 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
Rash postvaccination 1
|
21 Subjects
|
7 Subjects
|
6 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
Fever (≥ 38°C) postvaccination 1
|
27 Subjects
|
21 Subjects
|
23 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
Stayed home postvaccination 1
|
110 Subjects
|
26 Subjects
|
34 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
Chills postvaccination 2
|
23 Subjects
|
22 Subjects
|
26 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
Nausea postvaccination 2
|
38 Subjects
|
30 Subjects
|
29 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
Malaise postvaccination 2
|
53 Subjects
|
45 Subjects
|
34 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
Myalgia postvaccination 2
|
42 Subjects
|
38 Subjects
|
51 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
Arthralgia postvaccination 2
|
30 Subjects
|
28 Subjects
|
21 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
Headache postvaccination 2
|
88 Subjects
|
78 Subjects
|
71 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
Rash postvaccination 2
|
4 Subjects
|
11 Subjects
|
9 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
Fever (≥ 38°C) postvaccination 2
|
17 Subjects
|
22 Subjects
|
22 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
Chills postvaccination 3
|
22 Subjects
|
24 Subjects
|
25 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
Nausea postvaccination 3
|
32 Subjects
|
35 Subjects
|
34 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
Malaise postvaccination 3
|
49 Subjects
|
50 Subjects
|
41 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
Myalgia postvaccination 3
|
53 Subjects
|
49 Subjects
|
37 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
Arthralgia postvaccination 3
|
37 Subjects
|
26 Subjects
|
30 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
Headache postvaccination 3
|
79 Subjects
|
85 Subjects
|
79 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
Rash postvaccination 3
|
9 Subjects
|
7 Subjects
|
10 Subjects
|
|
Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
Fever (≥ 38°C) postvaccination 3
|
20 Subjects
|
16 Subjects
|
25 Subjects
|
Adverse Events
MenACWY+Tdap+HPV
Serious events: 1 serious events
Other events: 495 other events
Deaths: 0 deaths
MenACWY→Tdap→HPV
Serious events: 7 serious events
Other events: 489 other events
Deaths: 0 deaths
Tdap → MenACWY → HPV
Serious events: 3 serious events
Other events: 482 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MenACWY+Tdap+HPV
n=540 participants at risk
The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two vaccinations of the HPV vaccine at month 2 and 6.
|
MenACWY→Tdap→HPV
n=541 participants at risk
The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdpa vaccine at month 1, followed by three injections of the HPV at months 2,4 and 8.
|
Tdap → MenACWY → HPV
n=539 participants at risk
Tdpa was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of HPV at months 2,4 and 8.
|
|---|---|---|---|
|
Endocrine disorders
CUSHING'S SYNDROME
|
0.19%
1/540 • Number of events 1 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
0.00%
0/541 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
0.00%
0/539 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
|
Gastrointestinal disorders
BEZOAR
|
0.00%
0/540 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
0.18%
1/541 • Number of events 1 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
0.00%
0/539 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/540 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
0.37%
2/541 • Number of events 2 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
0.00%
0/539 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.00%
0/540 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
0.00%
0/541 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
0.19%
1/539 • Number of events 1 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PITUITARY TUMOUR BENIGN
|
0.19%
1/540 • Number of events 1 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
0.00%
0/541 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
0.00%
0/539 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION SPONTANEOUS
|
0.00%
0/540 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
0.18%
1/541 • Number of events 1 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
0.19%
1/539 • Number of events 1 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
|
Renal and urinary disorders
HYDRONEPHROSIS
|
0.00%
0/540 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
0.00%
0/541 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
0.19%
1/539 • Number of events 1 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
|
Reproductive system and breast disorders
HAEMORRHAGIC OVARIAN CYST
|
0.00%
0/540 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
0.18%
1/541 • Number of events 1 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
0.00%
0/539 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
|
Reproductive system and breast disorders
TESTICULAR TORSION
|
0.00%
0/540 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
0.18%
1/541 • Number of events 1 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
0.00%
0/539 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
|
Vascular disorders
BEHCET'S SYNDROME
|
0.00%
0/540 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
0.18%
1/541 • Number of events 1 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
0.00%
0/539 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
Other adverse events
| Measure |
MenACWY+Tdap+HPV
n=540 participants at risk
The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two vaccinations of the HPV vaccine at month 2 and 6.
|
MenACWY→Tdap→HPV
n=541 participants at risk
The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdpa vaccine at month 1, followed by three injections of the HPV at months 2,4 and 8.
|
Tdap → MenACWY → HPV
n=539 participants at risk
Tdpa was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of HPV at months 2,4 and 8.
|
|---|---|---|---|
|
Gastrointestinal disorders
NAUSEA
|
23.0%
124/540 • Number of events 191 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
24.6%
133/541 • Number of events 255 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
26.3%
142/539 • Number of events 289 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
|
General disorders
CHILLS
|
18.5%
100/540 • Number of events 131 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
21.6%
117/541 • Number of events 201 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
24.1%
130/539 • Number of events 238 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
|
General disorders
INJECTION SITE ERYTHEMA HPV
|
24.8%
134/540 • Number of events 212 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
19.4%
105/541 • Number of events 147 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
18.7%
101/539 • Number of events 166 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
|
General disorders
INJECTION SITE INDURATION HPV
|
22.0%
119/540 • Number of events 179 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
15.0%
81/541 • Number of events 116 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
15.8%
85/539 • Number of events 134 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
|
General disorders
INJECTION SITE PAIN HPV
|
71.7%
387/540 • Number of events 778 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
59.1%
320/541 • Number of events 666 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
58.1%
313/539 • Number of events 648 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
|
General disorders
MALAISE
|
31.7%
171/540 • Number of events 284 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
38.6%
209/541 • Number of events 402 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
36.0%
194/539 • Number of events 428 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
|
General disorders
PYREXIA
|
11.5%
62/540 • Number of events 77 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
16.3%
88/541 • Number of events 129 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
15.6%
84/539 • Number of events 123 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
22.0%
119/540 • Number of events 188 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
24.4%
132/541 • Number of events 225 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
24.3%
131/539 • Number of events 248 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
33.0%
178/540 • Number of events 276 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
34.6%
187/541 • Number of events 339 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
37.1%
200/539 • Number of events 440 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
|
Nervous system disorders
HEADACHE
|
48.1%
260/540 • Number of events 519 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
52.5%
284/541 • Number of events 749 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
51.6%
278/539 • Number of events 802 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
|
Skin and subcutaneous tissue disorders
RASH
|
5.7%
31/540 • Number of events 36 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
8.7%
47/541 • Number of events 64 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
7.8%
42/539 • Number of events 66 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
|
General disorders
INJECTION SITE ERYTHEMA MENVEO
|
12.8%
69/540 • Number of events 80 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
12.2%
66/541 • Number of events 68 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
12.1%
65/539 • Number of events 71 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
|
General disorders
INJECTION SITE ERYTHEMA Tdap
|
14.4%
78/540 • Number of events 93 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
7.0%
38/541 • Number of events 40 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
13.4%
72/539 • Number of events 82 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
|
General disorders
INJECTION SITE INDURATION MENVEO
|
12.6%
68/540 • Number of events 76 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
12.9%
70/541 • Number of events 72 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
12.1%
65/539 • Number of events 68 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
|
General disorders
INJECTION SITE INDURATION Tdap
|
16.7%
90/540 • Number of events 101 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
11.8%
64/541 • Number of events 67 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
20.4%
110/539 • Number of events 125 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
|
General disorders
INJECTION SITE PAIN MENVEO
|
48.9%
264/540 • Number of events 307 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
45.5%
246/541 • Number of events 289 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
44.3%
239/539 • Number of events 266 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
|
General disorders
INJECTION SITE PAIN Tdap
|
68.1%
368/540 • Number of events 407 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
57.3%
310/541 • Number of events 343 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
71.1%
383/539 • Number of events 427 • During the 30-day period following each vaccination.
Data provided in Other Adverse Events (\>5%) were collected during the 7-day period after each vaccination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place